COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2843

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette, Fingertip

Target type

Antibody, IgG

Specimen

Whole blood

Cross-reactivity (pathogens tested)

Coronaviruses (HCoV), Influenza A, Influenza B, SARS-CoV

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The neutralization antibody test uses immunochromatography. The test card contains:1) colloidal gold-labeled recombinant novel coronavirus S-RBD antigen, refering control and quality control antibody gold markers; 2) tow detection lines (T1 and T2) and one quality Control line (C line) of nitrocellulose membrane. The T line is immobilized with anti-human IgG for detecting novel coronavirus neutralizing antibody and the C line is immobilized with a quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The immune complex will be captured by the anti- human IgG antibody immobilized on the membrane to form a purple-red T line, showing that the novel coronavirus Neutralizing antibody is positive. The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card. The IgG test is based on the principle of colloidal gold immunochromatography to quaitatively detect the new coronavirus SARS-CoV-2 IgG antibody in serum, plasma or whole blood samples. When the SARS-CoV-2 IgG level in the specimen is at or above the target cutoff (the detection limit of the test), the antibody bound to the antigen-dye conjugate are captured by anti-human IgG immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 IgG level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.

Assay Type

Immuno-Antibody

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Microtiter

Detection Principle

Colloidal gold

LOD

nAbs：L1～L3,L1 and L2 are positive,L3 is positive or negative. IgG：L4～L6,L4 is positive,L5 is positive or negative，L6 is negative.

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

AU 0

False negatives

AU 0

Precision

Evaluated

Accuracy

99.86 % (95% CI:99.59%-99.97%)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.95 % (95% CI:96.25%-99.87%)

Clinical Specificity

99.86 % (95% CI:99.59%-99.97%)