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Immunoassay for the qualitative detection of total antibodies against hepatitis A virus (HAV)
Elecsys® Anti-HAV II
Testing Time
18 minutes
Test principle
Inverted 2-step competitive assay
Calibration
2-point
Interpretation
COI >1.0 = non-reactive (negative for HAV-specific antibodies)
COI ≤1.0 = reactive (positive for HAV-specific antibodies)
Traceability
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.
Sample material
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.
Sample volume
20 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
12 μL cobas e 402 / cobas e 801 analytical units
Onboard stability
8 week cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
16 weeks cobas e 402 / cobas e 801 analytical units
Intermediate precision in positive samples
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%
Relative sensitivity
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 %)