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Guidelines for Virological and Non-Viral Serological Examination Of 1 J Clin Pathol: first published as 10.1136/jcp.57.1.1 on 23 December 2003. Downloaded from Best Practice No 175 Guidelines for virological and non-viral serological examination of specimens in routine diagnostic microbiological laboratories J Francis, S P Barrett, M M Ogilvie, S Sutherland ............................................................................................................................... J Clin Pathol 2004;57:1–5 Viral examination is routinely carried out in most routine specialist centres should preferably be active in research in relevant diagnostic fields and should diagnostic microbiology laboratories. Most often, this be able to provide specialist services and exper- comprises the detection of viral antigens and antibodies, tise relevant to local needs. Smaller units with and less commonly the isolation of viruses and the single handed consultant virologists also exist; both centres and units have recently formed the detection of viral nucleic acids. However, there are no UK Clinical Virology Network and recommended standards or guidelines available for processing these a strategy for clinical virology in the UK (http:// specimens in routine diagnostic laboratories or for referral www.clinical-virology.org). All virology services, irrespective of site, should to specialist virology centres or units. Clinical Pathology provide timely reports of primary screening and, Accreditation (CPA) has defined standards for assessing if undertaken, timely confirmatory testing. They the quality of service provided by laboratories, but these do should be consultant led and provide 24 hour clinical support for the interpretation of results, not include the scientific and technical aspects of provision patient management, antiviral treatment, virol- of service. The Association of Medical Microbiologists has ogy support for occupational health, and control recently published Standards for Laboratory practice in of infection activity in the local provider unit(s). medical microbiology, which covers scientific and technical aspects of provision of microbiology service, mainly PROVISION OF VIROLOGY SERVICE Standard http://jcp.bmj.com/ bacteriological examination of specimens in routine Virological services should be available in the diagnostic microbiology laboratories. These guidelines are laboratory itself or by arrangement with another complementary to the CPA guidelines and aim to ensure a laboratory. An on call service should be provided. consistent and high quality service. This article presents Criteria guidelines for the examination of specimens for the N The service should be tailored to the number diagnosis of viral infections. and type of clinical units served by the on September 24, 2021 by guest. Protected copyright. hospital. The staff providing the service ........................................................................... should be appropriately trained and continu- ally updated. irological examination is routinely carried N All antenatal clinics should have easy access out in most diagnostic microbiology labora- to the full range of viral screening tests. tories. Most often this comprises the V N All tertiary units with organ transplant detection of viral antigens and antibodies, and services, or regional neonatal units, should less commonly the isolation of viruses and the have facilities readily available for culture, detection of viral nucleic acids. Nowadays, some virus detection, nucleic acid detection, and of these virological investigations are carried out serological testing. by experienced biomedical staff in routine See end of article for N An out of hours virology service should be authors’ affiliations diagnostic microbiology laboratories. However, available. This should include clinical advice ....................... some virological diagnostic procedures/tests and interpretation of results. Correspondence to: require expertise that is only available in Dr J Francis, Department of specialist virology centres or units (including N If the test is not available on site, there should Microbiology, Rotherham some reference laboratories or academic research be arrangements with another laboratory, General Hospitals NHS normally a specialist virology centre, for the Trust, Moorgate road, units). Rotherham S60 2UD, UK; Specialist virology centres are directed by josephine.francis@ clinically qualified, professionally trained, con- ................................................... rothgen.nhs.uk sultant virologists. These specialist centres are Abbreviations: HBsAg, hepatitis B surface antigen; HBV/ Accepted for publication accredited for the provision of a comprehensive HCV, hepatitis B/C virus; HIV, human immunodeficiency 27 June 2003 diagnostic virology service and for training of virus; NEQAS, National External Quality Assessment ....................... both clinical and scientific laboratory staff. These Scheme; VZV, varicella zoster virus www.jclinpath.com 2 Francis, Barrett, Ogilvie, et al provision of virological tests and out of hours service. See helpful.6 Notification of epidemiologically relevant findings to tests available, appendices A and B. local and regional public health should be prompt. J Clin Pathol: first published as 10.1136/jcp.57.1.1 on 23 December 2003. Downloaded from Criteria COLLECTION AND TRANSPORT OF SPECIMENS N Rapid turnaround times for viral serology may be affected Standard by financial constraints because of the need to ensure The specimens should be collected, transported, and stored in appropriate batch sizes. Cost benefit should be taken into a manner that will guarantee the best possible results within account and documented in a locally agreed protocol. the testing systems available (appendix C).1–3 N Emergency (or urgent) specimens: these should be tested immediately and the first results should be available in Criteria two to three hours. N The nature of the specimen and timing of its collection N Priority specimens: these should be tested on the same day as should be appropriate, and details of date of collection of receipt of the specimen and results should usually be available the specimen, and relevant clinical data including any in 24–36 hours (for example, immunity to varicella). antiviral chemotherapy should be documented. N Routine specimens: these are processed according to set N Swab specimens for viral culture should be transported in laboratory protocols in which the frequency of testing appropriate viral transport medium and should comply should be clearly documented. with local protocols. All samples should be transported safely. N By automating methods, the need for processing speci- mens in a batch is reduced and allows for more flexibility N Specimens for culture should be held at least until the and improved turnaround times. final report has been sent out. These specimens should be stored at 270˚C, except urine for cytomegalovirus, which N Infrequent requests should be referred to laboratories that should be kept at 4˚C. perform such tests more often to ensure a more rapid and cost effective service. N Serum (or plasma) should be stored at 220˚C unless nucleic aciddetectionisrequiredsuchasforhepatitisCvirus(HCV) N Urgent and clinically relevant results should be commu- or human immunodeficiency virus (HIV) viral load, in which nicated within the same working day, preferably by case 270˚C is recommended. Antenatal sera from pregnant telephone, in accordance with local protocol. women should be stored for at least one year.4 N Epidemiologically significant results should be reported to local consultant in communicable disease control/consul- tant in public health medicine and to Communicable METHODS FOR VIRAL DIAGNOSIS/SCREENING Disease Surveillance Centre/Scottish Centre for Infection Standard and Environmental Health in a timely manner. The methods used for the detection of viral antigens, nucleic acids, or antibodies should be as sensitive and specific as feasible.5 STORAGE OF SPECIMENS AND DATA Standard Criteria The rules regarding storage of data or specimens should be clearly documented in a written protocol.478 N Methods used to screen donors (of organs, cells, or tissues) http://jcp.bmj.com/ should be highly sensitive and thus require careful selection, particularly for emergency work. It should be Criteria ensured that the need for speed does not compromise the N Department of Health recommendations for personal sensitivity of the method. health records HC(89)20 and HSG(94)11 require the N HIV testing requires high specificity and all results found storage of information in patient notes until their 25th to be positive by screening methods should have at least birthday for children and for a period of eight years for two confirmatory tests. A second sample should be adults. Maternity records should be retained for 25 years. on September 24, 2021 by guest. Protected copyright. requested for repeat testing. Testing for the other serious N Because it is impracticable for laboratories to store even bloodborne viruses (HBV and HCV) requires similar care some of the results for 25 years, there should be provision in the confirmation of positive results. to ensure that the reports reach the patient’s notes. N Commercially available kits should be selected according N Whether on paper or electronically transferred, all to the following criteria: requests, reports, and test performance results should be stored for as long as space permits, but at least for the – good performance in formal comparative evaluation period
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