Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.
Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.
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DOI：
10.1371/journal.pone.0265334
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
这项研究的目的是评估7种抗原快速诊断试验(Ag RDT)在临床环境中的性能，以确定哪些可推荐用于诊断乌干达SARS-CoV-2感染。这是一项横断面前瞻性研究。在隔离中心和入境点连续采集新冠肺炎聚合酶链式反应阳性和新冠肺炎聚合酶链式反应阴性者的鼻咽拭子，用SARS-CoV-2抗原RDTs进行检测。通过将检测结果与周期阈值(Ct)为≤39的定量逆转录聚合酶链式反应结果(柏林方案)进行比较，得出检测的敏感性和特异性。以≤29和≤33为CT分界点，计算敏感度。在CT截止值≥33和≤39时，没有一种AgRDT的灵敏度为≤80%。两种试剂盒，潘比奥™新冠肺炎抗原和Viva Diag™SARS-CoV-2抗原的敏感性为≥80%，CT截断值为≤29。四种试剂盒：新冠肺炎抗原、新冠肺炎抗原反应条、MEDSAN®SARS-CoV-2抗原快速检测试剂盒和™新冠肺炎抗原快速检测试剂盒对SARS-CoV-2的特异性为≥97%。这项评估确定了一种抗原RDT，™新冠肺炎抗原，在高病毒载量(CT值≤29)下的表现达到世界卫生组织推荐的水平。建议将该试剂盒用于筛查在卫生机构出现新冠肺炎样症状的患者。
The objective of this study was to evaluate the performance of seven antigen rapid diagnostic tests (Ag RDTs) in a clinical setting to identify those that could be recommended for use in the diagnosis of SARS-CoV-2 infection in Uganda. This was a cross-sectional prospective study. Nasopharyngeal swabs were collected consecutively from COVID-19 PCR positive and COVID-19 PCR negative participants at isolation centers and points of entry, and tested with the SARS-CoV-2 Ag RDTs. Test sensitivity and specificity were generated by comparing results against qRT-PCR results (Berlin Protocol) at a cycle threshold (Ct) cut-off of ≤39. Sensitivity was also calculated at Ct cut-offs ≤29 and ≤33. None of the Ag RDTs had a sensitivity of ≥80% at Ct cut-off values ≤33 and ≤39. Two kits, Panbio™ COVID-19 Ag and VivaDiag™ SARS-CoV-2 Ag had a sensitivity of ≥80% at a Ct cut-off value of ≤29. Four kits: BIOCREDIT COVID -19 Ag, COVID-19 Ag Respi-Strip, MEDsan® SARS-CoV-2 Antigen Rapid Test and Panbio™ COVID-19 Ag Rapid Test had a specificity of ≥97%. This evaluation identified one Ag RDT, Panbio™ COVID-19 Ag with a performance at high viral load (Ct value ≤29) reaching that recommended by WHO. This kit was recommended for screening of patients with COVID -19-like symptoms presenting at health facilities.
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DOI：
10.1016/j.jinf.2021.02.014
发表时间：
2021-03
期刊：
The Journal of infection
影响因子：
--
作者：
Bulilete O;Lorente P;Leiva A;Carandell E;Oliver A;Rojo E;Pericas P;Llobera J;COVID-19 Primary Care Research Group
通讯作者：
COVID-19 Primary Care Research Group
影响因子：
3.9
作者：
Jacobs J;Kühne V;Lunguya O;Affolabi D;Hardy L;Vandenberg O
通讯作者：
Vandenberg O
影响因子：
15.1
作者：
Gremmels H;Winkel BMF;Schuurman R;Rosingh A;Rigter NAM;Rodriguez O;Ubijaan J;Wensing AMJ;Bonten MJM;Hofstra LM
通讯作者：
Hofstra LM
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier
影响因子：
6.7
作者：
Al Bayat S;Mundodan J;Hasnain S;Sallam M;Khogali H;Ali D;Alateeg S;Osama M;Elberdiny A;Al-Romaihi H;Al-Thani MHJ
通讯作者：
Al-Thani MHJ