SARS-CoV-2 Antigen Fast Test Kit 

(Immunofluorescence Assay)

Intended Use

SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples from patients suspected of COVID-19 infection by a healthcare provider.

About SARS-CoV-2

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

Contents

1. For Getein1100

Package specifications: 25 tests/box

1) Getein 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

3) User manual: 1 piece/box

4) SD card: 1 piece/box

Package specifications: 2×24 tests/kit, 2×48 tests/kit

1) Sealed cartridge with 24/48 Getein SARS-CoV-2 antigen test cards

2) User manual: 1 piece/box

Materials required for Getein1600:

1) Sample extraction solution: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

4) Sampling swab: 48 pieces/box, 96 pieces/box

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

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Operation

  Sample Pretreatment  

 Test 

Clinical Application

1. This test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

2. This test is only intended for professional and laboratory use, not for home testing.

3. Results from the test should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection.

4. As it is a novel disease diagnosis of which are being explored, please refer to the latest guidelines for diagnosis and treatment of COVID-19.