COVID-19 Nucleic Acid Detection Kit (RT-LAMP)
Manufactured by Langfang Xinruikang Biotechnology Co. Ltd., China
Device identification number
3091
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
performances Alpha(100;98);Beta(100;98);Gamma(100;98);Delta(100;98); Omicron(100;97)
Assay Type
Nucleic acid-Other
Self Test
No
Reader Required
No
Method
LAMP
Measurement
Qualitative
Time
30 minutes
LOD
500 cpm
Positive control
NA
Negative control
NA
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
98.5 %
Clinical Specificity
100 %
Throughput
Single tube
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