StrongStep® SARS-CoV-2 Antigen Rapid Test
Manufactured by Nanjing Liming BioProducts Co. Ltd., China - www.limingbio.com
Device identification number
2301
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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
Liverpool School of Tropical Medicine has evaluated this test which demonstrates sensitivity remains with different SARS-CoV-2 lineage. Two monoclonal antibodies were used in this assay. The first antibody corresponds to an antigen labeled from 40th to 54th amino acid; The other antibody corresponds to an antigen labeled from amino acid 100th to amino acid 130th.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
250 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.74 %
False negatives
3.81 %
Precision
Evaluated
Accuracy
98.63 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.19 %
Clinical Specificity
99.26 %
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