Ensuring accurate testing for human immunodeficiency virus in Myanmar

Abstract

ProblemUntil 2005, the quality of rapid diagnostic human immunodeficiency virus (HIV) testing was not monitored and no regular technical support was provided to hospital laboratories in Myanmar.ApproachThe national reference laboratory introduced a national external quality assessment scheme. The scheme involved (i) training laboratory technicians in HIV testing and in the requirements of the quality assessment system; (ii) implementing a biannual proficiency panel testing programme; (iii) on-site assessments of poorly-performing laboratories to improve testing procedures; and (iv) development of national guidelines.Local settingIn 2011, a total of 422 public hospitals in Myanmar had laboratories providing HIV tests. In addition, private laboratories supported by nongovernmental organizations (NGOs) conducted HIV testing.Relevant changesThe scheme was started in 65 public laboratories in 2005. In 2012, it had expanded nationwide to 347 laboratories, including 33 NGO laboratories. During the expansion of the scheme, laboratory response rates were greater than 90% and the proportion of laboratories reporting at least one aberrant result improved from 9.2% (6/65) in 2005 to 5.4% (17/316) in 2012.Lessons learntNational testing guidelines and a reference laboratory are needed to successfully implement quality assurance of HIV testing services. On-site assessments are crucial for all participating laboratories and the only source for insight on the causes of aberrant results; lessons that the reference laboratory can share nationally. Proficiency testing helps laboratory technicians to maintain HIV testing skills by ensuring that they regularly encountered HIV-positive samples.

To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status

“…Most studies were carried out in Africa ( n  = 48) [5,7,10–14,16,22–25,29,30,32–34,36,37,39,41,43,44,46,47,49,51,52,54–59,61–65,67–72,74,75], followed by in the Americas ( n  = 7) [28,31,42,50,53,60,66], Asia ( n  = 4) [8,35,45,73] and Europe ( n  = 1) [48]. There were also four multi-country/regional studies [26,27,38,40].…”

“…Thirty-seven studies reported using a suboptimal testing strategy that differed from the WHO recommendations [5,8,11–14,16,22–30,32–34,36–39,42–44,49,51,53,59,62,64–66,68,72,75]. Suboptimal testing strategies included using a highly specific first-line test and highly sensitive second-line test [14,33,39,55], using a single RDT for HIV-positive diagnoses [11,66,72], using a high prevalence testing strategy in a low prevalence setting [16,49], using a parallel testing algorithms and a tiebreaker testing strategy (where a third assay is used to resolve discrepant test results and rule in HIV infection) [5,12,13,16,24,25,27–30,32,34,36,37,68].…”

“…User errors, incorrectly performing the test procedure or incorrectly interpreting results, defined as human errors, were reported in 25 studies [7,8,11,14,26–28,31,33,34,37,40,42,46,52,54,57,60,65–68,70,72,73]. Errors identified included users having difficulty with specimen collection [14,28,68], performing RDTs [31,73], interpreting test results [10,24,27,30,32,40,42,48,62,65,66,74], reading test results too early [7] and not using the correct reagents/buffer [7].…”

“…Sixteen studies reported clerical errors [8,11,26,28,29,31,34,35,45,50,63–65,67,73,75]. Errors included poor record-keeping [35], data reporting problems, labelling and transcription mistakes [73] and specimen mix-ups.…”

“…the exact tests used within the testing strategy) according to high (≥5%) and low HIV prevalence (<5%), as recommended by the World Health Organization (WHO) [4–6]. Recent reports, however, have shown that HIV testing is not always conducted appropriately [7,8], and in some countries, quality systems have not kept pace with testing scale-up. According to a review of national HIV testing policies, less than 20% of testing strategies were consistent with WHO guidance, and only two included recommendations on retesting prior to the initiation of antiretroviral therapy (ART) [9].…”