General name: COVID-19 IgM Antibody Test Kit (colloidal gold method)
[PACKAGE SPECIFICATION]
1 Test/Kit; 20 Tests/Kit; 50 Tests/Kit.
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COVID-19 IgM Antibody Test Kit (colloidal gold method) Instruction
Novel coronavirusIgM antibody in blood was detected in 15 minutes
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[PRODUCT NAME]
General name: COVID-19 IgM Antibody Test Kit (colloidal gold method)
[PACKAGE SPECIFICATION]
1 Test/Kit; 20 Tests/Kit; 50 Tests/Kit.
[INTENDED USE]
This kit is only used for qualitative test of SARS-CoV-2 IgM from human serum and plasma in vitro. The kit
is to be used as supplementary test for the SARS-CoV-2-suspected patients whose nuclei acid is tested as
negative, or to be used together with nuclei acid test in the diagnosis of 2019-nCoV-suspected patients. The
test result cannot be used as the sole basis for diagnosis and exclusion decision. The kit is not suitable for the
general population screening.
The kit is provided use only for medical institute.
Positive test result needs to be further confirmed, negative result does not preclude 2019-nCoV infection.
This kit is an emergency clinical use and storage only during COVID-19 pandemics, cannot be used as regular
clinical IVD kit. The test results by this kit are for clinical reference only. It is suggested to consider patient’s
symptoms and other lab tests results to diagnose. Lab test of 2019-nCoV must follow the requirements of
Technical Guidelines for COVID-19 Laboratory Testing and make sure to be equipped with biosafety.