PathoDetect COVID-19 Ag Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL)
Manufactured by Mylab Discovery Solutions Pvt. Ltd., India - https://mylabdiscoverysolutions.com/
Device identification number
2357
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cartridge
Target type
Antigen
Specimen
Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Chlamydia Pneumoniae, 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
N/A
Assay Type
Unknown
Rapid Diagnostic
No
Reader Required
Yes
Subcategory
Sample preparation
Method
RT-PCR
Measurement
Qualitative
Time
180 minutes
LOD
1
Analytical Sensitivity
95
Analytical Specificity
100
Clinical Sensitivity
95
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