DEVELOPMENT AND CLINICAL VALIDATION OF A REAGENT KIT FOR SIMULTANEOUS DETECTION OF INFLUENZA A, B, INFLUENZA A H1pdm09 AND CORONAVIRUS SARS-CoV-2

Abstract

Respiratory tract infections are the main cause of temporary disability for work and take a major toll on economies in whole world. Early and accurate detection of etiological agent will improve treatment efficiency and prevent spreading of epidemy. The reagent kit for simultaneous detection of influenza A, B virus, H1pdm09 influenza A strain and coronavirus SARS-CoV-2 was developed. For clinical validation TIB Molbiol (E gene) kit (for detection of SARS-CoV-2) and CDC Influenza Virus Real-Time RT-PCR Panel Influenza A/B typing Panel were used. The assay has shown high sensitivity and specificity against different strains of SARS-CoV-2 and influenza viruses. The analytical sensitivity was 500 copies/ml for detection of Influenza A and B viruses and 250 copies/ml for SARS-CoV-2. No cross-reaction with other respiratory pathogens was detected. Clinical sensitivity and specificity against comparator test were 100%. Developed reagent kit intended for use in clinical laboratories for differentiating diagnosis of coronaviral infection and influenza A and B.