Background Human immunodeficiency virus (HIV) rapid diagnostic tests (RDTs) are widely used. However, buffer stockouts commonly lead to utilising non-approved liquids, resulting in errors. Our aim was to evaluate the diagnostic accuracy of an alternative buffer. Methods Paired Determine HIV-1/2 rapid tests with commercial buffer and locally produced 0.01M phosphate-buffered saline (PBS) were performed on consecutive consenting individuals requiring HIV testing. Serum samples were sent for confirmation through the local gold-standard algorithm (Murex HIV Ag/Ab, Hexagon HIV with/without Geenius HIV 1/2). Test accuracy, κ and exact McNemar's test were also carried out. Results Of 167 participants, 137 had confirmatory testing. The sensitivity of the Determine HIV-1/2 test using PBS compared with the gold standard was 100% (95% confidence interval [CI] 90.5 to 100) with a specificity of 98% (95% CI 92.9 to 99.8). The κ value was 0.94 compared with the gold standard and 0.92 compared with the Determine HIV-1/2 test using the commercial buffer. McNemar's test showed no evidence of differing sensitivities. Due to operational constraints, the study included 37 of the 49 positive cases as determined by the sample size calculation, resulting in an attained power of 80% instead of the intended 90%. Conclusions These results suggest that 0.01M PBS is an alternative solution for Determine HIV-1/2 when buffer stockouts occur.

中文翻译：

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使用冈比亚医学研究委员会部门生产的 0.01M 磷酸盐缓冲盐水评估 Define™ HIV-1/2 快速检测用于诊断 HIV 的敏感性和特异性

背景 人类免疫缺陷病毒（HIV）快速诊断测试（RDT）被广泛使用。然而，缓冲液缺货通常会导致使用未经批准的液体，从而导致错误。我们的目的是评估替代缓冲液的诊断准确性。方法 使用商业缓冲液和本地生产的 0.01M 磷酸盐缓冲盐水 (PBS) 对连续同意的需要 HIV 检测的个体进行配对确定 HIV-1/2 快速检测。血清样本通过当地金标准算法（Murex HIV Ag/Ab、带/不带 Geenius HIV 1/2 的 Hexagon HIV）进行确认。还进行了测试精度、κ 和精确 McNemar 测试。结果 167 名参与者中，137 人进行了确认性检测。与金标准相比，使用 PBS 确定 HIV-1/2 测试的敏感性为 100%（95% 置信区间 [CI] 90.5 至 100），特异性为 98%（95% CI 92.9 至 99.8）。与金标准相比，κ 值为 0.94，与使用商业缓冲液的确定 HIV-1/2 测试相比，κ 值为 0.92。麦克尼马尔的测试没有显示出不同敏感性的证据。由于操作限制，该研究纳入了样本量计算确定的 49 个阳性病例中的 37 个，结果达到了 80%，而不是预期的 90%。结论 这些结果表明，当发生缓冲液缺货时，0.01M PBS 是测定 HIV-1/2 的替代解决方案。