COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2439

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antibody, IgG, IgM

Targets

nucleocapsid protein

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 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG/IgM Rapid 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 Rapid 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. 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 Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

No

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

Subclass

Sandwich

LOD

100

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.037 % IgG

False positives

0.05 % IgM

False negatives

0.014 % IgG

False negatives

0.02 % IgM

Precision

Evaluated

Accuracy

98.1 % IgG

Accuracy

97.4 % IgM

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.3 % IgG

Clinical Sensitivity

95 % IgM

Clinical Specificity

98.6 % IgG

Clinical Specificity

98 % IgM

Type of antigen

Nucleoprotein