Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System

BD MAX 시스템용 BD SARS-CoV-2 시약의 성능 평가

Published on
Journal: Journal of Clinical Microbiology
[저자] Karen Yanson, William Laviers, Lori Neely, Elizabeth Lockamy, Luis Carlos Castillo-Hernandez, Christopher Oldfied, Ronald Ackerman, Jamie Ackerman, Daniel A. Ortiz, Sixto Pacheco, Patricia J. Simner, Stephen Young, Erin McElvania, Charles K. Cooper
[Category] MERS, SARS, 진단, 치료기술, 치료제,
PMC URL    [DOI] 10.1128/JCM.01019-21    
[Article Type] Virology
[Source] PMC

ABSTRACT Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two emergency use authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. The limits of detection (LOD) for the BD SARS-CoV-2 reagents for the BD MAX system (MAX SARS-CoV-2 assay), the bioMérieux BioFire respiratory panel 2.1 (BioFire SARS-CoV-2 assay), the Roche cobas SARS-CoV-2 assay (cobas SARS-CoV-2 assay), and the Hologic Aptima SARS-CoV-2 assay Panther (Aptima SARS-CoV-2 assay) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with 7 target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a postmarket clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using the cobas and BioFire SARS-CoV-2 NAATs. In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/ml; 95% confidence interval [CI], 186 to 427) was comparable to the cobas SARS-CoV-2 assay (298 copies/ml; 95% CI, 225 to 509) and the BioFire SARS-CoV-2 assay (302 copies/ml; 95% CI, 219 to 565); the Aptima SARS-CoV-2 assay had an LOD of 612 copies/ml (95% CI, 474 to 918). The MAX SARS-CoV-2 assay had a PPA of 100% (95% CI, 97.3% to 100.0%) and an NPA of 96.7% (95% CI, 94.9% to 97.9%) compared to the Aptima SARS-CoV-2 assay. The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.

All Keywords
【저자키워드】 COVID-19, SARS-CoV-2, RT-qPCR, BD MAX, Hologic Aptima, agreement, nucleic acid amplification test, 【초록키워드】 Emergency use authorization, EUA, amplification, NAAT, respiratory, Roche, clinical study, COVID-19 cases, Limits of detection, 95% CI, 95% confidence interval, limits, positive, reagent, nasopharyngeal specimen, Aptima SARS-CoV-2 assay, BD MAX system, approach, collected, evaluated, comparable, MAX, 【제목키워드】 performance, reagent, System,
요약 SARS-CoV-2에 대한 핵산 증폭 검사(NAAT)는 COVID-19 사례를 확인하기 위한 표준 접근 방식입니다. 이 연구는 불일치 테스트에 사용된 두 개의 추가 EUA NAAT와 함께 두 개의 EUA(긴급 사용 승인) NAAT 간의 결과를 비교했습니다. BD MAX 시스템용 BD SARS-CoV-2 시약(MAX SARS-CoV-2 분석), bioMérieux BioFire 호흡기 패널 2.1(BioFire SARS-CoV-2 분석), Roche cobas의 검출 한계(LOD) SARS-CoV-2 assay(cobas SARS-CoV-2 assay)와 Hologic Aptima SARS-CoV-2 assay Panther(Aptima SARS-CoV-2 assay) NAAT 시스템은 총 84개의 인공 비인두 검체를 이용하여 7개 각 비교기의 목표 수준. 앱티마 SARS-CoV-2 분석과 비교한 MAX SARS-CoV-2 분석의 양성 및 음성 백분율 일치(각각 PPA 및 NPA)는 의심되는 COVID-19에서 수집한 708개의 비인두 표본을 사용한 시판 후 임상 연구에서 평가되었습니다. 19건. cobas 및 BioFire SARS-CoV-2 NAAT를 사용하여 불일치 테스트를 수행했습니다. 이 연구에서 MAX SARS-CoV-2 분석(251 사본/ml, 95% 신뢰 구간[CI], 186~427)에 대해 측정된 LOD는 cobas SARS-CoV-2 분석(298 사본/ml 95% CI, 225~509) 및 BioFire SARS-CoV-2 분석(302개/ml; 95% CI, 219~565); Aptima SARS-CoV-2 분석의 LOD는 612copy/ml(95% CI, 474~918)입니다. MAX SARS-CoV-2 분석의 PPA는 100%(95% CI, 97.3%~100.0%)이고 NPA는 96.7%(95% CI, 94.9%~97.9%)였습니다. 2 분석. MAX SARS-CoV-2 분석의 임상 성능은 다른 민감한 EUA 분석과 일치했습니다.