Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit
Manufactured by Hayat Genetics Inc., Turkey - www.hayatgenetics.com
Device identification number
1230
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test is an isothermal nucleic acid amplification method intended for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal and nasopharyngeal swabs) and saliva collected from individuals suspected of COVID-19 by their healthcare provider. Testing is intended to be carried out in a clinical laboratory setting https://www.hayatgenetics.com/additional-info
Assay Type
Nucleic acid-Other
Method
LAMP
Time
30 minutes
LOD
5 cpr
Positive control
Synthetic SARS-CoV-2 DNA
Negative control
Nuclease Free Water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
99 %
Throughput
96 samples per run
Notes
Information provided by manufacturer: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test is an isothermal nucleic acid amplification method intended for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal and nasopharyngeal swabs) and saliva collected from individuals suspected of COVID-19 by their healthcare provider. Testing is intended to be carried out in a clinical laboratory setting
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