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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

TripleLock SARS-CoV-2 Test

Manufactured by Precision Biomonitoring Inc., Canada - www.precisionbiomonitoring.com 

Device identification number
2618
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://precisionbiomonitoring.com/triplelock-lab-testing/
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
60 minutes
LOD
200 cpr
Positive control
RNase P as internal control
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