COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2796

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Near POC / POC

Physical Support

Chip

Target type

Nucleic acid

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, 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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), 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

This Real-time PCR kit is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab specimens from individuals who are suspected of COVID-19. Saliva samples can also be tested, and saliva should be collected using the Veri-Q saliva collection kit (MiCo BioMed, Cat No. 7K401). Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

Assay Type

Nucleic acid-PCR

Reader Required

Yes

Subcategory

N.A.

Method

RT-PCR

Measurement

Qualitative

Time

100 minutes

Subclass

JRC-S

LOD

301.1 copies/ml

Positive control

SARS-CoV-2 Positive Control Material

Negative control

Nuclease Free Water

Analytical Sensitivity

95 %

Analytical Specificity

95 %