High concordance in SARSCoV-2 detection between automated (Abbott m2000) and manual (DaAn gene) RT-PCR systems: The EDCTP PERFECT-Study in Cameroon

Molecular diagnosis of COVID-19 is critical to the control of the pandemic, which is a major threat to global health. Several molecular tests have been validated by WHO, but would require operational evaluation in the field to ensure their interoperability in diagnosis. In order to ensure field inte...

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Published inJournal of public health in Africa Vol. 13; no. 1; p. 6
Main Authors Fainguem, Nadine N., Fokam, Joseph, Semengue, Ezechiel N.J., Nka, Alex D., Takou, Désiré, Nkembi-leke, Joshua A., Alteri, Claudia, Colagrossi, Luna, Yagai, Roméo B., Chenwi, Collins A., Tommo, Michel C.T., Beloumou, Grace A., Ka’e, Aude C., Djupsa, Sandrine C.N., Abba, Aissatou, Yatchou, Laeticia G.H., Zam, Krystel N., Kamgaing, Rachel, Sosso, Samuel M., Mama, Lucien, Ndembi, Nicaise, Colizzi, Vittorio, Perno, Carlo-Federico, Cappelli, Giulia, Ndjolo, Alexis
Format Journal Article
LanguageEnglish
Published PAGEPress Publications, Pavia, Italy 24.05.2022
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Summary:Molecular diagnosis of COVID-19 is critical to the control of the pandemic, which is a major threat to global health. Several molecular tests have been validated by WHO, but would require operational evaluation in the field to ensure their interoperability in diagnosis. In order to ensure field interoperability in molecular assays for detection of SARS-CoV-2 RNA, we evaluated the diagnostic concordance of SARS-CoV-2 between an automated (Abbott) and a manual (DaAn gene) realtime PCR (rRT-PCR), two commonly used assays in Africa. A comparative study was conducted on 287 nasopharyngeal specimens at the Chantal BIYA International Reference Centre (CIRCB) in Yaounde-Cameroon. Samples were tested in parallel with Abbott and DaAn gene rRT-PCR, and performance characteristics were evaluated by Cohen’s coefficient and Spearman’s correlation. A total of 273 participants [median age (IQR) 36 (26-46) years] and 14 EQA specimens were included in the study. Positivity was on 30.0% (86/287) Abbott and 37.6% (108/287) DaAn gene. Overall agreement was 82.6% (237/287), with k=0.82 (95%CI: 0.777-0.863), indicating an excellent diagnostic agreement. The positive and negative agreement was 66.67% (72/108) and 92.18 % (165/179) respectively. Regarding Viral Load (VL), positive agreement was 100% for samples with high VLs (CT80%) between the Abbott and DaAn gene rRTPCR platforms supports interoperability between the two assays. Discordance occurs at low-VL, thus underscoring these tools as efficient weapons in limiting SARS-CoV-2 community transmission.
Bibliography:Availability of data and materials: All data generated or analyzed during this study are included in this published article.
Ethics approval and consent to participate: The study has obtained ethical approval from the Cameroon National Ethics Committee for Human Health Research (reference N°01/143/CNERSH/SP). Per the Helsinki’s declaration and the national regulations, informed consent was obtained from all participants. Informed consent: Informed informed consent was obtained.
Contributions: All authors have given approval to the final version of the manuscript. NNF and JF contributed equally and are corresponding authors; GC and AN are cosenior authors.
Publisher's note: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Conflict of interests: The authors declare no conflicts of interests.
ISSN:2038-9922
2038-9930
DOI:10.4081/jphia.2022.2163