Laboratory reports of hepatitis A and C infection in England and Wales: January to March

Transcription

1 Volume 4 29 Published on: 23 July 2010 Current News Increased diagnoses of HIV infection in the over-50s in UK Infection Reports Immunisation Laboratory reports of hepatitis A and C infection in England and Wales: January to March Quarterly report from the sentinel surveillance study of hepatitis testing in England: data for January to March (quarter 1) Invasive meningococcal infections, England and Wales: laboratory reports, weeks 14-26/10 Surveillance of viral infections in donated blood: England and Wales, 2009 Transfusion transmitted infections reported to NHS Blood & Transplant/HPA,

2 News Volume 4 29 Published on: 23 July 2010 Increased diagnoses of HIV infection in the over-50s in UK HIV infections diagnosed in the over-50s have more than doubled over a period of seven in England, Wales and Northern Ireland (EWNI), according to HPA research published online in the journal AIDS [1]. Researchers from the HPA's Centre for Infections who reviewed all reports of adults aged 15 and over newly diagnosed with HIV between 2000 and 2007 in EWNI report that newly diagnosed cases rose from 299 to 710 over the seven-year period. The researchers estimated that nearly half of older adults diagnosed during the study period were infected at age 50 or over. The impact of late diagnosis on life-expectancy was also considered by the authors. They found that of those aged over 50 diagnosed during the study period, half were diagnosed late, compared with the level of late diagnosis in younger adults, which is one third. They also found the number of over-50s seeking treatment for HIV in the UK had also shown a significant increase: three-fold over the study period. The increase is partly explained by the improved life expectancy of adults infected in their 20s, 30s and 40s, as well as those diagnosed soon after infection in the over 50s. Reference 1. Smith RD, Delpech V, Brown AE, Rice BD. HIV Transmission and high rates of HIV diagnosis among adults aged 50 and over. AIDS 2010, published "ahead-of-print", July 2010, (subscription required).

3 Infection reports Volume 4 29 Published on: 23 July 2010 Immunisation Laboratory reports of hepatitis A and C in England and Wales: January to March 2010 Hepatitis A The first quarter of 2010 (January to March) saw a total of 89 laboratory reports of hepatitis A virus being reported to the HPA/CfI. This constituted a 4.7% rise on the last quarter (which had 85 cases), but a 21.9% decrease on the same quarter of Males accounted for more reports in all age groups, with the biggest difference between the sexes seen among the year olds. Of the total number of laboratory reports during the first quarter of 2010, 24.7% (22) and 12.4% (11) were in males and females, respectively, aged over 45 old. Among those aged old, 31.5% (28) and 13.5% (12) were male and female, respectively, while 9.0% (8) were male and 6.7% (6) female, in the under-15 age group. Over 45 year olds accounted for 37.1%, less than the year olds, who accounted for 44.9% of reports. The under-15s, as is usually observed, accounted for the smallest proportion of reports at 18.0%. Laboratory reports of hepatitis A in England and Wales, January-March 2010 Age group Male Female Unknown Total <1 year Unknown Total

4 Laboratory reports of hepatitis A in England and Wales by age group and sex: January 2002 to March 2010 Hepatitis C There were a total of 2086 laboratory reports of hepatitis C virus reported to the HPA/CfI between January and March This was an 11.7% increase on the previous quarter, but a 15.8% decrease on the same quarter in Males accounted for 67.0% of reports, while females accounted for 30.1%. Consistent with previous quarters, the majority of diagnoses were among those aged between 25 and 44 old (58.9%). Age group Male Female Unknown Total <1 year Unknown Total

5 Quarterly report from the sentinel surveillance study of hepatitis testing in England: data for January to March (quarter 1) The sentinel surveillance study of hepatitis testing, which began in 2002, aims to supplement routine surveillance of hepatitis A, B and C infections in England by providing information on trends in testing, individual risk exposures and clinical symptoms. The study collects information on hepatitis A, B and C testing carried out in participating centres regardless of test result and therefore can also be used to estimate prevalence in those individuals. The de-duplication process that identifies and excludes duplicate patient records has been further enhanced to identify duplicate patients who have undergone testing at multiple sentinel laboratories, producing even more accurate data. All reporting from this point forward uses this improved process. Dried blood spot testing [1] data from three sentinel laboratories are presented in section 4. Concateno Plc. have kindly made available oral fluid and dried blood spot testing data which are presented in sections 4 and 5. These data are presented for the first time in this report. Please note that testing data provided by Concanteno Plc represents indicative results only and is not intended to be used for diagnosis. The testing is performed to help identify those individuals that need to see a specialist and get them into treatment. 1. Hepatitis A IgM testing The sentinel surveillance study collects data on testing for hepatitis A-specific IgM antibody (anti-hav IgM), a marker of acute hepatitis A infection. During the first quarter of 2010, a total of 6,063 individuals were at least once for anti-hav IgM in 19 participating sentinel centres (table 1). This is the first time these individuals had been reported to the sentinel surveillance scheme. As with previous quarters [2], 0.6% of individuals for anti-hav IgM during the first quarter were positive, though this varied by region. The highest proportion of positive tests in England was from the South West (table 1). This may reflect a higher incidence of hepatitis A infection in people being in this region. Table 1. of individuals, and testing positive, for anti-hav IgM in participating centres, January March 2010* Region (number of centres) positive East Midlands (1) 950 East of England (1) (0.5) London (5) (1.0) North East (1) 7 North West (5) 1,065 5 (0.5) South Central (1) 148 South East Coast (1) (0.3) South West (1) (1.2) Wales * 9 West Midlands (1) (0.4) Yorkshire & the Humber (2) (0.6) Total, all regions (19) 6, (0.6) * Excludes reference and confirmatory testing. Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional.

6 Results from two London laboratories not included due to data extraction issues. The low number of individuals in the North East is due to changes in sample referral patterns which mean that most of the testing carried out by the sentinel laboratory in this region is referred from other hospitals and is therefore excluded from these quarterly analyses. * Although there are no sentinel centres outside England, limited first-line testing from general practices in Wales is carried out by sentinel centres in the North West and is therefore included here. Table 2 shows the age and gender of individuals, and testing positive, for anti-hav IgM in sentinel laboratories between January and March Gender and age were reported for the majority of people (>99%). Slightly more males were than females (55.5% male), which is the same as previous quarters. The mean age of individuals was 47.2 (range ), where as the mean age of those testing positive was 37.8 (range 2-81 ). The largest group were aged 65 and over (n= 1,150). The highest overall percentage of individuals testing positive was among year olds and children aged 1-14 although few people were in this latter age group. These results are largely consistent with those reported for the previous quarters of Table 2. of individuals, and testing positive, for anti-hav IgM in participating centres, January March 2010* Female Male Unknown Total Age group positive positive positive positive Under 1 year ( ) 26 ( ) ( ) 46 ( ) 68 2 (2.9) 82 3 (3.7) ( ) (3.3) (0.6) (1.1) 12 ( ) (0.8) (0.3) (0.7) 10 ( ) (0.5) (0.6) (0.7) 12 ( ) 1,035 7 (0.7) (0.4) (0.6) 7 ( ) 1,109 6 (0.5) (0.2) (0.2) 5 ( ) (0.2) (0.2) (0.5) 2 ( ) 1,150 4 (0.3) Unknown 2 ( ) 4 ( ) 3 ( ) 9 ( ) Total, all age groups 2, (0.4) 3, (0.7) 51 0 (0.0) 6, (0.6) * Excludes reference and confirmatory testing. Some duplication of individual patients may occur due to limitations of the information supplied. Results from two London laboratories not included due to data extraction issues. All data are provisional. To provide an indication of trends in testing, data from 19 sentinel centres for which full data were available were compared for the first quarters of 2010 and In the period January to March 2010, 34 of 6,063 (0.6%) people positive for anti-hav IgM compared to 45 of 6,515 (0.7%) for the same period and centres in This shows a slight decrease in the number of people and conversely a slight increase in percentage of individuals testing positive. Figure 1 shows the five-weekly moving average for number of people for anti-hav IgM and percentage positive over the last year (April 2009 to March 2010 inclusive) for the 19 sentinel centres from

7 which full data were available. Testing has remained stable over the last year with noticeable troughs during the summer, Christmas, and Easter holiday periods. The proportion positive fluctuated, with a slight decline suggested from April to July, then several peaks from July to October. A slight increase is noticeable from January to March, data from next quarter will show if this trend continues. Figure 1. Five-weekly moving average of number of people, and percentage positive, for anti- HAV IgM between April 2009 to March 2010* (Note difference in scale of axes compared with figures 2,3) * Excludes reference and confirmatory testing. Some duplication of individual patients may occur due to limitations of the information supplied. Results from two London laboratories not included due to data extraction issues. All data are provisional. 2. Hepatitis B surface antigen (HBsAg) testing All pregnant women in the UK are offered hepatitis B screening as part of their antenatal care. Data from the test request location and freetext clinical details field accompanying the test request were reviewed to distinguish individuals for HBsAg as part of routine antenatal screening (section 2a) from those in other settings and for other reasons (section 2b). It is possible that some women undergoing antenatal screening may not be identified as such and may therefore be included in section 2b as non-antenatal testing. a) Antenatal HBsAg screening During the first quarter of 2010, a total of 13,486 individuals were identified as undergoing antenatal screening for HBsAg in 19 participating sentinel centres (table 3). Of these, 0.5% (n=71) were positive. This is the first time these individuals had been reported to the sentinel surveillance scheme. Individuals identified as undergoing antenatal screening comprised 25.8% of all individuals for HBsAg in participating laboratories during the first quarter of In those regions where few samples were (e.g. East and West Midlands ) it is likely that routine antenatal screening was performed by another laboratory that does not participate in the sentinel surveillance study and that the sentinel laboratory is performing reference testing.

8 Table 3. of individuals, and testing positive, for HBsAg through antenatal screening in participating laboratories, January March 2010* Region (number of centres) positive East Midlands (1) (0.5) East of England (1) (0.1) London (5) (1.0) North East (1) ( ) North West (5) (0.6) South Central (1) 941 ( ) South East Coast (1) (0.2) South West (1) (0.3) West Midlands (1) 92 2 (2.2) Yorkshire & the Humber (2) (0.3) Total, all regions (19) 13, (0.5) * Excludes reference and confirmatory testing. Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional. Results from two London laboratories not included due to data extraction issues. b) Non-antenatal HBsAg testing This includes all individuals for HBsAg at participating centres who are not identified from the test request location or the clinical details accompanying the test request as undergoing antenatal screening. During the first quarter of 2010, a total of 38,874 individuals were for HBsAg in 19 participating sentinel centres, excluding antenatal testing (table 4) and dried blood spot testing. Of these, 1.5% (n=571) were positive. This is the first time these individuals had been reported to the sentinel surveillance scheme. London had the highest proportion of individuals testing positive (2.4%) for the eighth consecutive quarter. The North West and West Midlands also had a high proportion of individuals testing positive (1.6% and 1.8% respectively), which is consistent with previous quarters. This may reflect more targeted testing of risk groups and/or genuinely higher prevalence in people being in these regions. Table 4. of individuals, and testing positive, for HBsAg in participating centres (excluding antenatal testing), January March 2010* Region (number of centres) positive East Midlands (1) 3, (0.8) East of England (1) 2, (1.0) London (5) 11, (2.4) North East (1) (0.2) North West (5) 6, (1.6) South Central (1) 1, (1.1) South East Coast (1) 3, (0.5) South West (1) 3, (0.8)

9 Wales 16 ( ) West Midlands (1) 1, (1.8) Yorkshire & the Humber (2) 4, (1.3) Total, all regions (19) 38, (1.5) * Excludes dried blood spot, reference and confirmatory testing. Excludes individuals aged less than one year, in whom positive tests may reflect the presence of passively-acquired maternal antibody rather than true infection. Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional. Results from two London laboratories not included due to data extraction issues. Although there are no sentinel centres outside England, limited first-line testing from general practices in Northern Ireland and Wales is carried out by sentinel centres in the North West and is therefore included here. Gender and age were reported for the majority of people (>98%). Excluding individuals identified from the test request location or clinical details as undergoing antenatal testing, similar numbers of men and women were for HBsAg (table 5). The number of women may include some antenatal testing that cannot be identified as such from the information provided, or may reflect similar levels of testing among men and women. As reported previously the proportion testing positive for HBsAg was higher among men than women (2.1% v 1.0%).The largest group were aged ; where as the percentage of individuals testing positive was highest among people aged The mean age of individuals was 38.5 (range ) and of those testing positive was 37.0 (range 0-83 ). As with previous quarters, the relatively high prevalence of HBsAg among individuals of unknown gender (2.1%) and age (2.3%) may reflect testing of individuals in settings such as prisons, drug services and GUM clinics where few demographic details on patients (such as gender) were available and where service users may be at high risk of hepatitis B infection. Table 5. Age and gender of individuals for HBsAg in participating centres (excluding antenatal testing), January March 2010* Female Male Unknown Total Age group positive positive positive positive Under 1 year ( ) 66 2 (3.0) 3 ( ) (1.6) (1.7) (2.2) 14 ( ) (1.9) 4, (0.7) 3, (1.4) (1.0) 8, (1.0) 5, (1.1) 4, (2.3) (2.7) 11, (1.7) 3, (1.2) 3, (2.5) (3.9) 7, (1.9) 1, (1.1) 2, (2.4) 39 1 (2.6) 4, (1.8) 1, (0.7) 1, (1.4) 21 ( ) 3, (1.1) 65 1, (0.6) 2, (0.9) 12 ( ) 3, (0.8) Unknown 15 1 (6.7) 32 ( ) 40 1 (2.5) 87 2 (2.3) Total, all age groups 19, (1.0) 18, (2.0) (2.1) 38, (1.5)

10 * Excludes reference and confirmatory testing. Some duplication of individual patients may occur due to limitations of the information supplied. Results from two London laboratories not included due to data extraction issues. All data are provisional. To provide an indication of trends in testing, data from the 19 sentinel centres for which full data were available were compared for the first quarters of 2010 and In the period January to March 2010, 571 of 38,874 (1.5%) people positive for HBsAg (excluding antenatal testing), compared to 653 of 40,865 (1.6%) for the same period in This shows a slight decrease in the number of people and the proportion of individuals testing positive for HBsAg. Figure 2 shows the five-weekly moving average for number of people for HBsAg and percentage positive over the last year (excluding antenatal testing; April 2009 to March 2010 inclusive) for the 17 sentinel centres from which full data were available. Testing overall has declined slightly over the past year with troughs in testing during the Christmas and Easter holiday period. The slight decline in the proportion positive over the past 12 months has continued. Figure 2. Five-weekly moving average of number of people, and percentage positive, for HBsAg between January 2009 and December 2009 (excluding antenatal testing)* (Note difference in scale of axes compared with figures 1 and 3) 3. Hepatitis C testing During the first quarter of 2010, a total of 31,406 individuals were at least once for hepatitis C-specific antibodies (anti-hcv) in 19 participating sentinel centres (table 7), excluding dried blood spot testing. This is the first time these individuals had been reported to the sentinel surveillance scheme. Overall, 2.5% of individuals for anti-hcv were positive, though this varied by region. As with previous quarters the highest proportion of positive tests in England were from the North West (table 6). This may reflect a higher prevalence in people being in this region. It is important to note that no laboratory methods are currently available to distinguish between acute or chronic hepatitis C virus infections. These positive anti-hcv results do not therefore necessarily represent incident infections.

11 Table 6. of individuals, and testing positive, for anti-hcv in participating centres, January March 2010* Region (number of centres) positive East Midlands (1) 2, (1.9) East of England (1) 1, (1.9) London (5) 8, (2.3) North East (1) (2.4) North West (5) 5, (4.1) South Central (1) (2.8) South East Coast (1) 3, (1.1) South West (1) 3, (2.4) Wales 13 ( ) West Midlands (1) 1, (1.3) Yorkshire & the Humber (2) 3, (3.1) Total, all regions (19) 31, (2.5) * Excludes dried blood spot, oral fluid, reference and confirmatory testing. Excludes individuals aged less than one year, in whom positive tests may reflect the presence of passively-acquired maternal antibody rather than true infection. Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional. Results from two London laboratories not included due to data extraction issues. Although all sentinel centres are in England, a small amount of first-line testing from general practices in Wales is carried out by laboratories in the North West and West Midlands. Of the 790 individuals testing positive for anti-hcv during the first quarter of 2010, 482 (61.0%) were also for HCV RNA by PCR (qualitative and/or quantitative). Of these individuals, 322 were PCR positive (66.8%). Gender and age was reported for the majority of people (>98%) (table 7). Slightly more males (52.4%) were than females. As reported previously the proportion testing positive was nearly twice as high among men as among women (3.1% vs. 1.8%). The mean age of individuals was 40.5 (range ) and of those testing positive was 40.5 (range 6-89 ). As with the previous quarter the largest group were aged The percentage of individuals with a known age testing positive was highest among year olds (4.0%). The relatively high level of individuals with unknown age testing positive (8.9%) may reflect testing of individuals in settings such as prisons, drug services and GUM clinics where fewer demographic details on patients were available and where service users may be at high risk of hepatitis C infection.

12 Table 7. Age and gender of individuals for anti-hcv in participating centres, January March 2010* Female Male Unknown Total Age group positive positive positive positive (0.4) (0.4) 14 ( ) (0.4) 3, (0.9) 2, (1.0) (1.2) 5, (1.0) 3, (2.1) 4, (3.4) (2.4) 8, (2.8) 2, (3.1) 3, (4.6) 92 7 (7.6) 6, (4.0) 1, (2.5) 2, (4.6) 32 1 (3.1) 4, (3.7) 1, (1.6) 1, (3.1) 22 1 (4.5) 2, (2.5) 65 1, (0.6) 1, (0.7) 11 ( ) 3, (0.6) Unknown 16 2 (12.5) 33 3 (9.1) 30 2 (6.7) 79 7 (8.9) Total, all age groups 14, (1.8) 16, (3.1) (3.2) 31, (2.5) * Excludes dried blood spot, oral fluid reference and confirmatory testing. Individuals aged less than one year are excluded since positive tests in this age group may reflect the presence of passively-acquired maternal antibody rather than true infection. Results from two London laboratories not included due to data extraction issues. Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional. To provide an indication of trends in testing, data from the 19 sentinel centres from which full data were available were compared for the first quarters of 2010 and In the period January to March 2010, 790 of 31,406 (2.5%) people were positive for anti-hcv, compared to 1,009 of 33,894 (3.0%) for the same period in As previously reported this may suggest a greater proportion of people at lower risk of infection were during the first quarter of 2010, and/or the prevalence of hepatitis C was decreasing among the individuals. Figure 3 shows the five-weekly moving average for number of people for anti-hcv and percentage positive over the last year (April 2009 to March 2010 inclusive) for the 19 sentinel centres from which full data were available. Apart from a trough during the summer, Christmas, and Easter holiday periods testing remained relatively consistent. As observed over the previous quarters, several peaks in testing correspond to simultaneous troughs in the percentage positive; perhaps suggesting increased testing of people at low risk of infection. An overall decline in the percentage positive over the past year is still apparent, in line with the long-term annual trend in declining percentage positive among individuals for anti-hcv observed over the course of the study. As reported previously this decline may be due in part to the role out of dried blood spot testing to high risk individuals who are difficult to bleed, mainly intravenous drug users.

13 Figure 3. Five-weekly moving average of number of people, and percentage positive, for anti- HCV between January 2009 and December 2009* (Note scale of axes c.f. above) 4. Dried blood spot testing Three sentinel laboratories provide dried blood spot testing facilities. Anti-HCV dried blood spot testing data have also been made available by Concateno Plc. These data are described here for the first time. Data are shown by region of the requesting clinician. a) HBsAg testing During the first quarter of 2010, a total of 727 individuals were at least once for HBsAg by dried blood spot testing. Overall, 0.7% (n=5) of individuals were positive, though this varied by region. This is the first time these individuals had been reported to the sentinel surveillance scheme. Table 8. of individuals, and testing positive, for HBsAg by dried blood spot (sentinel surveillance laboratories only), January March 2010* Region (number of centres) positive East Midlands (1) ( ) East of England (1) (1.4) London (5) ( ) North East (1) (0.5) North West (5) (0.5) South Central (1) 15 0 (0.0) South East Coast (1) (0.8) South West (1) 3 ( ) West Midlands (1) 2 ( ) Yorkshire & the Humber (2) 17 ( ) Total, all regions (19) (0.7) * Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional.

14 b) Anti-HCV testing During the first quarter of 2010, a combined total of 1,453 individuals were at least once for hepatitis C-specific antibodies (anti-hcv) by dried blood spot testing. This is the first time these individuals had been reported. Concateno Plc 483 individuals from drug action teams (DAT) of whom 38.1% (n=184) had a reactive result. A further 970 individuals were by sentinel laboratories, of whom 24.0% (n=233) positive. The comparatively lower proportion positive among individuals who were by sentinel laboratories may reflect differences in testing; for example dried blood spot testing has been trialled in pharmacies and other primary care settings as well as by specialist drug services. All samples by DBS by Concateno were taken in/by drug action teams. Table 9. of individuals, and testing positive, for anti-hcv by dried blood spot, January March 2010* Region of test request Data from sentinel surveillance positive Data from Concateno Plc. reactive Total reactive East Midlands ( ) (47.7) (47.7) East of England (25.0) ( ) (25.0) London ( ) (30.3) (30.3) North East (10.7) ( ) (10.7) North West (31.9) (54.5) (33.7) South Central 15 1 (6.7) 49 9 (18.4) (15.6) South East Coast (24.1) ( ) (24.1) South West 3 1 (33.3) (35.6) (35.5) West Midlands 14 ( ) ( ) 14 ( ) Yorkshire and Humberside 17 5 (29.4) (46.2) (42.7) Total, all regions (24.0) (38.1) 1, (28.7) * Dried blood spot testing excludes individuals aged less than one year, in whom positive tests may reflect the presence of passively-acquired maternal antibody rather than true infection. Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional. It should be noted that testing data provided by Concanteno Plc represents indicative results only and is not intended to be used for diagnosis. 5. Anti-HCV oral fluid testing Aggregate oral fluid testing data have been provided by Concateno Plc. These data are described here for the first time. Data are shown by region of the requesting clinician. During the first quarter of 2010, 1,276 individuals were at least once for hepatitis C-specific antibodies (anti-hcv) by oral fluid, of whom 13.1% (n=167) had a reactive test result.

15 Table 10. of individuals, and testing reactive, for anti-hcv by oral fluid, January March 2010* Region (number of centres) reactive East Midlands (1) (10.1) East of England (1) (10.7) London (5) (15.5) North East (1) 68 5 (7.4) North West (5) 3 ( ) South Central (1) 48 6 (12.5) South East Coast (1) 8 1 (12.5) South West (1) 9 ( ) Wales 23 9 (39.1) West Midlands (1) 32 2 (6.3) Yorkshire & the Humber (2) (17.4) Total, all regions (19) 1, (13.1) * Some duplication of individual patients may occur due to limitations of the information supplied. All data are provisional. Please note that testing data provided by Concanteno Plc represents indicative results only and is not intended to be used for diagnosis. References 1. Judd A, Parry J, Hickman M, McDonald T, Jordan L, Lewis K, et al. Evaluation of a modified commercial assay in detecting antibody to hepatitis C virus in oral fluids and dried blood spots. J Med Virol 2003; 71 (1) Health Protection Agency. Quarterly report from the sentinel surveillance study of hepatitis testing in England: data for October to December 2009 (quarter 4). Health Protection Report [serial online] 2010; 4(25) immunisation. Available at:

16 Invasive meningococcal infections, England and Wales: laboratory reports, weeks 14-26/10 CSF and blood Culture Method of diagnosis Nonculture Other sites Cumulative totals to week 26/2010 to week 26/2009 Group A 1 B C W X 1 2 Y Z/29E Nongroupable 1 Ungrouped Total Source: HPA Meningococcal Reference Unit

17 Surveillance of viral infections in donated blood: England and Wales, 2009 Donated blood is collected from volunteer (unpaid) adult donors who do not acknowledge any medical conditions, travel histories, or behaviours that are known to be associated with an increased risk of bloodborne infections. In 2009, all blood donations made in England and Wales were screened for hepatitis B surface antigen (HBsAg) antibodies to hepatitis C virus (HCV), human immunodeficiency virus (HIV) and human T-cell lymphotropic virus (HTLV). Donations were screened for HCV RNA and HIV RNA on pools of up to 48 donations and then on pools of up to 24 donations as triplex testing which included hepatitis B virus (HBV) DNA was rolled out from April Donations were also screened for antibodies to syphilis and in addition, some donations were for antibodies to hepatitis B core antigen (anti-hbc), malaria and Trypanosoma cruzi (Chagas disease) depending on the donor's history (not reported here). A donation found positive for any of these markers is excluded from the blood supply. The donor is informed of their infection, told to stop donating and referred to specialist services to receive appropriate care. Blood donation testing: England and Wales, 2009 In 2009, a total of 214 out of 2,207,467 donations collected by the English and Welsh blood services were positive for markers of viral infections, the majority for HBV (table 1). In 2009, new donors contributed 11% of all blood donations, but 93% of HBsAg, 96% of anti-hcv and 95% of anti-htlv infected donors. In contrast, only 52% of anti-hiv positive donations were donated by new donors. Table 1. Infections detected in 2,207,467 blood donations collected in England and Wales during 2009 HBV * (HBsAg / HBV DNA) HCV (anti-hcv / HCV RNA ) HIV (HIV Ab/Ag / HIV RNA) HTLV (anti- HTLV) Any of these four markers All donations per 100,000 donations ; in x donations 23,236 29,831 95, ,339 10,315 Donations form new donors* per 100,000 donations ; in x donations ,558 21,050 12,630 1,323 Donations form repeat donors per 100,000 donations ; in x donations 279, , , ,432 84,994 * New donors are classified by blood centres as individuals donating for the first time but may also include lapsed donors. Some repeat donors may be newly for markers of infection. * HBV DNA testing was rolled out from April Six donors had markers for more than one infection: two HBsAg carrier/ T.pallidum ; one HCV/ T.pallidum, one HTLV/HBsAg carrier, one HTLV/HCV and one HTLV/T. pallidum. There was an increase in the number of HTLV infections in new donors in 2009 including three which were dually infected - one with HCV, one HBsAg and one with syphilis. The introduction of HBV NAT screening led to the detection of four repeat donors in England and Wales that were HBsAg negative, HBV DNA positive. Further testing of archive and subsequent samples identified that two of these were acute infections and two were occult infections with antibodies to hepatitis B core. Altogether there were six acute HBV infections detected, one in a donation from a new donor and five in donations from repeat donors. No HCV or HIV infected donors were detected by NAT screening only.

18 Characteristics of infected blood donors: England and Wales, 2009 The frequency of HBsAg, anti-hcv, anti-hiv and anti-htlv in donations collected from new donors during 2009 by age group and gender of donors is shown (figure 1). There was generally a higher frequency among donations from male donors than females for all markers of infection, except for HTLV. The frequency in repeat donors was much lower than in new donors and there were much lower numbers of positive tests in repeat donors compared to new donors for all infections except HIV. The frequency of marker by age group and gender of repeat donors is only shown for anti-hiv (figure 2). Figure 1: Age and gender of infected blood donors: new donors. Donations collected during 2009 (Note different scales)

19 Figure 2. Age and gender of HIV infected repeat blood donors. Donations collected during 2009 (Note different scale from new donors)

20 The main characteristics of blood donors infected with HBV, HCV, HIV and of new donors infected with HTLV are shown in table 2. The characteristics varied between new and repeat donors and by infection. Possible routes of infection are determined from risk exposures disclosed to clinicians at post-test discussion by donors. Table 2. Main characteristics (where known) of blood donors infected with HBV, HCV, HIV and HTLV in England and Wales, 2009 HBV HCV HIV HTLV New Repeat New Repeat New Repeat New Repeat No. of donors* % male 80% 62% 56% 67% 36% 67% 24% Mean age % white- British 14% (12/82) 88% (7/8) 59% (41/67) 67% (2/3) 18% (2/11) 92% (11/12) 14% (3/21) % born UK 20% (15/82) 88% (7/8) 66% (44/67) 100% (3/3) 18% (2/11) 100% (12/12) 35% (7/20) Main possible route of exposure where known 64% born in, or to parents from, an endemic country (45/70) 57% heterosexual contact (4/7) 28% other possible blood contact (16/58) 50% other possible blood contact (1/2) 78% heterosexual contact (7/9) 72% heterosexual contact (8/11 68%born in, or to parents from, an endemic country (13/19) Second possible route of exposure,where known 21% other possible blood contact (15/70) 29% other possible blood contact (2/7) 26% injecting drug use (15/58) 50% piercing (1/2) 11% sex between men and 11% born in, or to, parents from an endemic country (each 1/9) 27% sex between men (3/11) 21% heterosexual contact (4/19) * s by new and repeat differ slightly from table 1 due to verification of two lapsed donors (1 HBV and 1 HIV) as repeat donors and 1 HTLV infected repeat donor whose previous donation was given prior to HTLV screening. Assumed to be UK if country of birth was not stated but ethnic group was white-british. Generally in new donors the majority were non-white and born abroad especially for HBV and HTLV. This was reflected in the main possible route of exposure for HBV and HTLV infected new donors of being born in or to parents from an endemic country. The main possible route of infection in HIV infected new donors was heterosexual contact, with five out of seven where they or their contact had had sex in sub-saharan Africa. In HCV infected new donors however, the majority were white and born in the UK. The main possible route of infection assigned for HCV infected new donors was possible blood contact which covers a range of situations including nosocomial, immunisation, needlestick or fights, attacks or bites where blood contact can potentially occur. This was closely followed by about a quarter who had injected drugs at some point in the past (on average 23 prior, range 6 to 46 ) despite being asked not to donate. In contrast the majority of repeat donors were white and born in the UK. Heterosexual contact was the main possible route of infection in HBV and HIV infected repeat donors. Four of these heterosexually infected HIV donors had high risk partners including three who may have had sex in sub-saharan Africa. Cumulative frequency in blood donations in England and Wales to December 2009 Blood donations have been for HBsAg since 1972, and national surveillance data have been available since Overall the frequency of HBsAg in new donors has shown no significant change over time, while declining in repeat donors (figure 3a). Anti-HCV testing of blood donations began in Since that time the frequency of anti-hcv has declined each year in blood donations from both new and repeat donors (figure 3b). The frequency of anti-hiv in blood donations has been low and variable since testing was introduced in 1985 in England and Wales. Although the frequency in new donors has increased from 3.1 per 100,000 donations

21 in 1996 to 4.7 per 100, 000 donations in 2009 the number of infections is small and annual fluctuations are to be expected (figure 3c). Figure 3: Blood donations with markers for a) HBV (from 01/10/1995), b) HCV (from 01/09/1991), c) HIV (from 01/12/1986) and d) HTLV (from 01/08/2002): England & Wales, donations collected to 31/12/2009 (note different scales).

22 Blood donations have been screened for HTLV since Since that time the frequency of infection in new donors has remained low and variable. When screening was first introduced in 2002 all repeat donors (ie people who have made a previous donation in the UK ) would have been for HTLV for the first time. Consequently the frequency of infection among repeat donors decreased sharply over the first two ( ) as all donors with chronic HTLV infections were removed from the donor panel (figure 3d). The current low frequency in repeat donors now reflects the low incidence in the UK. Four HTLV seroconverters have been detected between 2002 and 2009 in England and Wales. For more information on the surveillance of blood-borne infections in blood donors see the Bloodborne Infections in Blood Donors (BIBD) pages of the HPA website: (Home Topics Infectious Diseases Infections A-Z Bloodborne Infections in Blood Donors, BIBD). Specific enquiries about this report can be sent to infection.surveillance@nhsbt.nhs.uk.

23 Transfusion transmitted infections reported to NHS Blood & Transplant/HPA, 2009 The surveillance of suspected transfusion-transmitted infections (TTIs) began in October 1995 and is coordinated by the NHS Blood and Transplant (NHSBT)/ Health Protection Agency (HPA) Centre for Infections (CfI) Epidemiology Unit. Data collected forms part of the Serious Hazards of Transfusion (SHOT) haemovigilance scheme. Data presented here are for NHSBT/HPA TTI surveillance only. The 2009 SHOT Annual Report has already been published and is available via the SHOT website ( Methods Blood centres in England, Wales and Northern Ireland report possible TTI's of which they have been informed to NHSBT/HPA TTI surveillance. Blood centres in Scotland report all incidents to the Microbiology Reference Unit of the Scottish National Blood Transfusion Service for investigation. Details and findings on each incident are passed to NHSBT/HPA TTI surveillance annually. Reports of suspected transfusion transmitted infections Between 1 January 2009 and 31 December 2009, 39 reports of suspected TTIs were made by blood centres throughout the UK to NHSBT/HPA TTI surveillance. After complete investigation, two reports (both bacterial) were determined to be TTIs according to the definition below (see box). Thirty investigations were concluded not TTI (11 hepatitis B [HBV], one hepatitis C [HCV], three HIV, one herpes simplex virus type-2, one vcjd and thirteen bacterial). Four cases were concluded undetermined' (three bacterial, one HIV) and three cases are pending complete investigation (one HBV, one HCV and one human T-lymphotropic virus [HTLV]). Definition A report was classified as a transfusion-transmitted infection if, following investigation, the recipient had evidence of infection post-transfusion, and there was no evidence of infection prior to transfusion and no evidence of an alternative source of infection, and Either at least one component received by the infected recipient was donated by a donor who had evidence of the same transmissible infection, Or at least one component received by the infected recipient was shown to contain the agent of infection. Confirmed incidents, 2009 Report of transfusion transmitted Streptococcus pneumoniae An un-issued, expired unit of apheresis platelets was referred for microbiological testing after routine quality monitoring found the pack to have a low ph and abnormal colouration. Streptococcus pneumoniae was isolated from the unit. Four associated units had been transfused into two patients with Acute Myeloid Leukemia (AML) one unit to an adult and three neonatal units to a baby. Retrospective investigations revealed that both patients had experienced transfusion reactions (including a fever of 39.8 C in the adult patient and 40.5 C in the baby), but these were thought at the time to have been related to the patients' underlying conditions. All of the transfused packs had been discarded but a blood sample taken from the adult patient yielded S. pneumoniae. Blood cultures from the neonatal patient were negative however the patient was on antibiotics at the time of transfusion. The organisms isolated from both the contaminated index pack and the adult patient were compared using molecular techniques (Pulse Field Gel Electrophoresis, Multi Locus Sequence Typing and Variable

24 Tandem Repeat analyses) and were found to be indistinguishable from one another. Nose and throat swabs taken from the donor were negative, although S. pneumoniae is known to be difficult to culture from swabs [1,2]. Approximately 4-8% of adults carry S. pneumoniae [2,3]. It is thought that the organism may have originated from the throat of the donor or donor carer and been transferred from there to the venepuncture site by fingers or a cough/sneeze. Report of transfusion transmitted Pseudomonas koreensis Three units of red cells were transfused into an elderly man receiving palliative care for cancer of the rectum and liver cirrhosis. Approximately two hours into transfusion of the third unit the patient became unwell with hypotension, fever (39.6 C), abdominal pain and vomiting, and died later the same day. Pseudomonas koreensis was cultured from the remains of the red cell unit at the microbiology laboratories of both the hospital and the blood service, and also from the patient blood cultures. All three isolates were found to be indistinguishable on molecular typing. P. koreensis is associated with cold temperatures and it was thought that contamination of the unit may have occurred within a cold storage room or processing area at the blood service or the hospital. Skin carriage of P. koreensis is rare. The donor was recalled and swabs were taken from the arms but these were negative. The donor was thought unlikely to have been the source of the contaminating bacteria. Despite extensive environmental sampling of processing and cold storage areas at the hospital and blood services, the source of the contamination could not be identified. The red cell pack was pressure but this did not reveal any holes or defects and so it is unclear how the bacteria may have entered the pack. T he incident has led to an extensive review of cold room cleaning protocols within processing and issues areas. Undetermined cases, 2009 Of the four undetermined cases in 2009, three related to bacterial investigations and one to HIV. In two of the bacterial cases there was growth from the patient blood cultures (gram negative rods and Pseudomonas, respectively) but the transfused packs had been discarded and so were not available for further investigation. As a result, it was not possible to exclude the blood as the possible source of contamination. In the third bacterial case, coagulase negative staphylococci were isolated from a unit of transfused platelets at the hospital microbiology laboratory. The patient's blood cultures were negative but these were taken four days after the patient had been started on antibiotics. The pack was not returned to the blood service for further investigation, and environmental contamination during sampling of the unit at the hospital microbiology laboratory could not be ruled out. Near miss Incident, 2009 Staphylococcus aureus was isolated from two of three un-issued, four day old units of apheresis platelets after visible clumps/aggregates were noted in the packs. The donor was sampled and S. aureus was isolated from the nose, throat and venepuncture site pre arm-cleansing. Coagulase negative staphylococci were isolated from the venepuncture site post-cleansing. The isolates identified from the donor and platelet packs were found to be a single clonal type. In light of the results of the swabs taken from the donor it was agreed that he should be permanently deferred from the panel due to S. aureus colonization. Carriage of this organism varies, it is suggested that between 20-40% of the population carry it in their nose [4]. Increased carriage of S. aureus on the skin is associated with eczema and other dermatological conditions. Cumulative total ( ) Since surveillance began in 1995, 69 confirmed TTI incidents have been reported to the scheme, (see table). More than half (60.9%, 42/69) of all confirmed TTIs were due to bacterial contamination. There have been no confirmed viral TTIs since To date, the most commonly confirmed viral TTI has been hepatitis B. Commentary Currently, the greatest risk of transfusion-transmitted infection is associated with bacterial contamination, although there is likely to be under-reporting of both viral and bacterial incidents. One of the confirmed bacterial incidents in 2009 was only revealed upon retrospective investigation after an expired unit of platelets was found to have a low ph and abnormal colouration, and the fate of associated components was

25 investigated. This case demonstrates that acute transfusion reactions can be difficult to recognise, particularly when patients have other underlying symptoms and/or they are taking antibiotics which may mask their symptoms. This case was also the first known report of transfusion-transmitted Streptococcus pneumoniae infection in the UK. The most likely source of the organism in the Pseudomonas koreensis case was thought to have been environmental contamination within a cold storage room or issues area. While the MHRA's Orange Guide' includes recommendations on standards of environmental cleanliness for clean' rooms (where sterile conditions are maintained) [5], there are no guidelines which cover acceptable levels of cleanliness within cold storage areas. Nonetheless, cleaning protocols for such areas should be reviewed regularly and compliance with these should be audited. Strategies to reduce the bacterial contamination of blood components should be continually reviewed. At a meeting in July 2009, the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) did not recommend the adoption of pathogen inactivation of platelets at present, until further data on the cost benefit and safety of this method become available. Most of the UK blood services already screen platelet donations for bacterial contamination and this is planned for introduction in England in early It should be noted that the effectiveness of screening is influenced by the methodology used and data from a number of studies have shown that bacterial screening is unlikely to prevent all transmissions [6]. The UK Standing Advisory Committee on Transfusion Transmitted Infection (SACTII) have tasked a sub-group to recommend how bacterial screening should be performed. The current estimated risks of transmission of HBV, HCV, HIV and HTLV via blood transfusion are low (1.09, 0.01, 0.19 and 0.04 per million donations for HBV, HCV, HIV and HTLV-1 respectively) [7]. Clinicians investigating suspected viral TTIs should explore all possible risk exposures (eg surgery, or discuss with the patient any sexual risks, injecting drug use, occupational exposure) in parallel with the blood service investigations, as highlighted by the undetermined HIV investigation this year. Cumulative total of reports of transfusion transmitted infections made to NHSBT/HPA TTI surveillance between 1/10/1995 and 31/12/2009 by year of transfusion and infection, UK* Year of transf'n Pre-1997 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 Total Deaths Infection HAV 1(1) 1(1) 1(1) 3(3) HBV 3(3) 1(1) 1(1) 2(3) 1(1) 1(1) 1(1) 1(1) 11(12) HCV 1(1) 1(1) 2(2) HEV 1(1) 1(1) HIV 1(3) 1(1) 2(4) HTLV1 2(2) 2(2) Bacteria 2(2) 3(3) 4(4) 4(4) 7(7) 5(5) 1(1) 3(3) * 2(2) 2(2) 3(3) 4(6) 2(3) 42(45) 11 Malaria 1(1) 1(1) 2(2) 1 vcjd/prion 1(1) 2(2) 1(1) 4(4) 3 Total 11(13) 8(8) 5(5) 7(8) 9(9) 5(5) 3(8) 5(5) 1(1) 4(4) 2(2) 3(3) 4(6) 2(3) 69(75) 12 * The number of incidents is shown with the total number of identified infected recipients in brackets. Data is included from the beginning of the NHSBT/HPA Infection Surveillance Programme (October 1995) to December Data presented in the SHOT Report 2009 is from October 1996 only. Therefore, the numbers shown in this table do not match those presented in the SHOT report. One investigation not included in this table. In 2003 an anti-hiv negative donation (donated in 2002) was found to be HIV RNA positive on retrospective PCR testing of a seroconverting donor. Red cells from the seronegative unit had been transfused into an elderly patient during surgery for a fractured femur in The recipient died soon after surgery and her HIV status was not determined. This case was classified as a near miss. * One investigation not included in this table. In 2004 there was an incident involving contamination of a pooled platelet pack with Staphyloccoccus epidermidis, which did not meet the TTI definition because transmission to the recipient was not confirmed, but it would seem likely. This case was classified as not transfusion-transmitted'. A further prion case died but transfusion was not implicated as the cause of death.