Evaluation of SARS-CoV-2 antibody point of care devices in the laboratory and clinical setting.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2022
2022
Historique:
received:
08
12
2021
accepted:
13
03
2022
entrez:
31
3
2022
pubmed:
1
4
2022
medline:
15
4
2022
Statut:
epublish
Résumé
SARS-CoV-2 antibody tests have been marketed to diagnose previous SARS-CoV-2 infection and as a test of immune status. There is a lack of evidence on the performance and clinical utility of these tests. We aimed to carry out an evaluation of 14 point of care (POC) SARS-CoV-2 antibody tests. Serum from participants with previous RT-PCR (real-time polymerase chain reaction) confirmed SARS-CoV-2 infection and pre-pandemic serum controls were used to determine specificity and sensitivity of each POC device. Changes in sensitivity with increasing time from infection were determined on a cohort of study participants. Corresponding neutralising antibody status was measured to establish whether the detection of antibodies by the POC device correlated with immune status. Paired capillary and serum samples were collected to ascertain whether POC devices performed comparably on capillary samples. Sensitivity and specificity varied between the POC devices and in general did not meet the manufacturers' reported performance characteristics, which signifies the importance of independent evaluation of these tests. The sensitivity peaked at ≥20 days following onset of symptoms, however sensitivity of 3 of the POC devices evaluated at extended time points showed that sensitivity declined with time. This was particularly marked at >140 days post infection. This is relevant if the tests are to be used for sero-prevalence studies. Neutralising antibody data showed that positive antibody results on POC devices did not necessarily confer high neutralising antibody titres, and that these POC devices cannot be used to determine immune status to the SARS-CoV-2 virus. Comparison of paired serum and capillary results showed that there was a decline in sensitivity using capillary blood. This has implications in the utility of the tests as they are designed to be used on capillary blood by the general population.
Identifiants
pubmed: 35358263
doi: 10.1371/journal.pone.0266086
pii: PONE-D-21-38836
pmc: PMC8970483
doi:
Substances chimiques
Antibodies, Neutralizing
0
Antibodies, Viral
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0266086Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Nature. 2021 Mar;591(7848):124-130
pubmed: 33494096
J Infect Dis. 2021 Feb 13;223(3):389-398
pubmed: 33140086
Nat Med. 2020 Jun;26(6):845-848
pubmed: 32350462
Thorax. 2020 Dec;75(12):1082-1088
pubmed: 32796119
Lancet. 2021 Feb 6;397(10273):452-455
pubmed: 33515491
Eur Respir J. 2020 Aug 27;56(2):
pubmed: 32430429
Science. 2020 Dec 4;370(6521):1227-1230
pubmed: 33115920
Science. 2021 Feb 5;371(6529):
pubmed: 33408181
Biometrics. 1977 Mar;33(1):159-74
pubmed: 843571
mBio. 2021 Jan 19;12(1):
pubmed: 33468695
Clin Infect Dis. 2020 Nov 19;71(16):2027-2034
pubmed: 32221519
Clin Microbiol Infect. 2021 Jun;27(6):933-935
pubmed: 33450388
PLoS Pathog. 2020 Sep 24;16(9):e1008817
pubmed: 32970782
J Clin Microbiol. 2020 Oct 21;58(11):
pubmed: 32826322
Cell. 2021 Apr 29;184(9):2384-2393.e12
pubmed: 33794143
Nat Med. 2022 Jan;28(1):39-50
pubmed: 35064248
Clin Infect Dis. 2020 Jul 28;71(15):778-785
pubmed: 32198501
Clin Microbiol Infect. 2021 Jan 20;:
pubmed: 33482352
Elife. 2020 Sep 07;9:
pubmed: 32894217
J Virol. 2021 Jun 24;95(14):e0040421
pubmed: 33893169
Cell Rep. 2021 Feb 9;34(6):108728
pubmed: 33516277
JAMA. 2020 Jun 9;323(22):2249-2251
pubmed: 32374370
Emerg Microbes Infect. 2020 Dec;9(1):2091-2093
pubmed: 32930052