COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

4138

CE Marking

×No

HSC common list (RAT)

×No

Format

Lab-based

Physical Support

Other (Tube)

Target type

cDNA, DNA, Nucleic acid, RNA

Targets

membrane protein/gene, nucleocapsid protein/gene, spike protein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Sputum

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus A, SARS-CoV-2

Pathogens detected

SARS-CoV-2

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

2022-09-30 09:56:21 CET

Comments

This kit detects specific mutations within S and M genes and identifies the SARS-CoV-2 variant or lineage present. This kit can identify: Delta Omicron And within the Omicron group, it identifies BA.1, BA.1.1, BA.2, BA.2.12.1, BA.2.75, BA.4, and BA.5

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

No

Self Test

No

Reader Required

Yes

Subcategory

Other (Mutation Screening test)

Method

RT-PCR

Measurement

Semiquantitative

Time

90 minutes

Subclass

Other (Mutation Screening within S and M genes of SARS-CoV-2)

Detection Principle

Fluorescence

Analytical Sensitivity

99 %

Accuracy

99 % (Accuracy on identifying SARS-CoV-2 variant)

Throughput

48 samples per run