Rapid diagnostic testing for SARS‐CoV‐2: Validation and comparison of three point‐of‐care antibody tests

Abstract

With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), a need for diagnostic tests has surfaced. Point‐of‐care (POC) antibody tests can detect immunoglobulin (Ig) G and M against SARS‐CoV‐2 in serum, plasma or whole blood and give results within 15 minutes. Validation of the performance of such tests is needed if they are to be used in clinical practice. In this study we evaluated three POC antibody tests. Convalescent serum samples from 47 reverse transcription polymerase chain reaction (RT‐PCR) verified coronavirus disease 2019 (COVID‐19) patients collected at least 28 days post RT‐PCR diagnosis as well as 50 negative pre‐COVID‐19 controls were tested. The three tests (denoted the J‐, N‐ and Z‐tests) displayed the sensitivities of 87, 96 and 85 percent, respectively, for the detection of IgG. All tests had the same specificity for IgG (98 percent). The tests did not differ significantly for the detection of IgG. The sensitivities for IgM were lower (15, 67 and 70 percent) and the specificities were 90, 98 and 90 percent, respectively. The positive and negative predictive values were similar among the tests. Our results indicate that these POC antibody tests might be accurate enough to use in routine clinical practice. This article is protected by copyright. All rights reserved.

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“…Antibodies are only produced after at least 10 days of virus infection [ 32 ], so this general late response may lead to false-negatives [ 33 ]. Negative results of antibody tests may not confirm that the patient is not infected [ 34 ]. At the same time, serological testing as an invasive method is not convenient and not suitable for rapid detection at all.…”

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“…99,130,145,147 These contrasting differences usually arise from the lack of a standard test evaluation protocol, and depend on the number of true positive/negative samples, age or pre-health conditions of volunteers, the severity of infection, test settings, etc. 161–165 Therefore, a standard test evaluation protocol is needed along with more extensive and well-planned evaluation studies to avoid false negative/positive results and improve diagnostic performance. Nonetheless, rapid antibody diagnostics will help in the epidemiology and assessment of both short-term and long-term immune system response and vaccine research, development, and effectiveness.…”