The performance of point-of-care antibody test for COVID-19 diagnosis in a tertiary hospital in Bandung, Indonesia

Abstract

Introduction: We aim to describe the performance of combined IgM and IgG point-of-care antibody test (POC-Ab) (Wondfo®) compared to real-time reverse transcriptase (rRT-PCR) (Allplex™ 2019-nCoV Assay) in detecting coronavirus disease 2019 (COVID-19).
 Methodology: We compared POC-Ab with rRT-PCR results among patients in a tertiary hospital from January to March 2020 in Bandung, Indonesia. We selected presumptive COVID-19 patients with positive rRT-PCR consecutively and 20 patients with negative rRT-PCR results were selected randomly from the same group of patients as controls. We described the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) with corresponding 95% confidence interval using serum and capillary blood samples. We also tested POC-Ab using non-COVID-19 (confirmed dengue and typhoid) patients’ sera.
 Results: Twenty-seven patients with positive rRT-PCR result and 20 negative controls were included (68.1% males, mean age 46 (SD: 15.4)). Using the serum, the sensitivity of the POC-Ab was 63.0% (42.4-80.6), specificity was 95.0% (75.1-99.9), PPV was 94.4% (72.7-99.8), NPV was 65.5% (45.7-82.1). A subset of 20 patients was tested using a capillary blood sample. The accuracy of the capillary blood sample is lower compared to serum (50.0% vs. 78.7%). None of the non-COVID-19 sera tested were reactive.
 Conclusions: POC-Ab for COVID-19 has a high specificity with no false-positive result in non-COVID-19 sera. Therefore, it can be used to guide diagnostic among symptomatic patients in resource limited settings. Given its low sensitivity, patients with high suspicion of COVID-19 but non-reactive result should be prioritized for rRT-PCR testing.

The Pre-Vaccination Donated Blood Is Free from Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) but Is Rich with Anti-SARS-CoV-2 Antibodies: A Cross-Section Saudi Study

“…During a pandemic, many cases may be asymptomatic or afford their prolonged and/or progressive symptoms before seeking medical care. Thus, serologic testing, being cheaper and easier than the rRT-PCR, can help in picking up many of these patients instead of the standard molecular technique [ 31 ]. The current study’s findings confirm the notion that the true extent of the COVID-19 burden may be underestimated, and improved serological detection of specific SARS-CoV-2 immunoglobulins may aid in estimating the true rates of SARS-CoV-2 infections, especially where rRT-PCR is not available, a key point for effective planning and implementation of efficient infection prevention and control strategies.…”

SARS-CoV-2 Antibody Rapid Tests: Valuable Epidemiological Tools in Challenging Settings

“…However, whereas serological mass screening in high-income countries could be feasible using automatic, high-throughput technologies ( 5 , 6 ), this may not be a practical option in several challenging diagnostic settings where the prevalence of SARS-CoV-2 infection is still widely unknown ( 7 ). In these countries, lateral flow assays (LFAs) for the identification of SARS-CoV-2 antibodies may represent an affordable and practical tool to perform epidemiological evaluations, but only a few serological surveys have been conducted to date employing LFAs, associated or not with enzyme-linked immunosorbent assays (ELISA) ( 8 , 9 ).…”

Update on Rapid Diagnostics for COVID-19: A Systematic Review

“…Lower sensitivity values were observed in the first days after infection [57,61,62,64] than the days postinfection. Accuracy was reported in three studies [56,63,65], and values lower than 80% were found only in the study by Fauziah et al [62]. The accuracy of 100% was verified in the study by Kumar et al [56].…”

“…Regarding immunoglobulin detection tests, we identified nine studies that assessed IgM and IgG levels [56][57][58][59][60][61][62][63][64], three evaluating only IgG [65][66][67], and one evaluating IgA, IgG, and IgM [68]. A total of 10 antibody tests were performed by lateral-flow assays (considering gold and fluorescence assays) [57][58][59][60][61][62][63][64][65]68], 1 by electrochemical enzyme immunoassay (ELISA) [56], 1 by magnetofluidic immuno-PCR platform [66], and 1 by the Split Luciferase (spLUC) antibody sensor [67].…”