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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-Cov-2 Antigen Rapid Test Cassette (Swab)

Manufactured by SPRING HEALTHCARE SERVICES SP Z O O, Poland - www.springhealthcare.org 

Device identification number
1780
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus A, SARS-CoV
Pathogens detected
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), SARS-CoV
Lineages detected
B.1.1.529 (Omicron), 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
Positiv tested at PEI for Omicron See Bfarm AT837/21 We like to get the Test listed also at BAG Switzerland as Validated (IFU= DE/FR/IT). The research results show that the pathogens have no effect on the negative test results and positive test results of the product at the following concentrations, and there is no cross-reaction.
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
125 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 False = 100 X 202/202 = >99.99% (95% CI: 97.90% - 100%)
False negatives
1.75 % (2 False = 100 X 112/114 = 98.25% (95% CI: 96.80% - 99.70%))
Precision
Evaluated
Accuracy
99.37 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.25 %
Clinical Specificity
99.9 %
Type of antigen
Nucleocapsid protein
Notes
Linkages performance: https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers/evaluierung-sensitivitaet-sars-cov-2-antigentests.pdf?__blob=publicationFile&v=84

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