COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2921

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Specimen

Nasopharyngeal swab

Lineages detected

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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

The 1copy™ COVID-19 MDx Kit Professional is an In vitro diagnostic medical device intended to diagnose COVID-19 infection by detecting S gene and N gene of SARS-CoV-2 via loop-mediated isothermal amplification (LAMP) in upper respiratory specimens, nasopharyngeal swabs, collected from patients suspected of COVID-19. 1POT™ Professional device, used with 1copy™ COVID-19 MDx Kit Professional, is an in-vitro diagnostic system intended for the qualitative detection of nucleic acids via loop-mediated isothermal amplification (LAMP) from SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of COVID-19.

Assay Type

Nucleic acid-PCR

Self Test

No

Reader Required

Yes

Method

LAMP

Measurement

Qualitative

Time

20 minutes

LOD

100 cpr

Clinical Sensitivity

93.3 %

Clinical Specificity

99.5 %