Clinical Comparison and Agreement of PCR, Antigen, and Viral Culture for the Diagnosis of COVID-19

21 Pages Posted: 9 Feb 2022

See all articles by Amanda Agard

Amanda Agard

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Omar Elsheikh

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Drew Bell

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Ryan Relich

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Bryan Schmitt

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Josh Sadowski

affiliation not provided to SSRN

William Fadel

affiliation not provided to SSRN

Douglas Webb

affiliation not provided to SSRN

Lana Dbeibo

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Kristen Kelley

affiliation not provided to SSRN

Mariel Carozza

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Guang-Shen Lei

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Paul Calkins

affiliation not provided to SSRN

Cole Beeler

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine

Multiple version iconThere are 2 versions of this paper

Abstract

The COVID-19 nasopharyngeal PCR (NP PCR) is limited by lack of specificity after previous illness, healthcare personnel collection, and discomfort.  Superficial testing using antigen (Ag) tests or nasal PCR may be an alternative.  One-hundred-and-fourteen risk-stratified patients were tested by culture, nasal PCR, NP PCR, and Ag testing.  Twenty (48%) of the high preset risk and 23 (32%) of the low pretest risk were NP PCR positive.  Compared with NP PCR, the sensitivity of nasal PCR, Sofia Ag, BinaxNOW Ag, and culture were 44%, 31%, 37%, and 15%.  In the high risk group, the sensitivity of these tests improved to 71%, 37%, 50%, and 22%.  Agreement between tests was highest between nasal PCR and both antigen tests.  Patients who were NP PCR positive but antigen negative were more likely to have remote prior COVID-19 infection (p<0.01).  Nasal PCR and antigen positive patients were more likely to have symptoms (p = 0.01).

Note:
Funding Information: nternal funding was used to make this work possible through Indiana University Health. Dr. April Abbott from Deaconness Health System provided the Binax COVID Ag Cards free of charge.

Declaration of Interests: Dr. Schmitt has received industry sponsored grant funding from DiaSorin, Cepheid and Roche for diagnostic assay development unrelated to the current study. Dr. Relich receives research support from bioMerieux/BioFire Diagnostics, Cepheid, QIAGEN, and Roche Diagnostics. Dr. Relich receives research support from bioMerieux/BioFire Diagnostics, Cepheid, QIAGEN, and Roche Diagnostics. All other authors have nothing to declare.

Ethics Approval Statement: Patients agreed via written consent. All patient activities were performed according to protocols approved by the Indiana University Institutional Review Board (IU IRB# 2003718653).

Keywords: COVID-19, SARS-CoV-2, Antigen testing, PCR testing, Viral culture, Infection Prevention, Diagnostics

Suggested Citation

Agard, Amanda and Elsheikh, Omar and Bell, Drew and Relich, Ryan and Schmitt, Bryan and Sadowski, Josh and Fadel, William and Webb, Douglas and Dbeibo, Lana and Kelley, Kristen and Carozza, Mariel and Lei, Guang-Shen and Calkins, Paul and Beeler, Cole, Clinical Comparison and Agreement of PCR, Antigen, and Viral Culture for the Diagnosis of COVID-19. Available at SSRN: https://ssrn.com/abstract=4011125 or http://dx.doi.org/10.2139/ssrn.4011125

Amanda Agard

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Omar Elsheikh

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Drew Bell

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Ryan Relich

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Bryan Schmitt

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Josh Sadowski

affiliation not provided to SSRN ( email )

No Address Available

William Fadel

affiliation not provided to SSRN ( email )

No Address Available

Douglas Webb

affiliation not provided to SSRN ( email )

No Address Available

Lana Dbeibo

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Kristen Kelley

affiliation not provided to SSRN ( email )

No Address Available

Mariel Carozza

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Guang-Shen Lei

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

Paul Calkins

affiliation not provided to SSRN ( email )

No Address Available

Cole Beeler (Contact Author)

Indiana University Purdue University Indianapolis (IUPUI) - Indiana University School of Medicine ( email )

Riley Hospital for Children
705 Riley Hospital Dr.
Indianapolis, ID 46202
United States

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