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

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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