Dotz SARS-CoV-2 Rapid Diagnostic Kit
Manufactured by Dotz Nano Ltd., Israel - www.dotz.tech
Device identification number
2927
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot), Semi-automated
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Rapid Diagnostic Kit is designed to extract and detect SARS-CoV-2 RNA. The product detects the amplification of extracted viral RNA derived from saliva or nasopharyngeal/oropharyngeal (NP/OP) swabs.
Assay Type
Nucleic acid-Other
Self Test
No
Method
LAMP
Measurement
Qualitative
Time
34 minutes
LOD
1250 copies/reaction
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 %
False negatives
0 %
Precision
Not evaluated
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
97 %
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