快速抗体检测和RT-PCR作为妊娠期COVID-19诊断一线检测的表现:印度尼西亚的经验

E. S. Pangkahila, Ryan S. Mulyana, Hariyasa Sanjaya, Mulyantari K, Daniel H. Susanto
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摘要

确保准确诊断对于限制SARS-CoV-2的传播和COVID-19的临床管理至关重要,特别是在孕妇中。实时逆转录聚合酶链反应(RT-qPCR)是目前推荐的诊断急性SARS-CoV-2感染的实验室方法。最近,开发了几种易于执行的快速抗原检测方法,并在一些国家被推荐为一线筛查方法。本研究的目的是评估快速抗体试验和RT-PCR检测SARS-CoV-2感染的比较性能,作为诊断妊娠期COVID-19的一线检测。本研究方法为描述性研究,描述SARS-CoV-2抗体快速检测与金标准鼻咽RT-PCR拭子检测的敏感性和特异性比较。271份样本中,只有257份符合条件,14例因缺乏快速抗体检测和RT-PCR结果而被排除在研究之外。本研究结果显示,快速SARS-CoV-2抗体检测敏感性为80.95%,特异性为90.68%,NPV(阴性预测值)和PPV(阳性预后值)分别为98.17%和43.59%。仅根据IgM和IgG检测结果,IgM和IgG的敏感性分别为33.33%(7/21)和71.43%(15/21),特异性分别为91.1%(215/236、21假阳性)和91.53%(216/236、20假阳性)。在怀孕期间使用快速抗体测试是一种筛查工具,目前不适用于诊断工具。为尽量减少假阳性和阴性结果,应将快速抗体检测与RT-PCR检测结果结合使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Performance of Rapid Antibody Test and RT-PCR as Frontline Test for COVID-19 Diagnosis in Pregnancy: an Experience in Indonesia
Ensuring an accurate diagnosis is critical for limiting the spread of SARS-CoV-2 and for the clinical management of COVID-19, especially in pregnant women. For now real-time reverse transcription polymerase chain reaction (RT-qPCR) is the currently recommended laboratory method for the diagnosis of acute SARS-CoV-2 infection. More recently, several easy-to-perform rapid antigen detection tests have been developed and are recommended as first-line screening test in several countries. The purpose of this study was to evaluate the comparative performance of a rapid antibody test and RT-PCR for the detection of SARS-CoV-2 infection, as a front-line test for the diagnosis of COVID-19 in pregnancy. This research method is a descriptive study to describe comparation of sensitivity and specificity between rapid SARS-CoV-2 antibody test to the gold standard nasopharyngeal RT-PCR swab test. Of the 271 samples, only 257 were eligible and fourteen cases were excluded from the study due to a lack of rapid antibody test and RT-PCR results. The results of this study showed that the rapid SARS-CoV-2 antibody test sensitivity was 80.95%, and the specificity was 90.68%, the NPV (negative predictive value) and the PPV (positive prognosis value) were 98.17% and 43.59%, respectively. Based only on the results of IgM and IgG, IgM and IgG sensitivity were 33.33% (7/21) and 71.43% (15/21), respectively, and the specificity was 91.1% (215/236, 21 false positive) and 91.53% (216/236, 20 false positive), respectively. The use of rapid antibody tests during pregnancy is a screening tool and is not currently applicable for diagnostic tool. To minimize false positives and negatives results, the use of rapid antibody tests should be combined with the RT-PCR test results.
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