HIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
Department of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Sci Rep. 2022 Nov 24;12(1):20282. doi: 10.1038/s41598-022-24411-2.
Since Coronavirus Disease-2019 (COVID-19) outbreak was reported, many commercial Nucleic Acid Amplification Tests (NAAT) have been developed all over the world, and it has been the standard method. Even though several assays were rapidly developed and applied to laboratory diagnostic testing, the performance of these assays was not evaluated in different contexts. Thus, this study aimed to assess the performance of Abbott SARS-CoV-2, Daan Gene, BGI and Sansure Biotech assays by using Composite Reference Standard (CRS). The study was conducted at the Ethiopian Public Health Institute (EPHI) from December 1 to 30/2020. Of the 164 nasopharyngeal samples were extracted by using a QIAamp RNA mini kit and Abbott DNA sample preparation system. Out of 164 samples, 59.1% were positive and 40.9% were negative by CRS. Sansure Biotech positivity was significantly low compared to CRS (p < 0.05). The overall agreement of the four assays compared to CRS was 96.3-100%. The performance of the four assays had almost comparable diagnostic performance, except for a low positive rate of Sansure Biotech assay. Hence, Sansure Biotech assay [Research Use Only (RUO)] needs further verification on its use in Ethiopia. Finally an additional study should be considered for evaluating assays with respective manufacturer claims.
自 2019 年冠状病毒病(COVID-19)爆发以来,世界各地已经开发出许多商业核酸扩增检测(NAAT),并已成为标准方法。尽管已经迅速开发并应用了几种检测方法进行实验室诊断检测,但这些检测方法在不同的情况下的性能尚未得到评估。因此,本研究旨在使用综合参考标准(CRS)评估 Abbott SARS-CoV-2、Daan Gene、BGI 和 Sansure Biotech 检测方法的性能。该研究于 2020 年 12 月 1 日至 30 日在埃塞俄比亚公共卫生研究所(EPHI)进行。用 QIAamp RNA 迷你试剂盒和 Abbott DNA 样品制备系统从 164 个鼻咽样品中提取。在 164 个样本中,59.1%为阳性,40.9%为阴性。与 CRS 相比,Sansure Biotech 的阳性率明显较低(p < 0.05)。与 CRS 相比,四种检测方法的总体一致性为 96.3-100%。除了 Sansure Biotech 检测方法的阳性率较低外,这四种检测方法的诊断性能几乎相当。因此,Sansure Biotech 检测方法(仅供研究使用)需要在埃塞俄比亚进一步验证其使用情况。最后,应该考虑进行额外的研究来评估具有各自制造商声明的检测方法。