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Test ID: PHSP    
Prenatal Hepatitis Evaluation

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

Specimens are first tested by the VITROS HBsAg assay. Per assay manufacturer's recommendation, all hepatitis B surface antigen (HBsAg)-reactive specimens (signal-to-cutoff ratios > or =1.00) in prenatal screening should be confirmed by the VITROS HBsAg Confirmatory assay.

 

HBsAg:

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, number J03798, version 1.0; Ortho-Clinical Diagnostics, Inc, Rochester, NY)

 

HBsAg 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 nonneutralizing 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 nonneutralized control sample. (Package insert: VITROS HBsAg Confirmation assay, number J10583, version 1.0; Ortho-Clinical Diagnostics, Inc, Rochester, NY)

 

See individual test ID for reflexed tests.

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.

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