Abstract

Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in late 2019 and rapidly evolved into the current coronavirus pandemic. SARS-CoV-2 is a respiratory virus that causes symptoms similar to those caused by influenza A and B viruses. Although patients infected with SARS-CoV-2, influenza A and influenza B show comparable or similar manifestations, the therapeutic approaches of these respiratory viral infections are different, which requires an accurate diagnosis. Identification of viral RNA by real-time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) remains the gold standard for diagnosing SARS-CoV-2 infection. However, laboratory equipment cost, availability and the need for trained personnel limit testing capacity. Through an unprecedented research effort, new diagnostic techniques such as rapid diagnostic testing, isothermal amplification techniques, and next-generation sequencing were developed, enabling accurate and accessible diagnosis. Influenza viruses are responsible for seasonal outbreaks infecting up to a quarter of the global human population. Influenza and SARS-CoV-2 present with flu-like symptoms making the differential diagnosis challenging solely on clinical presentation. Healthcare systems are likely to be faced with overlapping SARS-CoV-2 and Influenza outbreaks. On July 2, 2020, the U.S. Food and Drug Administration (FDA) granted emergency use authorization for an in vitro diagnostic multiplex assay for SARS-CoV-2 influenza.

Objective: The main purpose of this evaluation report is to assess the accuracy of the COVID-19 and flu A/B multiplex panel for home use (Nasal Swab) for the rapid qualitative detection of SARS-CoV-2 nucleocapsid protein, influenza A and influenza B nucleoprotein antigens in nasal swab specimens.

Methods: Run a rapid in vitro diagnostic test device for the detection of antigens to SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins in nasal swab and compare with a leading commercial RT-PCR test for validation of performance.

Results: The results show that in the comparative experiment with RT-PCR, the relative accuracy of COVID-19 and flu A/B multiplex panel for home use (Nasal swab) in the qualitative detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens are respectively 98.69%, 99.10% and 98.92%.

Conclusion: CITEST COVID-19 and flu A/B multiplex panel for home use (Nasal swab) is a rapid test that is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens in human nasal swab specimen. The product is simple to operate and has been validated against an industry leading commercial RT-PCR test to give results within 10 minutes of the sample being tested. The COVID-19 and flu A/B multiplex panel for home use (Nasal swab) has been evaluated with specimens obtained from patients. In the comparison test with RT-PCR, the accuracy rate of the SARS-CoV-2 test reached 98.69%, the accuracy rate of influenza A antigen test reached 99.10%, and the accuracy rate of influenza B antigen test reached 98.92%. In the case of simultaneous outbreaks of the SARS-CoV-2 and influenza, these test kits can be used to obtain accurate results.

Keywords: COVID-19; SARS-CoV-2; Influenza A; Influenza B; Rapid test; RT-PCR; Accuracy