Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum
Method Description Describes how the test is performed and provides a method-specific reference
Temporary method as of December 3rd, 2013:
The ADVIA Centaur Anti-HBs2 assay is a sandwich immunoassay using direct, chemiluminometric technology. HBsAg (ad and ay) is coupled to magnetic latex particles in the solid phase. In the lite reagent, the HBsAg (ad and ay) is labeled with acridinium ester. Non-magnetic latex particles are added from the ancillary well. The sample is incubated simultaneously with lite reagent, solid phase, and ancillary reagent. Antibody-antigen complexes will form if anti-HBs is present in the sample. Low and high anti-HBs2 calibrators are used to calibrate the ADVIA Centaur immunodiagnostic system. A direct relationship exists between the amount of anti-HBs activity present in the patient sample and the amount of relative light units (RLUs) detected by the system. This assay is traceable to the WHO Hepatitis B Immunoglobulin First International Reference Preparation (1977), and quantitative anti-HBs result is expressed in mIU/mL.(Package insert: ADVIA Centaur anti-HBs2; Siemens Healthcare Diagnostics Inc., Tarrytown, NY. Publication no. 10698735_EN Rev. A, 2012-02)
VITROS hepatitis B surface antibody (anti-HBs) quantitative assay is performed using the VITROS Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators on the automated VITROS Immunodiagnostic System.
This chemiluminescent immunoassay is based on an immunometric technique in which the anti-HBs present in the clinical serum sample reacts with hepatitis B surface antigen (HBsAg) (ad and ay subtypes) coated onto the assay reaction wells. A horseradish peroxidase (HRP)-labeled HBsAg conjugate (ad and ay subtypes) then complexes with the bound anti-HBs forming an "antigen sandwich." Unbound materials are removed by washing.
A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. HRP in the bound conjugate catalyzes the oxidation of the luminol derivative to produce light. The electron transfer agent increases the level and duration of the light produced. The light signals are detected by the VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs antibody present.(Package insert: VITROS Anti-HBs Quantitative Assay, Ortho-Clinical Diagnostics, Inc., Rochester, NY, publication no. GEM1208 EN, v 2.0)
Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test