Enzygnost* Anti-HBs II - Medcorp

Tab. 1 Storage and Stability
Material/reagent State Storage Stability •
Enzygnost * Anti-HBs II (Test plate) once opened +2 to +8 °C 4 weeks
in the bag
with the desiccant
HBsAg/POD Conjugate (anti-HBs II) once opened +2 to +8 °C 4 weeks
Anti-HBs Serum 100 once opened +2 to +8 °C 4 weeks
Anti-HBs Serum, negative < -20° C 3 months
Chromogen TMB once opened +2 to +8 °C expiry date
Buffer/Substrate TMB once opened +2 to +8 °C expiry date
Working Chromogen Solution diluted +2 to +8 °C 5 days
1 + 10 +15 to +25 °C 8 hours
in closed container
protected from light
Washing Solution POD (concentrate) once opened +2 to +8 °C expiry date
diluted 1:20 +2 to +8 °C 1 week
diluted 1:20 +18 to +25 °C 1 day
Stopping Solution POD once opened +2 to +8 °C expiry date
• use each component by the expiry date at the latest
Tab. 2 Sensitivity
The sensitivity studies, run at different sample panels, yielded the following data:
Sample population Number Enzygnost * Anti-HBs II
of samples
reactive
Anti-HBs positive (Germany) 106 106
Anti-HBs positive (America) 52 52
Follow-up samples 25 25
Anti-HBs positive 100 100
Different stages of HBV infection 41 41
HBV vaccinees 111 111
anti-HBs positive 80 80
vaccination profiles 32 profiles Sensitivity equivalent
seroconversion 9 profiles to that of
comparable tests
Tab. 3 Specificity
The specificity studies, run with samples from different blood banks, yielded the following data:
Sample population Number Enzygnost * Anti-HBs II
of samples
reactive
Normal negative sera 2296 11
Normal negative plasmas 646 2
Normal negative sera 1508 5
Normal negative plasmas 286 1
OQNE G11 C0541 (906) H/R 10