COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1870

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Lateral flow, Strip

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab, Throat swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, SARS-CoV

Pathogens detected

SARS-CoV-2

Type of Antigen (in case of Antigen-based)

Nucleocapsid protein

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-09-20 02:48:19 CET

Comments

This kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Visualisation system

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

Detection Principle

Colloidal gold

LOD

396.22 TCID50/ml

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

3.38 %

False negatives

0.24 %

Precision

Evaluated

Accuracy

98.87 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.62 %

Clinical Specificity

99.76 %

Type of antigen

Nucleocapsid protein