Haeri Mazanderani Ahmad, Moyo Faith, Sherman Gayle G
Centre for HIV & STIs, National Institute for Communicable Diseases, Johannesburg, South Africa.
Department of Medical Virology, University of Pretoria, Pretoria, South Africa.
PLoS One. 2017 May 11;12(5):e0177173. doi: 10.1371/journal.pone.0177173. eCollection 2017.
Samples submitted for HIV PCR testing that fail to yield a positive or negative result represent missed diagnostic opportunities. We describe HIV PCR test rejections and indeterminate results, and the associated delay in diagnosis, within South Africa's early infant diagnosis (EID) program from 2010 to 2015.
HIV PCR test data from January 2010 to December 2015 were extracted from the National Health Laboratory Service Corporate Data Warehouse, a central data repository of all registered test-sets within the public health sector in South Africa, by laboratory number, result, date, facility, and testing laboratory. Samples that failed to yield either a positive or negative result were categorized according to the rejection code on the laboratory information system, and descriptive analysis performed using Microsoft Excel. Delay in diagnosis was calculated for patients who had a missed diagnostic opportunity registered between January 2013 and December 2015 by means of a patient linking-algorithm employing demographic details.
Between 2010 and 2015, 2 178 582 samples were registered for HIV PCR testing of which 6.2% (n = 134 339) failed to yield either a positive or negative result, decreasing proportionally from 7.0% (n = 20 556) in 2010 to 4.4% (n = 21 388) in 2015 (p<0.001). Amongst 76 972 coded missed diagnostic opportunities, 49 585 (64.4%) were a result of pre-analytical error and 27 387 (35.6%) analytical error. Amongst 49 694 patients searched for follow-up results, 16 895 (34.0%) had at least one subsequent HIV PCR test registered after a median of 29 days (IQR: 13-57), of which 8.4% tested positive compared with 3.6% of all samples submitted for the same period.
Routine laboratory data provides the opportunity for near real-time surveillance and quality improvement within the EID program. Delay in diagnosis and wastage of resources associated with missed diagnostic opportunities must be addressed and infants actively followed-up as South Africa works towards elimination of mother-to-child transmission.
提交进行HIV PCR检测的样本若未得出阳性或阴性结果，则意味着错失诊断机会。我们描述了2010年至2015年南非早期婴儿诊断（EID）项目中HIV PCR检测的拒收情况和不确定结果，以及与之相关的诊断延迟。
从国家卫生实验室服务机构企业数据仓库中提取2010年1月至2015年12月的HIV PCR检测数据，该仓库是南非公共卫生部门所有注册检测集的中央数据存储库，提取信息包括实验室编号、结果、日期、机构和检测实验室。未得出阳性或阴性结果的样本根据实验室信息系统上的拒收代码进行分类，并使用Microsoft Excel进行描述性分析。对于2013年1月至2015年12月期间有错失诊断机会记录的患者，通过采用人口统计学细节的患者关联算法计算诊断延迟。
2010年至2015年期间，共有2178582个样本进行了HIV PCR检测，其中6.2%（n = 134339）未得出阳性或阴性结果，从2010年的7.0%（n = 20556）按比例下降至2015年的4.4%（n = 21388）（p<0.001）。在76972例编码的错失诊断机会中，49585例（64.4%）是分析前误差导致的，27387例（35.6%）是分析误差导致的。在49694例被查找后续结果的患者中，16895例（34.0%）在中位数为29天（四分位间距：13 - 57天）后至少进行了一次后续HIV PCR检测，其中8.4%检测呈阳性，而同期提交的所有样本中这一比例为3.6%。
常规实验室数据为EID项目中的近实时监测和质量改进提供了机会。随着南非努力消除母婴传播，必须解决与错失诊断机会相关的诊断延迟和资源浪费问题，并积极对婴儿进行随访。
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