1. 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

2. 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

3. 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

4. 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

5. 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.

6. 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 – Oct

7. 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

8. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. *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

16. 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.

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

18. 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

19. 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

20. 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