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Diagnostic value of SARS-CoV-2 RDT-Ab with RT-PCR: Secondary data at Diponegoro National Hospital

Faculty of Medicine, Universitas Diponegoro, Indonesia

Received: 4 Mar 2022; Revised: 27 Apr 2022; Accepted: 27 Apr 2022; Available online: 28 Apr 2022; Published: 28 Apr 2022.
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Background: The SARS-CoV-2 rapid diagnostic test antibody (RDT-Ab) was most often used as an early detection tool for COVID-19 at the beginning of pandemic. Whereas the antibody response was formed in the second week after the onset of symptoms.

Objective: To evaluate the diagnostic value of the SARS-CoV-2 RDT-Ab, including sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR), in patients at Diponegoro National Hospital, Semarang, Indonesia.

Methods: Data subjects have been selected retrospectively using purposive sampling based on inclusion criteria (patients who had shortness of breath, pneumonia, suspected, possible, or confirmed COVID-19, and data on the results of the SARS-CoV-2 RDT-Ab IgM and/or IgG (Leccurate® SARS-CoV-2 Antibody Rapid Test Kit) with a valid RT-PCR as gold standard) and exclusion criteria (patients who only had one of either SARS-CoV-2 RDT-Ab or RT-PCR). Researchers analyzed the diagnostic value of SARS-CoV-2 RDT-Ab with RT-PCR which gave the possibility of true-positive, false-positive, true-negative, and false-negative results arranged in a 2x2 table. According to WHO, the diagnostic value is said to be good at least having a sensitivity value of 80% and specificity of 97%.

Results: The diagnostic value of SARS-CoV-2 RDT-Ab with RT-PCR, which was evaluated from 1142 patients retrospectively, included IgM (Se 65.25%, Sp 89.51%, PPV 46.70%, NPV 94.81%, PLR 6.22, NLR 0.39), IgG (Se 58.16%, Sp 93.01%, PPV 53.95%, NPV 94.04%, PLR 8.32, NLR 0.45), IgM and IgG (Se 53.90%, Sp 94.21%, PPV 56.72%, NPV 93.55%, PLR 9.30, NLR 0.49), IgM and/or IgG (Se 69.50%, Sp 88.31%, PPV 45.58%, NPV 95.36%, PLR 5.95, NLR 0.35).

Conclusion: SARS-CoV-2 RDT-Ab (Leccurate® SARS-CoV-2 Antibody Rapid Test Kit) is not ideal to be used as a rapid diagnostic test for COVID-19.

Keywords: COVID-19, Rapid diagnostic test, RT-PCR, SARS-CoV-2 antibody

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Keywords: COVID-19; Rapid diagnostic test; RT-PCR; SARS-CoV-2 antibody

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