ViroTrack Sero COVID-19 Total Ab
Manufactured by BluSense Diagnostics ApS, Denmark - https://www.blusense-diagnostics.com/
Device identification number
2906
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Target type
Antibody
Targets
spike protein
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ViroTrack Sero COVID-19 Total Ab is an in vitro diagnostic (IVD) immunomagnetic (IMA) assay intended for the quantitative detection of anti-SARS-CoV-2 total human antibodies in human whole blood, serum or plasma as an aid at identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. The cartridge is single-use and intended to be used exclusively in combination with the BluBox reader (Ref.: 60BB01). The system is automated. The assay kit is intended to be used by Healthcare Professionals in a laboratory environment and by Healthcare Professionals in office-like near-patient testing environments, for example in hospitals, clinics, pharmacies, long-term care facilities, primary care settings, or General Practitioners offices with the purpose of testing patients of both genders in all age classes. Results must be confirmed by clinical assessment by an expert physician and/or using another marketed test method.
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
7 minutes
LOD
9.1 (BAU/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.28 % (2 FP out of 699 samples)
False negatives
0.55 % (1 FN out of 179 samples ( Detected as equivocal))
Precision
Evaluated
Accuracy
99.7 % ((875/878) [99.0%;99.9%])
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.4 % ((178/179) [96.9%;100.0%])
Clinical Specificity
99.7 % ((697/699) [99.0%;100.0%])
Type of antigen
Spike 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