HEPATITIS B NON-IMMEDIATE NOTIFICATION EPIDEMIOLOGY PROGRAM

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HEPATITIS B NON-IMMEDIATE NOTIFICATION EPIDEMIOLOGY PROGRAM Event Name: Event Time Period: ACUTE Clinical Presentation (CDC 2012): CDC Event (2012): HEPB Lifelong immunity An acute illness with a discrete onset of symptoms consistent with acute viral hepatitis (e.g., fever, headache, malaise, anorexia, nausea, vomiting, diarrhea, and abdominal pain) and either a) jaundice or b) elevated serum alanine aminotransferase levels > 100 IU/L Confirmed Clinically compatible case* not known to have chronic hepatitis B and 1. HBsAg positive, AND 2. IgM antibody to hepatitis B core antigen (IgM anti HBc) positive, if done Massachusetts Event (2013): Confirmed Suspect Revoked * A documented negative hepatitis B surface antigen (HBsAg) laboratory test result within 6 months prior to a positive test (either HBsAg, Hepatitis B e antigen (HBeAg), or hepatitis B virus nucleic acid testing (HBV NAT) including genotype) result does NOT require an acute clinical presentation to meet the surveillance case definition. Same as CDC definition Positive IgM antibody to hepatitis B core antigen (IgM anti-hbc) that does not meet the clinical definition Any case that does not meet the confirmed or suspect acute case definition. PERINATAL Clinical Presentation (CDC 1995): CDC Event (1995): Massachusetts Event (2013): Perinatal hepatitis B in the newborn may range from asymptomatic to fulminant hepatitis. Confirmed Follows CDC definition HBsAg positivity in any infant aged >1-24 months who was born in the United States or in U.S. territories to an HBsAg-positive mother MDPH Case Manual Page 1 of 6

CHRONIC Event Description (CDC 2012): CSTE Event (2012): Massachusetts Event (2013): Persons with chronic HBV infection may have no evidence of liver disease or may have a spectrum of disease ranging from chronic hepatitis to cirrhosis or liver cancer. Persons with chronic infection may be asymptomatic. Confirmed IgM antibodies to hepatitis B core antigen (IgM anti-hbc) negative AND a positive result on one of the following tests: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), or nucleic acid test for hepatitis B virus DNA (including qualitative, quantitative and genotype testing), OR HBsAg positive or nucleic acid test for hepatitis B virus DNA (including qualitative, quantitative and genotype testing), or HBeAg positive two times at least 6 months apart (Any combination of these tests performed 6 months apart is acceptable.) Probable A case with a single HBsAg positive or HBV DNA positive (including qualitative, quantitative and genotype testing), or HBeAg positive lab result when no IgM anti-hbc results are available Confirmed Same as CDC definition Probable Same as CDC definition Suspect Anti-HBc IgM antibody positive that does not otherwise meet the confirmed or revoked case definition Revoked In an individual that has never met the CONFIRMED case classification criteria for chronic hepatitis B OR in an anti-hbc IgM negative individual with a single positive HBsAg, HBeAg, or HBV DNA test, any of the following: Recent documented vaccination (<=1 month prior to positive HBsAg) Negative HBsAg confirmation/neutralization results for the same specimen as a reported positive HBsAg Two negative HBsAg >=24 hours apart Two negative HBV DNA tests at least one month apart in a person NOT on treatment Negative HBV DNA in a person NOT on treatment AND any of the following: negative HBsAg, positive anti-hbs, negative anti-hbc Negative HBsAg AND positive anti-hbs AND negative anti-hbc MDPH Case Manual Page 2 of 6

Report Type Test Type Source Result New or beyond Data Entry Laboratory report Hepatitis B core IgM antibody OR HBc-IgM OR SUSPECT Hepatitis Bc Ab, IgM, P/S OR Hepatitis B core AB (IgM) Select: Hep B virus core Ab.IgM ACnc: Pt: Ser: Ord: Laboratory report Total anti-hbc OR Hepatitis B core OR anti- HBc OR Hepatitis Bc Ab, Positive Yes Do NOT create a new Enter IgG & IgM, P/S Select: Hep B virus core Ab: ACnc: Pt: Ser: Ord: Laboratory report Genotyping Laboratory report Select: Hep B virus genotype: Prid: Pt: Ser/Plas: m: Probe. Amp. Tar HBsAg OR HBAg OR Select: Hep B virus surface Ag: ACnc: Pt: Ser: Ord: Letter value Yes New event MDPH Case Manual Page 3 of 6

Report Type Test Type Source Result New or beyond Data Entry Laboratory report HBsAg Neutralization OR HBsAg Confirmation Select: Hep B virus surface Ag: ACnc: Pt: Ser: Ord: Neut: Laboratory report HBeAg OR Hepatitis B virus little E Ag(EIA, RIBA or other test) Select (EIA): Hep B virus little e Ag: ACnc: Pt: Ser: Ord: EIA Select (RIA): Hep B virus little e Ag: ACnc: Pt: Ser: Ord: RIA Laboratory report HBeAb OR Hepatitis B virus little E Ab(EIA, RIBA or other test) Select: Hep B virus little e Ab: Acnc: Pt: Ser: Qn: Laboratory report PCR for HBV DNA OR Hepatitis B Viral DNA OR RT-PCR OR Viral load Select: Hep B virus DNA: ACnc: Pt: xxx: Ord: Probe.Amp.Tar Positive Yes Do NOT create a new Enter Results may be positive or negative (no numeric result included) Yes New event Consult Interpreting Consult Interpreting MDPH Case Manual Page 4 of 6

Report Type Test Type Source Result New or beyond Laboratory report PCR for HBV DNA OR Results may be positive, Yes Hepatitis B Viral DNA OR negative or trace. Select RT-PCR OR Viral load trace if the numeric result appears negative ( e.g., shown as <20) but a comment or interpretation is included stating that the virus was detected but could not be quantified. Data Entry New event Consult Interpreting Consult Interpreting Select: Hepatitis B virus DNA : ACnc : Pt : Ser/Plas : Qn: Probe.Amp.Tar Laboratory report Hepatitis B RNA Consult Interpreting Consult Interpreting Select: Hepatitis B virus RNA: ACnc: Pt: xxx: Ord: Probe.Amp.Tar Laboratory report rrna (ribosomal RNA) Select: Hep B virus rrna: ACnc: Pt: xxx: Ord: Probe Laboratory report Hepatitis B Surface antibody OR HBsAb (Qualitative) Select: HBV surface Ab Ser Ql Results may be positive or negative (no numeric result included) MDPH Case Manual Page 5 of 6 Yes Do NOT create a new Enter

Report Type Test Type Source Result New or beyond Laboratory report Hepatitis B Surface antibody Results may be positive or Yes OR HBsAb (Quantitative) negative with a numeric value (ex. <10) Select: Hep B virus surface Ab: Acnc: Pt: Ser: Qn Data Entry Do NOT create a new Enter MDPH Case Manual Page 6 of 6