WHO/MVP/EMP/2019.05

Second WHO Model List of Essential In Vitro Diagnostics

© World Health Organization 2019. All rights reserved. The content of this document is not final, and the text may be subject to revisions before publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization. The final version will be published as an annex to the report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics in the WHO Technical Report Series. WHO/MVP/EMP/2019.05

Second WHO Model List of Essential In Vitro Diagnostics

© World Health Organization 2019. All rights reserved. The content of this document is not final, and the text may be subject to revisions before publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization. The final version will be published as an annex to the report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics in the WHO Technical Report Series.

1 Contents

Preface 3 1. Explanatory notes 4 1.1 Introduction 4 1.2 Objective 4 1.3 Scope of the second EDL 4 1.4 Content and presentation 5 1.5 Recommended use of the EDL 6 1.6 Definitions 7 2. Second Model List of Essential In Vitro Diagnostics (EDL) 9 I. List of Essential In Vitro Diagnostics (EDL): For community settings and health facilities without laboratories 9 II. Health care facilities with clinical laboratories 17

2 Preface The second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) was held from 18 to 22 March 2019 in Geneva. The objectives of the meeting were among others: to review the first WHO Model List of Essential In Vitro Diagnostics (EDL), to consider submission of new tests and general input from stakeholders, to review and make recommendations for the Second EDL and to discuss on eligibility criteria for prequalification of IVDs. WHO secretariat prepared a working draft of the second EDL for open consultation and for review by the SAGE IVD members. The proposed Second list was developed based on changes proposed to the first EDL, submissions for new product categories, a suggested list of general laboratory and anatomical pathology tests and a report on therapeutic drug monitoring tests. All the procedures were transparent and based on input from internal and external stakeholders, SAGE IVD members and members of the public interested in policy or implementation of the EDL. All the suggested changes, submissions, reviews and responses to the reviews were published on the WHO website for comment, and all public comments received were acknowledged. The agenda and members of the SAGE IVD as well as all background documents, were posted under: https://www. who.int/medical_devices/diagnostics/selection_in-vitro/selection_in-vitro-meetings/sage-ivd-2nd-meeting. The Second WHO Model List of Essential In Vitro Diagnostics (EDL) and its explanatory notes, are presented in this document which will become the annex to the report of the second SAGE IVD meeting. The notes describe the objectives, limitations and guidance for its use. The full report of the Second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) is being finalized, to be published in August -September 2019 as part of the WHO Technical Report Series. The final report will present a full description of the methodologies, reviews, evidence, references and recommendations of the SAGE IVD members and will be found at: https://www.who.int/medical_devices/ diagnostics/selection_in-vitro/en/.

3 1. Explanatory notes

1.1 Introduction WHO presents the second Model List of Essential In Vitro Diagnostics (EDL), which extends the first List, published in May 2018.1 The List recognizes that in vitro diagnostics (IVDs) are essential for advancing universal health coverage, addressing health emergencies and promoting healthier populations, which are the three strategic priorities of the Thirteenth WHO General Programme of Work, 2019–2023.2

1.2 Objective The EDL lists IVDs that are recommended by WHO for use in countries. The EDL is not intended to be prescriptive with respect to the IVDs listed or the levels at which they can or should be used; rather, countries should decide which IVDs to select and where to use them, depending on their epidemiology, human resources and infrastructure. The EDL is expected to provide guidance and serve as a reference for Member States (programme managers, laboratory managers, procurement officers and reimbursement officers) that are developing and/or updating national EDLs for interventions within universal health coverage and for selecting and using IVDs. It will also be informative for United Nations agencies and nongovernmental organizations that support selection, procurement, supply, donation or provision of IVDs and will inform the private medical technology sector about the diagnostic priorities and the IVDs necessary to address global health issues.

1.3 Scope of the second EDL The EDL consists of 122 test categories presented as follows: ■■ 46 general IVD tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions; ■■ 69 IVDs intended for the detection, diagnosis and monitoring of specific diseases. The first EDL listed tests for the following WHO priority disease areas: HIV infection, tuberculosis, malaria and hepatitis B and C as well as syphilis and human papillomavirus infection. The second EDL extends the diseases to include noncommunicable diseases, with an extensive new section covering cancer tests as well as a set of general tests, including a new anatomical pathology section; and ■■ 7 test categories intended for screening of blood donations. The EDL does not name specific test brands but rather consists of test categories described according to their biological targets. When specific products in categories of tests on the EDL have been prequalified by WHO or are recommended by a WHO disease programme, a link is provided to that information, which is updated regularly. The EDL comprises test types or categories and is not intended for use as a guideline for use of the types of test. The purpose of each test category is stated briefly, and links to WHO guidelines are provided when available. Many tests are used in the context of broader testing strategies, and the results might have to be confirmed or interpreted in accordance with defined clinical signs and symptoms. The EDL does not specify the desirable minimal performance characteristics for each test category, nor does it state the minimum quality standards to be considered in selecting specific brands of the test types listed. The quality of tests in each category that are on the market in different regions of the world may vary widely, and this should be taken into account when selecting tests for procurement. Some regulatory agencies define the minimum performance standards required for specific tests in order to avoid false results and the consequent treatment decisions.

1 First WHO model list of in essential vitro diagnostics. Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1017) (https://apps. who.int/iris/handle/10665/311567, accessed May 2019). 2 Draft thirteenth general programme of work, 2019–2023 (document A71/4). Geneva: World Health Organization; 2018 (http://apps.who.int/gb/ ebwha/pdf_files/WHA71/A71_4-en.pdf, accessed May 2019).

4 Test safety and performance guidelines and quality standards should be taken into account in selecting diagnostic tests for procurement, when available, and only tests validated for the intended purpose and with regulatory approval from national authorities should be procured.

1.4 Content and presentation The second EDL is presented by health care facility level in two tiers: I. Community and health settings without laboratories, with two sections: a. General IVDs for community and health settings without laboratories b. Disease-specific IVDs for community and health settings without laboratories II. Health care facilities with clinical laboratories, with three sections: a. General IVDs for clinical laboratories b. Disease-specific IVDs for clinical laboratories c. Disease-specific IVDs for blood screening laboratories Community and health settings without laboratories are defined as community and health facilities such as health posts and centres, doctors’ offices, outreach clinics, ambulatory care and home-based and self-testing. If laboratory facilities are not available, specimens may be collected, transported to and processed at a higher tier of the health system; specimens must be shipped under appropriate conditions in order to obtain reliable results. The tests in this section of the EDL are also assumed to be available, in combination with the extended list in Section II, at healthcare facilities with laboratories. The title of tier I was changed from that in the first EDL, where it was “Primary health care”. The change was made to differentiate between tests that do not require a laboratory (whether basic or not) and those that must be performed in a laboratory. This change resulted in the deletion of some tests from the original first tier, as their performance was deemed by SAGE IVD to require qualified personnel and a basic laboratory. Health care facilities with clinical laboratories are defined as district, regional, provincial or specialized hospitals or laboratories and national reference laboratories. It is assumed that trained laboratory technologists, laboratory scientists and pathologists, as well as laboratory infrastructure and equipment, are available as required at the appropriate level. All diagnostic tests available at primary care level are assumed to be available at higher levels, as appropriate. General IVDs are grouped by test discipline – e.g. clinical chemistry, serology, haematology, microbiology; and specific test types within each discipline are listed in alphabetical order – e.g. bilirubin, complete blood count. Disease-specific IVDs are grouped by disease area in alphabetical order. For each specific test category on the EDL, the following are described: Test purpose: Intended use of the test Assay format: The technique on which the test is generally based, e.g. immunoassay, nucleic acid test Specimen type: The types of specimens that can be used for the test. Although all validated specimen types are listed for each test category, not all tests on the market are validated for all specimen types. Users are requested to always follow the manufacturer’s instructions for specimen preparation and storage. WHO prequalified or recommended products: For each test for which there are name brand products either prequalified or otherwise recommended by WHO, a link is provided. Link to WHO guidance: If there is WHO guidance on use of the test category, a link is provided to the appropriate site on the WHO website.

5 In general, the following terms were used for the different test purposes: ■■ Screening test:3 Screening tests are used to determine the status of a disease, disorder or other physiological state in an asymptomatic individual. Depending on the nature of the condition and the targeted patient population, screening tests may be used routinely or may be restricted to ‘at risk’ patients. These tests are designed to evaluate an individual’s current state. ■■ Diagnostic test:3 Diagnostic tests are used to determine, verify or confirm a patient’s clinical condition as a sole determinant. This type of testing also includes sole confirmatory assays (to verify results of previous testing) and sole exclusion assays (to rule out a particular condition). These tests are designed to evaluate a patient’s current state. ■■ Aid to diagnosis:3 Tests that are used as aids to diagnosis provide additional information to assist in the determination or verification of a patient’s clinical status. The test is not the sole determinant. These tests are designed to evaluate a patient’s current state. ■■ Monitoring test:3 Monitoring tests are used for measuring levels of analytes for the purpose of adjusting treatments or interventions as required. Monitoring tests include: –– Assays which are used to ensure that an analyte remains within physiological levels or within an established therapeutic drug range. These types of monitoring tests are designed to evaluate an individual’s current state. –– Assays which are used for serial measurement, whereby multiple determinations are taken over time. These types of monitoring tests are typically used for the detection/assessment of disease progression/regression, disease recurrence, minimum residual disease, response/resistance to therapy, and/or adverse effects due to therapy. These types of monitoring tests are designed to evaluate changes in an individual’s state. ■■ Prognostic tests:3 These tests are used to measure factors linked to clinical outcome irrespective of treatment. Such tests may be used to estimate the natural progression of a disease (i.e. outcome in the absence of treatment), or to determine the likelihood of a clinical outcome irrespective of therapeutic intervention. These tests are designed to evaluate a patient’s future state. ■■ Surveillance test: Performed on populations of interest to track the progression of disease incidence and/or prevalence. ■■ Staging test: Performed on patients with a confirmed disease or condition to determine its state at the time of diagnosis and establish a baseline to make relevant treatment decisions.

1.5 Recommended use of the EDL

■■ WHO recognizes that, in order to use the EDL effectively and adapt it to national needs, Member States should consider a variety of factors. These include: local demographics and pattern of diseases; treatment facilities; the training and experience of personnel to collect specimens, to perform diagnostics tests, to transport specimens, to interpret test results and to manage diagnostics laboratories; local testing gaps; supply chain; quality assurance capacity; local availability of treatments; financial resources; available infrastructure and environmental factors. ■■ The EDL should not be read in isolation but in the context of the scope of testing services that meet the clinical needs and expectations of each country in its own testing networks. An illustration of a tiered testing network in resource-limited countries is shown in Fig. 1. The pyramid reflects the fact that there are generally a large number of level I facilities that serve most patients directly. Going up the levels of the system, there are fewer centralized facilities serving fewer patients directly.

3 Clinical evidence for IVD medical devices – clinical performance studies for in vitro diagnostic medical devices. Study group 5 final document GHTF/ SG5/N8:2012. International Medical Device Regulators Forum; 2012 (http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n8-2012- clinical-performance-studies-ivd-medical-devices-121102.pdf, accessed May 2019).

6 National reference laboratories and some provincial laboratories may not provide a broad set of consultative services but are rather referral centres for quality assurance and training or for conducting complex tests (either with specimens taken at facilities lower in the system and transported or by receiving patients referred directly from other facilities).4

Fig. 1 The types of testing appropriate at each tier will be country-specific and will depend on factors such as access to electricity, reagent-grade water, phlebotomy and specialized human resources5

5

Information to support the selection and use of IVDs on the EDL is available on the WHO Laboratory and in vitro diagnostics website: https://www.who.int/in-vitro-diagnostic.

1.6 Definitions Essential diagnostics are those that satisfy the priority health care needs of the population and are selected with due regard to disease prevalence, public health relevance, evidence of utility and accuracy and comparative cost- effectiveness. In vitro diagnostics6 are a subset of medical devices. They are defined as devices which, whether used alone or in combination, are intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnosis or monitoring for compatibility purposes. They include reagents, calibrators, control material and test kits. A medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: ■■ diagnosis, prevention, monitoring, treatment or alleviation of disease; ■■ diagnosis, monitoring, treatment, alleviation of or compensation for an injury; ■■ investigation, replacement, modification or support of the anatomy or of a physiological process, supporting or sustaining life; ■■ control of conception;

4 Consultation on technical and operational recommendations for clinical laboratory testing harmonization and standardization. Geneva: World Health Organization; 2008 (http://www.who.int/healthsystems/round9_9.pdf, accessed May 2019). 5 Guidance for procurement of in vitro diagnostics and related laboratory items and equipment. Geneva: World Health Organization; 2017 (http:// www.who.int/diagnostics_laboratory/publications/procurement, accessed May 2019). 6 Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ Study Group 1 Final Document GHTF/SG1/N071:2012 (http:// www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf, accessed May 2019).

7 ■■ disinfection of medical devices; or ■■ providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.7

7 Medical device – full definition. Geneva: World Health Organization; 2019 (https://www.who.int/medical_devices/full_deffinition, accessed May 2019).

8 2. Second Model List of Essential In Vitro Diagnostics (EDL) The EDL is presented by health care facility level in two tiers: I. Community and health settings without laboratories, with two sections: a. General IVDs for community and health settings without laboratories b. Disease-specific IVDs for community and health settings without laboratories II. Health care facilities with clinical laboratories, with three sections: a. General IVDs for clinical laboratories b. Disease-specific IVDs for clinical laboratories c. Disease-specific IVDs for blood screening laboratories Note: The specimen types listed for each diagnostic test category comprise all possible specimens for that category; however, not all test brands within each category will be validated for all the specimen types listed. Immunoassays are available in various formats – manual microplate assays and automated platforms – with various types of chemical detection (e.g. turbidimetry, chemiluminescence and electrochemiluminescence assays).

I. List of Essential In Vitro Diagnostics (EDL): For community settings and health facilities without laboratories These lists contain tests for community settings and health facilities that include health posts and centres, doctors’ offices, outreach clinics, ambulatory care and home-based and self-testing. If laboratory facilities are available in community settings, please refer to the IVDs described in Section II. If laboratory facilities are not available, specimens may be collected, transported to and processed at a higher tier of the health system. The tests in this section of the EDL are also assumed to be available, in combination with the extended list in Section II, at healthcare facilities with laboratories.

9 1 1 1 Specimen type Capillary whole blood whole blood Venous Urine Urine Capillary whole blood Urine Capillary whole blood Urine Capillary whole blood whole blood Venous Capillary whole blood whole blood Venous Urine Urine Urine (early morning) Slide agglutination test Slide agglutination Dipstick Dipstick Handheld and small analyser Handheld analyser Assay format Assay Dipstick Dipstick Glucometer Haemoglobinometer Multi-parameter strips (dipstick) Multi-parameter Rapid (RDT) test diagnostic (dipstick agglutination latex and cassette), Dipstick To diagnose and screen for diabetes and diabetes for and screen diagnose To hyperglycaemia intermediate hypoglycaemia diagnose To To diagnose and monitor anaemia and monitor diagnose To of certain the safety monitor drugs (e.g. To HIV infection) for zidovudine blood donors potential screen To Clinical marker for certain severe infections (e.g. (e.g. infections certainClinical marker for severe haemorrhagicmalaria, fevers) viral haemolysis, of intravascular aid in the diagnosis To (myoglobinuria) rhabdomyolysis conditions, renal To determine A, B and O groups and Rh type A, B and O groups determine To disease and bile duct detect liver or monitor To disorders • • diabetic ketoacidosis diagnose To mellitus diabetes and monitor diagnose To diabetic keto-acidosis, assess metabolic acidosis, To sepsis and dehydration Test purpose Test detect kidney or monitor disease To • • • To detect urinary tract infections To aid in the early detection of pregnancy To • • A, B and O rhesus factor (Rh) Bilirubin Glucose Ketones Haemoglobin A1c (HbA1c) blood lactate Whole Diagnostic test Diagnostic Albumin Haemoglobin (Hb) Urinalysis test strips test Urinalysis Human chorionic (hCG) gonadotropin General IVDs for use in community settings and health facilities without laboratories use in community IVDs for General If is available. a phlebotomist Blood typing I.a Discipline Clinical chemistry Haematology Microbiology Pregnancy testing

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10 WHO supporting documents Interim technical note: The use of The note: Interim technical (2016) tests, diagnostic rapid cholera https://www.who.int/cholera/task_ force/Interim-guidance-cholera-RDT.pdf B and C testing Guidelines on hepatitis 2017) (February https://apps.who.int/iris/handle/ 10665/254621 B and C testing Guidelines on hepatitis 2017) (February https://apps.who.int/iris/handle/ 10665/254621 N/A WHO prequalified or WHO prequalified products recommended Public reports of WHO- reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ hbsag/public_report/en/ N/A WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hcv/ public_report 1 1 1 Stool Rectal swab Capillary whole blood whole blood Venous Oral fluid Oral Capillary whole blood whole blood Venous Specimen type Capillary whole blood whole blood Venous RDT RDT RDT Assay Assay format RDT For initial detection or For of a cholera exclusion outbreak use in case (Not for management) To screen for acute and acute for screen To HBV infection: chronic > 12 months infants children, of age, and adults adolescents To screen for HCV for screen To infection: infants of age, > 18 months adolescents children, and adults Test purpose Test Staging to assess need to Staging in HBV treatment for HBV infection chronic cholerae Vibrio antigen Hepatitis B Hepatitis surface antigen (HBsAg) Anti-HCV antibody Diagnostic test Diagnostic Hepatitis B e Hepatitis (HBeAg) antigen Disease-specificcommunity settings and health facilities without laboratories for use in IVDs If is available. a phlebotomist Cholera Hepatitis B Hepatitis virus (HBV) infection Hepatitis C Hepatitis virus (HCV) infection I.b Disease

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11 WHO supporting documents Guidelines on HIV self-testing and Guidelines on HIV self-testing partner (2016) notification https://apps.who.int/iris/handle/ 10665/251655 guidelines on HIV testing Consolidated services (July 2015) https://apps.who.int/iris/handle/ 10665/179870 pre- for tool WHO implementation of HIV (PrEP) prophylaxis exposure testing infection, module 10 for (2017) providers http://www.who.int/hiv/pub/prep/prep- implementation-tool guidelines on HIV testing Consolidated services (2015) https://apps.who.int/iris/handle/ 10665/179870 WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/self- testing_public-report/ en/ WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hiv- rdts/public_report WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hiv- vrl/public_report 1 1 1 1 Oral fluid Oral Capillary whole blood whole blood Venous Capillary whole blood whole blood Venous Specimen type Capillary whole blood whole blood Venous Oral fluid Oral Capillary whole blood whole blood Venous Dried blood spots RDT RDT Assay Assay format Point-of- nucleic care acid test RDT HIV self-testing For the diagnosis the diagnosis For of HIV infection: adolescents, adults, and infants children of age > 18 months Test purpose Test For diagnosis of HIV diagnosis For infection in infants of age < 18 months To diagnose HIV diagnose To infection: adults, adolescents, and infants children of age > 18 months HIV 1/2 antibody HIV 1/2 antibody Ab) (anti-HIV Combined HIV Combined antibody/p24 (anti- antigen HIV/p24 Ag) Diagnostic test Diagnostic Qualitative Qualitative HIV virological nucleic acid test Disease-specific IVDs for use in community settings and health facilities without laboratories continued Disease-specificcommunity settings and health facilities without laboratories for use in IVDs If is available. a phlebotomist HIV infection I.b Disease

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12 WHO supporting documents Consolidated guidelines on HIV testing guidelines on HIV testing Consolidated services (2015) https://apps.who.int/iris/handle/ 10665/179870 advanced managing Guidelines for of initiation HIV disease and rapid (2017) therapy antiretroviral https://apps.who.int/iris/handle/ 10665/255884 prevention, the diagnosis, Guidelines for of cryptococcaland management adults, disease in HIV-infected (2018) and children adolescents http://apps.who.int/iris/handle/ 10665/260399 advanced managing Guidelines for of initiation HIV disease and rapid (2017) therapy antiretroviral https://apps.who.int/iris/handle/ 10665/255884 WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/cd4/ public_report N/A 1 1 Specimen type Capillary whole blood whole blood Venous Capillary whole blood whole blood Venous Assay Assay format Point-of- care flow cytometry platform RDT For staging advanced advanced staging For HIV disease monitoring For to response therapy. antiretroviral (In settings where load is not viral available) Test purpose Test • • For screening screening For of and diagnosis cryptococcal meningitis in people with HIV disease advanced Diagnostic test Diagnostic CD4 cell CD4 cell enumeration Cryptococcal antigen Disease-specific IVDs for use in community settings and health facilities without laboratories continued Disease-specificcommunity settings and health facilities without laboratories for use in IVDs If is available. a phlebotomist HIV infection I.b Disease continued

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13 WHO supporting documents Use of influenza rapid diagnostic tests rapid diagnostic of influenza Use (2010) https://apps.who.int/iris/handle/ 10665/44304/ on the use of WHO recommendations influenza diagnosis: for testing rapid https://www.who.int/influenza/ resources/documents/ RapidTestInfluenza_WebVersion.pdf the laboratory Manual diagnosis for surveillance of influenza and virological (2011) https://apps.who.int/iris/handle/ 10665/44518 SurveillanceGlobal Epidemiological Influenza: for Standards https://www.who.int/influenza/ resources/documents/WHO_ Epidemiological_Influenza_ Surveillance_Standards_2014.pdf of on clinical management Guidance influenza infections: https://www.who.int/influenza/ resources/documents/clinical_ management_2012 N/A N/A WHO prequalified or WHO prequalified products recommended Nasal swab Nasopharyngeal swab Nasopharyngeal or wash aspirate Nasal swab Nasopharyngeal swab Nasopharyngeal or wash aspirate Specimen type RDT Point-of- nucleic care acid test Assay Assay format Instrument- based point-of-care immunoassay To aid in the diagnosis aid in the diagnosis To of seasonal influenza infection for (Not recommended surveillance testing) For diagnosis of diagnosis For seasonal influenza infection Test purpose Test Influenza A and B antigen detection Influenza A and B nucleic acid test Diagnostic test Diagnostic Disease-specific IVDs for use in community settings and health facilities without laboratories continued Disease-specificcommunity settings and health facilities without laboratories for use in IVDs Influenza I.b Disease

14 WHO supporting documents WHO guidelines for the treatment of the treatment WHO guidelines for edition (2015) malaria, third https://apps.who.int/iris/handle/ 10665/162441 test Malaria diagnostic rapid WHO product performance. Results of Round 8 of malaria RDTs: testing (2016–2018) https://www.who.int/malaria/ publications/atoz/9789241514965 selectingWHO good practices for and for tests diagnostic rapid procuring malaria (2011) https://apps.who.int/iris/handle/ 10665/44530 on recommended note Information of selection procurement criteria for tests diagnostic malaria rapid https://www.who.int/malaria/ publications/atoz/rdt_selection_criteria WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ malaria/public_report 1 Capillary whole blood whole blood Venous Specimen type RDT Assay Assay format For diagnosis of one or diagnosis For human malaria more , falciparum species ( P. malariae , , P. vivax P. ) P. ovale Test purpose Test Plasmodium antigens; spp. species- specific HRP2) and/ (e.g. or pan-species specific (e.g. pan-pLDH) Diagnostic test Diagnostic Disease-specific IVDs for use in community settings and health facilities without laboratories continued Disease-specificcommunity settings and health facilities without laboratories for use in IVDs If is available. a phlebotomist Malaria I.b Disease

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15 WHO supporting documents WHO laboratory of sexually diagnosis including human infections, transmitted immunodeficiency virus (2013) http://apps.who.int/iris/bitstream/ handle/10665/85343/9789241505840_ eng.pdf on the use of note WHO Information tests diagnostic dual HIV/syphilis rapid (RDT) (2017) http://apps.who.int/iris/handle/ 10665/252849 TB infection: updated Latent guidelines for and consolidated (2018) management programmatic http://apps.who.int/iris/bitstream/ handle/10665/260233/9789241550239- eng.pdf Report Series 949 Technical WHO https://apps.who.int/iris/handle/ 10665/44412 1

WHO prequalified or WHO prequalified products recommended N/A WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ hiv_syphilis/en/ N/A 2 2 2 2 Capillary whole blood whole blood Venous N/A Serum Specimen type Capillary whole blood whole blood Venous Capillary whole blood whole blood Venous RDT Intradermal test RDT Assay Assay format RDT For diagnosis or as an diagnosis For of aid in the diagnosis T. pallidum of latent diagnosis For TB infection aid in the diagnosis To of clinically suspected leishmaniasis visceral Test purpose Test For diagnosis or as an diagnosis For aid in the diagnosis and/or of HIV-1/2 T. pallidum Antibodies to to Antibodies Treponema pallidum skin Tuberculin test (Mantoux) (TST) rK39 antigen visceral for test leishmaniasis Diagnostic test Diagnostic Combined Combined to antibodies and T. pallidum HIV-1/2 to Disease-specific IVDs for use in community settings and health facilities without laboratories continued Disease-specificcommunity settings and health facilities without laboratories for use in IVDs All TB tests are evaluated and guidelines developed by the WHO global TB programme. WHO global the by and guidelines developed evaluated are TB tests All If is available. a phlebotomist Syphilis Tuberculosis (TB) Visceral leishmaniasis I.b Disease

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16 WHO supporting documents WHO priority medical devices for cancer cancer WHO priority for medical devices management https://apps.who.int/iris/handle/ 10665/255262 and anatomical Basic histopathology servicespathology developing for with variable servicescountries https://apps.who.int/iris/handle/ 10665/119675 Specimen type Surgical resection Surgical Biopsy biopsy Core block Cell Cervical specimen for smear (Pap) Papanicolaou cerebrospinal e.g. Body fluids: and pleural urine, fluid, fluids peritoneal (FNA) Fine-needle aspirate spleen, of lymph node, bone marrow other tissues, sputum, bronchial aspirate, bronchoalveolar brushings, (BAL), skinlavage samples Assay format Assay Macroscopic assessment of assessment Macroscopic tissue and selection of areas examination. microscopic for of tissue sectionsMicroscopy on slides and mounted with stained most commonly and eosin in haematoxylin then treated the first instance, with a variety of special stains, selected case-by-case to and other identify pathogens abnormal features Microscopy of stained cells of stained cells Microscopy on slides Test purpose Test Assessment of tissue Assessment infection, neoplasia, for inflammatory and disorders degenerative Assessment of cells for for of cells Assessment infection, neoplasia, inflammatory and disorders degenerative Diagnostic test Diagnostic Histopathology Cytology Cytology (cytopathology) General IVDs for use in clinical laboratories use in clinical laboratories General for IVDs useclinical Disease-specific in laboratories for IVDs blood Disease-specific laboratories for screening IVDs 1

a. b. c. General IVDs for use in clinical laboratories IVDs for General Note: The tests described in this section require specialized anatomical pathology laboratories and trained anatomical pathologists. anatomical and trained laboratories pathology anatomical specialized described in this section tests require The Note: Anatomical Anatomical pathology II.a Discipline

II. Health care facilities with clinical laboratories II. Health care assumed is It laboratories. reference national and or laboratories specialized or hospitals provincial regional, district, for tests additional contain These lists All tests diagnostic level. the appropriate at available are equipment specialist infrastructure expertise and technologists, laboratory laboratory and trained that comprises list The appropriate. as higher levels, at described be as health facilities to available and assumed settings in Section I are in community available sections for: 1

17 WHO supporting documents International guidelines for the International guidelines for I – Phase of death determination https://www.who.int/patientsafety/ montreal-forum-report.pdf Cadaver Surgical resection Surgical Biopsy biopsy Core block Cell Specimen type Macroscopic assessment and assessment Macroscopic of tissue sections. microscopy selectedcase case by Procedures Microscopy of histopathology of histopathology Microscopy tissue sections mounted on slides and stained with specific markers. to antibodies EDL sections to on disease-Refer for individual tests specific assays Assay format Assay Determination Determination of cause death and correlation with pre-mortem and clinical features investigations Assessment of Assessment specific for cells identify markers to infection, neoplasia, inflammatory and disorders degenerative Test purpose Test Post-mortem Post-mortem examination Immunohisto- chemistry (IHC) Diagnostic test Diagnostic 1 General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General Note: The tests described in this section require specialized anatomical pathology laboratories and trained anatomical pathologists. anatomical and trained laboratories pathology anatomical specialized described in this section tests require The Note: Anatomical Anatomical pathology II.a Discipline continued

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18 Microbial isolates Microbial isolates Specimen type Urine Disease-appropriate venous specimens (e.g. stool, urine, whole blood, fluid) or cerebrospinal cultures Disease-appropriate urine, specimens (e.g. fluid, cerebrospinal stool, etc.) Venous whole blood Venous Isolates from bacterial from or Isolates fungal cultures Antimicrobial susceptibility testing of isolates of isolates susceptibility testing Antimicrobial disc diffusion, be done manually by May or automated microdilution broth tests, gradient platforms Assay format Assay Multi-parameter strips test including nitrite Multi-parameter Microscopic examination of slides as wet of slides as wet examination Microscopic with organism-specific or treated preparations stain, Giemsa Gram chemical stains (e.g. for fungi) modified Ziehl-Nielsen stain, stains Culture on growth media plates or broth in or broth media plates on growth Culture of isolates recovery by followed an incubator manual (traditional and species identification equipment) or automated techniques Blood culture bottle in an incubator followed followed bottle in an incubator Blood culture manual (traditional of isolates recovery by equipment) or automated techniques A range of biochemical tests that may be may that of biochemical tests A range performed manually or on automated equipment. 2 and CLSI guidelines 1 Note: WHO regards the development of the development WHO regards Note: a high- (AMR) resistance antimicrobial WHO Global priority See global health issue. Surveillance Resistance (GLASS) Antimicrobial http://www.who.int/glass/en/ programme: Test purpose Test Detection of urinary tract infections (UTIs) Microbial morphology, presence or absence of or absence presence Microbial morphology, squamous versus blood cells red blood cells, white identification; presumptive for epithelial cells of casts and crystalspresence in urine Initial in detection step and identification selectionof bacterial and fungal species for of regimens antibiotic appropriate For the detection of bacterial and fungal For infections (sepsis) bloodstream For the identification of the genus or species the identification For isolates cultured of bacteria from or fungi Final step in selection of appropriate antibiotics antibiotics in selection step of appropriate Final by and interpretation after species identification EUCAST Diagnostic test Diagnostic Urinalysis test strips test Urinalysis Microscopy Culture Blood culture Blood culture Genus and species of identification bacteria and fungi Antimicrobial Antimicrobial susceptibility testing (AST) General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General EUCAST, European Committee on Antimicrobial Susceptibility Testing: Breakpoint tables for interpretation of MICs and zone diameters Version 9.0. Version diameters of MICs and zone interpretation tables for Breakpoint Testing: Susceptibility on Antimicrobial Committee European EUCAST, 29th Edition. Testing, Susceptibility Antimicrobial for Standards Institute: CLSI M 100 Performance and LaboratoryCLSI, Clinical Standards II.a Discipline Bacteriology, Bacteriology, and mycology parasitology

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19 Specimen type Serum Plasma Serum Plasma Urine Serum Plasma Serum Plasma Venous whole blood Venous Serum Plasma Serum Plasma Serum Plasma Assay format Assay Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Photometric and colorimetric testing, ion-selective and colorimetric testing, Photometric clinical potentiometry automated (8-parameter chemistry analyser) Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Test purpose Test To assess liver function assess liver To To detect or monitor malnutrition, kidney, liver liver detect malnutrition, kidney, or monitor To disease or malabsorption To detect kidney or monitor disease To To aid in diagnosis of hepatobiliary aid in diagnosis diseases and To bone disorders To assess liver function assess liver To To measure the levels of glucose, sodium, of glucose, the levels measure To blood urea carbon dioxide, potassium chloride, glomerular ratio, (BUN), BUN:creatinine nitrogen include calcium (eGFR) and may rate filtration for emergency and Result time sensitive Note: critical care To detect or monitor liver disease, bile duct disease, detect liver or monitor To destruction cell and red disorders To detect or monitor liver disease, bile duct disease, detect liver or monitor To and haemolytic anaemia to disorders these causes of jaundice between differentiate Diagnostic test Diagnostic Alanine amino-Alanine (ALT) transferase Albumin Alkaline (ALP) phosphatase Aspartate amino- (AST)transferase Basic metabolic panel (BMP) Bilirubin Direct and indirect bilirubin General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline Clinical chemistry

20 Venous whole blood Venous Serum Plasma Arterial whole blood Specimen type Venous whole blood Venous Serum Plasma Venous whole blood Venous Serum Plasma Serum Urine Serum Plasma Optical methods, automated chemistry automated analyser Optical methods, if available Blood gas analysers, including portableBlood gas analysers, analysers emergency and criticalfor care Assay format Assay As for basic metabolic panel for As clinical automated parameter (14 or more chemistry analyser) Latex agglutination assay agglutination Latex Immunoassay chemistry automated analyser Optical methods, if available RDT Automated chemistry analyser Automated , serum 2 and CO 2 To estimate glomerular filtration rate (eGFR) and rate glomerular filtration estimate To and urine (ACR) ratio urine albumin:creatinine ratio protein:creatinine kidney monitor management function for To and Lassa fever) sepsis, infections (i.e. of severe adjustment regimen antimicrobial bicarbonate, anion gap bicarbonate, for emergency and Result time sensitive Note: critical care assess kidney function To for emergency and Result time sensitive Note: critical care To assess lung function, metabolic or kidney To therapy oxygen and monitor disorders Test purpose Test To measure levels of basic metabolic panel levels measure To protein, total plus magnesium, parameters bilirubin albumin, globulin, albumin:globulin ratio, alkaline alanine(direct or total), (ALP), phosphatase and AST) (ALT and aspartate aminotransferases To measure blood pH, O measure To • • for emergency and Result time sensitive Note: critical care To detect inflammation as an indicator of various of detect as an indicator inflammation To upper respiratory infections sepsis, e.g. conditions, for emergency and Result time sensitive Note: critical care To monitor fluid, electrolyte and acid-base balance electrolyte fluid, monitor To for emergency and Result time sensitive Note: critical care Blood urea Blood urea nitrogen (BUN) Blood pH and gases Diagnostic test Diagnostic Comprehensive Comprehensive metabolic panel (CMP) Creatinine C-reactive protein protein C-reactive (CRP) Electrolytes (sodium, Electrolytes potassium, chloride, bicarbonate) General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline continued Clinical chemistry

21 Plasma Serum Specimen type Plasma Serum Venous whole blood Venous Venous whole blood Venous Serum Plasma fluid (amylase) Peritoneal Plasma Serum Serum Plasma Serum Plasma whole blood Venous Capillary whole blood Plasma Serum Plasma Optical methods, automated chemistry automated analyser Optical methods, if available Assay format Assay Optical methods, automated chemistry automated analyser Optical methods, if available Semi-quantitative fluorescent spot test spot Semi-quantitative fluorescent Immunoassay Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Optical methods, automated chemistry automated analyser Optical methods, if available Point-of-care immunoassay instrument immunoassay Point-of-care Immunoassay RDT density lipoproteins (LDL) and high-densitydensity lipoproteins ‑ To assess hepatobiliary function To bone and hepatobiliary distinguish between To ALP causes of raised To monitor chronic kidney chronic monitor disease To syndrome and manage tumour lysis prevent To • • Test purpose Test To diagnose and screen for diabetes and diabetes for and screen diagnose To diagnose to hyperglycaemia, intermediate hypoglycaemia for emergency and Result time sensitive Note: critical care For screening newborns for G6PD deficiency newborns for screening For To diagnose and monitor diabetes mellitus diabetes and monitor diagnose To To assess acute pancreatitis and other pancreatic and other pancreatic pancreatitis assess acute To disorders for emergency and time sensitive Lipase result Note: care critical To assess risk of cardiovascular disease (CVD) disease (CVD) assess risk of cardiovascular To triglycerides, measuring cholesterol, by low lipoproteins (HDL) • • To guide antibiotic therapy or discontinuation in or discontinuation therapy guide antibiotic To tract respiratory infection sepsis and lower use only in tertiary(For facilities and above) care Gamma-glutamyl (GGT)transferase Diagnostic test Diagnostic Glucose Glucose-6- phosphate dehydrogenase activity (G6PD) Haemoglobin A1c (HbA1c) Lipase or amylase Lipid profile Phosphate Procalcitonin General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline continued Clinical chemistry

22 Serum Plasma Capillary whole blood (neonates) Specimen type Venous whole blood Venous Serum Plasma Serum Plasma Urine Immunoassay Assay format Assay Immunoassay (handheld or large automated automated Immunoassay (handheld or large instrument) Optical methods, automated chemistry automated analyser Optical methods, if available Automated chemical analyser Automated To diagnose and monitor gout and monitor diagnose To syndrome and manage tumour lysis prevent To To screen for hypothyroidism and hyperthyroidism hypothyroidism for screen To Test purpose Test To diagnose myocardial infarction myocardial diagnose To for emergency and Result time sensitive Note: critical care • • To detect and quantify substances in the urine detect substances and quantify To renal with metabolic disorders, associated dysfunction or urinary tract infections for emergency and Result time sensitive Note: critical care Thyroid-stimulating Thyroid-stimulating hormone (TSH) Diagnostic test Diagnostic Troponin T/I Troponin Uric acid Urine chemistry General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline continued Clinical chemistry

23 Specimen type Venous whole blood Venous Capillary blood Capillary whole blood whole blood Venous Citrate plasma Citrate Venous whole blood Venous Citrate plasma Citrate Capillary whole blood whole blood Venous Assay format Assay Slide and/or tube agglutination test Slide and/or tube agglutination Automated haematology analyser, total and total analyser, haematology Automated cell blood of white counts differential (WBC), haemoglobin (Hb) (RBC), cell red blood platelets, (Hct)and haematocrit Immunoassay Red blood cell agglutination Red blood cell Hand-held or automated coagulation analyser analyser coagulation Hand-held or automated (fibrinogen activity) Enzyme (fibrinogen antigen) (EIA) immunoassay Haematology analyser (preferred) analyser Haematology Micro-haematocrit method (if automated Micro-haematocrit method (if automated not available) analyser haematology To evaluate overall health and to detect health and to a overall evaluate To including anaemia, of disorders, wide range white blood cell, leukaemias, red infections, abnormalities and and platelet blood cell primary immune disorders chemotherapy- and monitor diagnose To myelotoxicity associated To aid in the diagnosis of the cause immune aid in the diagnosis To haemolytic anaemias reaction a blood transfusion investigate To haemolytic disease of the newborn diagnose To Test purpose Test To determine blood compatibility for blood for blood compatibility determine To transfusions for emergency and Result time sensitive Note: critical care • • for emergency and Result time sensitive Note: care critical To diagnose disseminated intravascular intravascular disseminated diagnose To coagulation • • • To diagnose disseminated intravascular intravascular disseminated diagnose To coagulation To diagnose and monitor anaemia and monitor diagnose To for emergency and Result time sensitive Note: critical care Diagnostic test Diagnostic Blood cross- matching Complete blood Complete (CBC) count Automated D-Dimer Direct antiglobulin Direct antiglobulin also (DAT) test, known as direct test Coombs Fibrinogen Haematocrit (Hct)Haematocrit General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline Haematology

24 Serum Plasma Capillary whole blood whole blood Venous Serum Specimen type Citrate plasma Citrate Capillary whole blood whole blood Venous (ferritin and transferrin) (ferritin 1 Haemoglobinometer, if automated haematology haematology if automated Haemoglobinometer, not available analyser (preferred) analyser Haematology agglutination Red blood cell Assay format Assay Hand-held or automated coagulation analyser coagulation Hand-held or automated Optical methods (iron and TIBC) and Optical methods (iron Immunoassay Romanowsky stained blood films To screen for antibodies to red blood cells before before blood cells red to antibodies for screen To or in pregnancy a blood transfusion of haemolytic anaemia aid in the diagnosis To reaction and blood transfusion To diagnose and monitor anaemia and and monitor diagnose To polycythaemia of certain the safety monitor drugs (e.g. To HIV infection) for zidovudine blood donors potential screen To infections certainClinical marker for severe haemorrhagic fevers) viral (e.g. malaria, of intravascular in the diagnosis Aid rhabdomyolysis conditions, renal haemolysis, (myoglobinuria) To diagnose a bleeding disorder or a a bleeding disorder diagnose To thrombotic disorder therapy anticoagulant monitor To • • • • • • • Test purpose Test • • To diagnose iron deficiency iron overload diagnose and To For detection of red blood cell, white blood cell blood cell white blood cell, detection of red For and malignancies abnormalities, and platelet count differential blood cell white and for parasites Indirect antiglobulin also (IAT), test known as indirect or red test Coombs antibody blood cell screen Haemoglobin (Hb) Diagnostic test Diagnostic Partial Partial time thromboplastin (PTT), also known partialas activated thromboplastin time (APTT) Iron studies: Iron Ferritin iron-binding Total capacity (TIBC) or transferrin Calculated saturation transferrin Peripheral blood film Peripheral examination General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline continued Haematology

25 Capillary whole blood whole blood Venous plasma Citrate Specimen type Capillary whole blood whole blood Venous whole blood Venous whole blood Venous Serum Haemocytometer, if automated haematology haematology if automated Haemocytometer, is not available analyser (preferred) analyser Haematology analyser coagulation Hand-held or automated Assay format Assay Haematology analyser (preferred) analyser Haematology test Sodium slide metabisulfite Haemoglobin solubility Haemoglobin electrophoresis Haemocytometer, if automated haematology haematology if automated Haemocytometer, not available analyser Immunoassay Optical method Diagnosis of thrombocytopenia or Diagnosis thrombocytosis infections associated Marker manage severe to haemorrhagic viral with bleeding and sepsis (e.g. and certain meningococcaemia) fever, disorders haematological To detect pregnancy and/or confirm To detect neoplasms germ cell To To detect or diagnose a bleeding disorder detect a bleeding disorder or diagnose To time (prothrombin disorder or thrombotic (PT)); performance monitor of anticoagulant (INR)) ratio (International normalized medications for emergency and Result time sensitive Note: critical care • • for emergency and Result time sensitive Note: critical care Test purpose Test To aid in the diagnosis of sickle aid in the diagnosis anaemia, sickle cell To and other sickling trait cell disorders of sickle the diagnosis anaemia, sickle cell cell For and other sicklingtrait disorders To aid in the diagnosis of infections and aid in the diagnosis To leukaemias • • Prothrombin time Prothrombin and international ratio normalized (PT/INR) Platelet count Platelet Diagnostic test Diagnostic Sickle testing cell White blood cell blood cell White count Human chorionic (hCG) gonadotropin General IVDs for use in clinical laboratories continued use in clinical laboratories IVDs for General II.a Discipline continued Haematology Serology

26 WHO supporting documents Guidelines for the care and treatment and treatment the care Guidelines for with chronic of persons diagnosed (2018). https:// virus infection hepatitis C apps.who.int/iris/handle/10665/273174 care the prevention, Guidelines for of persons with chronic and treatment https://apps.who.int/ B infection. hepatitis iris/handle/10665/154590 of tumours the WHO classification urinary and male genital organs. system of tumours, WHO classification 8. 4th edition, volume http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification-Of- Tumours/Who-Classification-Of-Tumours- Of-The-Urinary-System-And-Male- Genital-Organs-2016 female of tumours WHO classification WHO classification organs. reproductive 6. 4th edition, volume of tumours, http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification-Of- Tumours/WHO-Classification-Of-Tumours- Of-Female-Reproductive-Organs-2014 of tumours WHO classification and lymphoid tissues. haematopoietic revised of tumours, WHO classification 2. 4th edition, volume https://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification- Of-Tumours/Who-Classification-Of- Tumours-Of-Haematopoietic-And- Lymphoid-Tissues-2017 N/A WHO prequalified or WHO prequalified products recommended N/A 1 Serum Plasma Specimen type Formalin-fixed Formalin-fixed paraffin-embedded tissue (FFPE) Immunoassay Assay format Assay IHC testing For screening for for screening For hepatocellular in (HCC) carcinoma high-risk individuals cirrhosis or with liver with a family history, in conjunction with ultrasound and disease staging For of germmonitoring cell tumours Test purpose Test To aid in the diagnosis, aid in the diagnosis, To sub-classification, and prognosis of lymphoma treatment (including HIV- conditions) associated Alpha- (AFP) fetoprotein immunoassay Diagnostic test Diagnostic Basic panel for Basic panel for immunohisto- chemical (IHC) for testing of diagnosis lymphoma Disease-specificfor use in clinical laboratories IVDs Only for use in specialized anatomical pathology laboratories – see Anatomical Pathology section use in clinical laboratories. under II. a General IVDs for Pathology – see Anatomical laboratories pathology anatomical use in specialized Only for Cancer II.b Disease

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27 WHO supporting documents WHO classification of tumours, of tumours, WHO classification 4th edition. http://publications.iarc.fr/ Book-And-Report-Series/Who-Iarc- Classification-Of-Tumours WHO list of priority for medical devices management cancer https://apps.who.int/iris/bitstream/ handle/10665/255262/9789241565462- eng.pdf of tumours WHO classification and lymphoid tissues. haematopoietic revised of tumours, WHO classification 2. https://publications. 4th edition, volume iarc.fr/Book-And-Report-Series/ Who-Iarc-Classification-Of-Tumours/ Who-Classification-Of-Tumours-Of- Haematopoietic-And-Lymphoid- Tissues-2017 Medicines20th Essential List (2017) https://apps.who.int/iris/handle/ 10665/273826 of tumours WHO classification and lymphoid tissues. haematopoietic revised of tumours, WHO classification 2. https://publications. 4th edition, volume iarc.fr/Book-And-Report-Series/ Who-Iarc-Classification-Of-Tumours/ Who-Classification-Of-Tumours-Of- Haematopoietic-And-Lymphoid- Tissues-2017 WHO list of priority for medical devices https://apps.who.int/ management. cancer iris/handle/10665/255262 WHO prequalified or WHO prequalified products recommended N/A N/A N/A 1 Specimen type Whole blood Whole Bone marrow blood Peripheral Body fluid Tissue node Lymph Formalin-fixed Formalin-fixed paraffin-embedded tissue (FFPE) Assay format Assay Nucleic acid test Flow cytometry IHC testing Test purpose Test For diagnosis and diagnosis For monitoring therapeutic myelocytic of chronic leukaemia (CML) and CML variants CML) (neutrophilic of and prognosis lymphoblastic acute leukaemia (ALL) aid in the diagnosis To leukaemiasof acute To aid in diagnosis, aid in diagnosis, To and prognosis of solid treatment especially tumours, childhood cancer Diagnostic test Diagnostic BCR-ABL1 and BCR-ABL1 ABL1 transcripts flow Essential cytometry panel for of antibodies leukaemia Basic panel of immunohisto- chemical (IHC) markers for of diagnosis solid tumours Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Only for use in specialized anatomical pathology laboratories – see Anatomical Pathology section use in clinical laboratories. under II. a General IVDs for Pathology – see Anatomical laboratories pathology anatomical use in specialized Only for Cancer II.b Disease continued

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28 WHO supporting documents WHO priority medical devices for cancer cancer WHO priority for medical devices management https://apps.who.int/iris/handle/ 10665/255262 IARC screening. cancer Colorectal Prevention, Handbooks of Cancer 17 volume http://publications.iarc.fr/Book-And- Report-Series/Iarc-Handbooks-Of- Cancer-Prevention/Colorectal-Cancer- Screening-2019 of tumours the WHO classification urinary and male genital organs. system of tumours, WHO classification Volume 8 4th Edition, http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification- Of-Tumours/Who-Classification-Of- Tumours-Of-The-Urinary-System-And- Male-Genital-Organs-2016 female of tumours WHO classification WHO classification organs. reproductive 6 4th edition, volume of tumours, http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification- Of-Tumours/WHO-Classification-Of- Tumours-Of-Female-Reproductive- Organs-2014 WHO prequalified or WHO prequalified products recommended N/A N/A Specimen type Plasma Stool Assay format Assay Immunoassay Latex Latex agglutination immuno- turbidimetry Test purpose Test To aid in the diagnosis aid in the diagnosis To of and surveillance tumours germ cell for and gestational disease trophoblastic Screening for for Screening colorectal cancer Diagnostic test Diagnostic Human chorionic gonadotrophin plus beta- (hCG) hCG Faecal Faecal immunochemical (FIT)test Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Cancer II.b Disease continued

29 WHO supporting documents WHO classification of tumours WHO classification and lymphoid tissues. haematopoietic revised of tumours, WHO classification 2 4th edition, volume https://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification-Of- Tumours/Who-Classification-Of-Tumours- Of-Haematopoietic-And-Lymphoid- Tissues-2017 of tumours the WHO classification urinary and male genital organs. system of tumours, WHO classification 8 4th edition, volume http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification-Of- Tumours/Who-Classification-Of-Tumours- Of-The-Urinary-System-And-Male- Genital-Organs-2016 female of tumours WHO classification WHO classification organs. reproductive 6 4th edition, volume of tumours, http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification-Of- Tumours/WHO-Classification-Of-Tumours- Of-Female-Reproductive-Organs-2014 WHO prequalified or WHO prequalified products recommended N/A Specimen type Serum Plasma Assay format Assay Optical methods, automated chemistry if analyser available Test purpose Test To aid in the prognosis aid in the prognosis To and monitoring of haematological malignancies (lymphoma) and germ tumours cell Diagnostic test Diagnostic Lactate dehydrogenase (LDH) activity Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Cancer II.b Disease continued

30 WHO supporting documents WHO classification of tumours the WHO classification of tumours, WHO classification breast. 4. 4th edition, volume http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification- Of-Tumours/WHO-Classification-Of- Tumours-Of-The-Breast-2012 WHO list of priority for medical devices management cancer https://apps.who.int/iris/handle/ 10665/255262/ medicines List (2017) WHO 20th Essential https://apps.who.int/iris/handle/ 10665/273826/ of breast management Guidelines for for the Office WHO Regional cancer. (2006) Mediterranean Eastern http://applications.emro.who.int/dsaf/ dsa697.pdf and treatment screening Guidelines for cervical lesion for cancer of precancerous (2013) WHO guidelines. prevention. https://apps.who.int/iris/handle/ 10665/94830 of tumours the WHO classification urinary and male genital organs. system of tumours, WHO classification 8 4th edition, volume http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification- Of-Tumours/Who-Classification-Of- Tumours-Of-The-Urinary-System-And- Male-Genital-Organs-2016 WHO prequalified or WHO prequalified products recommended N/A N/A N/A 1 Specimen type Cervical smear from liquid cytology specimen blood Peripheral Formalin-fixed Formalin-fixed embedded paraffin tissue (FFPE) Assay format Assay Microscopic Microscopic examination of cervical on slides cells Immunoassay Immunohisto- chemical testing Test purpose Test For screening and as an screening For of aid in early diagnosis cervical cancer aid in diagnosis, To and prognosis of prostate monitoring cancer To aid in diagnosis, aid in diagnosis, To and prognosis of breast treatment cancer Diagnostic test Diagnostic Papanicolaou Papanicolaou smear test (Pap) specific Prostate (PSA) antigen Oestrogen Oestrogen (ER) and progesterone receptors (PgR) Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Only for use in specialized anatomical pathology laboratories – see Anatomical Pathology section use in clinical laboratories. under II. a General IVDs for Pathology – see Anatomical laboratories pathology anatomical use in specialized Only for Cancer II.b Disease continued

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31 WHO supporting documents WHO classification of tumours the WHO classification of tumours, WHO classification breast. 4 4th edition, volume http://publications.iarc.fr/Book-And- Report-Series/Who-Iarc-Classification- Of-Tumours/WHO-Classification-Of- Tumours-Of-The-Breast-2012 WHO list of priority for medical devices management cancer https://apps.who.int/iris/handle/ 10665/255262 MedicinesWHO 20th Essential List (2017) https://apps.who.int/iris/handle/ 10665/273826 WHO prequalified or WHO prequalified products recommended N/A 1 Specimen type Formalin-fixed Formalin-fixed paraffin-embedded tissue (FFPE) (Referred specimens (Referred must be fixed correctly before transport) ­ Assay format Assay Immunohisto chemical as testing confirmatory test Test purpose Test To aid in diagnosis, aid in diagnosis, To and prognosis of breast treatment cancer ‑ 2) Diagnostic test Diagnostic or human epidermal factor growth receptor 2 (HER-2) overexpression Tyrosine- kinaseprotein (erbB receptor Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Only for use in specialized anatomical pathology laboratories – see Anatomical Pathology section use in clinical laboratories. under II. a General IVDs for Pathology – see Anatomical laboratories pathology anatomical use in specialized Only for Cancer II.b Disease continued

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32 WHO supporting documents Guidelines on hepatitis B and C testing B and C testing Guidelines on hepatitis 2017) (February http://apps.who.int/iris/handle/ 10665/254621 N/A N/A WHO prequalified or WHO prequalified products recommended N/A Public reports of WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ hbsag/public_report Serum Plasma Serum Plasma Venous whole blood Venous Plasma Serum Serum Plasma Specimen type Serum Plasma Plasma Serum Immunoassay Immunoassay RDT Immunoassay Assay format Assay Nucleic acid test Immunoassay To determine determine To of HBV effectiveness individual at vaccination levels. and population used as a markerAlso HBV from of recovery infection For the diagnosis of the diagnosis For HBV infection acute outbreak – used for investigation Screening for acute and acute for Screening B virus hepatitis chronic (HBV) infection: infants of age, > 12 months adolescents children, and adults Staging to assess the to Staging in treatment need for HBV infection chronic Test purpose Test Staging to assess the to Staging in treatment need for HBV infection chronic of and monitoring treatment to response Antibodies Antibodies B hepatitis to surface antigen (anti-HBs) IgM-specific antibodies B hepatitis to antigen core (IgM anti-HBc) Hepatitis B virus Hepatitis (HBV) surface (HBsAg) antigen Hepatitis B e Hepatitis (HBeAg) antigen Diagnostic test Diagnostic Quantitative Quantitative HBV virological nucleic acid test Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Hepatitis B Hepatitis II.b Disease

33 WHO supporting documents Guidelines on hepatitis B and C testing B and C testing Guidelines on hepatitis 2017) (February http://apps.who.int/iris/handle/ 10665/254621 WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hcv/ public_report Capillary whole blood whole blood Venous Plasma Serum Capillary whole blood whole blood Venous Serum Plasma Serum Plasma Specimen type Serum Plasma Serum Plasma RDT Nucleic acid test Immunoassay Assay format Assay Immunoassay Immunoassay Screening for HCV for Screening infection: infants of age, > 18 months adolescents children, and adults For diagnosis of diagnosis For HCVviraemic and of response monitoring and as a treatment, to of cure test For diagnosis of diagnosis For HCVviraemic Test purpose Test Screening for past or for Screening HCV infection: present > 18 months infants children, of age, and adults adolescents Antibodies to to Antibodies C virus hepatitis (HCV) (anti-HCV) Qualitative or Qualitative quantitative HCV virological nucleic acid HCV core HCV core antigen (HCVcAg) Diagnostic test Diagnostic Combined Combined antibodies HCVto (anti- HCV) and HCV antigen core (HCVcAg) Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Hepatitis C Hepatitis II.b Disease

34 WHO supporting documents Guidelines on HIV self-testing and Guidelines on HIV self-testing partner (2016) notification http://apps.who.int/iris/handle/ 10665/251655 guidelines on HIV testing Consolidated services (July 2015) https://apps.who.int/iris/handle/ 10665/179870 pre- for tool WHO implementation of HIV (PrEP) prophylaxis exposure testing infection, module 10 for (2017) providers http://www.who.int/hiv/pub/prep/prep- implementation-tool guidelines on HIV testing Consolidated services (2015) https://apps.who.int/iris/handle/ 10665/179870 guidelines on the use of Consolidated and treating drugs for antiretroviral HIV infection (2016) preventing https://apps.who.int/iris/handle/ 10665/208825 WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hiv- rdts/public_report WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hiv- vrl/public_report Venous whole blood Venous Plasma Serum Specimen type Venous whole blood Venous Plasma Serum Capillary whole blood whole blood Venous Dried blood spots Plasma Dried blood spots (whole blood or plasma) Serum Plasma Serum Plasma Serum Plasma RDT Assay format Assay RDT Nucleic acid test Nucleic acid test Immunoassay Immunoassay For monitoring monitoring For antiviral to response treatment of HIV diagnosis For infection in infants of age < 18 months by (only if validated the manufacturer) For the diagnosis the diagnosis For of HIV infection: adolescents, adults, and infants children of age > 18 months Test purpose Test For the diagnosis the diagnosis For of HIV infection: adolescents, adults, and infants children of age > 18 months of HIV diagnosis For infection in infants of age < 18 months • • Antibodies Antibodies HIV-1/2 to ‑ HIV Ab) (anti Diagnostic test Diagnostic Combined HIV Combined antibody/p24 (anti- antigen HIV/p24 Ag) Qualitative HIV virological nucleic acid test Quantitative HIV virological nucleic acid test Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs HIV infection II.b Disease

35 WHO supporting documents Consolidated guidelines on the use of Consolidated and treating drugs for antiretroviral HIV infection (2016) preventing https://apps.who.int/iris/handle/ 10665/208825 advanced managing Guidelines for of initiation HIV disease and rapid therapy antiretroviral https://apps.who.int/iris/handle/ 10665/208825 prevention, the diagnosis, Guidelines for of cryptococcaland management adults, disease in HIV-infected (2018) and children adolescents http://apps.who.int/iris/handle/ 10665/260399 advanced managing Guidelines for of initiation HIV disease and rapid (2017) therapy antiretroviral https://apps.who.int/iris/handle/ 10665/255884 advanced managing Guidelines for of initiation HIV disease and rapid (2017) therapy antiretroviral https://apps.who.int/iris/handle/ 10665/255884 laboratoryWHO human papillomavirus first edition (2009) manual, http://apps.who.int/iris/handle/ 10665/70505 WHO prequalified or WHO prequalified products recommended N/A N/A Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/cd4/ public_report WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ public_report_hpv Specimen type Cerebrospinal fluid Cerebrospinal Capillary whole blood whole blood Venous Serum Plasma Urine Cervical cells collected in test- specific transport fluid Capillary whole blood whole blood Venous Cerebrospinal fluid Cerebrospinal Serum Plasma Assay format Assay RDT Immunoassay Nucleic acid test Flow Flow cytometry Immunoassay For staging advanced advanced staging For HIV disease monitoring For to response antiretroviral therapy. (In settings where load is not viral available) Test purpose Test For screening screening For of and diagnosis cryptococcal meningitis in people living with HIV disease advanced aid in the diagnosis To of disseminated histoplasmosis For cervical cancer For screening • • Diagnostic test Diagnostic Cryptococcal antigen Histoplasma antigen HPV nucleic acid test CD4 cell CD4 cell enumeration Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs HIV infection II.b Disease continued Human papilloma- virus (HPV) Infection

36 WHO supporting documents WHO guidelines for the treatment of the treatment WHO guidelines for edition (2015) malaria, third http://apps.who.int/iris/10665/162441 test Malaria diagnostic rapid WHO product performance: Results of Round 8 of malaria RDTs: testing (2016–2018) https://www.who.int/malaria/ publications/atoz/9789241514965 on recommended note Information of selection procurement criteria for tests diagnostic malaria rapid https://www.who.int/malaria/ publications/atoz/rdt_selection_criteria selectingWHO good practices for and for tests diagnostic rapid procuring malaria (2011) http://apps.who.int/iris/handle/ 10665/44530 WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified http://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ malaria/public_report Capillary whole blood whole blood Venous Specimen type RDT Assay format Assay For diagnosis of one or diagnosis For human malaria more , falciparum species ( P. malariae , , P. vivax P. ) P. ovale Test purpose Test Plasmodium antigens; spp. species-specific HRP2) and/ (e.g. or pan-species- specific (e.g. pan-pLDH) Diagnostic test Diagnostic Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Malaria II.b Disease

37 WHO supporting documents WHO guidelines for the treatment of the treatment WHO guidelines for edition (2015) malaria, third http://apps.who.int/iris/10665/162441 I: Learner’s Part Basic malaria microscopy guide (2010) http://apps.who.int/iris/handle/ 10665/44208 operating standard Malaria microscopy (2015) procedures http://www.wpro.who.int/mvp/lab_ quality/mm_sop/en/ of the treatment WHO guidelines for edition (2015) malaria, third http://apps.who.int/iris/10665/162441 WHO prequalified or WHO prequalified products recommended N/A N/A Specimen type Venous whole blood Venous Capillary whole blood whole blood Venous Assay format Assay Semi- quantitative fluorescent spot test Light Light microscopy Test purpose Test To determine G6PD determine To activity (normal, intermediate, for a deficient) administer decision to 8-aminoquinoline drugs for group vivax of P. cure radical malaria For diagnosis of one or diagnosis For human malaria more , falciparum species ( P. malariae , , P. vivax P. ) and monitoring P. ovale to treatment response Diagnostic test Diagnostic Glucose-6- phosphate dehydrogenase activity(G6PD) Plasmodium spp. Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Malaria II.b Disease continued

38 WHO supporting documents Dengue: guidelines for diagnosis, diagnosis, Dengue: guidelines for (2009) and control prevention treatment, https://www.who.int/tdr/publications/ documents/dengue-diagnosis.pdf of Kato-KatzVideo method https://www.who.int/neglected_ diseases/preventive_chemotherapy/ Basic_Lab_methods_in_human_ parasitology/en/index2.html N/A N/A N/A WHO prequalified or WHO prequalified products recommended N/A Fresh stool Fresh Serum Plasma Serum Plasma paper stored Filter blood Serum whole blood Venous Venous whole blood Venous paper stored Filter blood Dried blood spots (DBS) Saliva Specimen type Serum whole blood Venous Microscope Microscope slide examination Immunoassay Nucleic acid test RDT Immunoassay Assay format Assay RDT S. mekongi For surveillance For of and diagnosis soil- transmitted and helminthiasis schistosomiasis caused by Schistosoma mansoni , , S. intercalatum , S. japonicum For surveillance For (serotype and differentiation) of confirmation outbreaks To aid in the diagnosis aid in the diagnosis To (always of dengue fever with in combination population IgM) and for surveys Test purpose Test To aid in the diagnosis aid in the diagnosis To of dengue fever in combination (always with NS1) and for surveyspopulation Kato-Katz Qualitative Qualitative dengue virus nucleic acid test Dengue virus (NS1) antigen Diagnostic test Diagnostic Dengue virus antibody (immunoglobulin M) (IgM) Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Neglected tropical diseases II.b Disease

39 N/A WHO supporting documents N/A N/A N/A WHO prequalified or WHO prequalified products recommended Venous whole blood Venous Serum Plasma Serum Oral fluid Oral Capillary whole blood whole blood Venous Specimen type ­ Flow Flow cytometry Immunoassay diffusion (RID) Radial immuno RDT Assay format Assay To aid in the To of primarydiagnosis and secondary immunodeficiencies To identify patients patients identify To and Ig levels with low replacement monitor For differential differential For of primarydiagnosis immunodeficiencies Test purpose Test Lymphocyte Lymphocyte subtype enumeration: CD4, CD8, CD20 and CD15/26 cells HIV to (Refer infection for of enumeration only) CD4 cells Immunoglobulin plasma levels (IgG, IgA, IgM) HIV 1/2 antibody HIV 1/2 antibody Ab) (anti-HIV Diagnostic test Diagnostic Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Primary Immuno- deficiencies II.b Disease

40 WHO supporting documents WHO sexually transmitted infection transmitted WHO sexually laboratory manual https://apps.who.int/iris/handle/ 10665/85343 guidelines on HIV Consolidated and treatment diagnosis, prevention, key populations for care https://apps.who.int/iris/handle/ 10665/246200 WHO laboratory of sexually diagnosis including human infections, transmitted immunodeficiency virus (2013) http://apps.who.int/iris/handle/ 10665/85343 on the use of dual note WHO Information (RDT) tests diagnostic HIV/syphilis rapid (2017) http://apps.who.int/iris/handle/ 10665/252849/ guidelines on HIV Consolidated and treatment diagnosis, prevention, key populations for care https://apps.who.int/iris/handle/ 10665/246200 infection transmitted WHO sexually laboratory manual https://apps.who.int/iris/handle/ 10665/85343 N/A WHO prequalified or WHO prequalified products recommended N/A N/A N/A Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ hiv_syphilis/en/ Urine, urethral swabs urethral Urine, endocervical swabs, swabs, vaginal rectal swabs, oropharyngeal swabs, Liquid cytology Specimen type Venous whole blood Venous Plasma Serum whole blood Venous Plasma Serum Serum Plasma Serum Plasma fluid Cerebrospinal Serum Plasma Nucleic acid test Assay format Assay RDT RDT Particle/ charcoal agglutination assay Flocculation test Immunoassay For the diagnosis the diagnosis For and/ of chlamydial or gonorrhoeal disease and urogenital extragenital infection Test purpose Test For diagnosis or as an diagnosis For of aid in the diagnosis syphilis or as diagnosis For of an aid in diagnosis infection and/ HIV-1/2 or syphilis screening For syphilis and for treatment monitoring effectiveness diagnosis screening, For of and confirmation neurosyphilis Qualitative test test Qualitative Chlamydia for (CT)trachomatis and Neisseria gonorrhoeae (NG) infections Diagnostic test Diagnostic Antibodies to to Antibodies Treponema pallidum to Antibodies and T. pallidum (anti- HIV-1/2 to HIV Ab) Non-treponemal plasma rapid (RPR) test reagin Non-treponemal venereal disease research laboratory (VDRL) test Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Sexually transmitted infections II.b Disease

41 WHO supporting documents Laboratory of sexually diagnosis including human infections, transmitted immunodeficiency virus https://www.who.int/ reproductivehealth/publications/ rtis/9789241505840 WHO prequalified or WHO prequalified products recommended N/A N/A Specimen type Serum (preferred) Plasma Assay format Assay Red cell Red cell agglutination assay Particle Particle agglutination assay Test purpose Test For confirmation of confirmation For syphilis infection and of early and diagnosis syphilis infection late Diagnostic test Diagnostic T. pallidum T. particle agglutination test (TPPA) T. pallidum T. haemagglutina - tion (TPHA) test Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Sexually transmitted infections II.b Disease continued

42 WHO supporting documents WHO guidelines and of Compendium Ensuring optimum standards: associated delivery for of the cascade care edition second tuberculosis, patients with (2018) https://apps.who.int/iris/handle/ 10665/272644 diagnostics: Implementing tuberculosis policy (2015) framework https://apps.who.int/iris/handle/ 10665/162712 1 WHO prequalified or WHO prequalified products recommended Implementing diagnostics: tuberculosis policy (2015) framework https://apps.who.int/iris/ handle/10665/162712 WHO meeting report expertof a technical non- consultation: of inferiority analysis Xpert Ultra MTB/RIF Xpert to compared MTB/ RIF (2017) http://apps.who.int/iris/ handle/10665/254792 real-time Automated nucleic acid amplification and rapid for technology simultaneous detection and of tuberculosis rifampicin resistance: (2013) update Policy https://apps.who.int/iris/ handle/10665/112472 use of loop-The isothermal mediated amplification (TB-LAMP) of the diagnosis for pulmonary tuberculosis: policy (2016) guidance http://apps.who.int/ iris/10665/249154 Sputum Specimen type Sputum or other specimen types Sputum Broncho-alveolar (BAL) or lavage extra-pulmonary TB specimen types Sputum or other specimen types Loop- mediated isothermal amplification (LAMP) Assay format Assay Microscopy Nucleic acid test Bacterial culture For diagnosis of diagnosis For active TB Test purpose Test For diagnosis, diagnosis, For and treatment TB of activemonitoring For diagnosis of active diagnosis For TB and simultaneous detection of rifampicin resistance For diagnosis and diagnosis For monitoring treatment TB including of active TB drug-resistant M. tuberculosis DNA Diagnostic test Diagnostic Mycobacterium Mycobacterium tuberculosis bacteria M. tuberculosis DNA Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs All TB tests are evaluated and guidelines developed by the WHO global TB programme. WHO global the by and guidelines developed evaluated are TB tests All II.b Disease Tuberculosis Tuberculosis (TB)

1

43 WHO supporting documents WHO guidelines and of Compendium Ensuring optimum standards: associated delivery for of the cascade care edition second tuberculosis, patients with (2018) https://apps.who.int/iris/handle/ 10665/272644 diagnostics: Implementing tuberculosis policy (2015) framework https://apps.who.int/iris/handle/ 10665/162712 1 WHO prequalified or WHO prequalified products recommended The use of molecular The the for assays line probe to detection of resistance isoniazid and rifampicin: policy (2016) update https://apps.who.int/iris/ handle/10665/250586 use of molecular The the for assays line probe detection of resistance anti- second-line to drugs: tuberculosis policy (2016) update http://apps.who.int/iris/ handle/10665/246131 report on Technical critical concentrations drug susceptibility for of medicines testing used in the treatment of drug-resistant (2018) tuberculosis http://www.who.int/ tb/publications/2018/ WHO_technical_report_ concentrations_TB_ drug_susceptibility Bacterial of culture M. tuberculosis Specimen type Sputum Sputum Drug susceptibility testing Assay format Assay Molecular line probe (LPA) assay Molecular line probe (LPA) assay To detect resistance to to detect resistance To and/or second- first-line medicines line anti-TB Test purpose Test For detection of For second- for resistance medicines line anti-TB For detection of For first-line to resistance medicines anti-TB Drug susceptibility with testing M. tuberculosis culture Diagnostic test Diagnostic M. tuberculosis DNA mutations with associated resistance M. tuberculosis DNA mutations with associated resistance Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs All TB tests are evaluated and guidelines developed by the WHO global TB programme. WHO global the by and guidelines developed evaluated are TB tests All II.b Disease continued Tuberculosis

1

44 WHO supporting documents WHO guidelines and of Compendium Ensuring optimum standards: associated delivery for of the cascade care edition second tuberculosis, patients with (2018) https://apps.who.int/iris/handle/ 10665/272644 diagnostics: Implementing tuberculosis policy (2015) framework https://apps.who.int/iris/handle/ 10665/162712 TB Infection: updated Latent guidelines for and consolidated (2018) management programmatic http://apps.who.int/iris/handle/ 10665/260233 1 WHO prequalified or WHO prequalified products recommended The use of lateral flow flow use of lateral The urinelipoarabinomannan the for (LF-LAM) assay and screening diagnosis in of active tuberculosis people living with HIV: policy (2015) update http://apps.who.int/iris/ handle/10665/193633 Specimen type Venous whole blood Venous Urine Assay format Assay Immunoassay or ELISPOT assay RDT positive inpatients ‑ positive Test purpose Test For diagnosis of latent of latent diagnosis For TB infection To aid in the diagnosis aid in the diagnosis To TB in seriously ill of HIV Diagnostic test Diagnostic Immune by response Interferon- gamma release (IGRA) assay Lipoarabino- mannan (LAM) antigen Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs All TB tests are evaluated and guidelines developed by the WHO global TB programme. WHO global the by and guidelines developed evaluated are TB tests All II.b Disease continued Tuberculosis

1

45 WHO supporting documents Laboratory testing for ZikaLaboratory for virus infection testing guidance interim https://www.who.int/csr/resources/ publications/zika/laboratory-testing WHO prequalified or WHO prequalified products recommended N/A WHO listing through WHO listing through Emergency Use and Listing Assessment procedure: (EUAL) https://www.who.int/ diagnostics_laboratory/ eual-zika-virus/zika/en/ Specimen type Serum be used with (Not to fluid) cerebrospinal whole blood Venous Serum Plasma Urine CSF Assay format Assay Immunoassay Nucleic acid test 2,3 1 To aid in the diagnosis aid in the diagnosis To of suspected Zika virus infection Test purpose Test To diagnose acute Zika acute diagnose To virus infection Detection of IgM to antibodies Zika virus Diagnostic test Diagnostic Virological Virological detection of Zika virus Disease-specific IVDs for use in clinical laboratories continued Disease-specificfor use in clinical laboratories IVDs Because of potential cross-reactivity with dengue and other flaviviruses and persistence of Zika IgM antibody that may reflect infection prior to pregnancy, currently available Zika virus IgM test results should not beavailable Zika test virus IgM currently pregnancy, reflect to of Zika infection prior may and persistence that with dengue and other flaviviruses IgM antibody cross-reactivity Because of potential clinical decision-makingused alone for in pregnancy. result does not rule out infection. week of infection. A negative only within the first assays Zika virus RNA is typically NAT detectable in serum by testing of the same specimen. re-extractionby should be confirmed test NAT repeat and NAT a positive women, risk of false-positive in pregnant reduce results To Zika virus infection II.b Disease

1 2 3

46 WHO supporting documents Screening donated blood for blood for donated Screening infections: transmissible transfusion (2009) recommendations http://apps.who.int/iris/handle/ 10665/44202 WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/ hbsag/public_report WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hcv/ public_report Capillary whole blood whole blood Venous Plasma Serum Plasma Serum Plasma Serum Capillary whole blood whole blood Venous Plasma Serum Serum Plasma Serum Plasma Specimen type 1 1 1 1,2 1,2 1,2 RDT Immunoassay RDT Immunoassay Assay format Assay Immunoassay Particle Particle agglutination assay For screening blood screening For HBV for donations For screening blood screening For HCV for donations For screening blood screening For HCV for donations Test purpose Test Hepatitis B Hepatitis surface antigen (HBsAg) Antibodies to to Antibodies HCV (anti-HCV) Combined Combined to antibodies HCV (anti-HCV) and HCV core (HCVantigen cAg) Screening test Screening Disease-specific laboratories for blood screening IVDs The only assays recommended for blood screening are those that have been validated for this purpose by the manufacturer. this purpose by for been validated have those that are blood screening for recommended only assays The or emergency situations. areas in remote be performedMay with small throughput, in laboratories Hepatitis B Hepatitis virus (HBV) Hepatitis C Hepatitis virus (HCV) II.c Organism

1 2 NOTE: Please refer to the Haematology section for information on General IVDs for blood transfusion. on General IVDs for section information the Haematology for to refer Please NOTE:

47 WHO supporting documents Screening donated blood for blood for donated Screening infections: transmissible transfusion (2009) recommendations http://apps.who.int/iris/handle/ 10665/44202 N/A N/A WHO prequalified or WHO prequalified products recommended Public reports of WHO reports of Public IVDs prequalified https://www.who.int/ diagnostics_laboratory/ evaluations/pq-list/hiv- rdts/public_report Capillary whole blood whole blood Venous Serum Plasma Serum Plasma Serum Plasma Serum Plasma Serum Plasma Serum Plasma Specimen type 1,2 1,2 1,2,3 1,2 1 1 RDT Immunoassay Immunoassay Immunoassay Immunoassay Assay format Assay Particle Particle agglutination assay For screening blood screening For HIV for donations For screening blood screening For syphilis for donations For screening blood screening For HIV for donations Test purpose Test Antibodies to to Antibodies (anti-HIV HIV-1/2 test Ab) Antibodies to T. Antibodies T. to pallidum cruzi , Trypanosoma e.g. for screen To I/II), virus (HTLV T-lymphotropic human Nile virus in West Zika Babesia and virus, depending on local risk blood donations, of contamination. Combined HIV Combined antibody/p24 (anti- antigen test HIV/p24 Ag) Screening test Screening Disease-specific IVDs for blood screening laboratories continued Disease-specific laboratories for blood screening IVDs The only assays recommended for blood screening purposes are those that have been validated for this purpose by the manufacturer. this purpose by for been validated have those that purposes are blood screening for recommended only assays The or emergency situations. areas in remote be performedMay with small throughput, in laboratories laboratory (VDRL) should be performed disease research assay: screening (RPR). In with a non-treponemal of syphilis, venereal with a high incidence populations plasma reagin or rapid HIV Treponema Treponema pallidum Other transfusion- transmitted organisms II.c Organism

1 2 3 NOTE: Please refer to the Haematology section for information on General IVDs for blood transfusion. on General IVDs for section information the Haematology for to refer Please NOTE:

48 World Health Organization Essential Medicines and Health Products 20 Avenue Appia CH1211 Geneva 27 Switzerland [email protected] https://www.who.int/medical_devices/diagnostics/selection_in-vitro/en/