Comparison of Two Molecular Diagnostic Tests for COVID-19: Abbott RealTime SARS-CoV-2 and Allplex™2019-nCoV, in the Epidemic Context in Senegal  

作　　者：Babacar Faye Oulimata Gueye Doudou Georges Massar Niang Babacar Mbengue Alioune Dièye Babacar Faye;Oulimata Gueye;Doudou Georges Massar Niang;Babacar Mbengue;Alioune Dièye(Laboratory of Molecular Biology, Military Hospital of Ouakam, Dakar, Senegal;AIDS Program of the Senegalese Armed Forces, Military Hospital of Ouakam, Dakar, Senegal;Service of Molecular Biology, Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology, Cheikh Anta Diop University, Dakar, Senegal;Service of Immunology, Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology, Cheikh Anta Diop University, Dakar, Senegal)

机构地区：[1]Laboratory of Molecular Biology, Military Hospital of Ouakam, Dakar, Senegal [2]AIDS Program of the Senegalese Armed Forces, Military Hospital of Ouakam, Dakar, Senegal [3]Service of Molecular Biology, Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology, Cheikh Anta Diop University, Dakar, Senegal [4]Service of Immunology, Department of Pharmacy, Faculty of Medicine, Pharmacy and Odonto-Stomatology, Cheikh Anta Diop University, Dakar, Senegal

出　　处：《American Journal of Molecular Biology》2023年第1期46-56,共11页美国分子生物学期刊（英文）

摘　　要：Background: The persistence of the rapid spread of the COVID-19 pandemic is linked to the appearance of several variants of SARS-CoV2 with an impact on biological diagnosis, treatment and vaccination. The United States Food and Drug Administration (FDA) has granted several SARS-CoV-2 detection tests Emergency Use Authorization (EUA) for diagnosis and better epidemiological surveillance. Thus, multiple RT-PCR tests have been developed and brought to market in order to meet the urgent need for the diagnosis of COVID-19. However, comparative data between these tests in clinical laboratories are scarcely available to assess their performance. Objective: To compare two molecular methods for detecting SARS-CoV-2: the RT-PCR, Allplex™2019-nCoV tests on CFX96 Bio-Rad and the Abbott m2000sp/rt RealTime SARS-CoV-2. Materials and Methods: Nasopharyngeal and oropharyngeal swabs were taken from patients to diagnose SARS-CoV-2 infection. For each sample, we searched for the virus with two different RT-PCR tests: 1) first on Abbott m2000 SARS-CoV-2 targeting the N and RdRp genes, 2) then on Allplex™2019-nCoV Assay looking for the E, N and RdRp genes. Results: Percentages of the agreement were calculated. A total of 100 samples that tested negative and 90 positives on Abbott m2000 SARS-CoV-2 were retested on Allplex™2019-nCoV. Overall agreement was 74.74% on all samples. The specific agreement was 84% and 64.4% respectively for negative and positive samples with the RealTime SARS-CoV-2 test. A positive correlation (r² = 0.63;p Conclusion: Our results showed good overall agreement between RT-PCR, Allplex™2019-nCoV and Abbott RealTime SARS-CoV-2 tests in the diagnosis of COVID-19. As the concordance is low for small viremias, the RT-PCR Allplex™2019-nCoV Assay would be better indicated during the acute and symptomatic phase of the disease.Background: The persistence of the rapid spread of the COVID-19 pandemic is linked to the appearance of several variants of SARS-CoV2 with an impact on biological diagnosis, treatment and vaccination. The United States Food and Drug Administration (FDA) has granted several SARS-CoV-2 detection tests Emergency Use Authorization (EUA) for diagnosis and better epidemiological surveillance. Thus, multiple RT-PCR tests have been developed and brought to market in order to meet the urgent need for the diagnosis of COVID-19. However, comparative data between these tests in clinical laboratories are scarcely available to assess their performance. Objective: To compare two molecular methods for detecting SARS-CoV-2: the RT-PCR, Allplex™2019-nCoV tests on CFX96 Bio-Rad and the Abbott m2000sp/rt RealTime SARS-CoV-2. Materials and Methods: Nasopharyngeal and oropharyngeal swabs were taken from patients to diagnose SARS-CoV-2 infection. For each sample, we searched for the virus with two different RT-PCR tests: 1) first on Abbott m2000 SARS-CoV-2 targeting the N and RdRp genes, 2) then on Allplex™2019-nCoV Assay looking for the E, N and RdRp genes. Results: Percentages of the agreement were calculated. A total of 100 samples that tested negative and 90 positives on Abbott m2000 SARS-CoV-2 were retested on Allplex™2019-nCoV. Overall agreement was 74.74% on all samples. The specific agreement was 84% and 64.4% respectively for negative and positive samples with the RealTime SARS-CoV-2 test. A positive correlation (r² = 0.63;p Conclusion: Our results showed good overall agreement between RT-PCR, Allplex™2019-nCoV and Abbott RealTime SARS-CoV-2 tests in the diagnosis of COVID-19. As the concordance is low for small viremias, the RT-PCR Allplex™2019-nCoV Assay would be better indicated during the acute and symptomatic phase of the disease.

关 键 词：SARS-CoV-2 COVID-19 DIAGNOSTICS RT-PCR Abbott RealTime Seegene-Allplex 

分 类 号：R73[医药卫生—肿瘤]