Mwangala Sheila, Musonda Kunda G, Monze Mwaka, Musukwa Katoba K, Fylkesnes Knut
Virology Laboratory, Department of Pathology and Microbiology, University Teaching Hospital, Lusaka, Zambia.
Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
PLoS One. 2016 Jan 8;11(1):e0146700. doi: 10.1371/journal.pone.0146700. eCollection 2016.
Despite rapid task-shifting and scale-up of HIV testing services in high HIV prevalence countries, studies evaluating accuracy remain limited. This study aimed to assess overall accuracy level and factors associated with accuracy in HIV rapid testing in Zambia.
Accuracy was investigated among rural and urban HIV testing sites participating in two annual national HIV proficiency testing (PT) exercises conducted in 2009 (n = 282 sites) and 2010 (n = 488 sites). Testers included lay counselors, nurses, laboratory personnel and others. PT panels of five dry tube specimens (DTS) were issued to testing sites by the national reference laboratory (NRL). Site accuracy level was assessed by comparison of reported results to the expected results. Non-parametric rank tests and multiple linear regression models were used to assess variation in accuracy between PT cycles and between tester groups, and to examine factors associated with accuracy respectively.
Overall accuracy level was 93.1% (95% CI: 91.2-94.9) in 2009 and 96.9% (95% CI: 96.1-97.8) in 2010. Differences in accuracy were seen between the tester groups in 2009 with laboratory personnel being more accurate than non-laboratory personnel, while in 2010 no differences were seen. In both PT exercises, lay counselors and nurses had more difficulties interpreting results, with more occurrences of false-negative, false-positive and indeterminate results. Having received the standard HIV rapid testing training and adherence to the national HIV testing algorithm were positively associated with accuracy.
The study showed an improvement in tester group and overall accuracy from the first PT exercise to the next. Average number of incorrect test results per 1000 tests performed was reduced from 69 to 31. Further improvement is needed, however, and the national HIV proficiency testing system seems to be an important tool in this regard, which should be continued and needs to be urgently strengthened.
尽管在艾滋病病毒高流行国家，艾滋病病毒检测服务迅速进行任务转移并扩大规模，但评估检测准确性的研究仍然有限。本研究旨在评估赞比亚艾滋病病毒快速检测的总体准确性水平以及与准确性相关的因素。
在参与2009年（n = 282个检测点）和2010年（n = 488个检测点）举行的两次年度全国艾滋病病毒能力验证检测（PT）活动的农村和城市艾滋病病毒检测点中调查准确性。检测人员包括外展咨询员、护士、实验室工作人员及其他人员。国家参考实验室（NRL）向检测点发放包含五个干管标本（DTS）的PT检测板。通过将报告结果与预期结果进行比较来评估检测点的准确性水平。使用非参数秩检验和多元线性回归模型分别评估PT周期之间以及检测人员组之间准确性的差异，并检查与准确性相关的因素。
2009年总体准确性水平为93.1%（95%可信区间：91.2 - 94.9），2010年为96.9%（95%可信区间：96.1 - 97.8）。2009年不同检测人员组之间存在准确性差异，实验室工作人员比非实验室工作人员更准确，而2010年未发现差异。在两次PT活动中，外展咨询员和护士在解读结果方面困难更大，出现假阴性、假阳性和不确定结果的情况更多。接受标准的艾滋病病毒快速检测培训并遵循国家艾滋病病毒检测算法与准确性呈正相关。
该研究表明从第一次PT活动到下一次，检测人员组及总体准确性均有提高。每1000次检测中错误检测结果的平均数量从69减少到31。然而，仍需要进一步改进，国家艾滋病病毒能力验证检测系统似乎是这方面的一个重要工具，应继续开展并亟需加强。
