This Detection kit is for in vitro qualitative detection of SARS-CoV-2 antigen in nasal swab samples. This test is intended for non-prescription home use self-testing with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19 or adult collected nasal swab samples from individuals under 15 years old who are suspected of COVID-19.
Epidemiology
Coronavirus Disease 2019(COVID-19), is a pneumonia caused by infection with a novel coronavirus named as Severe Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2). SARS-CoV-2 is a novel coronavirus in β genus, enveloped particles in round or oval, with a diameter from 60 nm to 140 nm. Human is generally susceptible to SARS-CoV-2. The main sources of infection are the confirmed COVID-19 patients and asymptomatic carrier of SARSCoV-2.
Technical Parameters
Storage temperature - 4℃-30℃
Sample type - Nasal swab samples
Shelf life - 24 months
Auxiliary instruments - Not required
Extra Consumables - Not required
Detection time - 15-20 mins
Specificity -
There is no cross-reactivity with pathogens such as human Coronavirus ( HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1 (2009), seasonal influenza A (H1N1, H3N2, H5N1, H7N9), Influenza B (Yamagata, Victoria), Respiratory syncytial virus A/B, Parainfluenza virus(1, 2 and 3), Rhinovirus (A, B, C), Adenovirus (1, 2, 3, 4,5, 7, 55).
Work Flow
1. Sampling
● Gently insert the entire soft tip of the swab (usually 1/2 to 3/4 of an inch) into one nostril, Using medium pressure, rub the swab against all the inside walls of your nostril. Make at least 5 big circles.