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 1st Jan. to 31st Dec. 2006

0 - 999 antibody tests

1000 - 3999 antibody tests

4000 - 7999 antibody tests

8000 - 11999 antibody tests

12000+ 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

0 - 999 antibody tests

1000 - 3999 antibody tests

4000 - 7999 antibody tests

8000 – 11999 antibody tests

12000+ 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

0 - 999 antibody tests

1000 - 3999 antibody tests

4000 - 7999 antibody tests

8000 – 11999 antibody tests

12000+ 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 request All HCV antibody tests (N=61,700)

GP 25%

Hospital inpatient 21%

Renal 16%

Hospital outpatient (not GUM)

15%

GUM clinic 9%

Occupational Health 9%

Counselling Clinic 3%

Prison 1%

Other 1%

* 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 request All HCV antibody tests(N=61,700)

New HCV antibody positive tests

(N=1,520)

GP 25% 25%

Hospital inpatient 21% 11%

Renal 16% 0%

Hospital outpatient (not GUM)

15% 43%

GUM clinic 9% 6%

Occupational Health 9% 3%

Counselling Clinic 3% 9%

Prison 1% 2%

Other 1% 1%

* 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 request All HCV antibody tests

(N=61,700)

New HCV antibody positive tests

(N=1,520)

New HCV diagnosis rate

(per 1,000 tests)

GP 25% 25% 25

Hospital inpatient 21% 11% 13

Renal 16% 0% 0

Hospital outpatient (not GUM)

15% 43% 72

GUM clinic 9% 6% 15

Occupational Health 9% 3% 8

Counselling Clinic 3% 9% 73

Prison 1% 2% 48

Other 1% 1% 11

Overall 100% 100% 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

– 2006n % of N

1 675 43.52 89 5.73 769 49.64 15 1.05 2 0.2

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

1st sample

1st sample

Local laboratories

antibody testing 1st sample

(n=11)

Local laboratory testing algorithms following a positive antibody test result

0

2

4

6

8

10

12

Ab at local lab PCR at local lab Confirmation Abat ref lab

PCR at ref lab No testing at reflab

No.

of l

ocal

labo

rato

ries

* Responses are not mutually exclusive

Positive test result

Local laboratories

antibody testing 1st sample

(n=11)

Local laboratory testing algorithms on second samples

2nd sample

0

2

4

6

8

10

12

Ab at local lab PCR at local lab Confirmation Abat ref lab

PCR at ref lab No testing at reflab

No.

of l

ocal

labo

rato

ries

Positive test result

1st sample

0

1

2

3

4

5

6

7

8

Ab at local lab PCR at local lab Ab at ref lab PCR at ref lab

No.

of l

ocal

labo

rato

ries

* 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)

2nd sample

Local laboratory reporting algorithms

Antibody result only reported to source of request

(n=6)

Positive test result

1st sampleNo 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)

1st sample

2nd 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)

1st sample

2nd 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 results12/14 laboratories provided data with median turn-around time of 15-21 days reported (range 1-3 days to 22-28 days)

* From date of initial sample at laboratory to date of reporting result to test request source

0

1

2

3

4

5

6

1-3 days 4-7 days 8-14 days 15-21days

22-28days

>28 days

Time (days)

No. of re

sponse

s

Test result turn-around times

ii) Hepatitis C PCR test results 11/14 laboratories provided data with median turn-around time of 15-21 days reported (range 8-14 days to 22-28 days)

0

1

2

3

4

5

6

7

1-3 days 4-7 days 8-14days

15-21days

22-28days

>28 days

Time (days)

No. of

resp

on

ses

* 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 15-21 days