未经评估:巴西是全球COVID-19阳性病例第二大国家。由于病毒的强大传播以及试剂盒和用品的匮乏,巴西卫生部已批准在此紧急情况下使用可用的工具包,没有对他们的表现进行准确的评估。这项研究比较了圣保罗提供的七个分子测定/试剂盒的性能和成本效益,巴西,用于SARS-CoV-2诊断。
UNASSIGNED:使用以下方法对疑似COVID-19病例的205份鼻咽/口咽样本进行了测试:(i)GeneFinderCOVID-19加RealAmp试剂盒;(ii)2019-nCoVRNAPCR-荧光探测,达安基因公司;(iii)内部RT-qPCRSARS-CoV-2IAL;(iv)2019-nCoV试剂盒,IDT;(v)分子SARS-CoV-2(E)试剂盒,Bio-Manguinhos;(vi)Allplex2019-nCoV改良测定法,SeegeneInc,和(七)生物醇一步法COVID-19试剂盒,IBMP。确定SARS-CoV-2真阳性结果的标准包括循环阈值截止值,指数/线性曲线的特征,基因靶标的多样性,和至少两个检测结果为阳性。
UASSIGNED:列出的检测方法的总体灵敏度为GeneFinder83.6%,达安基因100.0%,IAL90.4%,IDT94.6%,Bio-Manguinhos87.7%,Allplex97.3%,和IBMP87.7%。次要敏感基因靶标是RdRP。尽管所有测定的CohenKappa指数≥0.893,但最好的测试使用鉴定N基因和/或E基因靶标的多重测定。
未经评估:所有测试的检测都是准确诊断的,但考虑到成本效益(成本,时间消耗,测试的样品数量,和性能),内部IAL检测是圣保罗诊断COVID-19的理想选择,巴西。
UNASSIGNED: Brazil is the second largest country with COVID-19 positive cases worldwide. Due to the potent spread of the virus and the scarcity of kits and supplies, the Brazilian Ministry of Health has granted authorization for the use of kits available during this emergency, without an accurate evaluation of their performance. This study compared the performance and cost-effectiveness of seven molecular assays/kits available in São Paulo, Brazil, for SARS-CoV-2 diagnosis.
UNASSIGNED: A total of 205 nasopharyngeal/oropharyngeal samples from suspected cases of COVID-19, were tested using the following assays: (i) GeneFinder COVID-19 plus RealAmp kit; (ii) 2019-nCoV RNA PCR-Fluorescence Probing, Da An Gene Co.; (iii) in-house RT-qPCR SARS-CoV-2 IAL; (iv) 2019-nCoV kit, IDT; (v) molecular SARS-CoV-2 (E) kit, Bio-Manguinhos; (vi) Allplex 2019-nCoV modified Assay, Seegene Inc, and (vii) Biomol one-step COVID-19 kit, IBMP. The criteria for determining a SARS-CoV-2 true positive result included the cycle threshold cut-off values, the characteristics of exponential/linear curves, the gene target diversity, and a positive result in at least two assays.
UNASSIGNED: The overall sensitivity of the assays listed were GeneFinder 83.6%, Da An Gene 100.0%, IAL 90.4%, IDT 94.6%, Bio-Manguinhos 87.7%, Allplex 97.3%, and IBMP 87.7%. The minor sensitive gene target was RdRP. Although all assays had a Cohen\'s Kappa index ≥0.893, the best tests used multiplex assays identifying N-gene and/or E-gene targets.
UNASSIGNED: All assays tested accurate for diagnosis, but considering cost-effectiveness (cost, time consumption, number of samples tested, and performance), the in-house IAL assay was ideal for COVID-19 diagnosis in São Paulo, Brazil.