COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2704

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV) Type B, SARS-CoV

Pathogens detected

SARS-CoV

Information on antigen epitope targeted by the antibodies used in the design of the device

clone1 binding site: INTNSSP(74-80) clone2 binding site: GTRNPANN(147-154)

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) is a lateral flow chromatographic immunoassay. It has two pre-coated lines, “T” Test line and “C” Control line on the nitrocellulose membrane. Mouse monoclonal anti-SARS-CoV-2 antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region. When the specimen is processed and added to the sample well, SARS-CoV-2 antigens in the sample interact with the SARS-CoV-2 Antibody-labeled conjugate forming antigen-antibody color particle complexs .The complexs migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-SARS-CoV-2 antibodies. A colored test line is visible in the result window if SARS-CoV-2 antigens are present in the specimen and the intensity depends upon the amount of SARS-CoV-2 antigen. When the SARS-CoV-2 antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Other ()

Method

Chromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

LOD

28.8 (pg/ml (Nucleocapsid protein Concentration))

Analysis of cross reactivity

Evaluated

False positives

6 AU

False negatives

2 AU

Accuracy

98.4 % (Antigen)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.9 % (Antigen)

Clinical Specificity

98.11 % (Antigen)

Type of antigen

Nucleocapsid protein

Notes

INTNSSP(74-80) clone2 binding site:GTRNPANN(147-154)