ichroma™ COVID-19 Ag
Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en
Device identification number
1990
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Chip, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
In the link I have attached, you may see that the sensitivity of iChroma COvid 19 Ag is "Ct ≤ 25" The clinical evaluation can be found on the website of FIND : https://www.finddx.org/wp-content/uploads/2021/02/iChroma_Ag-Public-Report_v1_20210223.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Other ()
Method
Immunochromatography
Measurement
Semiquantitative
Time
12 minutes
Subclass
Sandwich
LOD
35.15 AU
Calibration
Evaluated
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
12 AU
Precision
Evaluated
Accuracy
95.2 %
Accuracy
95.2 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
90.9 %
Clinical Specificity
98.7 %
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