Utility of serological VivaDiag IgM/IgG rapid test kits for COVID-19 screening, during disease progression and following recovery

Dalal Alarabi

doi:10.17485/ijst/v13i34.1575

Abstract

Objectives: This study evaluated VivaDiag IgM/IgG Rapid Test (VDtest) for covid-19 screening, during disease progression and following recovery. Methods: Prospectively, 969 patients RT-PCR positive for SARS-CoV-2 virus were compared to VDtest in 166 individuals upon airport arrival; 62 active inpatient COVID-19 cases ranging 2-23 days; 741 recovered COVID-19 patients from diagnosis date (median 24-days). Findings: Screening; VDtest assay sensitivity 7.6% (95% CI 2.8–15.8%), specificity 94.3% (95% CI 87.1–98.1%). Active disease patients, positive IgG rate 27.4% and IgM positivity 0 of 62 patients. Recovery phase patients: positive rates of IgM and IgG were 0.7% and 1.2%, respectively, within 14-days of diagnosis date, increasing to 25.9% and 43.4%, respectively 14-days after diagnosis. Novelty: VDtest kit showed poor sensitivity and identification of COVID-19 infection for screening, moreover,need for larger sample study to confirm our findings. Keywords: COVID19; SARSCoV2; RTPCR; serological testing; rapid test

Highlights

In late December 2019, an acute febrile illness associated with respiratory distress emerged in Wuhan, China[1] due to a virus that showed 79.5% homology at the whole genome level to the SARS-CoV virus that caused an outbreak in 2002 [1]
The blood samples from 969 patients who were tested positive with nasopharyngeal swab in RT-PCR were tested using the the VivaDiag IgM/IgG Rapid tests (VivaChek Biotech (Hangzhou)) that uses finger prick blood samples in accord with the manufacturer’s instructions, in 3 different clinical scenarios; disease screening, during active covid-19 symptomatic disease, and following disease recovery
Nasopharyngeal swab PCR and VivaDiag IgM/IgG rapid tests were performed every 48hrs for patients until PCR negative, the tests were repeated at 24 hours until two consecutive PCR results were negative

Summary

Introduction

In late December 2019, an acute febrile illness associated with respiratory distress emerged in Wuhan, China[1] due to a virus that showed 79.5% homology at the whole genome level to the SARS-CoV virus that caused an outbreak in 2002 [1]. RT-PCR is the gold standard test for the diagnosis of COVID-19, but usage of RT-PCR kits require expertise, expensive equipment and specialized laboratories [2]. These tests do not provide for rapid diagnosis and mass rapid screening in the setting of a public health emergency such as the COVID-19 pandemic[2]. Despite being the gold standard test, patients who displayed clinical and radiological manifestations of COVID-19 have tested negative for RT-PCR[1,3]. These limitations of the RT-PCR tests may hinder the process of outbreak control

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