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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



1copy™ COVID-19 qPCR 4plex Kit

Manufactured by 1drop Inc, South Korea - www.1drop.co.kr/ 

Device identification number
2920
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
envelope protein, nucleocapsid protein, ORF1ab polyprotein,
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasal aspirate, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
1copy™ COVID-19 qPCR 4plex 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, nasal aspirate and saliva specimens collected from individuals suspected of COVID-19 by their healthcare providers. 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 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 the 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. 1copy™ COVID-19 qPCR 4plex 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
Self Test
No
Method
RT-PCR
Measurement
Qualitative
Time
50 minutes
LOD
400 cpm
Positive control
N gene plasmid, E gene plasmid and RdRp gene plasmid
Negative control
DEPC DW
Clinical Sensitivity
100 %
Clinical Specificity
100 % (10)
Throughput
96 samples per run

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements