For Professional Use [Intended Use]

This product is used for the qualitative detection of SARS-CoV-2 antigen in vitro in human nasopharyngeal (NP) or oropharyngeal swabs.

The new coronaviruses belong to the β genus. COVID-19 is an acute respiratory infection. People are generally receptive to it.

Currently, patients infected with the novel coronavirus are the main source of infection, asymptomatically infected people can also be a source of infection.

Based on the current epidemiological investigation, the incubation period is between 1 and 14 days, mainly between 3 and 7 days.

The main symptoms are fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in some cases.

Materials included

1) Sterilized tampon

2) Antigen extraction tube with extraction reagent

3) Test device

4) Instruction

5) Test tube rack (only 25 pcs/box)

Storage conditions and expiration date

1. Store at 4℃~30℃ and it is valid for 24 months.

2. After opening the aluminum foil bag, the test device should be used as soon as possible and within one hour.

Clinical performance

Sensitivity: 96.4% (95% CI: 90.8% - 98.2%)

Specificity: 99.8% (95% CI: 94.4% - 99.9%)