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- Title
Performance of High Throughput SARS-CoV-2 Antigen Testing Compared to Nucleic Acid Testing.
- Authors
Palmer, Octavia Peck; Hasskamp, Joanne H; La, Hae-Sun; Patwardhan, Pranav Pramod; Ghumman, Shmyle; Baloda, Vandana; Jung, Yujung; Wheeler, Sarah E
- Abstract
Objective Independent assessment of SARS-CoV-2 antigen (COV2Ag) tests remains important as varying performance between assays is common. We assessed the performance of a new high-throughput COV2Ag test compared to SARS-CoV-2 nucleic acid amplification tests (NAAT). Methods A total of 347 nasopharyngeal samples collected from January to October 2021 were assessed by NAAT as part of standard-of-care testing (CDC LDT or GeneXpert System, Cepheid) and COV2Ag using the ADVIA Centaur CoV2Ag assay (Siemens Healthineers). Results Among NAAT positive specimens we found 82.4% agreement and in NAAT negative specimens we found 97.3% agreement (overall agreement 85.6%). In symptomatic persons, COV2Ag agreed with NAAT 90.0% (n = 291), and in asymptomatic persons, 62.5% (n = 56). Agreement between positive NAAT and COV2Ag increased at lower cycle threshold (Ct) values. Conclusion The COV2Ag assay exceeded the World Health Organization minimum performance requirements of ≥ 80% sensitivity and ≥ 97% specificity. The COV2Ag assay is helpful for large scale screening efforts due to high-throughput and reduced wait times.
- Subjects
NONPARAMETRIC statistics; STATISTICS; CONFIDENCE intervals; MANN Whitney U Test; COMPARATIVE studies; RESEARCH funding; COVID-19 testing; SENSITIVITY &; specificity (Statistics); DATA analysis software; DATA analysis; ANTIGENS; NUCLEIC acid amplification techniques
- Publication
Laboratory Medicine, 2023, Vol 54, Issue 2, pe54
- ISSN
0007-5027
- Publication type
Article
- DOI
10.1093/labmed/lmac107