Abstract
BackgroundReal-time polymerase chain reaction (RT-PCR) testing for the identification of viral nucleic acid is the current standard for the diagnosis of SARS-CoV-2 infection, but technical issues limit its utilization for large-scale screening. Serological immunoglobulin M (IgM)/IgG testing has been proposed as a useful tool for detecting SARS-CoV-2 exposure.ObjectiveThe objective of our study was to compare the results of the rapid serological VivaDiag test for SARS-CoV-2–related IgM/IgG detection with those of the standard RT-PCR laboratory test for identifying SARS-CoV-2 nucleic acid.MethodsWe simultaneously performed both serological and molecular tests with a consecutive series of 191 symptomatic patients. The results provided by a new rapid serological colorimetric test for analyzing IgM/IgG expression were compared with those of RT-PCR testing for SARS-CoV-2 detection.ResultsOf the 191 subjects, 70 (36.6%) tested positive for SARS-CoV-2 based on RT-PCR results, while 34 (17.3%) tested positive based on serological IgM/IgG expression. Additionally, 13 (6.8%) subjects tested positive based on serological test results, but also tested negative based on RT-PCR results. The rapid serological test had a sensitivity of 30% and a specificity of 89% compared to the standard RT-PCR assay. Interestingly, the performance of both assays improved 8 days after symptom appearance. After 10 days had passed since symptom appearance, the predictive value of the rapid serological test was higher than that of the standard molecular assay (proportion of positive results: 40% vs 20%). Multivariate analysis showed that age >58 years (P<.01) and period of >15 days after symptom onset (P<.02) were significant and independent factors associated with serological test positivity.ConclusionsThe rapid serological test analyzed in this study seems limited in terms of usefulness when diagnosing SARS-CoV-2 infection. However, it may be useful for providing relevant information on people’s immunoreaction to COVID-19 exposure.
Highlights
A novel coronavirus, which was first reported in China, capable of interperson transmission has been causing lethal pneumonia in humans [1]
All 191 subjects enrolled in the study underwent a SARS-CoV-2 RT-polymerase chain reaction (PCR) test and immunoglobulin M (IgM)/immunoglobulin G (IgG) rapid test
Of the 191 patients, 70 (36.6%) tested positive for SARS-CoV-2 based on Real-time polymerase chain reaction (RT-PCR) results, while 34 (17.8%) tested positive based on serum IgM/IgG rapid test results
Summary
A novel coronavirus, which was first reported in China, capable of interperson transmission has been causing lethal pneumonia in humans [1]. As the COVID-19 disease rapidly spread to other Asian and European countries, the Italian Government had to take drastic measures to contain the outbreak, including establishing strict criteria to define patients from whom oropharyngeal swabs should be collected for the molecular polymerase chain reaction (PCR) diagnosis of COVID-19 and quarantining individuals who may have been in contact with SARS-CoV-2–infected people [3] These measures were active for weeks, during which the number of new SARS-CoV-2 infection cases in Italy continued to increase, with more than 4000 new cases being reported daily [4]. The real-time PCR (RT-PCR) test for identifying viral nucleic acid is the current standard for the diagnosis of COVID-19 This assay has some practical limitations [3], such as the unpleasantness of obtaining biological material from the nasopharynx, the relatively long time required to generate results, and the need for certified laboratories and specific expertise. Serological immunoglobulin M (IgM)/IgG testing has been proposed as a useful tool for detecting SARS-CoV-2 exposure
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