COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3094

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A

Pathogens detected

SARS-CoV

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526.1, B.1.526.2, B.1.617.2 (Delta), 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

3.7 × 10^5 TCID50 / mL SARS-CoV-2 virus is tested after heat extinguishing, and there is no HOOK effect. The following substances, which are naturally present in respiratory specimens or may be artificially introduced into the nasal cavity or nasopharynx, were evaluated at the following concentrations during the SARS-CoV-2 antigen rapid test and found that they did not affect the test performance: 5 mg/mL Human blood (EDTA anticoagulated), 5 mg/mL Mucin, 5 mg/mL Oseltamivir phosphate, 5 mg/mL Ribavirin, 5 mg/mL Levofloxacin, 5 mg/mL Azithromycin, 5 mg/mL Meropenem, 5 mg/mL Tobramycin, 20% (v/v) Phenylephrine, 20% (v/v) . Oxymetazoline, 20% (v/v) 0.9% sodium chloride, 20% (v/v) A natural soothing ALKALOL, 20% (v/v) Beclomethasone, 20% (v/v) Triamcinolone, 20% (v/v) Budesonide, 20% (v/v) Mometasone, 20% (v/v) Fluticasone, 20% (v/v) Fluticasone propionate

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Membrane-based

LOD

120 TCID50/ml

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

0.78 %

False negatives

0.79 %

Precision

Evaluated

Accuracy

99.22 % (Antigen)

Reproducibility

Not evaluated

Robustness

Not evaluated

Clinical Sensitivity

97.67 % (Antigen)

Clinical Specificity

99.48 % (Antigen)

Type of antigen

Nucleocapsid protein