COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2316

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Specimen

Nasal 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), Influenza A H1N1, Influenza A H3N2, Influenza B, Mumps Virus (MuV), Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Rhinovirus A, Rhinovirus B

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The SARS-CoV-2 Ag Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human swab specimen. Anti-SARS-CoV-2 antibody is coated in the test line region. During testing, SARS-CoV-2 antigens in the specimen react with anti-SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates forward on the membrane by capillary action and reacts with the anti-SARS-CoV-2 antibody in the test line region. If the specimen contains SARS-CoV-2 antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens of SARS-CoV-2, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Assay Type

Immuno-Antigen

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.006 AU

False negatives

0.066 AU

Precision

Evaluated

Accuracy

97.6 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

93.5 %

Clinical Specificity

99.3 %

Type of antigen

Nucleoprotein