Abstract
The pandemic of novel coronavirus disease COVID-19 is rapidly expanding across the world. A positive result of antibody tests suggests that the individual has potentially been exposed to SARS-CoV-2, thus allowing to identify asymptomatic infections and determine the seroprevalence in a given population. The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgM antibody detection on the Luminex MAGPIX platform. Clinical agreement studies were performed in 42 COVID-19 patient serum samples and 162 negative donor serum/plasma samples. Positive percent agreement (PPA) was 42.86% (95% CI: 9.90% to 81.59%), 71.43% (95% CI: 29.04% to 96.33%), and 28.57% (95% CI: 13.22% to 48.67%) for samples collected on 0-7 days, 8-14 days, and 2-8 weeks from symptom onset, respectively. Negative Percent Agreement (NPA) was 97.53% (95% CI: 93.80% to 99.32%). There was no cross-reactivity with the SARS-CoV-2 IgG antibody. Hemoglobin (200 mg/dL), bilirubin (2 mg/dL), triglyceride (250 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. In conclusion, an anti-SARS-CoV-2 IgM antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up the anti-SARS-CoV-2 IgM testing.
Highlights
The SARS-CoV-2 virus has been identified as the cause of a respiratory illness outbreak in Wuhan, China in late 2019 and has since evolved into a global pandemic, COVID-19
According to the guidance issued by Centers for Disease Control (CDC) and the World Health Organization (WHO), all studies were conducted in a Biosafety Level 2 (BSL-2) cabinet when handling COVID-19 patient samples
Forty-two (42) serum samples collected at different times from individuals who tested positive with a RT-PCR method for SARS-CoV-2 infection were used in the evaluation of positive percent agreement (PPA)
Summary
The SARS-CoV-2 virus has been identified as the cause of a respiratory illness outbreak in Wuhan, China in late 2019 and has since evolved into a global pandemic, COVID-19. Nucleic acid amplification testing methods such as PCR have been the gold standard for COVID-19 detection during the early phase of infection. There is an increasing demand for antibody detection for determining the seroprevalence of COVID-19 in the general population. The shortage of swabs and nucleic acid detection kits in certain areas have evoked the appreciation of serology tests. The SARS-CoV-2 serostatus of asymptomatic patients or patients with symptoms appearing late into the infection is of particular interest. The government and the media have been promoting positive antibody tests as an alternative or additional screening standard for individuals returning to work.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
