COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3123

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Latex, Strip

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Anterior nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus

Pathogens detected

SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The sample to be tested moves forward due to capillary action. The N protein in the sample binds to the gold-labeled SARS-CoV-2 N protein mouse anti human monoclonal antibody 1 pre-coated on the binding pad, and the conjugate moves upward under capillary action. If the sample contains the novel coronavirus antigens and concentration of antigens is higher than the limit of detection, the antigen will bind to the N proteinmouseanti human monoclonal antibody.

Assay Type

Immuno-Antigen

Self Test

Yes

Reader Required

Yes

Subcategory

Other ()

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Other ()

LOD

2.5 µg/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

1.54 % (After comparison of clinical test, there were7 false positives for 454 positive samples.)

False negatives

5.45 % (After comparison of clinical test, there were 6 false negatives for 110 positive samples.)

Precision

Evaluated

Accuracy

97.7 % (Antigen)

Reproducibility

Not evaluated

Robustness

Evaluated

Clinical Sensitivity

94.54 % (Antigen)

Clinical Specificity

98.46 % (Antigen)

Type of antigen

Other

Notes

COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) detects the SARS-CoV-2 with the principle of antigen-antibody reaction. The test strip contains (1) coated with red latex microspheres labeled SARS-CoV-2 N protein mouse anti human monoclonal antibody 1 and blue latex microspheres labeled chicken IgY fixed on a binding pad, (2) test line (T red) Coated paired SARS-CoV-2 N protein mouse anti human monoclonal antibody 2, quality control line (C blue) coated goat anti chicken IgY antibody fixed on a nitrocellulose membrane. T is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the C line. The immune complex will be captured by the anti-SARS-CoV-2 antibody immobilized on the membrane, forming a red T line and indicating a positive result for the novel coronavirus. The higher the N protein content in the sample, the more conjugates will be captured and the darker the color of the test line (T red). Additionally, the test Strip also contains a quality control line (C blue). Regardless of whether there is a virus in the sample, a blue band will appear in the control line (C blue). What appears in the Control Line (C blue) is the standard for judging whether there are enough samples and whether the chromatographic process is normal. If the C line does not appear it indicates that the test result is invalid and the sample is required to retest.