One Step Test for Novel Coronavirus (2019-NCoV) IgM/IGG Antibody Colloidal Method

Product Name: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody Detection Method: (Colloidal Gold method)

Brief Introduction:

— Qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody   

CE Marked and included in the export whitelist issued by Ministry of Commerce of China

Sample Type: Serum, plasma or whole blood

Reaction time: 5-15 min

Storage Temperature: 4-30 degree Celsius

Shelf Time: 24 months

Intended Use:

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) 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.

Characteristics:  Read test result directly and no need test equipment.

● Result could be shown in 5-10min

● Whole blood/serum/plasma could be tested

● Test both IgG and IgM to improve sensitivity

● Use in combination with w2019-nCoV nucleic acid test for better diagnosis.

Application

● Screening large numbers of suspected cases of COVID-19 for CDC or Outpatient and Emergency in hospitals.

● Rapid screening for primary health care institutions

● Rapid screening for resumption of work in public institutions and companies

● Screening for students back to school

● Clinical application

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) 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. 

This test is only intended for professional and laboratory use, not for home testing. Results from the test should not be used as the sole basis for diagnosis and exclusion of 2019-nCoV infection. In the future, this test may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection.

Package:

A box package contains 25 tests:

● Foil bag, which contains one test card and one desiccant: 25

● User manual : 1

● Sample diluent: 2

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