A Synchronous Blind Test and Methodological Comparison Between Colloidal Gold Rapid Test vs RT-PCR For Sars-Cov-2 Detection

Abstract

Background: The current pandemic due to novel SARS-CoV-2 virus dramatically affected health care systems and public health worldwide. The present study aimed to evaluate two analytical methods, colloidal gold antigen rapid test vs reference PCR for the detection of SARS-CoV-2. The patients enrolled in the trial were admitted at the emergency department of a tertiary care hospital, with symptoms of suspected COVID-19 disease. Methods: A total of 300 patients participated in the study. Patients’ age, gender and result from the Colloidal antigen rapid test were recorded. PCR detection for SARS-CoV-2 was then applied, according to the manufacturer’s instructions. Statistical analysis of all collected data was performed for sensitivity, specificity, ROC curves, PV+, PV- and Cohen’s kappa coefficient. McNemar’s chi-squared test and p-values were also tested. Results: A p-value=0.045 from McNemar’s chi-squared test for CI 95% was observed, so H0 marginally is not rejected. The sensitivity of colloidal gold antigen rapid test was 79%, the specificity 96%, PV+89%, PV-91% and the kappa coefficient=0.79 (>0.5) that correlates to substantial agreement according to Cohen’s Kappa interpretation. Conclusions: Through the methodological comparisons and according to WHO guidelines for the sensitivity, specificity and kappa coefficient that correlates to substantial agreement the Colloidal Gold Antigen Rapid Test for SARS-CoV-2 meet the needs of clinical test in the emergency unit playing an important role in the context of mass patient screening and screening in remote areas.