Cargando…
Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers
OBJECTIVES: Serologic testing for SARS-CoV-2 is an important element in the fight to slow the COVID-19 pandemic. This study aimed to validate two serologic tests for total (IgM, IgG, IgA) SARS-CoV-2 antibodies, (i) the Ortho-Clinical Diagnostics Anti-SARS-CoV-2 Total Antibody assay for the Vitros 56...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Canadian Society of Clinical Chemists. Published by Elsevier Inc.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813506/ https://www.ncbi.nlm.nih.gov/pubmed/33472036 http://dx.doi.org/10.1016/j.clinbiochem.2021.01.004 |
_version_ | 1783637863249739776 |
---|---|
author | Mullins, Kristin E. Merrill, VeRonika Ward, Matthew King, Brent Rock, Peter Caswell, Mary Ahlman, Mark Harris, Anthony D. Christenson, Robert |
author_facet | Mullins, Kristin E. Merrill, VeRonika Ward, Matthew King, Brent Rock, Peter Caswell, Mary Ahlman, Mark Harris, Anthony D. Christenson, Robert |
author_sort | Mullins, Kristin E. |
collection | PubMed |
description | OBJECTIVES: Serologic testing for SARS-CoV-2 is an important element in the fight to slow the COVID-19 pandemic. This study aimed to validate two serologic tests for total (IgM, IgG, IgA) SARS-CoV-2 antibodies, (i) the Ortho-Clinical Diagnostics Anti-SARS-CoV-2 Total Antibody assay for the Vitros 5600 analyzers and (ii) a manual laboratory developed ELISA (FDA EUA pending), for use in parallel orthogonal testing of asymptomatic healthcare workers and affiliates of the University of Maryland Medical System. DESIGN AND METHODS: Validation and verification of the two tests was performed using samples from hospitalized patients that were found to be PCR positive for SARS-CoV-2, samples pre-COVID-19, and samples from individuals with current/previous infections with other viruses. Healthcare workers and affiliates from across the University of Maryland Health System were provided testing free of charge and their results were reported as reactive or non-reactive if the two tests were concordance, or indeterminate if the results were discordant. RESULTS: Validation testing found the Ortho Vitros test to be 100% (73/73) sensitive, and 99.3% (152/153) specific, while the UMMC ELISA was found to be 97.6% (204/209) sensitive and 100% (288/288) specific. Real world testing among 8399 healthcare workers found that 2.9% (247/8399) of healthcare workers were positive for anti- SARS-CoV-2 antibodies by both tests. An indeterminate rate of 1.1% (91/8399), in which one test reported reactive results, and one as non-reactive was also seen. CONCLUSIONS: Parallel orthogonal testing improves the positive and negative predictive value of serologic testing in populations with low prevalence. The use of an indeterminate result from parallel orthogonal testing allows for the follow-up and re-testing, which helps resolve discrepancies between assays. |
format | Online Article Text |
id | pubmed-7813506 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | The Canadian Society of Clinical Chemists. Published by Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-78135062021-01-19 Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers Mullins, Kristin E. Merrill, VeRonika Ward, Matthew King, Brent Rock, Peter Caswell, Mary Ahlman, Mark Harris, Anthony D. Christenson, Robert Clin Biochem Article OBJECTIVES: Serologic testing for SARS-CoV-2 is an important element in the fight to slow the COVID-19 pandemic. This study aimed to validate two serologic tests for total (IgM, IgG, IgA) SARS-CoV-2 antibodies, (i) the Ortho-Clinical Diagnostics Anti-SARS-CoV-2 Total Antibody assay for the Vitros 5600 analyzers and (ii) a manual laboratory developed ELISA (FDA EUA pending), for use in parallel orthogonal testing of asymptomatic healthcare workers and affiliates of the University of Maryland Medical System. DESIGN AND METHODS: Validation and verification of the two tests was performed using samples from hospitalized patients that were found to be PCR positive for SARS-CoV-2, samples pre-COVID-19, and samples from individuals with current/previous infections with other viruses. Healthcare workers and affiliates from across the University of Maryland Health System were provided testing free of charge and their results were reported as reactive or non-reactive if the two tests were concordance, or indeterminate if the results were discordant. RESULTS: Validation testing found the Ortho Vitros test to be 100% (73/73) sensitive, and 99.3% (152/153) specific, while the UMMC ELISA was found to be 97.6% (204/209) sensitive and 100% (288/288) specific. Real world testing among 8399 healthcare workers found that 2.9% (247/8399) of healthcare workers were positive for anti- SARS-CoV-2 antibodies by both tests. An indeterminate rate of 1.1% (91/8399), in which one test reported reactive results, and one as non-reactive was also seen. CONCLUSIONS: Parallel orthogonal testing improves the positive and negative predictive value of serologic testing in populations with low prevalence. The use of an indeterminate result from parallel orthogonal testing allows for the follow-up and re-testing, which helps resolve discrepancies between assays. The Canadian Society of Clinical Chemists. Published by Elsevier Inc. 2021-04 2021-01-17 /pmc/articles/PMC7813506/ /pubmed/33472036 http://dx.doi.org/10.1016/j.clinbiochem.2021.01.004 Text en © 2021 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Mullins, Kristin E. Merrill, VeRonika Ward, Matthew King, Brent Rock, Peter Caswell, Mary Ahlman, Mark Harris, Anthony D. Christenson, Robert Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers |
title | Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers |
title_full | Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers |
title_fullStr | Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers |
title_full_unstemmed | Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers |
title_short | Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers |
title_sort | validation of covid-19 serologic tests and large scale screening of asymptomatic healthcare workers |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813506/ https://www.ncbi.nlm.nih.gov/pubmed/33472036 http://dx.doi.org/10.1016/j.clinbiochem.2021.01.004 |
work_keys_str_mv | AT mullinskristine validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT merrillveronika validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT wardmatthew validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT kingbrent validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT rockpeter validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT caswellmary validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT ahlmanmark validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT harrisanthonyd validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers AT christensonrobert validationofcovid19serologictestsandlargescalescreeningofasymptomatichealthcareworkers |