Choko Augustine T, Taegtmeyer Miriam, MacPherson Peter, Cocker Derek, Khundi McEwen, Thindwa Deus, Sambakunsi Rodrick S, Kumwenda Moses K, Chiumya Kondwani, Malema Owen, Makombe Simon D, Webb Emily L, Corbett Elizabeth L
TB and HIV theme, Malawi Liverpool Wellcome Trust, Blantyre, Malawi.
Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
PLoS One. 2016 Jun 23;11(6):e0158107. doi: 10.1371/journal.pone.0158107. eCollection 2016.
To evaluate the effect of storing commonly used rapid diagnostic tests above manufacturer-recommended temperature (at 37°C), and the accuracy of delayed reading of oral fluid kits with relevance to HIV self-testing programmes.
A quality assurance study of OraQuick (OraSure), Determine HIV 1/2™ (Alere) and Uni-Gold™ (Recombigen®).
Consecutive adults (≥18y) attending Ndirande Health Centre in urban Blantyre, Malawi in January to April 2012 underwent HIV testing with two of each of the three rapid diagnostic test kits stored for 28 days at either 18°C (optimally-stored) or at 37°C (pre-incubated). Used OraQuick test kits were stored in a laboratory for delayed day 1 and subsequent monthly re-reading was undertaken for one year.
Of 378 individuals who underwent parallel testing, 5 (1.3%) were dropped from the final analysis due to discordant or missing reference standard results (optimally-stored Determine and Uni-Gold). Compared to the diagnostic reference standard, OraQuick had a sensitivity of 97.2% (95% CI: 93.6-99.6). There were 7 false negative results among all test kits stored at 37°C and three false negatives among optimally stored kits. Excellent agreement between pre-incubated tests and optimally-stored tests with Kappa values of 1.00 for Determine and Uni-Gold; and 0.97 (95% CI: 0.95; 1.00) for OraQuick were observed. There was high visual stability on re-reading of OraQuick, with only 1/375 pre-incubated and 1/371 optimally-stored OraQuick kits changing from the initial result over 12 months.
Erroneous results observed during HIV testing in low income settings are likely to be due to factors other than suboptimal storage conditions. Re-reading returned OraQuick kits may offer a convenient and accurate quality assurance approach, including in HIV self-testing programmes.
评估将常用快速诊断检测试剂存储于高于制造商推荐温度（37°C）的环境下的影响，以及与HIV自我检测项目相关的口腔液体检测试剂盒延迟判读的准确性。
对奥芮可（OraSure）、Determine HIV 1/2™（Alere）和优利康（Uni-Gold™，Recombigen®）进行质量保证研究。
2012年1月至4月期间，连续有成年患者（≥18岁）前往马拉维布兰太尔市城区的恩迪兰德健康中心，使用三种快速诊断检测试剂盒中的两种进行HIV检测，每种试剂盒各两份，分别在18°C（最佳存储温度）或37°C（预孵育温度）下存储28天。使用过的奥芮可检测试剂盒在实验室存储，第1天进行延迟判读，随后在一年时间里每月重新判读一次。
在378名接受平行检测者中，5人（1.3%）因参考标准结果不一致或缺失而被排除在最终分析之外（最佳存储条件下的Determine和优利康）。与诊断参考标准相比，奥芮可的灵敏度为97.2%（95%CI：93.6 - 99.6）。在所有存储于37°C的检测试剂盒中有7例假阴性结果，在最佳存储条件下的试剂盒中有3例假阴性结果。预孵育检测与最佳存储条件下检测之间一致性良好，Determine和优利康的Kappa值为1.00；奥芮可的Kappa值为0.97（95%CI：0.95；1.00）。重新判读奥芮可时视觉稳定性高，在12个月期间，预孵育的奥芮可检测试剂盒中只有1/375、最佳存储条件下的奥芮可检测试剂盒中只有1/371的结果与初始结果不同。
在低收入环境下进行HIV检测时观察到的错误结果可能是由存储条件欠佳以外的因素导致的。重新判读回收的奥芮可检测试剂盒可能提供一种方便且准确的质量保证方法，包括在HIV自我检测项目中。
