Kanwar Neena, Banerjee Dithi, Sasidharan Anjana, Abdulhamid Ayah, Larson Marissa, Lee Brian, Selvarangan Rangaraj, Liesman Rachael M
Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA; School of Medicine, University of Missouri- Kansas City, MO, USA.
Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA.
Diagn Microbiol Infect Dis. 2021 Dec;101(4):115518. doi: 10.1016/j.diagmicrobio.2021.115518. Epub 2021 Aug 6.
We compared the performance of the Abbott Real Time SARS-CoV-2 assay (Abbott assay), Aptima™ SARS-CoV-2 assay (Aptima assay), BGI Real-Time SARS-CoV-2 assay (BGI assay), Lyra® SARS-CoV-2 assay (Lyra assay), and DiaSorin Simplexa™ COVID assay for SARS-CoV-2 detection. Residual nasopharyngeal samples (n = 201) submitted for routine SARS-CoV-2 testing by Simplexa assay during June-July 2020 and January 2021 were salvaged. Aliquots were tested on other assays and compared against the CDC 2019-nCoV Real-Time RT-PCR assay. Viral load in positive samples was determined by droplet digital PCR. Among 201 samples, 99 were positive and 102 were negative by the CDC assay. The Aptima and Abbott assays exhibited the highest positive percent agreement (PPA) at 98.9% while the BGI assay demonstrated the lowest PPA of 89.9% with 10 missed detections. Negative percent agreement for all 5 platforms was comparable, ranging from 96.1% to 100%. The performance of all five assays was comparable.
我们比较了雅培实时SARS-CoV-2检测法（雅培检测法）、Aptima™ SARS-CoV-2检测法（Aptima检测法）、华大基因实时SARS-CoV-2检测法（华大基因检测法）、Lyra® SARS-CoV-2检测法（Lyra检测法）以及DiaSorin Simplexa™ COVID-19 SARS-CoV-2检测法在检测SARS-CoV-2方面的性能。对2020年6月至7月以及2021年1月期间通过Simplexa检测法提交进行常规SARS-CoV-2检测的剩余鼻咽样本（n = 201）进行了挽救处理。将样本分装后用其他检测法进行检测，并与美国疾病控制与预防中心（CDC）的2019-nCoV实时逆转录聚合酶链反应（RT-PCR）检测法进行比较。通过滴液数字PCR测定阳性样本中的病毒载量。在201个样本中，CDC检测法检测出99个阳性样本和102个阴性样本。Aptima检测法和雅培检测法的阳性百分一致率（PPA）最高，为98.9%，而华大基因检测法的PPA最低，为89.9%，有10例假阴性。所有5个平台的阴性百分一致率相当，在96.1%至100%之间。所有5种检测法的性能相当。
