Skip to main content
European Commission logo
Live, work, travel in the EU
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CBDNA RT-LAMP RAPID TEST

Manufactured by Centrum BadaÅ„ DNA ul. Åšciegiennego 20 60-128 PoznaÅ„, Poland - https://www.cbdna.pl/ 

Device identification number
2567
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal 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
2022-08-24 09:08:01 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
Unknown
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
20 minutes
Subclass
JRC-S
LOD
10 cpr ((≥10 cpr))
Positive control
97 % ((≥97%))
Negative control
100 %
Analytical Sensitivity
100 %
Analytical 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