Objectives

We describe the extent of, and variables associated with, indeterminate HIV-PCR results and final HIV status within South Africa's early infant diagnosis (EID) programme between 2010 and 2019.

Methods

Retrospective analysis of routine paediatric HIV-PCR laboratory data from South Africa's National Health Laboratory Service Data Warehouse between 2010 and 2019. Final HIV status was determined by linking patient results (including HIV-PCR, HIV viral load, HIV serology and CD4 counts) using a probabilistic matching algorithm. Multivariate logistic regression was performed to determine variables associated with final HIV status among patients with an indeterminate HIV-PCR result.

Results

Among 4 429 742 specimens registered for HIV-PCR testing from 3 816 166 patients, 113 209 (2.97%) tested positive and 22 899 (0.6%) tested indeterminate. As a proportion of HIV-detected results, 15.7% (23 896/151 832) of total and 31.5% (4900/15 566), 18.8% (11 400/60 794) and 10.1% (7596/75 472) among patients aged <7 days, 7 days–3 months and ≥3 months, respectively, were reported as indeterminate. Overall, 39.7% of patients with an indeterminate result had a linked HIV test to determine HIV status, of which 53.6% were positive with a median time to repeat testing of 30 days (interquartile range 15–69). Among patients who tested indeterminate, variables associated with a significantly higher odds of having a positive HIV status included testing indeterminate at birth (adjusted odds ratio (AOR) 0.63 (0.48–0.83) and 0.52 (0.39–0.69) for testing indeterminate at 7 days–3 months and ≥3 months respectively compared with birth), within a hospital (AOR 2.45 (1.99–3.03)), and in districts with an intra-uterine transmission rate ≥1.1% (AOR 3.14 (1.84–5.35)) (p < 0.001).

Discussion

Indeterminate HIV-PCR results represent a considerable burden of missed diagnostic opportunities, diagnostic dilemmas and delays in making a definite diagnosis among HIV-infected infants within South Africa's EID programme. Alternative EID verification practices are urgently needed.

中文翻译：

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2010-2019 年南非早期婴儿诊断计划中不确定的 HIV PCR 结果

目标

我们描述了 2010 年至 2019 年间南非早期婴儿诊断 (EID) 计划中不确定的 HIV-PCR 结果和最终 HIV 状态的程度和相关变量。

方法

对 2010 年至 2019 年间来自南非国家卫生实验室服务数据仓库的常规儿科 HIV-PCR 实验室数据进行回顾性分析。最终 HIV 状态是通过将患者结果（包括 HIV-PCR、HIV 病毒载量、HIV 血清学和 CD4 计数）联系起来确定的一种概率匹配算法。进行多变量逻辑回归以确定与 HIV-PCR 结果不确定的患者最终 HIV 状态相关的变量。

结果

在来自 3 816 166 名患者的 4 429 742 份登记进行 HIV-PCR 检测的样本中，113 209 份（2.97%）检测呈阳性，22 899 份（0.6%）检测不确定。作为 HIV 检测结果的比例，患者总数的 15.7% (23 896/151 832) 和 31.5% (4900/15 566)、18.8% (11 400/60 794) 和 10.1% (7596/75 472)年龄<7 天、7 天-3 个月和≥3 个月分别被报告为不确定。总体而言，39.7% 的结果不确定的患者进行了相关的 HIV 检测以确定 HIV 状态，其中 53.6% 为阳性，中位重复检测时间为 30 天（四分位数范围 15-69）。在检测不确定的患者中，与显着更高的 HIV 阳性几率相关的变量包括出生时检测不确定（调整优势比 (AOR) 0.63 (0.48–0.83) 和 0.52 (0.39–0.

讨论

不确定的 HIV-PCR 结果代表了在南非 EID 计划中对 HIV 感染婴儿的错过诊断机会、诊断困境和延迟做出明确诊断的巨大负担。迫切需要替代的 EID 验证实践。