A Real-Life Approach for Evaluation of Rapid Ag Testing in Sars-Cov2 Infection

M. Prost
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Abstract

Keywords: Respiratory infections;SARS-CoV2;Ag rapid test Received: March 19, 2021, Accepted: April 03, 2021, Published: April 03, 2021 Introduction Biological diagnosis of respiratory infections by SARS-CoV2 uses molecular tools targeting viral genes by RT-PCR analysis or isothermal gene amplification. PCR-positive samples RT-PCR Thermo gave positive results on 86 specimens. * Ct ranged from 10.74 to 40.92 for S target (with 10 lacking of S response due to variations). * Ct ranged from 12.59 to 32.97 for N target. * Ct ranged from 10.41 to 33.68 for Orf1ab target. * For 70 of 86 specimens, all the 3 Ct were <26.00. [...]unexpected negative results by Ag testing (although Ct<26.00 by RT-PCR) were 5 with RAPID TEST 1, 7 with RAPID TEST 2, 2 with AllTest and 2 with Acro Biotech. Variants of SARS-CoV2 Among the 86 RT-PCR positive specimens, there was 10 variants of SARS-COV2: * Two of them (UK and del 69-70 variants) gave a strong and quick positive result by each of the Ag testing device. * Three variant samples gave a negative result by each of the Ag testing device (low burden for two of them: UK and del 69-70 variants;high burden for the other: del 69-70 variant). * Three variant samples gave positive results (even slight or late) for some of the device: RAPID TEST 1 with one ZA variant, RAPID TEST 2 with one UK variant, both RAPID TEST 1 and RAPID TEST 2 with another UK variant. * Two variant samples gave a negative result by one of the 4 devices (AllTest with a del 69-70 variant, low burden) or by two (RAPID TEST 1 and RAPID TEST 2 with a UK variant, high burden).
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评估Sars-Cov2感染快速抗原检测的现实方法
关键词:呼吸道感染;SARS-CoV2;抗原快速检测收稿日期:2021年3月19日,收稿日期:2021年4月03日,发表日期:2021年4月03日简介SARS-CoV2的呼吸道感染生物学诊断采用靶向病毒基因的分子工具,通过RT-PCR分析或等温基因扩增。pcr阳性标本RT-PCR Thermo阳性86例。* S靶的Ct值范围为10.74 ~ 40.92(其中10个由于变异而缺乏S反应)。* N靶Ct值为12.59 ~ 32.97。* Orf1ab靶的Ct值为10.41 ~ 33.68。* 86例标本中70例3 Ct均<26.00。[…在RAPID TEST 1、RAPID TEST 2、AllTest和Acro Biotech中,分别有5个、7个、2个和2个Ag检测结果为出乎意料的阴性(尽管RT-PCR的Ct<26.00)。86份RT-PCR阳性标本中,有10份SARS-CoV2变异:* 2份(英国和西班牙69-70个变异)均在各Ag检测装置中呈强烈且快速的阳性结果。*三个变异样本在每个Ag检测装置中都给出了阴性结果(其中两个低负荷:UK和del 69-70变体;另一个高负荷:del 69-70变体)。*对于某些设备,三个变体样本给出了阳性结果(甚至轻微或延迟):RAPID TEST 1带有一个ZA变体,RAPID TEST 2带有一个英国变体,RAPID TEST 1和RAPID TEST 2都带有另一个英国变体。*两个变体样本通过4个设备中的一个(AllTest带有del 69-70变体,低负担)或两个(RAPID TEST 1和RAPID TEST 2带有英国变体,高负担)给出阴性结果。
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