Truenat® SARS CoV-2
Manufactured by Molbio Diagnostics Private Limited, India - https://www.molbiodiagnostics.com/
Device identification number
286
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Near POC / POC
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Truenat® SARS CoV-2 is a chip-based Real Time Reverse Transcription Polymerase Chain Reaction (RT PCR) test for the semi quantitative detection of SARS CoV 2 RNA in human oropharyngeal and nasopharyngeal swab specimen and aids in confirmation of COVID-19. Truenat® SARS CoV-2 runs on the Truelab® Real Time micro PCR Analyzers.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Self Test
No
Reader Required
No
Method
RT-PCR
Measurement
Semiquantitative
Time
45 minutes
LOD
407 copies/ml (in transport medium for swab specimen, with 95% CI interval of 335-553)
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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