SD BIOSENSOR receives CE-IVD mark for STANDARD™ Q HCV Ab Test.
It is SD BIOSENSOR’s 1st 'List A' test, in compliance with the in vitro Diagnostic Directive (IVDD) 98/79/EC.
STANDARD™ Q HCV Ab Test qualitatively analyzes antibodies specific to hepatitis C virus in serum and plasma using immunochromatography.
With a simple test method, the screening test result can be obtained within 5 minutes with outstanding sensitivity and specificity.
- Diagnostic Sensitivity : 100.0% (413/413) with a Wilson 95% CI: [99.1% - 100.0%]
- Diagnostic Specificity : 99.4% (994/1,000) with a Wilson 95% CI: [98.7% - 99.7%]
SD BIOSENSOR is also working on WHO PQ approval of STANDARD™ Q HCV Ab Test. The expected approval is in Q4 2019.
The product was evaluated successfully in Belgium, Germany, Korea, and more evaluations are ongoing.