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KMID : 1100720210410060568
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Annals of Laboratory Medicine
2021 Volume.41 No. 6 p.568 ~ p.576
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Combination of a SARS-CoV-2 IgG Assay and RT-PCR for Improved COVID-19 Diagnosis
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Aoki Kotaro
Takai Kunitomo
Nagasawa Tatsuya
Kashiwagi Katsuhito
Mori Nobuaki
Matsubayashi Keiji
Satake Masahiro
Tanaka Ippei
Kodama Nanae
Shimodaira Takahiro
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Abstract
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Background: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is generally diagnosed by reverse transcription (RT)-PCR or serological assays. The SARS-CoV-2 viral load decreases a few days after symptom onset. Thus, the RT-PCR sensitivity peaks at three days after symptom onset (approximately 80%). We evaluated the performance of the ARCHITECT® SARS-CoV-2 IgG assay (henceforth termed IgG assay; Abbott Laboratories, Lake County, IL, USA), and the combination of RT-PCR and the IgG assay for COVID-19 diagnosis.
Methods: In this retrospective study, 206 samples from 70 COVID-19 cases at two hospitals in Tokyo that were positive using RT-PCR were used to analyze the diagnostic sensitivity. RT-PCR-negative (N=166), COVID-19-unrelated (N=418), and Japanese Red Cross Society (N=100) samples were used to evaluate specificity.
Results: Sensitivity increased daily after symptom onset and exceeded 84.4% after 10 days. Specificity ranged from 98.2% to 100% for samples from the three case groups. Seroconversion was confirmed from 9 to 20 days after symptom onset in 18 out of 32 COVID-19 cases with multiple samples and from another case with a positive result in the IgG assay for the first available sample.
Conclusions: The combination of RT-PCR and IgG assay improves the robustness of laboratory diagnostics by compensating for the limitations of each method.
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KEYWORD
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COVID-19, SARS-CoV-2 IgG, Immunoassay, ARCHITECT®, Reverse transcription (RT)-PCR, Sensitivity, Specificity
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