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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AFIAS COVID-19 SP/NP IgG

Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en 

Device identification number
2783
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antibody, IgG
Specimen
Plasma, Serum, Whole blood
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
AFIAS 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 whole blood/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
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
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
0.7 % (SP IgG)
False positives
1.4 % (NP IgG)
False negatives
1.4 % (SP IgG)
False negatives
1.4 % (NP IgG)
Precision
Evaluated
Accuracy
97.9 % (SP IgG)
Accuracy
97.2 % (NP IgG)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.8 % (SP IgG)
Clinical Sensitivity
96.1 % (NP IgG)
Clinical Specificity
96.7 % (SP IgG)
Clinical Specificity
97.8 % (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