Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients

ABSTRACT This study evaluated the BD Veritor system for rapid detection of SARS-CoV-2, an immunochromatographic point-of-care test, by comparing it with a standard reverse transcription-PCR (RT-PCR) methodology using samples from symptomatic patients. Samples from 146 symptomatic and 2 asymptomatic...

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Main Authors: Paula Koga, Maira Maluf, Fabiane Nunes, Juliana Campos, Lívia Gazarini, Tatiane Borghoff, Glaís Libanori, Marinês Martino
Format: Article
Language:English
Published: American Society for Microbiology 2022-10-01
Series:Microbiology Spectrum
Subjects:
Online Access:https://journals.asm.org/doi/10.1128/spectrum.00190-22
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author Paula Koga
Maira Maluf
Fabiane Nunes
Juliana Campos
Lívia Gazarini
Tatiane Borghoff
Glaís Libanori
Marinês Martino
author_facet Paula Koga
Maira Maluf
Fabiane Nunes
Juliana Campos
Lívia Gazarini
Tatiane Borghoff
Glaís Libanori
Marinês Martino
author_sort Paula Koga
collection DOAJ
description ABSTRACT This study evaluated the BD Veritor system for rapid detection of SARS-CoV-2, an immunochromatographic point-of-care test, by comparing it with a standard reverse transcription-PCR (RT-PCR) methodology using samples from symptomatic patients. Samples from 146 symptomatic and 2 asymptomatic patients between the 1st and the 40th day of infection were evaluated. The nasopharyngeal and/or oropharyngeal swabs were inserted in a tube containing 0.9% saline solution and stored at refrigerator temperature until the moment of use. The samples were first tested with the Xpert Xpress SARS-CoV-2 (GeneXpert) kit (RT-PCR method), and the cycle thresholds (CTs) for the E and N2 genes encoding the SARS-CoV-2 envelope and nucleoprotein, respectively, were established. Subsequently, the same samples were tested using the Veritor rapid test. We analyzed the CTs of the N2 gene, which is detected in both methodologies, and observed sensitivities of 100%, 98.8%, 89.6%, and 82.7% for the CTs of <25, <27, and <30 and all the CTs, respectively. The greatest sensitivity was observed when we performed the test on patients within 5 days of symptom onset. The BD Veritor system’s workflow is simple and fast, taking approximately 16 min from sample preparation to obtaining the test result. In addition to its satisfactory sensitivity, with results that correlate with those of the RT-PCR, the BD Veritor analyzer instrument reduces the subjectivity of unaided visual readings and consequent potential variation in result interpretation. Therefore, our results showed that the BD Veritor diagnostic test can provide a rapid and accurate diagnosis for SARS-CoV-2. IMPORTANCE This study provides important and useful information, especially for diagnostic laboratories, since the results show that the BD Veritor system can provide a fast and safe point-of-care antigen diagnostic test for rapid detection of COVID-19 that has high sensitivity, reproducibility, and accuracy.
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spelling doaj.art-e51e71b3c68741ba91ada874fd050f632022-12-22T03:22:09ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972022-10-0110510.1128/spectrum.00190-22Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic PatientsPaula Koga0Maira Maluf1Fabiane Nunes2Juliana Campos3Lívia Gazarini4Tatiane Borghoff5Glaís Libanori6Marinês Martino7Clinical Laboratory Microbiology Department, Hospital Israelita Albert Einstein, São Paulo, São Paulo, BrazilClinical Laboratory Microbiology Department, Hospital Israelita Albert Einstein, São Paulo, São Paulo, BrazilClinical Laboratory Microbiology Department, Hospital Israelita Albert Einstein, São Paulo, São Paulo, BrazilBecton and Dickinson Company, BD Life Sciences – Integrated Diagnostic Solutions, São Paulo, São Paulo, BrazilBecton and Dickinson Company, BD Life Sciences – Integrated Diagnostic Solutions, São Paulo, São Paulo, BrazilBecton and Dickinson Company, BD Life Sciences – Integrated Diagnostic Solutions, São Paulo, São Paulo, BrazilBecton and Dickinson Company, BD Life Sciences – Integrated Diagnostic Solutions, São Paulo, São Paulo, BrazilClinical Laboratory Microbiology Department, Hospital Israelita Albert Einstein, São Paulo, São Paulo, BrazilABSTRACT This study evaluated the BD Veritor system for rapid detection of SARS-CoV-2, an immunochromatographic point-of-care test, by comparing it with a standard reverse transcription-PCR (RT-PCR) methodology using samples from symptomatic patients. Samples from 146 symptomatic and 2 asymptomatic patients between the 1st and the 40th day of infection were evaluated. The nasopharyngeal and/or oropharyngeal swabs were inserted in a tube containing 0.9% saline solution and stored at refrigerator temperature until the moment of use. The samples were first tested with the Xpert Xpress SARS-CoV-2 (GeneXpert) kit (RT-PCR method), and the cycle thresholds (CTs) for the E and N2 genes encoding the SARS-CoV-2 envelope and nucleoprotein, respectively, were established. Subsequently, the same samples were tested using the Veritor rapid test. We analyzed the CTs of the N2 gene, which is detected in both methodologies, and observed sensitivities of 100%, 98.8%, 89.6%, and 82.7% for the CTs of <25, <27, and <30 and all the CTs, respectively. The greatest sensitivity was observed when we performed the test on patients within 5 days of symptom onset. The BD Veritor system’s workflow is simple and fast, taking approximately 16 min from sample preparation to obtaining the test result. In addition to its satisfactory sensitivity, with results that correlate with those of the RT-PCR, the BD Veritor analyzer instrument reduces the subjectivity of unaided visual readings and consequent potential variation in result interpretation. Therefore, our results showed that the BD Veritor diagnostic test can provide a rapid and accurate diagnosis for SARS-CoV-2. IMPORTANCE This study provides important and useful information, especially for diagnostic laboratories, since the results show that the BD Veritor system can provide a fast and safe point-of-care antigen diagnostic test for rapid detection of COVID-19 that has high sensitivity, reproducibility, and accuracy.https://journals.asm.org/doi/10.1128/spectrum.00190-22SARS-CoV-2COVID-19rapid testsrapid antigen testPOC testVeritor test
spellingShingle Paula Koga
Maira Maluf
Fabiane Nunes
Juliana Campos
Lívia Gazarini
Tatiane Borghoff
Glaís Libanori
Marinês Martino
Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients
Microbiology Spectrum
SARS-CoV-2
COVID-19
rapid tests
rapid antigen test
POC test
Veritor test
title Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients
title_full Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients
title_fullStr Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients
title_full_unstemmed Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients
title_short Comparison of the SARS-CoV-2 BD Veritor Nasal Antigen Test with Nasopharyngeal Reverse Transcription-PCR in Symptomatic Patients
title_sort comparison of the sars cov 2 bd veritor nasal antigen test with nasopharyngeal reverse transcription pcr in symptomatic patients
topic SARS-CoV-2
COVID-19
rapid tests
rapid antigen test
POC test
Veritor test
url https://journals.asm.org/doi/10.1128/spectrum.00190-22
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