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.
This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal antihepatitis 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 Immunodiagnostic System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, GEM1201, version 10.1; Ortho-Clinical Diagnostics, Inc, Rochester, NY)
The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: one 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, GEM4201, version 10.1; Ortho-Clinical Diagnostics, Inc, Rochester, NY)
PDF 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