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Test ID: PHESP    
Previous Hepatitis Exposure Profile

Method Description Describes how the test is performed and provides a method-specific reference

Hepatitis Bs Antigen:

Specimens are first tested by the VITROS hepatitis B surface antigen (HBsAg) assay. With modification to the assay manufacturer's instructions for use, specimens yielding signal to cut off (S/CO) > or =1.00 but < or =50.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/CO >50.0) do not require this confirmation.

 

This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal anti-hepatitis B surface (anti-HBs) antibody coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is 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. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the VITROS ECi System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. J03798, version 1.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY)

 

Hepatitis Bs Antigen Confirmation:

The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: 1 aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, no. J10583, version 1.0; Ortho-Clinical Diagnostics, Inc., Rochester, NY)

 

Hepatitis Bs Antibody:

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.

 

Nonmagnetic 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 (RLU) 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)

 

Hepatitis Bc Total Antibody:

The VITROS anti-hepatitis B core (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with hepatitis B core antigen (HBcAg)-coated wells. Unbound sample is removed by washing. Horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-HBc) is then allowed to react with the remaining exposed HBcAg on the well surface. Unbound conjugate is removed by washing.

 

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the VITROS ECi System. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, no. J20866, version 2.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626-5101)

 

Hepatitis A Total Antibody:

The VITROS anti-hepatitis A virus (anti-HAV) total assay is a competitive immunoassay method based on the preincubation of anti-HAV total in the sample with HAV antigen in the assay reagent, followed by incubation with HRP-labeled antibody conjugate (mouse monoclonal anti-HAV). The immune complex is captured by streptavidin on the well surface. Unbound conjugate is removed by washing.

 

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the VITROS ECi system. The amount of HRP conjugate is indicative of the concentration of anti-HAV present in the sample.(Package insert: VITROS Anti-HAV Total Reagent Pack, no. GEM1235A, version 3.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626-5101, 8/18/2009)

 

Hepatitis C Virus (HCV) Antibody Screen:

The VITROS anti-HCV assay is performed using the VITROS Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator on the VITROS 3600 Immunodiagnostic System (Ortho-Clinical Diagnostics, Inc., Raritan, NJ). An immunometric technique is used, involving a 2-stage reaction. In the first stage, HCV antibody present in the sample binds to HCV recombinant antigens coated on the reaction wells, and unbound sample is removed by washing. In the second stage, HRP-labeled antibody conjugate (mouse monoclonal antihuman IgG) binds to human IgG captured on the well in the first stage. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminal derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminal derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The emitted light signals are detected and measured by the VITROS 3600 Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample.(Ismail N, Fish GE, Smith MN: Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol 2004;42:610-617)

Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 Friday; 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.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester