LollyTest 2019-nCoV Ag Rapid Test Kit
Manufactured by Hunan Zonka Biotech Co. Ltd., China
Device identification number
2473
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Influenza A, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
A.23.1, AT.1, B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for in vitro qualitative detection of 2019-nCoV antigen. It is an Immunochromatography sandwich assay, intended for the qualitative detection of the nucleocapsid protein antigen from 2019-nCoV in nasopharyngeal (NP) swab, nasal (NS) swab and oropharyngeal swab specimens.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.5 %
False negatives
3.17 %
Precision
Evaluated
Accuracy
98.47 % ((NP))
Accuracy
95.05 % ((NS))
Accuracy
96.55 % ((OP))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.83 % ((NP))
Clinical Sensitivity
93.91 % ((OP))
Clinical Sensitivity
90.52 % ((NS))
Clinical Specificity
99.5 % ((NP))
Clinical Specificity
99.22 % ((NS))
Clinical Specificity
99.15 % ((OP))
Type of antigen
Nucleoprotein
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