Diagnostic Performance of Five Rapid Serological Tests for SARS-CoV-2

Abstract

We conducted a study to evaluate the sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of five serologic tests. Subjects with negative or positive COVID-19 polymerase chain reaction (PRC) test results were tested with each of the serological tests. The results were compared with the reference PCR test. For the five tests evaluated, the Se ranged from 55.0% to 70.0% and the Sp ranged from 67.2% to 86.2%. PPV ranged from 53.2% to 80% and NPV from 75.0% to 86.2%. One test, the Wantai, had better specificity and sensitivity. None of the five tests had performance values of more than 90% in the entire sample. In symptomatic positive cases, the Wantai test reported excellent sensitivity. Overall, the low level of diagnostic performance of these tests does not support their use as an alternative to PCR for COVID-19 diagnostic. Test with better performance can be used for mass screening in low prevalence populations, to limit the indiscriminate use of PCR in context of resource-limited countries. Given the excellent sensitivity of Wantai in symptomatic cases, this test could be used as a referral test only in health facilities to discriminate suspected cases before PCR confirmation.

Seroprevalence of SARS-CoV-2 antibodies in Republic of Congo, February 2022

“…In this study, a probable bias of classification linked to the use of serologic tests must be taken into account when considering the prevalence obtained. Indeed, the serological test used in this study is neither 100% sensitive nor specific [ 40 ]. It would have been interesting to confirm the results of positive tests by [ 41 , 42 ] PCR in order to identify the true-positives among persons suspected of having an active infection (IgM positive or IgM positive + IgG positive).…”