Solsten SARS-CoV-2 Antigen ELISA Kit
Manufactured by Solsten Diagnostics Intl. ApS, Denmark - www.solsten-diag.com
Device identification number
2559
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual, Semi-automated
Physical Support
Microtiter plate, Strip
Target type
Antigen
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This ELISA is a unique and recommended screening tool for early detection of nosocomial SARS-CoV-2 infections. It employs blood samples, which are already collected from hospitalized patients: No inconvenience for patients, no extra sampling by personnel.
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
120 minutes
Subclass
Sandwich, Double
LOD
2 pg/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.2 %
False negatives
7.1 %
Precision
Evaluated
Accuracy
98.6 % ( (ROC-curve AUC vs PCR))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.9 %
Clinical Specificity
99.8 %
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