背景:人类免疫缺陷病毒(HIV)快速诊断测试(RDTs)被广泛使用。然而,缓冲库存通常导致使用未经批准的液体,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:配对测定使用商业缓冲液和本地生产的0.01M磷酸盐缓冲盐水(PBS)对连续同意需要HIV检测的个体进行HIV-1/2快速检测。血清样本通过当地金标准算法(MurexHIVAg/Ab,带有/不带有GeeniusHIV的六边形HIV1/2)。测试精度,还进行了κ和精确的McNemar测试。
结果:在167名参与者中,137进行了验证性测试。与金标准相比,使用PBS进行的DetermineHIV-1/2测试的灵敏度为100%(95%置信区间[CI]90.5至100),特异性为98%(95%CI92.9至99.8)。与黄金标准相比,κ值为0.94,与使用商业缓冲液的DeterminationHIV-1/2测试相比为0.92。McNemar的测试没有显示不同敏感性的证据。由于操作限制,该研究包括根据样本量计算确定的49例阳性病例中的37例,导致获得的功率为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,0.01MPBS是确定HIV-1/2的替代解决方案。
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.
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.
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%.
These results suggest that 0.01M PBS is an alternative solution for Determine HIV-1/2 when buffer stockouts occur.