COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2420

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antibody, IgG

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

Adenovirus, Enterovirus A71 (EV-A71), 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 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/ Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended to be used by trained laboratory personnel. Negative results will not preclude SARS-COV-2/M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.

Assay Type

Immuno-Antibody

Reader Required

No

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 AU (COVID-19 IgG),

False positives

0.078 AU ((Mycoplasma pneumoniae IgG))

False negatives

0.02 AU ((COVID-19 IgG),)

False negatives

0.054 AU ((Mycoplasma pneumoniae IgG))

Precision

Evaluated

Accuracy

98.6 % IgG ((COVID-19 IgG);)

Accuracy

93.7 % IgG ((Mycoplasma pneumoniae IgG).)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

100 % IgG ((COVID-19 IgG);)

Clinical Sensitivity

92.2 % IgG ((Mycoplasma pneumoniae IgG).)

Clinical Specificity

98 % IgG ((COVID-19 IgG);)

Clinical Specificity

94.6 % IgG ((Mycoplasma pneumoniae IgG).)

Type of antigen

Nucleoprotein