COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2393

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antibody, IgG, IgM

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

Adenovirus, Enterovirus A71 (EV-A71), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The COVID-19 IgG/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG/IgM Test 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 IgG/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.

Assay Type

Immuno-Antibody

Reader Required

Yes

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.033 AU

False negatives

0.031 AU

Precision

Evaluated

Accuracy

96.9 % ((IgG/IgM))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.7 % ((IgG/IgM))

Clinical Specificity

96.9 % ((IgG/IgM))

Type of antigen

Nucleoprotein