Needs Assessment of Hepatitis C Testing, Treatment and Support Services: Survey of Laboratories in Scotland Undertaking Hepatitis C Testing

Survey objectives: i)to describe the existing provision of laboratory Hepatitis C testing services across Scotland ii)to examine the way in which individual laboratories operate with regard to Hepatitis C testing

Survey response rate: Of 25 laboratories surveyed, 24 responses received 92% response rate Survey period: Data provided for period 1 st Jan. to 31 st Dec. 2006

antibody tests antibody tests antibody tests antibody tests antibody tests Hepatitis C antibody tests by NHS Board (where test performed), 2006 Not known (cf. 40,000 in 2002/2003) N=61,700 HCV antibody test

antibody tests antibody tests antibody tests 8000 – antibody tests antibody tests Hepatitis C antibody tests by NHS Board (where test performed), 2006 N=61,700 HCV antibody tests Grampian (13%) Tayside (8%) Lothian (19%) Ayrshire & Arran (8%) Greater Glasgow & Clyde (35%) Not known

antibody tests antibody tests antibody tests 8000 – antibody tests antibody tests Location of 14 Hepatitis C antibody testing laboratories* N=61,700 HCV antibody tests Hepatitis C antibody testing laboratory Hepatitis C testing reference laboratory Not known * 2 reference and 12 local laboratories

Hepatitis C antibody tests in Scotland, 2006 Total HCV antibody tests (from laboratory survey): 61,700 Total HCV antibody positive tests (from laboratory survey): 3,141 New HCV antibody positive diagnoses (from National 1,520 Hepatitis C Diagnoses Database): 2.5% of all HCV antibody tests were new HCV diagnoses

Source of all Hepatitis C antibody tests in Scotland, 2006 Source of test requestAll HCV antibody tests (N=61,700) GP25% Hospital inpatient21% Renal16% Hospital outpatient (not GUM) 15% GUM clinic9% Occupational Health9% Counselling Clinic3% Prison1% Other1% * Data on source of test provided by 2 reference laboratories and 10/12 local laboratories

Source of all Hepatitis C antibody tests in Scotland, 2006 Source of test requestAll HCV antibody tests (N=61,700) New HCV antibody positive tests (N=1,520) GP25% Hospital inpatient21%11% Renal16%0% Hospital outpatient (not GUM) 15%43% GUM clinic9%6% Occupational Health9%3% Counselling Clinic3%9% Prison1%2% Other1% * Data on source of test provided by 2 reference laboratories and 10/12 local laboratories

Source of all Hepatitis C antibody tests in Scotland, 2006 Source of test requestAll HCV antibody tests (N=61,700) New HCV antibody positive tests (N=1,520) New HCV diagnosis rate (per 1,000 tests) GP25% 25 Hospital inpatient21%11%13 Renal16%0%0 Hospital outpatient (not GUM) 15%43%72 GUM clinic9%6%15 Occupational Health9%3%8 Counselling Clinic3%9%73 Prison1%2%48 Other1% 11 Overall100% 25 * Data on source of test provided by 2 reference laboratories and 10/12 local laboratories

Hepatitis C PCR testing: 3 laboratories undertake PCR testing (for diagnostic and monitoring purposes) - a) West of Scotland Specialist Virology Centre (WSSVC) b) East of Scotland Specialist Virology Centre (ESSVC) c) Medical Microbiology Laboratory, Ninewells Hospital In 2006, 5700 PCR tests performed; 70% at WSSVC, 22% at ESSVC, 8% at Ninewells Hospital

Hepatitis C genotyping: 2 specialist virology centres in Glasgow and Edinburgh perform HCV genotyping

Genotype Among persons diagnosed with Hepatitis C during 2004 – 2006 n% of N Total number of tests (N)1550 Hepatitis C genotyping: * Data extracted from National Hepatitis C Diagnoses Database

Negative test result Local laboratories antibody testing 1st sample (n=11) Antibody result reported to source of request (n=11) Local laboratory testing/reporting algorithm following a negative antibody test result 1 st sample

Local laboratories antibody testing 1st sample (n=11) Local laboratory testing algorithms following a positive antibody test result * Responses are not mutually exclusive Positive test result

Local laboratories antibody testing 1st sample (n=11) Local laboratory testing algorithms on second samples 2 nd sample Positive test result 1 st sample * Responses are not mutually exclusive Second sample requested (n=7)

Antibody result reported to source of request (n=11) Negative test result Local laboratories antibody testing 1st sample (n=11) Confirmed antibody and PCR results reported to source of request (n=8) PCR result reported to source of request (n=2) PCR result only reported to source of request (n=2) Antibody and PCR results reported to source of request (n=1) 2 nd sample Local laboratory reporting algorithms Antibody result only reported to source of request (n=6) Positive test result 1 st sample No results reported to source of test request (n=1) No further results reported to source of request (n=4) Second sample requested (n=7)

Reference laboratory testing/reporting algorithms Confirmation PCR testing only at Ref. Lab. (n=1) Second sample requested for confirmation testing (n=2) Negative test result Reference laboratories antibody testing 1st sample (n=2) 1 st sample 2 nd sample Positive test result Initial sample tested for PCR at ref. lab. (n=2) Confirmation antibody and PCR testing at Ref. Lab. (n=1)

Reference laboratory testing/reporting algorithms Confirmation PCR testing only at Ref. Lab. (n=1) Second sample requested for confirmation testing (n=2) Result reported to source of request (n=2) Negative test result Reference laboratories antibody testing 1st sample (n=2) 1 st sample 2 nd sample Antibody result reported to source of request (n=1) Positive test result PCR result reported to source of request (n=1) Initial sample tested for PCR at ref. lab. (n=2) Confirmed antibody and PCR results reported to source of request (n=1) Confirmation antibody and PCR testing at Ref. Lab. (n=1)

Test result turn-around times* i)Hepatitis C antibody test results 12/14 laboratories provided data with median turn-around time of days reported (range 1-3 days to days) * From date of initial sample at laboratory to date of reporting result to test request source

Test result turn-around times ii)Hepatitis C PCR test results 11/14 laboratories provided data with median turn-around time of days reported (range 8-14 days to days) * From date of initial sample at laboratory to date of reporting result to test request source

Summary: At least one Hepatitis C antibody testing laboratory located in 10 of 14 NHS Board areas In Scotland, approx. 50% increase in amount of Hepatitis C antibody testing undertaken from 2002/2003 to 2006 Majority of PCR testing performed at WSSVC in Glasgow Variety of testing and reporting algorithms applied at local laboratories following positive antibody result Median turn-around time for antibody and PCR test results at local and reference laboratories days