COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

983

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette

Target type

Antibody, IgG, IgM

Targets

nucleocapsid protein

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

LIMITATIONS1. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 viral antigen from the nasopharyngeal swab.2. A negative test result may occur if the level of an antigen in a sample is below the detection limit of the test.3. According to CDC’s guidance, the COVID-19 antigen test has the best sensitivity from day 1 to day 5 after the onset of symptoms. Antigen levelsin specimens collected beyond 5-7 days of the onset of symptoms may drop below the limit of detection of the test.4. Failure to follow the Test Procedure and interpretations of Test Results may adversely affect test performance and/or invalidate the Test Results.5. Test Results must be evaluated in conjunction with other clinical data available to the physician.6. Negative test results do not rule out other potential non-SARS-CoV-2 viral infections. Negative results should be confirmed by molecular diagnosis ifCOVID-19 disease is suspected.7. Positive test results do not rule out co-infections with other pathogens.8. Monoclonal antibodies may fail to detect or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in thetarget epitope region.

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunoassay

Measurement

Qualitative

Clinical Sensitivity

93.7 % IgM

Clinical Sensitivity

98.8 % IgG

Clinical Specificity

99.1 % IgM

Clinical Specificity

98.7 % IgG

Type of antigen

nucleoprotein