Rapid diagnostic testing for SARS-CoV-2 : Validation and comparison of three point-of-care antibody tests
Strand, Rasmus ; Thelaus, Louise LU ; Fernström, Nils ; Sunnerhagen, Torgny LU
; Lindroth, Ylva
LU
; Linder, Adam
LU
and Rasmussen, Magnus
LU
(2021)
In Journal of Medical Virology
93(7).
p.4592-4596
- Abstract
With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a need for diagnostic tests has surfaced. Point-of-care (POC) antibody tests can detect immunoglobulin (Ig) G and M against SARS-CoV-2 in serum, plasma, or whole blood and give results within 15 min. Validation of the performance of such tests is needed if they are to be used in clinical practice. In this study, we evaluated three POC antibody tests. Convalescent serum samples from 47 reverse transcription-polymerase chain reaction (RT-PCR) verified patients with coronavirus disease 2019 (COVID-19) collected at least 28 days post RT-PCR diagnosis as well as 50 negative pre-COVID-19 controls were tested. The three tests (denoted the J-, N-, and Z-tests)... (More)
With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a need for diagnostic tests has surfaced. Point-of-care (POC) antibody tests can detect immunoglobulin (Ig) G and M against SARS-CoV-2 in serum, plasma, or whole blood and give results within 15 min. Validation of the performance of such tests is needed if they are to be used in clinical practice. In this study, we evaluated three POC antibody tests. Convalescent serum samples from 47 reverse transcription-polymerase chain reaction (RT-PCR) verified patients with coronavirus disease 2019 (COVID-19) collected at least 28 days post RT-PCR diagnosis as well as 50 negative pre-COVID-19 controls were tested. The three tests (denoted the J-, N-, and Z-tests) displayed the sensitivities of 87%, 96%, and 85%, respectively, for the detection of IgG. All tests had the same specificity for IgG (98%). The tests did not differ significantly for the detection of IgG. The sensitivities for IgM were lower (15%, 67%, and 70%) and the specificities were 90%, 98%, and 90%, respectively. The positive and negative predictive values were similar among the tests. Our results indicate that these POC antibody tests might be accurate enough to use in routine clinical practice.
(Less)
- author
- Strand, Rasmus
; Thelaus, Louise
LU
; Fernström, Nils
; Sunnerhagen, Torgny
LU
; Lindroth, Ylva
LU
; Linder, Adam
LU
and Rasmussen, Magnus
LU
- organization
- publishing date
- 2021-07-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- COVID-19, point-of-care test, SARS-CoV-2, sensitivity, specificity, validation
- in
- Journal of Medical Virology
- volume
- 93
- issue
- 7
- pages
- 5 pages
- publisher
- John Wiley & Sons Inc.
- external identifiers
-
- scopus:85104335896
- pmid:33666238
- ISSN
- 0146-6615
- DOI
- 10.1002/jmv.26913
- language
- English
- LU publication?
- yes
- id
- 32fba28d-7081-476a-82f9-8f4e89569b8f
- date added to LUP
- 2021-04-26 15:01:11
- date last changed
- 2024-06-15 10:31:06
@article{32fba28d-7081-476a-82f9-8f4e89569b8f,
abstract = {{<p>With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a need for diagnostic tests has surfaced. Point-of-care (POC) antibody tests can detect immunoglobulin (Ig) G and M against SARS-CoV-2 in serum, plasma, or whole blood and give results within 15 min. Validation of the performance of such tests is needed if they are to be used in clinical practice. In this study, we evaluated three POC antibody tests. Convalescent serum samples from 47 reverse transcription-polymerase chain reaction (RT-PCR) verified patients with coronavirus disease 2019 (COVID-19) collected at least 28 days post RT-PCR diagnosis as well as 50 negative pre-COVID-19 controls were tested. The three tests (denoted the J-, N-, and Z-tests) displayed the sensitivities of 87%, 96%, and 85%, respectively, for the detection of IgG. All tests had the same specificity for IgG (98%). The tests did not differ significantly for the detection of IgG. The sensitivities for IgM were lower (15%, 67%, and 70%) and the specificities were 90%, 98%, and 90%, respectively. The positive and negative predictive values were similar among the tests. Our results indicate that these POC antibody tests might be accurate enough to use in routine clinical practice.</p>}},
author = {{Strand, Rasmus and Thelaus, Louise and Fernström, Nils and Sunnerhagen, Torgny and Lindroth, Ylva and Linder, Adam and Rasmussen, Magnus}},
issn = {{0146-6615}},
keywords = {{COVID-19; point-of-care test; SARS-CoV-2; sensitivity; specificity; validation}},
language = {{eng}},
month = {{07}},
number = {{7}},
pages = {{4592--4596}},
publisher = {{John Wiley & Sons Inc.}},
series = {{Journal of Medical Virology}},
title = {{Rapid diagnostic testing for SARS-CoV-2 : Validation and comparison of three point-of-care antibody tests}},
url = {{https://lup.lub.lu.se/search/files/119180175/Rapid_diagnostic_testing_for_SARS_CoV_2pdf.pdf}},
doi = {{10.1002/jmv.26913}},
volume = {{93}},
year = {{2021}},
}