TY - JOUR
T1 - Clinical evaluation of the GSD NovaPrime® SARS-CoV-2 RTq-PCR assay
AU - Tré-Hardy, Marie
AU - Piteüs, Sébastien
AU - Beukinga, Ingrid
AU - Blairon, Laurent
N1 - Funding Information:
NovaPrime® tests were provided at no cost by NovaTec company (NovaTec® Immundiagnostica GmbH, Dietzenbach, Germany). The company had no role in study design, data collection and analysis, decision to publish, or preparing the manuscript.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/7
Y1 - 2022/7
N2 - Faced with the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), high-throughput respiratory tests are in high demand. We evaluated the clinical performance of the GSD NovaPrime® SARS-CoV-2 RTq-PCR assay, a new assay that detects 2 specific RNA sequences of the nucleocapsid (N) gene. It was assessed using 99 nasopharyngeal samples and compared in parallel with the Allplex® assay. Among those samples, 72 and 27 were included in the positive (PPA) and negative (NPA) percent agreement analyses, respectively. In case of discordance, samples were reanalyzed with another amplification technique, the Aptima® SARS-CoV-2 assay. Cross-reactivity, including specimens positive for another respiratory virus and collected before the COVID-19 outbreak, was also evaluated (n = 32). Based on the patients’ clinical history, the Ct (cycle threshold) values obtained, and the results of the Aptima® assay, the clinical performances were deemed satisfactory, with the PPA reaching a minimum percentage of 87.5% and the NPA reaching 100%. No cross-reactivity with other respiratory viruses was observed.
AB - Faced with the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), high-throughput respiratory tests are in high demand. We evaluated the clinical performance of the GSD NovaPrime® SARS-CoV-2 RTq-PCR assay, a new assay that detects 2 specific RNA sequences of the nucleocapsid (N) gene. It was assessed using 99 nasopharyngeal samples and compared in parallel with the Allplex® assay. Among those samples, 72 and 27 were included in the positive (PPA) and negative (NPA) percent agreement analyses, respectively. In case of discordance, samples were reanalyzed with another amplification technique, the Aptima® SARS-CoV-2 assay. Cross-reactivity, including specimens positive for another respiratory virus and collected before the COVID-19 outbreak, was also evaluated (n = 32). Based on the patients’ clinical history, the Ct (cycle threshold) values obtained, and the results of the Aptima® assay, the clinical performances were deemed satisfactory, with the PPA reaching a minimum percentage of 87.5% and the NPA reaching 100%. No cross-reactivity with other respiratory viruses was observed.
KW - Clinical evaluation
KW - COVID-19
KW - RT-qPCR
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85131396427&partnerID=8YFLogxK
U2 - 10.1016/j.diagmicrobio.2022.115718
DO - 10.1016/j.diagmicrobio.2022.115718
M3 - Article
C2 - 35641362
AN - SCOPUS:85131396427
SN - 0732-8893
VL - 103
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
IS - 3
M1 - 115718
ER -
