ichroma™ COVID-19 SP/NP IgG
Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en
Device identification number
2784
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antibody, IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), SARS-CoV, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ichroma™ COVID-19 SP/NP IgG is a fluorescence Immunoassay (FIA) for the qualitative determination of SP/NP IgG antibodies against of novel corona virus (SARS-CoV-2) in human serum/plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (eg. SARS-CoV-2)' infection. For in vitro diagnostic use only.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
37 AU/mL (BAU/mL (NP IgG))
LOD
26 AU/mL (BAU/mL (SP IgG))
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4.3 % (SP IgG)
False positives
8.3 % (NP IgG)
False negatives
4 % (SP IgG)
False negatives
0 % NP IgG
Precision
Evaluated
Accuracy
95.8 % (SP IgG)
Accuracy
98.3 % (NP IgG)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.7 % (SP IgG)
Clinical Sensitivity
91.7 % (NP IgG)
Clinical Specificity
96 % (SP IgG)
Clinical Specificity
100 % (NP IgG)
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