LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit
Manufactured by Hunan Zonka Biotech Co. Ltd., China
Device identification number
2474
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
IgG, IgM
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A H1N1, Influenza B, Respiratory Syncytial V (RSV), Rhinovirus
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
This Kit is an in vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to the 2019-nCoV in human serum, plasma, whole blood or finger stick blood.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.85 %
False negatives
4.88 %
Precision
Evaluated
Accuracy
96.14 % IgG
Accuracy
97.51 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.12 % IgG
Clinical Sensitivity
95.61 % IgM
Clinical Specificity
97.03 % IgG
Clinical Specificity
99.15 % IgM
Type of antigen
Other
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