Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests.
COVID-19
ELISA
IgM/IgG serology
SARS-CoV-2
immunofluorescence
rapid test
Journal
Journal of clinical medicine
ISSN: 2077-0383
Titre abrégé: J Clin Med
Pays: Switzerland
ID NLM: 101606588
Informations de publication
Date de publication:
24 Jul 2020
24 Jul 2020
Historique:
received:
29
06
2020
revised:
09
07
2020
accepted:
21
07
2020
entrez:
30
7
2020
pubmed:
30
7
2020
medline:
30
7
2020
Statut:
epublish
Résumé
Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. COVID-19 cases' median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13-31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78-98) and specificity (SP) 100% (95% CI: 91-100), RDT-B showed 87% SN (95% CI: 72-95) and 98% SP (95% CI: 88-100), and RDT-C 100% SN (95% CI: 88-100) and 98% SP (95% CI: 88-100). Against ELISA, SN and SP were above 90% for all three RDTs. RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.
Sections du résumé
BACKGROUND
BACKGROUND
Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs.
METHODS
METHODS
In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient.
RESULTS
RESULTS
COVID-19 cases' median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13-31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78-98) and specificity (SP) 100% (95% CI: 91-100), RDT-B showed 87% SN (95% CI: 72-95) and 98% SP (95% CI: 88-100), and RDT-C 100% SN (95% CI: 88-100) and 98% SP (95% CI: 88-100). Against ELISA, SN and SP were above 90% for all three RDTs.
CONCLUSIONS
CONCLUSIONS
RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.
Identifiants
pubmed: 32722191
pii: jcm9082369
doi: 10.3390/jcm9082369
pmc: PMC7463984
pii:
doi:
Types de publication
Journal Article
Langues
eng
Références
Am J Transl Res. 2020 Apr 15;12(4):1348-1354
pubmed: 32355546
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
Clin Infect Dis. 2020 Jul 28;71(15):778-785
pubmed: 32198501
Malays J Pathol. 2020 Apr;42(1):13-21
pubmed: 32342927
Diabetes Care. 1999 Feb;22(2):275-9
pubmed: 10333945
Emerg Infect Dis. 2020 Jul;26(7):1478-1488
pubmed: 32267220
J Med Virol. 2020 Feb 27;:
pubmed: 32104917
Clin Microbiol Infect. 2020 Jun 27;:
pubmed: 32603801
Rev Esp Quimioter. 2020 Aug;33(4):258-266
pubmed: 32492991
Lancet Infect Dis. 2015 May;15(5):559-64
pubmed: 25863564
Lancet. 2020 Aug 1;396(10247):313-319
pubmed: 32534626
Infect Ecol Epidemiol. 2020 Apr 14;10(1):1754538
pubmed: 32363011
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32245835
Sci Transl Med. 2020 Jun 3;12(546):
pubmed: 32493791
J Clin Virol. 2020 Aug;129:104473
pubmed: 32504945
Euro Surveill. 2012 Dec 06;17(49):
pubmed: 23231891
Biometrics. 1977 Mar;33(1):159-74
pubmed: 843571
J Med Virol. 2020 Mar 30;:
pubmed: 32227490
Clin Microbiol Infect. 2020 Aug;26(8):1082-1087
pubmed: 32473953