INDICAID COVID-19 Rapid Antigen Self-Test
Manufactured by PHASE Scientific International Limited, Hong Kong S.A.R - www.phasescientific.com
Device identification number
3150
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The INDICAID® COVID-19 Antigen Self-Test is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is intended for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or older with or without symptoms or other epidemiological reasons to suspect COVID-19. This test is also intended for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individual aged 2 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19.
Assay Type
Immuno-Antibody
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Semiquantitative
Time
20 minutes
Subclass
Sandwich
LOD
2800 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
100 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.09 % (Antigen)
Clinical Specificity
100 % (Antigen)
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