Paediatric HIV Diagnostics Division, Wits Health Consortium, Johannesburg, South Africa.
Centre for HIV & STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Pathology, Faculty of Health Sciences, University of Limpopo, Polokwane, South Africa.
Clin Microbiol Infect. 2022 Apr;28(4):609.e7-609.e13. doi: 10.1016/j.cmi.2021.08.002. Epub 2021 Aug 13.
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.
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.
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).
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.
我们描述了 2010 年至 2019 年期间南非早期婴儿诊断（EID）计划中不确定 HIV-PCR 结果和最终 HIV 状态的程度和相关变量。
对 2010 年至 2019 年期间南非国家卫生实验室服务数据仓库中常规儿科 HIV-PCR 实验室数据进行回顾性分析。通过使用概率匹配算法将患者的结果（包括 HIV-PCR、HIV 病毒载量、HIV 血清学和 CD4 计数）进行关联，以确定最终的 HIV 状态。对不确定 HIV-PCR 结果患者的最终 HIV 状态进行多变量逻辑回归分析。
在对来自 3 816 166 名患者的 4 429 742 份 HIV-PCR 检测标本进行登记中，113 209 份（2.97%）检测结果为阳性，22 899 份（0.6%）检测结果为不确定。作为 HIV 检测结果的比例，<7 天、7 天至 3 个月和≥3 个月的患者中，总人数的 15.7%（23 896/151 832）和 31.5%（4900/15 566）、分别为 18.8%（11 400/60 794）和 10.1%（7596/75 472）的结果被报告为不确定。总体而言，39.7%的不确定结果患者进行了 HIV 检测以确定 HIV 状态，其中 53.6%为阳性，重复检测的中位数时间为 30 天（四分位距 15-69）。在不确定检测的患者中，与 HIV 阳性状态的可能性显著增加相关的变量包括在出生时检测不确定（调整后的优势比（AOR）为 0.63（0.48-0.83）和 0.52（0.39-0.69），分别在 7 天至 3 个月和≥3 个月时检测不确定与出生时相比）、在医院内（AOR 2.45（1.99-3.03））和宫内传播率≥1.1%的地区（AOR 3.14（1.84-5.35））（p<0.001）。
在南非的 EID 计划中，不确定的 HIV-PCR 结果代表了相当大的漏诊机会、诊断困境和 HIV 感染婴儿明确诊断的延迟。迫切需要替代的 EID 验证实践。
