SARS-CoV-2 Rapid Antigen Test Kit (RAT-01)
Manufactured by HA TECH PTY Ltd., Australia - https://ha-tech-ltd.com/
Device identification number
4158
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antibody
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
The pro-Coated antibody epitope is as follows:
N-terminal(33-210): SGARSKQRRPQGLPNNTASWFTALTQHGKEDLKFPRGQGVPINTNSSPDDQIGYYRRATRRIRGGDGKMKDLSPRWYFYYLGTGPEAGLPYGANKDGIIWVATEGALNTPKDHIGTRNPANNAAIVLQLPQGTTLPKGFYAEGSRGGSQASSRSSSRSRNSSRNSTPGSSRGTSPARM
The labelled antibody epitope is as follows:
N-terminal(33-210): SGARSKQRRPQGLPNNTASWFTALTQHGKEDLKFPRGQGVPINTNSSPDDQIGYYRRATRRIRGGDGKMKDLSPRWYFYYLGTGPEAGLPYGANKDGIIWVATEGALNTPKDHIGTRNPANNAAIVLQLPQGTTLPKGFYAEGSRGGSQASSRSSSRSRNSSRNSTPGSSRGTSPARM
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-10-14 09:36:48 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
Detection Principle
Colorimetry
LOD
130 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
96.97 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
5 samples (The RAT-01 Kit correctly identified 103/108 RT-PCR positive samples )
False negatives
1 samples (The RAT-01 Kit correctly identified 300/301 RT-PCR negative samples)
Precision
Evaluated
Accuracy
98.53 %
Robustness
Evaluated
Clinical Sensitivity
95.58 %
Clinical Specificity
99.67 %
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