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Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
Diego O Andrey1,2, Patrick Cohen1, Benjamin Meyer3
1Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, 1205 Geneva, Switzerland.
Insights
Three SARS-CoV-2 IgM/IgG rapid diagnostic tests (RDTs) were compared. RDT-A and RDT-C demonstrated high sensitivity and specificity for IgG detection, making them suitable for widespread use.
Area of Science:
- Immunology
- Infectious Diseases
- Diagnostic Technologies
Background:
- Comparative data on SARS-CoV-2 IgM/IgG rapid diagnostic tests (RDTs) is limited.
- This study addresses the scarcity of comparative data by evaluating three commercially available RDTs head-to-head.
Purpose of the Study:
- To compare the diagnostic accuracy of three SARS-CoV-2 IgM/IgG RDTs.
- To assess the sensitivity and specificity of RDTs against established serological reference methods.
Main Methods:
- An unmatched case-control study involving 41 RT-PCR-confirmed COVID-19 cases and 50 controls.
- Diagnostic accuracy of NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C) was evaluated against immunofluorescence assay (rIFA) and IgG ELISA.
- Kendall coefficient was used to assess result concordance.
Main Results:
- Whole-blood IgG detection showed high concordance with rIFA for RDT-A (0.93) and RDT-C (0.98).
- RDT-A achieved 92% sensitivity and 100% specificity; RDT-C achieved 100% sensitivity and 98% specificity against rIFA.
- All three RDTs demonstrated over 90% sensitivity and specificity against ELISA.
Conclusions:
- RDT-A and RDT-C exhibited excellent IgG detection performance (SN/SP >90%) in whole blood.
- These RDTs are viable options for COVID-19 serological diagnosis, particularly where routine facilities are unavailable.
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:
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:
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:
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.
