输血医学环境中快速诊断测试算法的评估

M. Coulibaly, B. Maiga, D. Samaké, M. Diawara, M. Traoré, Valentin Sagara, B. Traoré, O. Guindo, A. Dolo
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引用次数: 1

摘要

背景:在资源有限的情况下,快速诊断测试在筛选血液中的病毒标志物以获得输血资格方面发挥着关键作用。因此,重要的是要评估其分析性能,以确保其正常运行。材料和方法:我们通过连续招募进行了一项横断面研究,以评估使用ELISA作为参考测试的快速诊断测试算法的诊断价值。本研究共招募了661名献血者的血液。由两位双盲生物技术专家对每个样本进行快速诊断测试(RDT)和ELISA测试。在病例报告表上收集数据并在Microsoft Excel中捕获,然后导入文件并使用4.0.3版R软件进行分析。结果:表1总结了算法的诊断准确性。HIV算法的内部有效性参数如下:敏感性(sens)为99.0%(95%CI=97.899.5);特异性(spec)98.3%(95%CI=90.999.7);阳性似然比(PLR)57.4(95%可信区间为8.2401.0);负似然比(NLR)0.01(95%CI=0.0005,0.02);诊断奇数比(DOR)4710。HBV-Ag/Ab-RDTs的诊断准确率为99.7%(95%CI=98.399.9);规格98.8%(95%置信区间=96.9,95.5);PLR 81.8(95%CI=30.9217.0);NLR 0.003(95%CI=0.0004,0.02);DOR 14110。HCV-Ab-RDTs的分析性能如下:敏感度98.7%(95%CI=97.5,99.4);规格93.1%(95%CI=78.0,98.1);PLR 14.3(95%CI=3.8,54.5);NLR 1.5(95%CI=0.8,2.8);或962.6。当理论流行率为5%时,评估三种病毒标志物RDT筛选的外部有效性的参数总结在图3中。在相同的流行率下,我们发现HIV Ag/Ab RDTs、HBV Ag-RDTs和HCV Ab-RDTs算法的阳性预测值(PPV)分别为70.82%、77.59%和37.35%。接收操作特性(ROC)曲线下的总面积分别为98.6%、99.2%和99.2%;HIV Ag/Ab RDTs、HBV Ag RDTs和HCV Ab-RDTs算法分别为95.9%。结论:在资源有限的国家,在资金和技术专业知识短缺的情况下,RDTs算法可以在HIV抗体/抗原、HBs抗原的筛查中发挥关键作用。然而,必须非常谨慎地将其用于诊断目的,并且必须使用ELISA或分子技术来确认结果,特别是对于NLR值>0.1的HCV RDTs算法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of Rapid Diagnostic Tests Algorithms in Transfusion Medicine Setting
Background: The rapid diagnostic tests play a pivotal role in the screening of viral markers in blood qualification for transfusion in limited resource setting. Therefore, it is important to assess their analytical performances to ensure their proper functioning. Material and Methods: We performed a cross- sectional study by successive recruitment to assess the diagnostic value of rapid diagnostic tests algorithms using ELISA as a reference test. A total of 661 blood from donors were enrolled for this study. Rapid Diagnostic Tests (RDTs) and ELISA tests were performed for each sample by a couple of double-blinded biotechnologists. Data were collected on case report form and captured in Microsoft Excel then the file was imported and analyzed using R software version 4.0.3. Results: The diagnostic accuracy for the algorithms are summarized in Table 1. For HIV-algorithm, the internal validity parameters were as follow: sensitivity (sens) 99.0% (95% CI = 97.8, 99.5); specificity (spec) 98.3% (95% CI = 90.9, 99.7); positive likelihood ratio (PLR) 57.4 (95% CI = 8.2, 401.0); negative likelihood ratio (NLR) 0.01 (95% CI = 0.0005, 0.02); diagnostic odd ratio (DOR) 4710. HBV-Ag/Ab RDTs achieve the following diagnostic accuracy: sens 99.7% (95% CI = 98.3, 99.9); spec 98.8% (95% CI = 96.9, 95.5); PLR 81.8 (95% CI = 30.9, 217.0); NLR 0.003 (95% CI = 0.0004, 0.02); DOR 14,110. The analytical performances of HCV-Ab RDTs were as follow: sens 98.7% (95% CI = 97.5, 99.4); spec 93.1% (95% CI = 78.0, 98.1); PLR 14.3 (95% CI = 3.8, 54.5); NLR 1.5 (95% CI = 0.8, 2.8); DOR 962.6. The parameters evaluating the external validity of RDTs screening for the three viral markers when the theorical prevalence was 5% are summarized in Figure 3. At the prevalence , 99.99% and 99.94%. At the same prevalence, we found the following Positive Predictive Values (PPV) 70.82%, 77.59% and 37.35% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. The overall areas under the received operating characteristic (ROC) curves were 98.6%, 99.2% and 99.2%; 95.9% for HIV-Ag/Ab RDTs, HBV-Ag RDTs and HCV-Ab RDTs algorithms, respectively. Conclusion: RDTs algorithms can play a pivotal role in the screening of HIV-Ab/Ag, HBs-Ag in the setting of resources limited-countries where financial and technical expertise shortages are a standard fare. However, their use for diagnostic purposes must be done with great caution and the result must necessarily be confirmed with an ELISA or molecular technique particularly for HCV-RDTs algorithm which achieved an NLR value > 0.1.
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