VITROS® ANTI-HBs Assay [Quantitative] - 2 Pages

Add to MyMedicalExpo favorites
VITROS® ANTI-HBs Assay [Quantitative]

Catalog excerpts

VITROS® ANTI-HBs Assay [Quantitative] Fully automated. Random access. Now that’s simple. Hepatitis testing is simple with the VITROS Anti-HBs assay on the VITROS ECi/ECiQ 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. The VITROS Anti-HBs assay is intended for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the VITROS ECi/ECiQ Immunodiagnostic System using Intellicheck Technology. Advanced Security I VITROS ECi/ECiQ Immunodiagnostic System using Intellicheck® Technology ensures quality result reporting Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis, in whom etiology is unknown.1 Cost Containment I Broad analytical measurement range up to 1000 mIU/mL • Reduces dilution and repeats I Extended stability • 28-day calibration stability • 56 day open on-board reagent stability Labor Optimization I Full automated random access, continuous sample load and unload I Testing availability 24 hours a day/7 days a week I Consolidation of hepatitis serology and core immunodiagnostic testing Enhanced Service Levels I Provide quantitative results to guide clinical management I Results available in as little as 55 minutes I Low sample volume of 80 µL Flexibility in Result Reporting Both the quantitative result in mIU/mL and the result text are printed on the instrument patient report as well as transmitted to an LIS. Depending on the request from the physician, a result can either be reported using the result text for those requesting a qualitative indication of immune status or the quantitative result in mIU/mL with or without the result text. Further, your LIS can be configured to either capture the result flag, the quantitative result or both. WARNING: Assay performance characteristics have not been established when the VITROS Anti-HBs Quantitative assay is used in conjunction with other manufacturers’ assays for specific HBV serological markers. Users are responsible for establishing their own performance characteristics.

 Open the catalog to page 1

Testing Algorithm Final results should be manually interpreted using the algorithm below: An initial result of <5.00 mIU/mL indicates a sample that is “Negative” for anti-HBs An initial result of ≥5.00 and <12.0 mIU/mL (“Indeterminate”) indicates a sample that requires duplicate repeat testing for anti-HBs An initial result of ≥12.0 mIU/mL indicates a sample that is “Positive” for anti-HBs No further testing required No further testing required If 2 of 3 results <5.00 mIU/mL, the sample is “Negative” for anti-HBs If 2 of 3 results ≥5.00 and <12.0 mIU/mL, the sample is “Indeterminate” If 2...

 Open the catalog to page 2

All Ortho Clinical Diagnostics catalogs and technical brochures

  1. ORTHO ProVue

    6 Pages

  2. VITROS® 350

    2 Pages

  3. Pathology

    4 Pages

Archived catalogs