Needs Assessment of Hepatitis C Testing, Treatment and Support Services: Survey of Laboratories in...
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Transcript of Needs Assessment of Hepatitis C Testing, Treatment and Support Services: Survey of Laboratories in...
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