Fainguem Nadine Nguendjoung, Fokam Joseph, Ngoufack Jagni Semengue Ezechiel, Durand Nka Alex, Takou Désiré, Ageboh Nkembi-Leke Joshua, Alteri Claudia, Colagrossi Luna, Yagai Roméo Bouba, Ambe Chenwi Collins, Tchouaket Tommo Michel Carlos, Angong Beloumou Grace, Ka'e Aude Christelle, Ndjeyep Djupsa Sandrine Claire, Abba Aissatou, Heunko Yatchou Laeticia Grace, Nnomo Zam Krystel, Kamgaing Rachel, Sosso Samuel Martin, Mama Lucien, Ndembi Nicaise, Colizzi Vittorio, Perno Carlo-Federico, Cappelli Giulia, Ndjolo Alexis
Chantal BIYA International Reference Centre for research on HIV/AIDS prevention and management (CIRCB), Yaoundé, Cameroon.
University of Rome Tor Vergata, Rome, Italy.
J Public Health Afr. 2022 May 24;13(1):2163. doi: 10.4081/jphia.2022.2163.
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 () and a manual () 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 and 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) and 37.6% (108/287) . 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 (CT<20). Among positive SARS-CoV- 2 cases, the mean difference in Cycle Threshold (CT) for the manual and Cycle Number (CN) for the automated was 6.75±0.3. The excellent agreement (>80%) between the and 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.
2019冠状病毒病的分子诊断对于控制这一全球健康重大威胁的大流行至关重要。世界卫生组织已验证了几种分子检测方法，但需要在实地进行操作评估，以确保其在诊断中的互操作性。为确保用于检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）RNA的分子检测在实地的互操作性，我们评估了在非洲常用的两种检测方法——一种自动化（）和一种手动（）实时荧光定量聚合酶链反应（rRT-PCR）——之间对SARS-CoV-2的诊断一致性。在喀麦隆雅温得的尚塔尔·比亚国际参考中心（CIRCB）对287份鼻咽标本进行了一项比较研究。样本同时采用和rRT-PCR进行检测，并通过科恩系数和斯皮尔曼相关性评估性能特征。该研究共纳入了273名参与者[年龄中位数（四分位间距）36（26 - 46）岁]和14份外部质量评估标本。检测阳性率在为30.0%（86/287），在为37.6%（108/287）。总体一致性为82.6%（237/287），κ = 0.82（95%置信区间：0.777 - 0.863），表明诊断一致性极佳。阳性和阴性一致性分别为66.67%（72/108）和92.18%（165/179）。关于病毒载量（VL），高病毒载量（CT < 20）样本的阳性一致性为100%。在SARS-CoV-2阳性病例中，手动检测的循环阈值（CT）与自动检测的循环数（CN）的平均差值为6.75±0.3。和rRT-PCR平台之间的极佳一致性（>80%）支持了这两种检测方法之间的互操作性。不一致情况出现在低病毒载量时，因此突出了这些工具作为限制SARS-CoV-2社区传播的有效武器的作用。
