Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit

(Immunofluorescence Assay)

Intended Use

Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay) is intended for the qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.

About 2019-nCoV

The novel coronaviruses belong to theβgenus. COVID-19 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 Novel Coronavirus (2019-nCoV) IgM/IgG antibody test card in a sealed pouch with desiccant

2) Sample diluent: 25 tubes/box

3) User manual: 1 piece/box

4) SD card: 1 piece/box

2. For Getein1600

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

1)Sealed cartridge with 24/48 Getein Novel Coronavirus (2019-nCoV) IgM/IgG antibody test cards

2)User manual: 1 piece/box

Materials required for Getein1600:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

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

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Clinical Application

1. This test is an aid in the diagnosis of patients with suspected 2019-nCoV 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 2019-nCoV 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.