Would CLSI M53-A have helped in the diagnosis of HIV in Canada? Results of the performance of Canadian laboratories participating in a recent NLHRS proficiency testing panel containing HIV-1 antigen positive (antibody negative) and HIV-2 samples

• Published in: Journal of clinical virology 2013-09, Vol.58 (1), p.303-305
• Main Authors: Kadivar, K, Malloch, L, Adonsou-Hoyi, Y, Ng, D, Lavoie, S, Pulido, K, Kim, J
• Format: Article
• Language: English
• Subjects: Algorithm; Algorithms; Allergy and Immunology; Canada; Clinical Laboratory Techniques - methods; CLSI; Guideline; HIV; HIV Infections - diagnosis; HIV Infections - virology; HIV-1 - isolation & purification; HIV-2 - isolation & purification; Humans; Infectious Disease; Laboratory Proficiency Testing; M53; New tests; Practice Guidelines as Topic; Virology - methods
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2013.04.009

Abstract Introduction The Clinical and Laboratory Standards Institute recently published M53-A, Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus ( HIV ) Infection ; Approved Guideline (2011), which includes a state of the art algorithm for identifying HIV-1 acute and HIV-2 infections. To assess the ability of Canadian laboratories to detect these sample types and the impact of M53-A, the National Laboratory for HIV Reference Services distributed a special proficiency testing panel. Methods HIVS425-2012Nov22 was sent to 42 laboratories across Canada. It contained one HIV negative sample (B), two HIV-1 positive samples (A and E), one HIV-2 positive sample (C) and one HIV-1/2 antibody negative-HIV-1 antigen positive sample (D). Data was collected and analyzed using DigitalPT; a standardized on-line tool. Results Forty-one laboratories returned results. Sample B (HIV negative) was identified by 95% of laboratories (39/41) and samples A and E (HIV-1 positive) by 98% (40/41). No laboratory identified sample C as HIV-2 positive, although 85% (35/41) detected reactivity prompting a referral for further testing. The remaining laboratories identified sample C as HIV-1 positive (4), indeterminate (1) or gave no final status (1). Sample D (HIV antibody negative-antigen positive) was correctly identified by two laboratories as HIV-1 antigen positive while 78% (32/41) detected reactivity, recommending further testing. One laboratory did not provide a final status. Alarmingly, six laboratories called this sample HIV negative. Conclusion Although there is a high quality of HIV testing across Canada, introduction of the M53-A guideline would further improve the ability of laboratories to diagnose HIV-1 acute and HIV-2 infection.