Rita Espinoza, MPH Emerging and Acute Infectious Disease Branch May 11, 2010 Screening of Pregnant...
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Transcript of Rita Espinoza, MPH Emerging and Acute Infectious Disease Branch May 11, 2010 Screening of Pregnant...
Rita Espinoza, MPHEmerging and Acute Infectious Disease Branch
May 11, 2010
Screening of Pregnant Women for Hepatitis B and Overview of Hepatitis B
Virus Serological Markers
Objectives
• Review screening requirements for pregnant women in Texas
• Review serological markers for hepatitis B virus infections
Outline
• Historical perspective/rationale
• Screening requirements in Texas
• Serologic markers– Importance of serologic markers– Review serologic markers
• Acute infection• Chronic infection
• Case Studies
Background Information
• 1991 hepatitis B screening of pregnant women recommended by ACOG, AAP, ACIP
• Risk of perinatal transmission– HBsAg and HBeAg + at delivery - 70-90%– HBsAg + only 5-20%
• 90% of infants infected perinatally will become chronic carriers of hepatitis B
• 25% of those infected will die of HBV-related disease
Strategies to Reduce HBV Disease
• Continue and enhance vaccination efforts– School and childcare requirements– HCW– Adults (20-44 years)– Birth dose
• Surveillance• Early detection • Education • Perinatal hepatitis B prevention program
Texas Rules
• Health & Safety Code, Chapter 81, Section §81.090
• Texas Administrative Code, Title 25, Part 1, Chapter 97– Subchapter A, Rule §97.1 – §97.6– Subchapter F, Rule §97.135
Screening Requirements in Texas – Health and Safety Code, Chapter 81,
Section §81.090
Sec. 81.090. DIAGNOSTIC TESTING DURING PREGNANCYAND AFTER BIRTH. (a) A physician or other person permitted by law to attend a
pregnant woman during gestation or at delivery of an infant shall:(1) take or cause to be taken a sample of the woman's blood or other appropriate specimen at the first examination and visit;(2) submit the sample to an appropriately certified laboratory for diagnostic testing approved by the United States Food and Drug Administration for:
(A) syphilis;(B) HIV infection; and(C) hepatitis B infection; and
(3) retain a report of each case for nine months and deliver the report to any successor in the case.
Screening Requirements in Texas – Health and Safety Code, Chapter 81,
Section §81.090, (cont’d)
(a-1) A physician or other person permitted by law to attend a pregnant woman during gestation or at delivery of an infant shall:(1) take or cause to be taken a sample of the woman's blood or other appropriate specimen at an examination in the third trimester of the pregnancy;(2) submit the sample to an appropriately certified laboratory for a diagnostic test approved by the United States Food and Drug Administration for HIV infection; and(3) retain a report of each case for nine months and deliver the report to any successor in the case.
(b) A successor is presumed to have complied with this section if the successor in good faith obtains a record that indicates compliance with Subsections (a) and (a-1), if applicable.
Screening Requirements in Texas – Health and Safety Code, Chapter 81,
Section §81.090, (cont’d)
(c) A physician or other person in attendance at a delivery shall:(1) take or cause to be taken a sample of blood or other appropriate specimen from the mother on admission for delivery; and(2) submit the sample to an appropriately certified laboratory for diagnostic testing approved by the United States Food and Drug Administration for:
(A) syphilis; and(B) hepatitis B infection.
Summary of Requirement
• Women should be tested– during pregnancy
And – At delivery
• Women should be educated on– Transmission– Prevention– Treatment
Serological Markers
Possible Outcomes of Hepatitis B Infection
Clinical Manifestations of HBV Infection
• S/SX not unique to HBV infection• Only 50% of adult infections are
symptomatic • Need diagnostic tests to distinguish• Incubation period - 45 to 180 days (average = 60-90 days)• Communicability – 1 to 2 months before
and after onset of symptoms; chronic carrier
Hepatitis B Lab MarkersMarker Abbreviation Use
Hepatitis B surface antigen HBsAg Detection of acutely or chronically infected persons; antigen used in hepatitis B vaccine
M class immunoglobulin antibody to hepatitis B core antigen
IgM Anti-HBc
Anti-HBc, IgM
HBcAb, IgM
Identification of acute or recent HBV infections (including those in HBsAg-negative persons during the “window” phase of infection)
Antibody to hepatitis B core antigen
Anti-HBc
HBcAb
Identification of persons with acute, resolved, or chronic HBV infection
(not present after vaccination)
Antibody to Hepatitis B surface antibody
Anti-HBs
HBsAb
Identification of persons who have resolved infection with HBV; determination of immunity after immunization
Hepatitis B e antigen HBeAg Identification of infected persons at increased risk for transmitting HBV
Antibody to Hepatitis B e antigen
Anti-HBe
HBeAb
Identification of infected person with lower risk for transmitting HBV
Typical Serological Markers for Acute Hepatitis B Infection
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBV DNA
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBV DNA
HBeAg
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBeAg anti-HBe
HBV DNA
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBeAg anti-HBe
Symptoms
HBV DNA
IgM anti-HBcIgM anti-HBc
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBeAg anti-HBe
Symptoms
HBV DNA
IgM anti-HBcIgM anti-HBc
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBeAg anti-HBe
Symptoms
Total anti-HBcTotal anti-HBc
HBV DNA
IgM anti-HBcIgM anti-HBc
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBeAg anti-HBe
Symptoms
anti-HBsanti-HBs
Total anti-HBcTotal anti-HBc
HBV DNA
IgM anti-HBcIgM anti-HBc
HBsAgHBsAg
0 4 8 12 16 20 24 28 32 36 52 100
Acute Hepatitis B Virus Infection with RecoveryAcute Hepatitis B Virus Infection with RecoveryTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
HBeAg anti-HBe
Symptoms
anti-HBsanti-HBs
Total anti-HBcTotal anti-HBc
HBV DNA
Window Period
Typical Serological Markers for Chronic Hepatitis B Infection
Chronic Hepatitis B Virus Infection Typical Serologic CourseTypical Serologic Course
0 1 2 3 4 5 6 7 8 9 10
Tite
r
Years After Exposure
HBsAg
0 1 2 3 4 5 6 7 8 9 10
Tite
r
Years After Exposure
HBsAg
Total anti-HBc
Chronic Hepatitis B Virus Infection Typical Serologic CourseTypical Serologic Course
0 1 2 3 4 5 6 7 8 9 10
Tite
r
Years After Exposure
HBsAg
Total anti-HBc
HBV DNA
Chronic Hepatitis B Virus Infection Typical Serologic CourseTypical Serologic Course
0 1 2 3 4 5 6 7 8 9 10
Tite
r
Years After Exposure
HBsAg
Total anti-HBc
HBV DNA
IgM, anti-HBc
Chronic Hepatitis B Virus Infection Typical Serologic CourseTypical Serologic Course
0 1 2 3 4 5 6 7 8 9 10
Tite
r
Years After Exposure
HBsAg
Total anti-HBc
HBV DNA
HBeAg
Chronic Hepatitis B Virus Infection Typical Serologic CourseTypical Serologic Course
0 1 2 3 4 5 6 7 8 9 10
Tite
r
Years After Exposure
HBsAg
Total anti-HBc
HBV DNA
HBeAg Anti-HBe
Chronic Hepatitis B Virus Infection Typical Serologic CourseTypical Serologic Course
Progression to Chronic Hepatitis B Virus InfectionProgression to Chronic Hepatitis B Virus InfectionTypical Serologic CourseTypical Serologic Course
Weeks after ExposureWeeks after Exposure
TiterTiter
IgM anti-HBc
Total anti-HBc
HBsAg
Acute(6 months)
HBeAg
Chronic(Years)
anti-HBe
0 4 8 12 16 20 24 28 32 36 52 Years
Acute vs. Chronic HBV Infection
Acute• HBsAg+ < 6 mos.• IgM anti-HBc +
positive• Infection will
resolve and person will have lifelong immunity
• HBsAb+ and HBcAb+
Chronic• HBsAg + for at least 6
months • Also known as a
“carrier”• Infection does not
resolve and the person remains infectious
• HBsAb- and HBcAB+
Hepatitis B, acute Surveillance Case Definition
• Confirmed:– Positive anti-HBc, IgM with or without
symptoms or – Meets clinical case definition and is
HBsAg-positive and anti-HAV IgM negative, if done
Hepatitis B, perinatal Surveillance Case Definition
• Confirmed:– HBsAg-positive– < 24 months of age– Born to an HBsAg-positive woman
Hepatitis B, chronicSurveillance Case Definition
• Confirmed: case that is laboratory-confirmed (2 positives 6 months apart or HBsAg+, anti-HBc+, and IgM-)
• Probable: case with a single HBsAg or HBeAg or HBV DNA positive lab when no IgM anti-HBc results are available
CASE STUDIES
Case Study A
Patient History:
John went to his doctor with jaundice, fatigue and abdominal pain. After reviewing John’s liver panel, the doctor diagnosed him with acute hepatitis B infection.
Question 1
What might his hepatitis B panel look like?
Answer
Marker Result
HBsAg Positive
HBeAg Positive
anti-HBc Positive
IgM anti-HBc Positive
anti-HBeAg Negative
anti-HBs Negative
Case Study B
Sara visits his doctor and has a hepatitis panel done. Her results are as follows:
HBsAg Positive
anti-HBc Positive
IgM anti-HBc Negative
anti-HBs 6mIU/mL
Question 1
How would you interpret Sara’s results?
Answer
• Chronic hepatitis B infection
Question 2
What significance is the anti-HBs?
Answer
• No biological significance
Case Study C
Jada went to her doctor for a routine physical. A hepatitis panel was done and her results were as follows:
HBsAg Negative
anti-HBs Positive
anti-HBc Negative
Question 1
• How would you interpret her results?
Answer
• She received the hepatitis B vaccine and is protected (immune)
Case Study D
Jeff went in for a routine annual physical. His doctor decided to run a hepatitis panel. His results are as follows:
HBsAg Positive
anti-HBs Negative
anti-HBc Positive
anti-HBc, IgM Positive
HBeAg Positive
Question 1
• How would you interpret his results?
Answer
• He has acute hepatitis B infection.
Case Study E
Stacy is pregnant. Her prenatal HBsAg test was negative. Upon admission for delivery, the HBsAg screen was repeated. The results came back positive.
Scenario 1:
Stacy insisted that there was no way
she could have contracted hepatitis B.
she had not engaged in any high-risk
activities. The doctor decided to
repeat the test.
Question 1
• What tests should be ordered?
Answer
• HBsAg
• anti-HBc
• anti-HBc, IgM
• anti-HBs
Her results were as follows:
HBsAg Negative
anti-HBs Negative
anti-HBc Negative
anti-HBc, IgM Negative
How would you interpret?
Answer
• False positive
Scenario 2: Stacy’s baby received the HBIG andhepatitis B vaccine at birth. The family isenrolled in the local perinatal hepatitis Bprevention program. Three months post-partum, Stacy’s physician decides to re-test her. Her results are as follows:
HBsAg Negativeanti-HBc Positiveanti-HBs Positive
Question 2
• What do the results indicate?
Answer
• Resolved Infection
Test Results Interpretation
HBsAg
anti-HBc
anti-HBs
Negative
Negative
Negative
Susceptible
(Never infected or vaccinated)
HBsAg
anti-HBc
anti-HBs
Negative
Negative
Positive
Immune
(Due to vaccine)
HBsAg
anti-HBc
anti-HBs
Negative
Positive
Positive
Immune
(Resolved Infection)
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs
Positive
Positive
Positive
Negative
Acutely Infected
HBsAg
anti-HBc
anti-HBs
IgM anti-HBc
Positive
Positive
Negative
Negative
Chronically Infected
HBsAg
anti-HBc
anti-HBs
Negative
Positive
Negative
Four Possible Interpretations
Interpretation of Serological Tests
Four Possible Interpretations
• May be recovering from acute HBV infection
• May be distantly immune and test not sensitive enough to detect very low level of anti-HBs in serum
• May be susceptible with a false positive anti-HBc
• May be undetectable level of HBsAg present in the serum and the person is actually a carrier
Summary
• Pregnant women should be screened during pregnancy and at delivery– Eliminate perinatal transmission– Documentation necessary
• Determination of hepatitis status is complicated
Resources
• American Academy of PediatricsRed Book – American Academy of Pediatrics (www.aap.org)
• DSHShttp://www.dshs.state.tx.us/idcu/disease/hepatitis/hepatitis_b/perinatal/Statistics/
• CDC – Pink Book http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm
– On-line CE Training From CDC on Serological Markershttp://www.cdc.gov/hepatitis/Resources/Professionals/Training/SerologyStart.htm
– Online resources
http://www.cdc.gov/hepatitis/HBV/index.htm• Immunization Action Coalition
http://www.immunize.org/hepatitis-b/