MERISCREEN COVID-19 Antigen Detection Test
Manufactured by Meril Diagnostics Pvt Ltd., India - www.merillife.com
Device identification number
2582
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, 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
The product is clinically tested, validated and approved by Indian council of medical research (ICMR). Notified with European Union with the EU Representative Obelis SA from Belgium having EAR certificate.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
MERISCREEN COVID-19 Antigen Detection Test is ≥ 933 TCID50/ml.
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % The product is having zero False positive, specificity is 100%
False negatives
2.88 % (The product is having sensitivity of 97.12%, Gives 2.88% false negative results)
Precision
Evaluated
Accuracy
97.12 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.12 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein
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