Performance of High Throughput SARS-CoV-2 Antigen Testing Compared to Nucleic Acid Testing

被引：5

作者：

Peck Palmer, Octavia ^{[1
,2
]}

Hasskamp, Joanne H. ^{[3
]}

La, Hae-Sun ^{[4
]}

Pramod Patwardhan, Pranav ^{[4
]}

Ghumman, Shmyle ^{[4
]}

Baloda, Vandana ^{[4
]}

Jung, Yujung ^{[4
]}

Wheeler, Sarah E. ^{[5
,6
]}

机构：

[1] Univ Pittsburgh, Dept Pathol, Pittsburgh, PA USA

[2] Univ Pittsburgh, Dept Crit Care Med, Pittsburgh, PA USA

[3] Univ Pittsburgh, Dept Pathol, Pittsburgh, PA USA

[4] Univ Pittsburgh, Dept Pathol, Med Ctr, Pittsburgh, PA USA

[5] Univ Pittsburgh, Dept Pathol, Pittsburgh, PA 15260 USA

[6] Univ Pittsburgh, Med Ctr, Pittsburgh, PA 15260 USA

来源：

LABORATORY MEDICINE | 2023年 / 54卷 / 02期

关键词：

SARS-CoV-2; COVID-19; antigen;

D O I：

10.1093/labmed/lmac107

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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.

引用

页码：E54 / E57

页数：4

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