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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/FluA/FluB/RSV qPCR Kit

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

Device identification number
2919
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein, ORF1ab polyprotein,
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasal aspirate, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Commercial Status
Commercialised
Last Update
2022-01-07 05:26:57 CET
Comments
1copy™ COVID-19/FluA/FluB/RSV qPCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2, Influenza A, Influenza B and RSV 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. Results are for the identification of SARS-CoV-2, Influenza A, Influenza B and RSV RNA. RNA from SARS-CoV-2 and/or Influenza A, Influenza B and RSV viruses is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other viruses; clinical correlation with patient history and other diagnostic information is necessary to determine patient 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, influenza A, influenza B and RSV infection and should not be used as the sole basis for diagnosis, treatment for other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results obtained from individuals who are not exhibiting clinical signs and symptoms associated with respiratory viral infection at the time of specimen collections should be interpreted with particular caution. Negative results in asymptomatic individuals cannot be used as definitive evidence that an individual has not been exposed to SARS-CoV-2 or influenza viruses and has not been infected with any of these viruses. 1copy™ COVID-19/FluA/FluB/RSV qPCR 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
800 cpm
Positive control
N gene plasmid, RdRp gene plasmid, Flu A gene plasmid, Flu B gene plasmid and RSV gene plasmid
Negative control
DEPC DW
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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