COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1113

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Manual

Target type

Antibody

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

from website (Clinical Specificity: 99.0%; Clinical Sensitivity: 87.5% (vs. RT-PCR confirmed samples); Accuracy: 96.8%); "MATERIALS PROVIDED1. CoV-Check COVID-19 IgG/IgM Test Device (Kit Size: 25 Tests / Box)2. Sample Buffer (1 Bottle – 3.0 ml)3. 2 ?L Capillary Pipette (25 pipettes / Bag)4. Instructions for Use – 1LIMITATIONS1. CoV-Check COVID-19 IgG/IgM Test Device is limited to the qualitative detection of anti-2019-nCoV antibody levels in serum, plasma, or whole blood specimen. The exact concentration of anti-2019-nCoV antibody cannot be determined by this assay.2. Although the test is very accurate in detecting anti-2019-nCoV antibody, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained.3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.4. In the early stage of infection, if IgM and IgG antibodies are not produced or the titer is very low, false negative results will occur. It is recommended that patients should collect samples again after 7-14 days, and test both the previously collected sample and the latest sample at the same time and compare the results to confirm whether there is serological positive conversion or significant increase in titer. In the later stage of infection, IgM titer will decrease or even be negative, while IgG will continue to increase"

Assay Type

Immuno-Antibody

Rapid Diagnostic

No

Reader Required

Yes

Method

ELISA

Time

150 minutes

Notes

Manual or automated