National Hepatitis Coordinators’ Conference Hepatitis B and Hepatitis C Testing in Florida’s High Risk Adults: Preliminary Data for Testing Program and Signal-to-Cut-Off Ratio Sandra W. Roush, MT, MPH National Hepatitis Coordinators’ Conference San Antonio 1/2003

Florida’s Hepatitis (A, B, C) Program Providing leadership, policy development, and technical assistance Development of a comprehensive prevention plan Counseling and testing services Vaccination for adults Patient care services Prevention initiatives Allocating state hepatitis resources

Florida’s Statewide High Risk Adult Hepatitis B and C Testing Program Initial purchase Dec. 2000: State Public Health Laboratory One-time carry over (lab and vaccine) 3,000 chronic panels with RIBA confirmation Subsequent purchases: state funds Eligibility: adult high risk Statewide memos March 2001, Dec. 2002 NO CHARGE TO CHD OR CLIENT

Florida Hepatitis and Liver Failure Prevention and Control Program Escambia Holmes Jackson Santa Rosa H o l m e s S a n t a R o s a J a c k s o n Okaloosa W Walton a l t o n Nassau W Washington a s h i n g o Gadsden G a d s d e n Leon Hamilton N a s s a u Calhoun Jefferson L e o n J e f f e r s o n M Madison a d i s o n H a m i l t o n Liberty Suwannee B a k Baker e r D u Duval v a l W Wakulla a k u l l a Taylor S u w a n n e e Columbia C o l u m b i a Bay T a y l o r Union Clay Gulf L a Lafayette f a y e t t e U n i o n Bradford C l a y St. John’s F r a Franklin n k l i n B r a d f o r d S t J o h n s i Gilchrist l c h r i s t Alachua Dixie A l a c h u a Putnam P u t n a m F l Flagler a g l e r Levy Florida Hepatitis and Liver Failure Prevention and Control Program Adult Hepatitis Laboratory Testing Program County Participation – 10/10/2002 M a Marion r i o n V o Volusia l u s i a Citrus C i t r u s Sumter Lake L a k e Seminole Hernando u m t e r S e m i n o l e O r a Orange n g e B r e v a r d Pasco Osceola i Hillsborough l l s b o r o u g h Pinellas Polk O s c e o l a Brevard P o l k I n d Indian River i a n R i v e r Manatee Hardee Okeechobee M a n a t e e H a r d e e O k e e c h o b e e St. Lucie Highlands S t L u c i e Desoto H i g h l a n d s Sarasota r o t a D e S o t o Martin Charlotte C h a r l o t t e G Glades l a d e s Hepatitis B and hepatitis C testing (HBsAg, HBsAb, HBcAb, HCV-antibody) available at no charge to county Hendry Lee P Palm Beach a l m B e a c h Collier B r Broward o w a r d Active programs using available hepatitis B and hepatitis C testing at no charge to county Monroe Miami-Dade D a d e Comprehensive hepatitis and liver failure programs funded from State Health Office

Hepatitis Adult High Risk Testing Program Sites* Number of Counties STD 35 HIV 30 Immunization/ Epidemiology 26 Family Planning 23 General 29 * Participation sites are not mutually exclusive; number among 48 counties responding.

Florida Chronic Hepatitis Testing Program: Results Summary* Positive No. (%) Negative Indeterm/unsat Missing HBsAg 137 (1.2) 10,833 (93.7) 10 584 (5.1) HBsAb 2,655 (23.0) 8,331 (72.0) 15 563 (5.0) HBcAb 1,456 (12.6) 9,204 (79.6) 14 890 (7.8) HCV-EIA 1,375 (11.9) 9,554 (82.6) 5 630 (5.5) * Number (percent) based on n=11,564 chronic panels Jan. 2001 – Oct. 2002.

Florida Chronic Hepatitis Testing Program: Results Summary for RR HCV-EIA* Positive No. (%) Negative Indeterm/ Unsat Missing PCR 869 (63.2) 291 (21.2) 1 214 (15.6) RIBA 339 (24.7) 30 (2.1) 29 (2.1) 977 (71.1) * Number (percent) based on 1,375 RR HCV-EIA 1/1/01 –10/02

Routine Testing for HCV Infection Serologic assays for anti-HCV Enzyme immunoassay (EIA) Recombinant immunoassay (RIBA™) Sensitivity >97% Indicates past or present infection False positivity 30%-50% if EIA used alone in low prevalence (<10%) populations

Confirming Anti-HCV EIA Positive Results RT-PCR for HCV RNA can be negative in “true” infections (resolved infection-15%-25%, intermittent viremia, low levels of virus, sample handling) Most reliable with clinical information If negative, need supplemental anti-HCV testing RIBA Anti-HCV present in active and resolved infections RIBA confirms presence of antibody Not routinely performed because of expense

Demographic Summary of Chronic Hepatitis C Results* Gender: 53 % female; 46 % male; 1 % unknown 620 (10 %) of tested females were HCV EIA RR 722 (14 %) of tested males were HCV EIA RR Race: 52% white; 16 % black; 5 % other; 31 % unknown 744 (12 %) white were HCV EIA RR 133 (7 %) black were HCV EIA RR 32 (11 %) other were HCV EIA RR 11,564 panels run; 1,375 (12 %) HCV EIA RR; data for 398 RIBAs

Improving Reliability and Consistency of Reported Anti-HCV Results Use EIA signal to cutoff ratios to predict RIBA Results above the cutoff should predict a positive RIBA result Only those results below the cutoff would require RIBA testing Cutoff should perform consistently, regardless of the population being tested

S/CO Ratio of HCV EIA 3. 0 by RIBA 3 S/CO Ratio of HCV EIA 3.0 by RIBA 3.0 Volunteer Blood Donors (n=24,704) 13 Source: S Stramer, ARC

S/CO Ratio of HCV EIA 3. 0 by RIBA 3 S/CO Ratio of HCV EIA 3.0 by RIBA 3.0 Florida Chronic Hepatitis Testing Program 1/1/01 – 10/31/02

*Of 1,375 RR anti-HCV EIA, 394 have s/co in dataset Proportion* of Anti-HCV EIA RR Results Requiring RIBA Based on S/CO Ratio <3.8 *Of 1,375 RR anti-HCV EIA, 394 have s/co in dataset

HCV-EIA Results Among Clients With Selected Hepatitis C Risk Factors Riba Result * Number (percent) based on n=11,564 chronic panels Jan 2001 – Oct 2002.

RIBA Results* Among Clients With Selected Hepatitis C Risk Factors * Among 1,375 HCV-EIA RR specimens

Use of EIA S/CO Ratio and RIBA for Reporting Anti-HCV Results RR samples with s/co >3.8 can be reported based on EIA alone >95% will be RIBA positive RR samples with s/co <3.8 require RIBA testing In high prevalence populations there are few in this range Limits cost while improving accuracy of reported results

Florida’s Draft Hepatitis C Testing Algorithm Using S/CO EIA for anti-HCV negative STOP positive Calculate S/CO s/co > = 3.8 s/co < 3.8 OR Report as HCV positive by EIA with S/CO > = 3.8 RIBA for anti-HCV RT-PCR for HCV RNA Medical Evaluation Pick up with existing algorithm STOP

Thanks to … HQ Hepatitis Staff, including: Jodi Baldy, Robbie Bouplon, Katrina Huffmaster, April Crowley, Sandy Teixeira County hepatitis and other programmatic staff HQ Bureaus of HIV/AIDS, Immunization, STD, TB/Refugee DOH Communications & Program Marketing Office NIP/CDC NCID/CDC