COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2854

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Coronaviruses (HCoV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV

Pathogens detected

SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, 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

The SARS-CoV-2 virus has the characteristics of strong nucleocapsid (N) protein stability. The mutant virus strains that have been found worldwide are derived from the SARS-CoV-2 20B/GR evolutionary strain (lineage B.1.1.7), including many mutation, the mutation location is the spike (S) protein of the new coronavirus, which is the location where the SARS-CoV-2 virus uses to bind to the cell's ACE2 receptor. The ZEKMED LUNA Ag Antigen Rapid Test Kit (N) produced by ZEKMED Ltd, is used for in vitro qualitative detection of SARS-CoV-2 virus nucleocapsid (N) protein in human nasopharyngeal , oropharyngeal , anterior -nasal or saliva samples. It can be seen that the mutation sites of mutated virus strains including Omicron strain have no effect on the detection rate of the kits produced by our company. The kit is suitable for assay of the SARS-CoV-2 variant virus called 'Omicron '.

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

LOD

400 TCID50/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0 %

False negatives

0 %

Precision

Evaluated

Accuracy

99.35 % (Antigen)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98 % (Antigen)

Clinical Specificity

100 % (Antigen)

Type of antigen

Nucleocapsid protein

Notes

Legionella pneumophila, Streptococcus pneumonia, Streptococcus pyrogens, Human etapneumovirus (hMPV) 3 Type B1