One Step Test for FluA/FluB/SARS-CoV-2 Antigen

(Colloidal Gold)

Intended Use

One Step Test for Flu A/Flu B/ SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from Flu A/Flu B/SARS-CoV-2 in human nasopharyngeal swab or oropharyngeal swab samples from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms. This test is only intended for professional and laboratory use, not for home testing.

About Flu A/ FIu B/ SARS-CoV-2 Antigen

Influenza viruses are causative agents of highly contagious, acute, viral infections of the respiratory tract. Influenza viruses are immunologically diverse, single-stranded RNA viruses.

There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both Type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season.

The novel coronaviruses belong to the β genus. SARS-CoV-2 is a generally susceptible acute respiratory infectious disease. The main source of infection is the SARS-CoV-2 infected patients and asymptomatic infected people. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main clinical symptoms include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Autumn and winter season are the season with high incidence of influenza virus, and the early symptoms of respiratory virus infection are similar, timely differentiate of disease is particularly important.

Contents

Package specifications: 25 tests/box

1) Getein Flu A/Flu B/ SARS-CoV-2 antigen test card in a sealed pouch with desiccant

2)Sample extraction solution: 25 tubes/box

3) Sampling Swab: 25 pieces/box

4) Disposable pipette: 25 pieces/box

5) User manual: 1 piece/box

Note: Do not mix or interchange different batches of kits.

Specifications

Clinical Application

As an aid in the differentiate of patients with suspected SARS-CoV-2 infection in conjunction with clinical symptoms and result of other diagnostic methods. Results from the test should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection.