ExdiaCOVID-19 IgG/IgM is a high sensitivity Time-Resolved Fluorescence immunoassay for the qualitative detection of human IgG/IgM

antibodies to SARS-CoV-2 in human whole blood, plasma (Heparin/EDTA) and serum sample collected by healthcare workers at the point of

care. TheExdiaCOVID-19 IgG/IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,

indicating recent or prior infection. Test results ofExdiaCOVID-19 IgG/IgM should not be used as the sole basis to diagnosis.

Features

• High sensitivity & accuracy

• Fast results in 15 minutes

• For use with Exdia TRF analyzers

   - Objective and reliable test results

   - Built-in printer

   - Network connectivity (LIS)

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

Test procedure

1. Collect 10mL of whole blood using disposable capillary tube (provided) or 5mL of plasma or serum using liquid handling pipette (not provided).

2. Allow the disposable capillary tube or liquid handling pipette to touch lightly on the pad underneath the sample well.

3. Add two drops of developer buffer into the developer well right after injecting the specimen.

4. Read the results at 15 minutes. The test cassette should be analyzed by theExdiaanalyzer according to the instruction manual.

Clinical performance

Positive Percent Agreement (PPA) =54/57(94.74%), 95% CI: 85.63 to 98.19%

Negative Percent Agreement (NPA) =145/150(96.67%), 95% CI: 92.43 to 98.57%

The Overall Percent Agreement (OPA) = 199/207(96.14 %)95% Cl: 92.56-98.03%

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