COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2980

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Specimen

Nasal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, 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), Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mycoplasma Pneumoniae, 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, Rhinovirus B

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

2022-12-02 09:22:17 CET

Comments

The kit includes a lysis reagent, which in conjunction with heat treatment, helps to split the virus and release genetic material for its detection using RT-PCR, so no extraction step is needed (*see IFUs)

Assay Type

Nucleic acid-PCR

Self Test

No

Method

RT-PCR

Measurement

Qualitative

Time

70 minutes

LOD

1.25 cpu

Positive control

E gene RNA, RdRp gene RNA, N gene RNA, endogenous human GADPH gene RNA

Analytical Sensitivity

97.4 %

Analytical Specificity

100 %

Clinical Sensitivity

99.4 %

Clinical Specificity

100 %

Throughput

Higher than 96 samples per run

Notes

In silico tests indicate that all variant are detected