COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2794

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

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This Real-time PCR kit is qualitatively detecting coronavirus disease 2019 (COVID-19) by using the extracted RNA from sputum, nasopharyngeal swab or oropharyngeal swab of suspected patients using Veri-Q PCR316 device, QD-P100. This Kit is designed as a professional use In Vitro diagnostic medical device with experience in molecular diagnosis experiments. This test can help diagnose infections of indivisual suspected of coronavirus disease 2019. Consultation with a medical specialist is required for final diagnosis. Calibration of the system is traceable to SARS-CoC-2 RNA NCCP 43326

Assay Type

Nucleic acid-PCR

Reader Required

Yes

Method

RT-PCR

Measurement

Qualitative

Time

80 minutes

LOD

150 copies/ml

Positive control

SARS-CoV-2 Positive Control Material

Negative control

Nuclease Free Water

Analytical Sensitivity

95 %

Analytical Specificity

95 %

Clinical Sensitivity

97.36 %

Clinical Specificity

100 %