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

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.

Keywords: APHL; Ab; Ag; Algorithm; Association of Public Health Laboratories; CDC; CE; CLSI; Centers for Disease Control and Prevention; Clinical and Laboratory Standards Institute; DNA; EIA; European conformity; FDA; Food and Drug Administration; GS; Guideline; HIV; INNO-LIA HIV I/II score; Ind; Inno-LIA; LSR; M53; N/T; NLHRS; National Laboratory for HIV Reference Services; New tests; PCR; Pos; RIPA; RNA; WB; Western blot; antibody; antigen; deoxyribonucleic acid; enzyme immunoassay; genetic systems; human immunodeficiency virus; indeterminate; lab-specific report; not tested; polymerase chain reaction; positive; radioimmunoprecipitation assay; ribonucleic acid.