COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2827

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Lateral flow

Target type

Antibody, IgG, IgM

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The COVID-19 Biokit IgG/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG/IgM is suitable for professional use. The COVID-19 Biokit IgG/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.

Assay Type

Immuno-Antibody

Reader Required

No

Subcategory

Sample collection device

Method

Immunochromatography

Measurement

Qualitative

Time

20 minutes

Subclass

Sandwich

LOD

PRNT50: 20

Calibration

Not evaluated

Analysis of cross reactivity

Not evaluated

False positives

9.91 %

False negatives

0.25 %

Precision

Evaluated

Accuracy

97.74 %

Reproducibility

Evaluated

Robustness

Not evaluated

Clinical Sensitivity

90.09 % (95% CI, 85.33% - 93.43%)

Clinical Specificity

99.75 % (95% CI, 99.1% - 99.93%)

Type of antigen

Spike protein