Test ID: PHSP
Prenatal Hepatitis Evaluation
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Screening pregnant women for chronic hepatitis B virus (HBV) infection
Determining the level of infectivity in pregnant women with chronic HBV infection
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBAGP | HBs Antigen Prenatal, S | Yes | Yes |
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| EAG | Hepatitis Be Ag, S | Yes | No |
| HEAB | HBe Antibody, S | Yes | No |
| HBGNT | HBs Antigen Confirmation, S | No | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If hepatitis B surface antigen (HBsAg) prenatal is reactive, then HBsAg confirmation will be performed at an additional charge. If HBsAg confirmation is positive, then hepatitis Be antigen and hepatitis Be antibody tests will be performed at an additional charge.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminescence Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Hepatitis Screen
Prenatal Hepatitis Profile ORDER 5566
Anti-Hepatitis Be ORDER 5566
HBsAg (Hepatitis Bs Ag) ORDER 5566
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2.5 mL
Collection Instructions: Immediately spin down.
Additional Information: Date of draw is required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | Plasma |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. After a course of acute illness, HBV persists in about 10% of patients who were infected during adulthood. Some carriers are asymptomatic; others may develop chronic liver disease including cirrhosis and hepatocellular carcinoma.
HBV is spread primarily through percutaneous contact with infected blood products (ie, blood transfusion, sharing of needles by drug addicts). The virus is found in virtually every type of human body fluid and also is spread through oral and genital contact.
HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally. Infection of the infant can occur if the mother is a chronic hepatitis B surface antigen carrier or has an acute HBV infection at the time of delivery. Transmission is rare if an acute infection occurs in either the first or second trimester of pregnancy.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative
See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following hepatitis B virus (HBV) infection. A positive result for HBsAg is diagnostic of acute or chronic HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months indicates development of either a chronic carrier state or chronic liver disease. Hepatitis B surface antibody (anti-HBs) appears with the resolution of HBV infection after the disappearance of HBsAg.
Hepatitis B envelope antigen (HBeAg) appears at approximately the same time as HBsAg and indicates that the virus is replicating and the individual is infectious. Appearance of hepatitis Be antibody (anti-HBe) after the disappearance of HBsAg and HBeAg usually indicates recovery and loss of infectivity.
If HBsAg is positive and the patient's condition warrants, consider testing for hepatitis B core antigen (anti-HBc) IgM, HBV-DNA, and anti-hepatitis delta virus (HDV) to evaluate viral replication and infectivity.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Positive hepatitis B surface antigen (HBsAg) test results should be reported by the patient care provider to the State Department of Heath as required by law in some states.
Assay performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triolein level of >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Contain particulate matter
-Cadaveric specimens
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Vranckx R, Alisjahbana A, Meheus A: Hepatitis B virus vaccination and antenatal transmission of HBV markers to neonates. J Viral Hepat 1999;6:135-139
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.
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
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87340-Hepatitis B surface antigen prenatal
86707-Hepatitis Be antibody (if appropriate)
87341-Hepatitis B surface antigen confirmation (if appropriate)
87350-Hepatitis Be antigen (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| HBSAP | HBs Antigen Prenatal, S | 5195-3 |
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