COVID-19 Resources for Clinical Chemistry Laboratories

Last updated: 8 September 2020 The following is a list of resources related to the laboratory management of the COVID-19 outbreak. Jump to section

• Resources from governing bodies • Personal safety and use of PPE • Disease transmission • Diagnostic testing • Clinical features and the role of laboratory testing • Paediatrics • Maternal medicine • Treatment for COVID-19 • Research

This collection of resources reflects a rapidly changing situation. We have not critically appraised all resources cited here for scientific validity but tried to present information that is believed to help laboratory professionals in formulating their local policies in a better- informed manner. The interim advice or conclusions presented here may change as more information is gathered.

If you wish to add a resource or have any other feedback, please get in touch via the contact details below:

Dr Simon Thompson Chemical Pathology Registrar, NSW Health Pathology [email protected]

Contents Resources from governing bodies ...... 3 Australian Government advice ...... 3 NSW Health ...... 3 World Health Organisation ...... 3 RCPA ...... 3 IFCC ...... 3 The Centre for Evidence-Based Medicine (Oxford) ...... 4 Medscape ...... 4 FIND Diagnostics ...... 4 Joint Commission International ...... 4 Resources from Singapore ...... 4 Association for Quality Management in Laboratory Medicine ...... 4 US Food and Drug Administration ...... 4 Mayo Clinic ...... 4 Personal safety and use of PPE ...... 4 Disease transmission ...... 6 Diagnostic testing for COVID-19 ...... 8 Guidelines and reviews ...... 8 Genetic and molecular testing – validation and evaluation of methods ...... 9 Genetic and molecular testing – other resources ...... 9 Serology - validation and evaluation of methods ...... 10 Serology – other resources ...... 13 Others ...... 14 Clinical features and the role of laboratory testing ...... 15 Clinical characteristics of COVID-19 ...... 15 Inflammatory markers ...... 19 Platelets and coagulation ...... 19 Cardiovascular manifestations of COVID-19 ...... 20 Renin-angiotensin-aldosterone system ...... 21 Miscellaneous ...... 22 COVID-19 in children ...... 24 Maternal Medicine ...... 25 Treatment of COVID-19 ...... 26 COVID-19 research resources ...... 28

Resources from governing bodies Australian Government advice Coronavirus Disease 2019 (COVID-19) CDNA National Guidelines for Public Health Units https://www1.health.gov.au/internet/main/publishing.nsf/Content/cdna-song-novel- coronavirus.htm Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology providers and healthcare managers. https://www.health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health- professionals-including-aged-care-providers-pathology-providers-and-healthcare-managers NSW Health COVID-19 resources for health professionals. https://www.health.nsw.gov.au/Infectious/diseases/Pages/coronavirus-professionals.aspx COVID-19 - clinical guidance and resources. https://www.health.nsw.gov.au/Infectious/covid- 19/Pages/Clinical-Guidance-and-resources.aspx Blood gas analysers during COVID-19: Cessation of pleural fluid testing and other guidance. https://www.health.nsw.gov.au/Infectious/covid-19/Pages/covid-blood-gas-analysers.aspx World Health Organisation Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19): interim guidance. https://apps.who.int/iris/handle/10665/331498 Infection prevention and control during health care when COVID-19 is suspected: interim guidance. https:// www.who.int/publications-detail/infection-prevention-and-control-during- health-care-when-novel-coronavirus-(ncov)-infection-is-suspected-20200125 Coronavirus disease (COVID-19) technical guidance: laboratory testing for 2019-nCoV in humans. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical- guidance/laboratory-guidance Laboratory biosafety guidance related to coronavirus disease 2019 (COVID-19): interim guidance. https://apps.who.int/iris/handle/10665/331138 RCPA COVID-19 useful resources. https://www.rcpa.edu.au/Library/COVID-19-Updates/COVID- 19-Useful-Resources IFCC IFCC Information Guide on COVID-19. https://www.ifcc.org/ifcc-news/2020-03-26-ifcc- information-guide-on-covid-19/ RCPath (UK) Recommendations from RCPath and Professional Bodies (IBMS, ACP and ACB) Prioritisation/deferral of Pathology Laboratory Work (in light of SARSCoV-2 (COVID19) epidemic). https://www.rcpath.org/uploads/assets/f5123842-950f-49c5- bf69ed866a7ca3da/Prioritisation-deferral-of-pathology-laboratory-work.pdf

The Centre for Evidence-Based Medicine (Oxford) Oxford COVID-19 Evidence Service. https://www.cebm.net/covid-19/ Medscape Medscape COVID-19 resources. https://www.medscape.com/resource/coronavirus FIND Diagnostics COVID-19 Diagnostics. https://www.finddx.org/covid-19/ Joint Commission International COVID-19 Resource page. https://www.jointcommissioninternational.org/news-and- support/coronavirus/ Resources from Singapore Practical laboratory considerations amidst the COVID-19 outbreak: early experience from Singapore: https://jcp.bmj.com/content/early/2020/03/20/jclinpath-2020-206563 Preparing the Biochemistry Laboratory for the Next Outbreak: Lessons from SARS in Singapore. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1240032/ COVID-19 in Singapore—Current Experience: Critical Global Issues That Require Attention and Action. https://jamanetwork.com/journals/jama/fullarticle/2761890 Association for Quality Management in Laboratory Medicine COVID-19 resources. https://www.aqmlm.org.uk/covid-19 US Food and Drug Administration Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (revised). https://www.fda.gov/regulatory-information/search-fda-guidance- documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health- emergency FDA list of in vitro diagnostics Emergency Use Authorisations. https://www.fda.gov/medical- devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd FDA - Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. https://www.fda.gov/regulatory-information/search-fda-guidance- documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health- emergency Mayo Clinic COVID-19 Testing Resource Centre - https://news.mayocliniclabs.com/covid19/

Personal safety and use of PPE Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19): interim guidance. https://apps.who.int/iris/handle/10665/331498 Infection prevention and control during health care when COVID-19 is suspected: interim guidance. https:// www.who.int/publications-detail/infection-prevention-and-control-during- health-care-when-novel-coronavirus-(ncov)-infection-is-suspected-20200125 COVID-19: safe handling and processing for samples in laboratories. https://www.gov.uk/government/publications/wuhan-novel-coronavirus-guidance-for-clinical- diagnostic-laboratories/wuhan-novel-coronavirus-handling-and-processing-of-laboratory- specimens Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019- ncov/lab/guidelines-clinical-specimens.html Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019- ncov/lab/lab-biosafety-guidelines.html Requirements and technical specifications of personal protective equipment (PPE) for the novel coronavirus (2019-ncov) in healthcare settings https://iris.paho.org/handle/10665.2/51906 Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. https://jamanetwork.com/journals/jama/fullarticle/2762692 Protecting health-care workers from subclinical coronavirus infection. https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30066-7/fulltext Universal Masking in Hospitals in the Covid-19 Era https://www.nejm.org/doi/full/10.1056/NEJMp2006372 Respiratory virus shedding in exhaled breath and efficacy of face masks. https://www.nature.com/articles/s41591-020-0843-2 US Centers for Disease Control and Prevention. Guidance for Use of Pneumatic Tube Systems for Transport of Respiratory Specimens from Suspected or Confirmed COVID-19 Patients. https://www.cdc.gov/csels/dls/locs/2020/transport_recommendations_for_covid- 19_specimens.html Biosafety measures for preventing infection from COVID-19 in clinical laboratories: IFCC Taskforce Recommendations. https://www.ncbi.nlm.nih.gov/pubmed/32396137 NSW Clinical Excellence Commission – Personal Protective Equipment. http://www.cec.health.nsw.gov.au/keep-patients-safe/COVID-19/Personal-Protective- Equipment-PPE Medical mask versus cotton mask for preventing respiratory droplet transmission in micro environments. https://www.sciencedirect.com/science/article/pii/S0048969720330278 Biosafety measures for preventing infection from COVID-19 in clinical laboratories: IFCC Taskforce Recommendations. https://www.degruyter.com/view/journals/cclm/58/7/article- p1053.xml Exposure to a Surrogate Measure of Contamination from Simulated Patients by Emergency Department Personnel Wearing Personal Protective Equipment. https://jamanetwork.com/journals/jama/fullarticle/2765377 Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31142-9/fulltext Practical Guidelines for Collection, Manipulation and Inactivation of SARS‐CoV‐2 and COVID‐19 Clinical Specimens. https://currentprotocols.onlinelibrary.wiley.com/doi/abs/10.1002/cpcy.77 Airborne Spread of SARS-CoV-2 and a Potential Role for Air Disinfection. https://jamanetwork.com/journals/jama/fullarticle/2766821 Laboratory practices to mitigate biohazard risks during the COVID-19 outbreak: an IFCC global survey. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515- cclm-2020-0711/article-10.1515-cclm-2020-0711.xml Use of personal protective equipment against coronavirus disease 2019 by healthcare professionals in Wuhan, China: cross sectional study. https://www.bmj.com/content/369/bmj.m2195 Moving Personal Protective Equipment into the Community. Face Shields and Containment of COVID-19. https://jamanetwork.com/journals/jama/fullarticle/2765525 Association Between Universal Masking in a Health Care System and SARS-CoV-2 Positivity Among Health Care Workers. https://jamanetwork.com/journals/jama/fullarticle/2768533 Heat inactivation of saliva samples for the analysis of cortisol and cortisone during the Covid-19 pandemic. https://academic.oup.com/jalm/advance- article/doi/10.1093/jalm/jfaa158/5898198

Disease transmission Fecal Evidence of COVID-19 Raises Transmission Concerns. https://www.medscape.com/viewarticle/926856?nlid=134607_1024&src=WNL_mdplsfeat_20 0324_mscpedit_path&uac=268487SK&spon=43&impID=2323212&faf=1 Early GI Symptoms in COVID-19 May Indicate Fecal Transmission. https://www.medscape.com/viewarticle/926682 Coronavirus May Cause Environmental Contamination Through Fecal Shedding. https://www.medscape.com/viewarticle/926390 Feco-oral route for transmission suspected: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(20)30048-0/fulltext Covid‐19 and the Digestive System. https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.15047 Rapid Expert Consultation on the Possibility of Bioaerosol Spread of SARS-CoV-2 for the COVID-19 Pandemic (April 1, 2020). https://www.nap.edu/read/25769/chapter/1 Stability of SARS-CoV-2 in different environmental conditions. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30003-3/fulltext Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. https://www.nejm.org/doi/full/10.1056/NEJMc2004973 SARS-CoV-2 viral load in upper respiratory specimens of infected patients. https://www.nejm.org/doi/full/10.1056/NEJMc2001737 Virological assessment of hospitalized patients with COVID-2019. https://www.nature.com/articles/s41586-020-2196-x Detection of SARS-CoV-2 in Different Types of Clinical Specimens. https://jamanetwork.com/journals/jama/article-abstract/2762997 Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. https://www.bmj.com/content/369/bmj.m1443 Isolation of infectious SARS-CoV-2 from urine of a COVID-19 patient. https://www.tandfonline.com/doi/full/10.1080/22221751.2020.1760144 The airborne lifetime of small speech droplets and their potential importance in SARS-CoV-2 transmission. https://www.pnas.org/content/early/2020/05/12/2006874117 Detection of SARS-CoV-2 in human breastmilk. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31181-8/fulltext Evidence for Gastrointestinal Infection of SARS-CoV-2. https://www.gastrojournal.org/article/S0016-5085(20)30282-1/fulltext Small droplet aerosols in poorly ventilated spaces and SARS-CoV-2 transmission. https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30245-9/fulltext Detectable severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human breast milk of a mildly symptomatic patient with coronavirus disease 2019 (COVID-19). https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa673/5848850 Airborne Transmission of SARS-CoV-2: Theoretical Considerations and Available Evidence. https://jamanetwork.com/journals/jama/fullarticle/2768396 Age-Related Differences in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Levels in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19). https://jamanetwork.com/journals/jamapediatrics/fullarticle/2768952 SARS-CoV-2 detection, viral load and infectivity over the course of an infection. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323671/ Temporal dynamics in viral shedding and transmissibility of COVID-19. https://www.nature.com/articles/s41591-020-0869-5 Evaluation for SARS-CoV-2 in Breast Milk From 18 Infected Women. https://jamanetwork.com/journals/jama/fullarticle/2769825

Diagnostic testing for COVID-19 Guidelines and reviews Public Health Laboratory Network Guidance on Laboratory Testing for SARS-CoV-2 https://www.health.gov.au/resources/publications/phln-guidance-on-laboratory-testing-for- sars-cov-2-the-virus-that-causes-covid-19 European Commission Guidelines on COVID-19 in vitro diagnostic tests and their performance. https://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:52020XC0415(04)&from=EN Medicines and Healthcare products Regulatory Agency (UK). Guidance on coronavirus (COVID-19) tests and testing kits. https://www.gov.uk/guidance/guidance-on-coronavirus- covid-19-tests-and-testing-kits Rapid health technology assessment of alternative diagnostic testing approaches for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). https://www.hiqa.ie/reports-and-publications/health-technology-assessment/rapid-hta- alternative-diagnostic-testing Public Health Laboratory Network Statement on Point-of-Care Serology Testing for SARS- CoV-2. https://www.health.gov.au/resources/publications/phln-statement-on-point-of-care- serology-testing-for-sars-cov-2-the-virus-that-causes-covid-19 Molecular and serological assays for SARS-CoV-2: insights from genome and clinical characteristics. https://academic.oup.com/clinchem/advance- article/doi/10.1093/clinchem/hvaa122/5841665 Molecular, serological, and biochemical diagnosis and monitoring of COVID-19: IFCC taskforce evaluation of the latest evidence. https://www.degruyter.com/view/journals/cclm/58/7/article-p1037.xml US Centers for Disease Control and Prevention - Interim Guidelines for COVID-19 Antibody Testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests- guidelines.html?fbclid=IwAR2RqNjKfypbpIZwH1JsEZHBlD- 3EDdhomaOY50dYmkopyFlTC3K4mT5TgU Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). https://www.degruyter.com/view/journals/cclm/58/7/article- p1070.xml Canadian Public Health Laboratory Network Statement on Point-of-Care Serology Testing in COVID-19. https://www.canada.ca/en/public-health/services/reports-publications/canada- communicable-disease-report-ccdr/monthly-issue/2020-46/issue-5-may-7-2020/point-care- serology-testing-covid-19.html Laboratory Diagnosis of Coronavirus Disease-2019 (COVID-19). https://www.sciencedirect.com/science/article/pii/S0009898120303090 Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19. https://www.ajicjournal.org/article/S0196-6553(20)30693-3/fulltext At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT- PCR based tests?: A systematic review of individual participant data. https://www.medrxiv.org/content/10.1101/2020.07.13.20152793v2 SARS-CoV-2 recurrent RNA positivity after recovering from coronavirus disease 2019 (COVID-19): a meta-analysis. https://www.medrxiv.org/content/10.1101/2020.07.19.20157453v1 Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705/full Genetic and molecular testing – validation and evaluation of methods Limits of Detection of Six Approved RT–PCR Kits for the Novel SARS-coronavirus-2 (SARS- CoV-2). https://academic.oup.com/clinchem/article/doi/10.1093/clinchem/hvaa099/5819547 Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens. https://jcm.asm.org/content/early/2020/04/24/JCM.00743- 20.long Performance of Abbott ID NOW COVID-19 rapid nucleic acid amplification test in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution. https://jcm.asm.org/content/early/2020/05/28/JCM.01136-20.long Clinical Validation of a SARS-CoV-2 Real-Time Reverse Transcription PCR Assay Targeting the Nucleocapsid Gene. https://academic.oup.com/jalm/advance- article/doi/10.1093/jalm/jfaa089/5850065 Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay. https://www.sciencedirect.com/science/article/abs/pii/S0166093420301774 Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT–qPCR primer–probe sets. https://www.nature.com/articles/s41564-020-0761-6 Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays. https://jcm.asm.org/content/early/2020/07/09/JCM.01535-20 Evaluation of seven commercial SARS-CoV-2 RNA detection kits based on real-time polymerase chain reaction (PCR) in China. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020- 0271/article-10.1515-cclm-2020-0271.xml Discrimination of False Negative Results in RT-PCR Detection of SARS-CoV-2 RNAs in Clinical Specimens by Using an Internal Reference. https://link.springer.com/article/10.1007/s12250-020-00273-8 Rapid Detection of SARS-CoV-2 by Low Volume Real-Time Single Tube Reverse Transcription Recombinase Polymerase Amplification Using an Exo Probe with an Internally Linked Quencher (Exo-IQ). https://academic.oup.com/clinchem/article/66/8/1047/5834714 Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS- CoV-2 RNA. https://academic.oup.com/jalm/advance- article/doi/10.1093/jalm/jfaa135/5881637 Comparison of qualitative and quantitative analyses of COVID-19 clinical samples. https://www.sciencedirect.com/science/article/pii/S0009898120304265 Genetic and molecular testing – other resources Sensitivity of Chest CT for COVID-19: Comparison to RT-PCR. https://pubs.rsna.org/doi/10.1148/radiol.2020200432 Saliva is a reliable tool to detect SARS-CoV-2. https://linkinghub.elsevier.com/retrieve/pii/S0163-4453(20)30213-9 Potential false-negative nucleic acid testing results for Severe Acute Respiratory Syndrome Coronavirus 2 from thermal inactivation of samples with low viral loads. https://academic.oup.com/clinchem/advance-article/doi/10.1093/clinchem/hvaa091/5815979 Comparison of throat swabs and sputum specimens for viral nucleic acid detection in 52 cases of novel coronavirus (SARS-Cov-2)-infected pneumonia (COVID-19). https://www.degruyter.com/view/journals/cclm/58/7/article-p1089.xml Sample Pooling as a Strategy to Detect Community Transmission of SARS-CoV-2. https://jamanetwork.com/journals/jama/fullarticle/2764364 Isolation and rapid sharing of the 2019 novel coronavirus (SARS‐CoV‐2) from the first patient diagnosed with COVID‐19 in Australia. https://www.mja.com.au/journal/2020/212/10/isolation-and-rapid-sharing-2019-novel- coronavirus-sars-cov-2-first-patient Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction– Based SARS-CoV-2 Tests by Time Since Exposure. https://www.acpjournals.org/doi/10.7326/M20-1495 Swabs Collected by Patients or Health Care Workers for SARS-CoV-2 Testing. https://www.nejm.org/doi/full/10.1056/NEJMc2016321 SARS-CoV-2 RNA identification in nasopharyngeal swabs: issues in pre-analytics. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020- 0749/article-10.1515-cclm-2020-0749.xml Impact of false-positives and false-negatives in the UK’s COVID-19 RT-PCR testing programme. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_da ta/file/895843/S0519_Impact_of_false_positives_and_negatives.pdf False Negative Tests for SARS-CoV-2 Infection — Challenges and Implications. https://www.nejm.org/doi/full/10.1056/NEJMp2015897 SARS-CoV-2 Viral Load Predicts COVID-19 Mortality. https://www.medrxiv.org/content/10.1101/2020.06.11.20128934v1 Clinical Course and Molecular Viral Shedding Among Asymptomatic and Symptomatic Patients with SARS-CoV-2 Infection in a Community Treatment Center in the Republic of Korea. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769235 SARS-CoV-2 PCR testing of skin for COVID-19 diagnostics: a case report. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31754-2/fulltext Cautionary note on contamination of reagents used for molecular detection of SARS-CoV-2. https://academic.oup.com/clinchem/advance-article/doi/10.1093/clinchem/hvaa214/5902447 Serology - validation and evaluation of methods Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. https://www.degruyter.com/view/journals/cclm/58/7/article-p1081.xml Assessment of immune response to SARS-CoV-2 with fully automated MAGLUMI 2019- nCoV IgG and IgM chemiluminescence immunoassays. https://www.degruyter.com/view/journals/cclm/58/7/article-p1156.xml Evaluation of eleven rapid tests for detection of antibodies against SARS-CoV-2. https://www.noklus.no/media/uzhkst0u/report_1-1_covid19_rapidtests_noklus_2020.pdf Evaluation of antibody testing for SARS-Cov-2 using ELISA and lateral flow immunoassays. https://www.medrxiv.org/content/10.1101/2020.04.15.20066407v1 Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence Testing in Boise, Idaho. https://jcm.asm.org/content/early/2020/05/07/JCM.00941-20 Clinical Performance of Two SARS-CoV-2 Serologic Assays. https://academic.oup.com/clinchem/advance-article/doi/10.1093/clinchem/hvaa120/5836557 Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. https://www.sciencedirect.com/science/article/pii/S1386653220301554 Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis. https://www.mdpi.com/2075-4418/10/5/319 Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data. https://www.mdpi.com/2077-0383/9/5/1515 Diagnostic performance of a SARS-CoV-2 IgG/IgM lateral flow immunochromatography assay in symptomatic patients presenting to the emergency department. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020- 0635/article-10.1515-cclm-2020-0635.xml Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020- 0594/article-10.1515-cclm-2020-0594.xml Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDITM enzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma. https://www.sciencedirect.com/science/article/pii/S0009898120302618 Clinical performance of the Elecsys electrochemiluminescent immunoassay for the detection of SARS-CoV-2 total antibodies. https://academic.oup.com/clinchem/advance- article/doi/10.1093/clinchem/hvaa131/5850401 Clinical Performance of the Roche SARS-CoV-2 Serologic Assay. https://academic.oup.com/clinchem/advance-article/doi/10.1093/clinchem/hvaa132/5850400 Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. https://www.sciencedirect.com/science/article/pii/S1386653220301979 SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays. https://www.sciencedirect.com/science/article/pii/S0009898120302680 Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays. https://www.sciencedirect.com/science/article/pii/S1386653220302225 Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2. https://jcm.asm.org/content/early/2020/06/08/JCM.01243- 20 Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 Infection. https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(20)30334-7/fulltext Meta-Analysis of Diagnostic Performance of Serological Tests for SARS-CoV-2 Antibodies up to 25 April 2020 and Public Health Implications. https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.23.2000980 Evaluation of interference effects from hemolysis, icterus and lipemia on the Roche Elecsys® Anti-SARS-CoV-2 assay. https://www.sciencedirect.com/science/article/pii/S0009898120303053 An Initial Evaluation of the Agreement Between Two SARS-CoV-2 Serologic Assays. https://academic.oup.com/jalm/article/doi/10.1093/jalm/jfaa114/5866552 Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis. https://www.bmj.com/content/370/bmj.m2516 Comparison of test performance of commercial anti-SARS-CoV-2 immunoassays in serum and plasma samples. https://www.sciencedirect.com/science/article/abs/pii/S0009898120303235 Preliminary evaluation of Roche Cobas Elecsys Anti-SARS-CoV-2 chemiluminescence immunoassay. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515- cclm-2020-1042/article-10.1515-cclm-2020-1042.xml Evaluation of an electrochemiluminescent SARS-CoV-2 antibody assay. https://academic.oup.com/jalm/article/doi/10.1093/jalm/jfaa134/5876837 Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays. https://academic.oup.com/jalm/article/doi/10.1093/jalm/jfaa125/5876836 Evaluation of Three Commercial Automated Assays for the Detection of anti-SARS-CoV-2 Antibodies. https://academic.oup.com/clinchem/advance- article/doi/10.1093/clinchem/hvaa193/5881629 Evaluation of three fully-automated SARS-CoV-2 antibody assays. https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020- 0975/article-10.1515-cclm-2020-0975.xml 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