Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method
Manufactured by K.K. Mirai Genomics, Japan - https://miraigenomics.com
Device identification number
2898
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Target type
Nucleic acid
Targets
non-structural protein/gene NSP15, ORF1a polyprotein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method (the Kit) is intended to perform the SARS-CoV-2 viral RNA extraction in nasopharyngeal, oropharyngeal, or combined oro- and nasopharyngeal swab collected from individuals who are suspected of COVID-19 infection, master mix preparation and further SARS-CoV-2 viral RNA detection in the specimen using PCR method. Results are used for the SARS-CoV-2 RNA identification. Positive results are indicative of the SARS-CoV-2 RNA presence. To determine a patient’s infection status, clinical comparability with patient clinical history and other diagnostic information is required. Negative results do not preclude the SARS-CoV-2 infection and should not be used as the sole basis for treatment. Negative results must be combined with clinical observations, patient clinical history, and epidemiological information. The Kit is intended to be performed by trained users in both laboratory and near patient testing settings. The Kit is intended for use with the LifePad Analyzer
Assay Type
Nucleic acid-PCR
Self Test
No
Method
RT-PCR
Measurement
Qualitative
Time
35 minutes
LOD
2000 cpm
Positive control
Dry mixture of an in vitro synthesized fragment of the SARS-CoV-2 RNA genome 4x107 cpm
Negative control
Guanidine Thiocyanate, Sodium polyacrylate, Tris-HCl buffer solution, pH 7.4, Triton X-100, Ethanol
Analytical Sensitivity
% 100.00
Analytical Specificity
% 100.00
Clinical Sensitivity
% 98.04
Clinical Specificity
% 100.00
Throughput
single cartige
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