PBCheck COVID-19 IgG/IgM is a rapid immunoassay for the qualitative detection of human IgG/IgM antibodies to SARS-CoV-2

in human whole blood, plasma and serum sample. The PBCheck  COVID-19 IgG/IgM Antibody Test is intended for use as an aid in identifying

individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Features

• Quick and Easy to use

• Fast results in 10 minutes

• No equipment required

• Multiple sample type

Application

Serology testing for COVID-19 can be used to identify whether people were previously infected by SARS-CoV-2 even if they haven’t shown

symptoms. This is important to determine, because the RT-PCR tests now being used to diagnose the coronavirus can detect the presence

of the viral material during infection, but it doesn’t indicate if the person was previously infected and subsequently recovered.

• Identify asymptomatic patients

• Help to verify quarantine release

• Rapid screening of suspected case

• Epidemiological tracing

Clinical performance

Positive Percent Agreement (PPA)= 52/55 (94.55%), 95% CI: 85.15% to 98.13%

Negative Percent Agreement (NPA)= 98/100 (98.00%), 95% CI: 93.00% to 99.45%

Test procedure

Interpretation of results

·IgM only positive: Appearance of pinkish red colored bands at the control line and

the IgM test line indicate that the SARS-CoV-2 IgM antibody was detected.

· IgG only positive: Appearance of pinkish red colored bands at the control line and

the IgG test line indicate that the SARS-CoV-2 IgG antibody was detected.

· IgM and IgG positive: Appearance of pinkish red colored bands at the control line,

the IgG test line and the IgM test line indicate that the SARS-CoV-2 IgG and IgM antibodies are detected.

· Invalid: If no colored line appears in the control region (C), the test results is invalid.

The test result is inconclusive, and assay should be repeated with a new test cassette.

Product Specification