Elecsys^® Anti-HAV II

18 minutes

Inverted 2-step competitive assay

2-point

COI >1.0 = non-reactive (negative for HAV-specific antibodies)
COI ≤1.0 = reactive (positive for HAV-specific antibodies)

Traceable to the “Second International Standard for Anti‑Hepatitis A, immunoglobulin, human”, NIBSC code 97/646 of the NIBSC (National Institute for Biological Standards and Control) via method comparison to the first generation Elecsys^® Anti‑HAV assay as reference.

Serum collected using standard sampling tubes or tubes containing separating gel.
Li‑heparin, Na‑heparin, K₂‑EDTA, K₃‑EDTA, ACD, CPD, CP2D, CPDA and Na‑citrate plasma. Plasma tubes containing separating gel can be used.

20 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
12 μL cobas e 402 / cobas e 801 analytical units

8 week cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
16 weeks cobas e 402 / cobas e 801 analytical units

cobas e 411 analyzer: CV 1.3 - 3.2%
cobas e 601 / cobas e 602 modules: CV 1.8 - 3.3%
cobas e 402 / cobas e 801 analytical units: CV 2.0 - 3.5%

Subjects vaccinated against hepatitis A (N = 238): 100 % (99.45 – 100 %*)
Subjects with acute hepatitis A infection (N = 234): 100 % (98.44 – 100 %)
Subjects recovered from hepatitis A infection (N = 256): 100 % (98.57 – 100 %)

Blood donors (N = 577): 99.48 % (98.49 – 99.89 %)
Subjects with routine request for anti‑HAV testing (N = 871): 99.66 % (99.00 – 99.93 %)