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The VITROS® ANTI-HBc IgM Assay

The VITROS® ANTI-HBc IgM Assay
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The VITROS ® ANTI-HBc IgM Assay Fully automated. Random access. Now, that’s simple. Hepatitis testing is simple with the VITROS Anti-HBc IgM assay on the VITROS ECi Immunodiagnostic System. Ease of operation is just a start—in addition, you’ll get advanced security, enhanced service levels, labor optimization, and cost containment all together in one unique system. Advanced Security • The VITROS ECi Immunodiagnostic System using Intellicheck™ Technology ensures quality result reporting Enhanced Service Levels • First result in as little as 43 minutes • Low sample volume of 10 µL • Excellent precision • Excellent discrimination of positive and negative samples around the cutoff Labor Optimization • Fully automated random access, continuous sample load and unload • Testing availability 24 hours a day/7 days a week • Consolidation of hepatitis serology with more than 30 multi-disease state assays Cost Containment • 28-day assay calibration stability • 8 weeks—(56 days) on-board reagent stability The VITROS Anti-HBc IgM Reagent Pack is intended for the in vitro qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (heparin, EDTA and citrate) and neonate serum using the VITROS ECi Immunodiagnostic System using Intellicheck Technology. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B.1 VITROS Immunodiagnostic products Anti-HBc IgM Reagent Pack Instructions For Use. Refer to appropriate sections for additional information related to intended use, warnings and limitations.

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Efficient Testing Algorithm for VITROS® Anti-HBc IgM Results are calculated as a signal, relative to the cutoff value (signal/cutoff, s/c). An initial result of < 0.90 s/c indicates a non-reactive sample that is Negative for anti-HBc IgM. An initial result of ≥ 0.90 and ≤ 1.10 s/c Retest? indicates a sample that requires duplicate repeat testing for anti-HBc IgM.* An initial result of > 1.10 s/c indicates a sample that is Reactive for anti-HBc IgM. No further testing required. Negative No further testing required. Reactive ▲ If 2 of 3 results < 1.00 s/c, the sample is Negative for anti-HBc...

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