COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2917

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Target type

Nucleic acid

Targets

envelope protein/gene, ORF1ab polyprotein/gene

Specimen

Anterior nasal swab, Mid-turbinates swab, Nasal aspirate, Nasopharyngeal swab, Oropharyngeal 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

2022-08-24 09:08:01 CET

Comments

1copy™ COVID-19 qPCR Multi Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab specimens as well as nasopharyngeal wash/aspirate and nasal aspirate specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests or by similarly qualified non-U.S. laboratories. Results are used to identify the presence of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during an acute phase of infection. Positive results indicate presence of SARS-CoV-2 RNA, but clinical correlation with patient history and other diagnostic information are necessary to rule out a patient's infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The 1copy™ COVID-19 qPCR Multi Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Measurement

Qualitative

Time

90 minutes

LOD

200 cpm

Positive control

E gene plasmid and RdRp gene plasmid

Negative control

DEPC DW

Clinical Sensitivity

100 %

Clinical Specificity

100 %