CBDNA RT-LAMP RAPID TEST
Manufactured by DNA Research Center Ltd., Poland
Device identification number
2607
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Strip
Specimen
Nasal swab, Nasopharyngeal swab, Saliva, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Two-gene genetic test performed with the RT LAMP method is a test for the specific detection of SARS-CoV-2 virus in humans. The key stage of the test is the detection of the viral genetic material, which takes place in the process of reverse transcription and isothermal amplification of the genetic material (Reverse Transcription Loop Mediated Isotermal Amplification).
Assay Type
Nucleic acid-Other
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
15 minutes
LOD
10 cpr (≥10 cpr)
Positive control
97 % (≥97%)
Negative control
100 %
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
97 %
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