Singclean
Manufactured by Hangzhou Singclean Medical Products Co. Ltd., China - www.singclean.net
Device identification number
1974
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Bfarm list AT 437/21
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
9.975 U/ml ([LOD (U/ml)=9.975 x 102 TCID50/mL])
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
The results of test reagent and control reagent both were 309 negative specimens, there are three sp
False negatives
The results of test reagent and control reagent both were 209 positive specimens, there are three sp
Precision
Not evaluated
Accuracy
98.84 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.56 %
Clinical Specificity
99.03 %
Type of antigen
Nucleoprotein
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