Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test (Latex)

Manufactured by Joinstar Biomedical Technology Co. Ltd., China - www.joinstar.cn 

Device identification number
1205
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow, Latex
Target type
Antigen
Targets
spike protein
Specimen
Saliva, Sputum, Stool
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
DIAGNOSTIC PERFORMANCE OF JOINSTAR COVID-19 ANTIGEN RAPID TEST (LATEX)- HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS. Athens, April 12th 2021. Test report G20202531 issued from HANGZHOU CENTER OF MEDICAL DEVICE SUPERVISION AND TESTING, October 19th 2020
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
5 ng/mL ( SARS-COV-2 Glicoprotein S)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Compared to PCR (n=60)
False negatives
2 % ((Compared to PCR (n=100))
Precision
Evaluated
Accuracy
93.33 %
Clinical Sensitivity
90 %
Clinical Specificity
100 %
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