For Professional Use

COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole Blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human disease. Four viruses-229E, OC43, NL63, and HKU1 - are prevalent and typically cause common cold symptoms in immunocompetent individuals. The three other strains - severe acute respiratory syndrome coronavirus(SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) - are zoonotic in origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. IgG remains positive, but the antibody level drops overtime.

For Serum or Plasma Specimens

Allow test kit, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.    Remove the test strip/cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2.    Place the test kit on a clean and level surface.

Strip: Add 2uL of serum/plasma to the sample pad(purple place with Colloidal gold) of the test strip, then add 2 drops (about -80μL) of sample buffer to the buffer pad (top of the strip) immediately.

Cassette:

Add 2uL of serum/plasma to the specimen well(S) of the test cassette, then add 2 drops (about 80μL) of sample buffer to the buffer well (B) immediately.

3.    Wait for the colored line(s) to appear. The result should be read at 10 minutes.

For whole blood specimen

Allow test kit, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.    Remove the test strip/cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2.    Place the test device on a clean and level surface.

Strip: Add 4μL of whole blood to the sample pad(purple place with Colloidal gold) of the test strip, then add 2 drops (about -80μL) of sample buffer to the buffer pad (top of the strip) immediately.

Cassette:

Add 4μL of whole blood to the specimen well(S) of the test cassette, then add 2 drops (about 80μL) of sample buffer to the buffer well (B) immediately.

3.    Wait for the colored line(s) to appear. The result should be read at 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

Type & Specification