MHRA warns against purchasing HIV and other self-test kits over the internet. Typhoid travel health leaflet available in four south Asian languages

Transcription

1 Volume 5 43 Published on: 28 October 2011 Current News MHRA warns against purchasing HIV and other self-test kits over the internet Tetanus-specific immunoglobulin shortage Travel Health Typhoid travel health leaflet available in four south Asian languages Infection Reports Immunisation Tetanus (England and Wales): 2009 to 2010 Sentinel surveillance study of hepatitis testing (England), April-June 2011 Laboratory reports of hepatitis A and C (England & Wales), April-June 2011 Invasive meningococcal infections (England and Wales), laboratory reports, weeks 27-39/2011

2 News Volume 5 43 Published on: 28 October 2011 MHRA warns against purchasing HIV and other self-test kits over the internet Home test kits being bought over the internet to diagnose HIV and other sexually transmitted infections could be giving users inaccurate results, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned [1]. The MHRA has been made aware of a UK hosted website selling non CE-marked self-test kits to diagnose HIV and sexually transmitted infections. These devices are not compliant with the Medical Devices Regulations and should not be placed on the UK market. Additionally, in the case of HIV kits, advertising, selling or supplying a home test kit for HIV is illegal under the HIV Testing Kits and Services Regulations The MHRA has advised: those using the internet to purchase HIV self-test kits to be aware that it is illegal to supply such devices in this way; and that as far as self-test kits for other sexually transmitted infections are concerned, purchasers should check that any kits purchased from internet sites are CE marked which should denote conformity with the relevant European legislation. The Health Protection Agency has been involved in contacting individuals known to have purchased noncompliant home test kits, informing them that the result may be unreliable. Reference 1. Regulator warns against purchasing all HIV and non-compliant self-test kits over the internet. MHRA press release, 26 October 2011, Tetanus-specific immunoglobulin shortage The Health Protection Agency has recently become aware of a shortage of tetanus-specific immunoglobulin (TIG) which used to provide immediate protection against tetanus. Alternative products to TIG are also in short supply. A Q&A document based on the Agency s current understanding of the situation is available via the Tetanus Guidelines page on the HPA website [1]. The Q&As advice should be read together with the guidance on using Vigam and Subgam as alternates for treatment and prophylaxis of tetanus, respectively. Both documents can be accessed via the Tetanus Guidelines webpage [1]. Alternative sources of TIG are currently being investigated and these documents will be updated if another source is identified. Local providers should be encouraged to use immunoglobulin only in accordance with advice in the green book (see page 381) [2]. A brief summary of tetanus cases in England and Wales for the can be found in the Infection Reports section of this issue of HPR. References 1. Human tetanus immunoglobulin Q & A. HPA website: Topics Infectious Diseases Infections A-Z Tetanus Guidelines. 2. Immunisation against infectious disease ("the Green Book"): chapter 30: tetanus. Downloadable at: digitalasset/dh_ pdf.

3 Travel Health Typhoid travel health leaflet available in four south Asian languages The HPA Travel and Migrant Health Section has published new, foreign-language versions of its patient information leaflet Typhoid health advice for travellers [1]. Typhoid and paratyphoid (enteric fever) are among the infectious diseases whose incidence in UK residents has been found to be typically associated with travel abroad to visit friends and relatives, particularly to Pakistan, Bangladesh, India and some African countries [2]. Most of those who travel abroad to visit friends and relatives (VFR) travel to countries of their own or their family s ethnic origin; the destination is familiar to them and they may underestimate the risk to their health from enteric fever. These translated leaflets will enable those for whom English is not their first language to be able to receive simple advice on how to reduce their risk of enteric fever while they are visiting family abroad. The translated leaflets are available to download in Bengali, Gujurati, Punjabi, Urdu, as well as in English from the HPA website [1]. Further information on enteric fever in VFR travellers and migrants to the UK is also available from the Migrant Health Guide [3]. References 1. Typhoid - health advice for travellers. HPA website: Home > Publications Infectious diseases Factsheets - Infectious diseases Typhoid health advice for travellers. 2. Foreign travel-associated illness a focus on those visiting friends and relatives: 2008 report (2009). HPA website: Home Publications Infectious diseases Travel health Foreign travel-associated illness a focus on those visiting friends and relatives: 2008 report. 3. Migrant Health Guide. HPA website: Home > Migrant Health Guide > Health Topics > Infectious diseases > Enteric fevers.

4 Infection reports Volume 5 43 Published on: 28 October 2011 Immunisation Tetanus (England and Wales): 2009 to 2010 Sentinel surveillance study of hepatitis testing (England), April-June 2011 Laboratory reports of hepatitis A and C (England & Wales), April-June 2011 Invasive meningococcal infections (England and Wales), laboratory reports, weeks 27-39/2011 Immunisation Tetanus (England and Wales): 2009 to 2010 Tetanus remains well controlled in England and Wales due to high vaccine coverage. Between January 2009 and December 2010, 16 cases were reported. Ten cases (63%) were older adults, born before routine childhood immunisations were introduced in 1961; none had received a complete course of tetanus immunisations. One case was reported in an unimmunised child. An elderly unimmunised woman died of the infection. Background Tetanus is a life-threatening but preventable disease caused by a neurotoxin produced by Clostridium tetani, an anaerobic spore-forming bacillus. Tetanus spores are widespread in the environment, including in soil, and can survive hostile conditions for long periods of time. Transmission occurs when spores are introduced into the body, often through a puncture wound but also through trivial, unnoticed wounds, through injecting drug use, and occasionally through abdominal surgery. Tetanus is not transmitted from person to person. The incubation period of the disease is usually between three and 21 days, although it may range from one day to several months, depending on the character, extent and localisation of the wound. Tetanus immunisation was introduced in the 1950s and became part of the national routine childhood programme in Since then, vaccine coverage at two of age has always exceeded 70% in England and Wales and since 2001 has been around 95%, the target coverage set by the World Health Organization (WHO). The objective of the immunisation programme in the UK is to provide a minimum of five doses of tetanus-containing vaccine at appropriate intervals for all individuals. As there is no herd immunity effect, individual protection through vaccination is essential. In most circumstances, a total of five doses of vaccine at the appropriate intervals are considered to give satisfactory long-term protection, and routine boosters every 10 are no longer recommended [1]. Tetanus is usually confirmed by a clinical diagnosis alone, although three diagnostic laboratory tests are available: detection of tetanus toxin in a serum sample, isolation of tetanus bacillus from the infection site, and demonstrating low levels or absent antibody to tetanus toxoid in serum. The first two tests may provide laboratory confirmation, whereas the third can only support the diagnosis. Clinical management of tetanus includes administration of tetanus immunoglobulin (TIG), wound debridement, antimicrobials including agents reliably active against anaerobes such as metronidazole, and vaccination with tetanus toxoid following recovery. Early treatment with TIG can be life saving. Where a suitable TIG stock cannot be sourced, the HPA recommends that human normal immunoglobulin (HNIG) for intravenous use may be used as an alternative for treatment of clinical tetanus [2]. A Q&A document has been published on the HPA website in response to a current shortage of TIG [3].

5 Data sources for the enhanced surveillance of tetanus include notifications, reference and NHS laboratory reports, death registrations, and individual case details such as vaccination history, source of infection, and severity of disease obtained from hospital records and general practitioners. This report updates a previous review of tetanus cases reported in England and Wales in the four-year period 2005 to 2008 [4]. Results Sixteen cases of tetanus were reported in England between 2009 and No cases were reported in Wales. Cases were aged between 8 and 91, with those aged over 64, the age group which historically has been the most affected [5], accounting for over half of the cases (table 1). The only child was an unvaccinated eight year old; only four tetanus cases in children aged 5-14 have been reported since 1984 [4-6]. Ten of the 16 cases (63%) were female. Characteristics of tetanus cases* in England and Wales: 2009 to 2010 Year Total Total number of cases Source of information Age breakdown Notified Other sources * Injecting drug users (IDUs) * Based on reports from hospital clinicians, laboratories and death registrations. One in each year subsequently found not to be tetanus. Two of the four cases in the year age group were reported in injecting drug users (IDUs). Vaccination histories were not available for either. Clusters of tetanus cases in IDUs presumed to be caused by contaminated heroin have been reported previously [7] but as the onset dates of the cases in were eleven months apart a common source or batch contamination is unlikely. Amongst non-idus, all 14 cases had a definite history of injury and were sustained in the garden or home. These included three penetrating wounds by nails/gardening equipment, and one patient with a bilateral heel ulcer. Details of treatment at time of exposure were known for all 14 non-idu cases. Three cases were treated at the time of exposure (22%); all were elderly and unimmunised and therefore indicated to receive TIG [8]. One case received tetanus toxiod, one received tetanus toxiod and antibiotics, and the third case received sutures with no mention of tetanus toxiod or TIG being offered. Two additional cases were treated a few days after exposure; one received tetanus toxiod, the other received diazepam while in hospital. The remaining nine cases did not receive treatment at time of exposure. Post exposure treatment details were also known for 14 cases of whom 10 were given TIG (71%), two were given HNIG (14%), and two were not treated with immunoglobulins (14%). There was one recorded death from tetanus in this period, an unimmunised 91 year old female who sustained a gardening injury and died six days later. This patient did not receive either TIG or tetanus toxoid vaccine at the time of her injury. None of the 16 cases had completed the recommended five doses of tetanus vaccine. Ten cases were born before 1961 when routine childhood immunisation was introduced; five were unimmunised, four had received only one documented dose and another had been received primary immunisations more than 30 previously but no booster doses. Of the six eligible for routine childhood vaccination, one was unimmunised, two were partially immunised and three had an unknown immunisation status.

6 References 1. Salisbury D, Ramsay M, Noakes K (2006). Immunisation against infectious disease (the Green Book'). London: The Stationary Office. Available at: 2. HPA recommendation on the treatment and prophylaxis of tetanus (April 2008) [97k PDF]. HPA website: Home Topics Infectious Diseases Infections A-Z Tetanus Guidelines. 3. Human tetanus immunoglobulin Q & A (October 2011) [80 KB]. HPA website: Home Topics Infectious Diseases Infections A-Z Tetanus Guidelines. 4. Tetanus in England and Wales: 2005 to Health Protection Report 2010, 4(8): immunisation. Available at: 5. Rushdy AA, White JM, Ramsay ME, Crowcroft NS. Tetanus in England and Wales Epidemiol Infect 2003; 130: Tetanus in England and Wales: 2001 to Commun Dis Rep CDR Wkly 2005; 15(34). Available at: 7. Hahne SJM, White JM, Brett M, George R, Beeching NJ, Roy K, et al. Tetanus emerges in injecting drug users in the UK [letter]. Emerg Infect Dis 2006; 12(4): Department of Health. Immunisation against infectious disease.chapter 30: Tetanus. Available at: digitalasset/dh_ pdf.

7 Sentinel surveillance study of hepatitis testing (England), April-June 2011 The sentinel surveillance study of hepatitis testing in England began in 2002, and provides information on trends in testing, individual risk exposures and clinical symptoms, as a supplement to the routine surveillance of hepatitis A, B and C. The study collects information on hepatitis A, B and C testing carried out in participating sentinel centres regardless of test result and therefore can also be used to estimate prevalence in those individuals. Data from 22 centres are detailed in this report. Limited first-line testing of individuals from Wales and Northern Ireland is performed by sentinel centres in the North West. These results are included where available. The data presented here are for individuals who were first reported to the sentinel surveillance scheme during the second quarter (April to June) of As presented in the previous quarter [1], hepatitis D (HDV total antibody) and hepatitis E (HEV IgM) testing data are presented in sections 4 and 5 respectively. Dried blood spot testing [2] data from three sentinel laboratories are presented in section 6. Concateno Plc. has kindly made oral fluid and dried blood spot testing data available which are presented in sections 6 and 7. Please note that these data represent indicative results only and are performed to identify individuals that should seek specialist services and where necessary, access 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 second quarter of 2011, a total of 6,844 individuals were at least once for anti-hav IgM. Overall, 0.3% (n=19) of individuals, which varied by region (table 1). The highest proportion of tests were from the West Midlands region. Table 1. of individuals, and testing, for anti-hav IgM in participating centres, April June 2011* Region (number of centres) East Midlands (1) 1,164 1 (0.1) East of England (1) (0.3) London (6) 1,381 8 (0.6) North East (2) (0.4) North West (5) (0.3) South Central (1) 50 (0.0) South East Coast (2) (0.1) South West (1) 679 (0.0) Wales * 8 (0.0) West Midlands (1) (1.1) Yorkshire & the Humber (2) 749 (0.0) Total, all regions (22) 6, (0.3) * Excludes reference testing and testing from hospitals referring all samples. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. 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.

8 Table 2 shows the age-group and gender of individuals, and testing, for anti-hav IgM in sentinel laboratories between April and June Gender and age were reported for the majority of people (>99%). As in previous quarters [1], where available, a slightly higher proportion of males were than females (56.5% vs. 43.5%). The mean age of individuals was 46.8 (range ), whereas the mean age of those testing was 42.5 (range ). The largest age-group were aged 65 and over (n=1,310). The proportion of males testing was slightly higher than females ( 0.3% vs 0.2%). The highest overall percentage of individuals testing were of unknown age, although few were in this group. Table 2. Age and gender of individuals for anti-hav IgM in participating centres, April June 2011* Age group Female Male Unknown Total Under 1 year (0.0) 26 (0.0) (0.0) 43 (0.0) 64 (0.0) 88 (0.0) (0.0) 152 (0.0) (0.9) (0.5) 8 (0.0) (0.7) (0.4) (0.1) 14 (0.0) 1,200 3 (0.3) 447 (0.0) (0.4) 4 (0.0) 1,193 3 (0.3) 526 (0.0) (0.4) 3 (0.0) 1,214 3 (0.2) 477 (0.0) 502 (0.0) 1 (0.0) 980 (0.0) (0.3) (0.3) 4 (0.0) 1,310 4 (0.3) Unknown 1 (0.0) 5 (0.0) 6 1 (16.7) 12 1 (8.3) Total, all age groups 2,940 7 (0.2) 3, (0.3) 40 1 (2.5) 6, (0.3) * Excludes reference testing and testing from hospitals referring all samples. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. To provide an indication of trends in testing, data for the period April to June 2011 (0.3%; 19/6844) were compared to data received for the same time periods of 2010 and These show a reduction in the number of people and testing compared to both 2010 (0.5%; 44/8086) and 2009 ( 0.5%; 41/8071). Figure 1 shows the five-weekly moving average for number of people for anti-hav IgM and percentage between July 2010 and June 2011, inclusive, for 22 participating sentinel centres. The numbers of individuals has declined over recent months, with noticeable troughs during the Christmas and Easter holiday periods. The proportion testing has declined over the last year, although there was a noticeable peak in the number and proportion of tests during September 2010.

9 Figure 1. Five-weekly moving average of number of people, and percentage, for anti-hav IgM between July 2010 and June 2011* (Note difference in scale of axes compared with figures 2 and 3) * Excludes reference testing and testing from hospitals referring all samples. Data are de-duplicated subject to availability of date of birth, soundex and first initial. 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 nonantenatal testing. a) Antenatal HBsAg screening During the second quarter of 2011, a total of 18,137 women were identified as undergoing antenatal screening for HBsAg, representing 29.2 % (18,137 / 62,093) of all individuals in participating sentinel centres (table 3). Overall 0.4% (n=81) of individuals. Among the 81 HBsAg women identified, 9 (11.5%) were HBeAg.

10 Table 3. of individuals, and testing, for HBsAg through antenatal screening in participating laboratories, April June 2011* Region (number of centres) East Midlands (1) 155 (0.0) East of England (1) 1,184 1 (0.1) London (6) 3, (1.1) North East (2) (0.2) North West (5) 2, (0.6) South Central (1) (0.3) South East Coast (2) 2,139 6 (0.3) South West (1) 1,862 3 (0.2) West Midlands (1) 2,769 7 (0.3) Yorkshire & the Humber (2) 2,465 7 (0.3) Total, all regions (22) 18, (0.4) * Excludes dried blood spot, oral fluid, reference testing and testing from hospitals referring all samples. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. 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. b) Non-antenatal HBsAg testing During the second quarter of 2011, excluding dried blood-spot and antenatal testing 43,956 individuals were for HBsAg in participating sentinel centres (table 4). Overall, 1.6% (n=716) of individuals. London had the highest proportion of individuals testing (2.3%) for the thirteenth consecutive quarter. The West Midlands also had a relatively high proportion of individuals testing (1.8%), 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, for HBsAg in participating centres (excluding antenatal testing), April June 2011* Region (number of centres) East Midlands (1) 3, (0.9) East of England (1) 1, (1.2) London (6) 15, (2.3) North East (6) 2, (1.3) North West (5) 6, (1.6) South Central (1) 1, (1.6) South East Coast (2) 3, (0.9) South West (1) 3, (1.0) Wales 14 (0.0) West Midlands (1) 2, (1.8) Yorkshire & the Humber (2) 4, (1.0) Total, all regions (22) 43, (1.6) * Excludes dried blood spot, oral fluid, reference testing and testing from hospitals referring all samples. Individuals aged less than one year are included. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional.

11 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. Table 5 shows the age and gender of individuals, and testing, for HBsAg in sentinel laboratories between April and June Gender and age were reported for the majority of individuals (>98%). There were slightly more men compared to women (53.8% and 46.2% respectively). The number of women may include some antenatal testing that cannot be identified as such from the information provided. As reported previously [1], the proportion testing for HBsAg was higher among men than women (2.1% v 1.1%).The largest age-group were aged old and the percentage of individuals testing was also highest among this age-group. The mean age of individuals was 39.1 (range ) and of those testing was 36.4 (range ). As reported last quarter [1], the relatively high prevalence of HBsAg among individuals of unknown gender (2.4%) may reflect testing 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 higher risk of hepatitis B infection. Table 5. Age and gender of individuals for HBsAg in participating centres (excluding antenatal testing), April June 2011* Age group Female Male Unknown Total Under 1 year (0.0) 63 (0.0) 5 (0.0) 138 (0.0) (1.4) (0.5) 7 (0.0) (0.9) 3, (0.9) 3, (2.0) (2.1) 7, (1.4) 6, (1.4) 6, (2.7) (3.3) 13, (2.1) 3, (1.1) 5, (2.5) (1.0) 8, (1.9) 2, (1.0) 3, (1.9) 35 1 (2.9) 5, (1.5) 1, (0.9) 1, (0.9) 20 1 (5.0) 3, (0.9) 65 1, (0.6) 2, (1.1) 15 (0.0) 4, (0.9) Unknown 23 (0.0) 33 (0.0) 83 2 (2.4) (1.4) Total, all age groups 19, (1.1) 23, (2.1) (2.4) 43, (1.6) * Excludes dried blood spot, oral fluid, reference testing and testing from hospitals referring all samples. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. To provide an indication of trends in testing, data for the period April to June 2011 (1.6%; 716/43956) were compared to data received for the same time periods of 2010 and As reported last quarter [1] there was a slight decrease in the number of people when compared to both 2010 (1.5%; 717 / 47,664) and 2009 (1.6%; 780 / 49,311). The proportion of individuals testing has remained relatively consistent over this time period. Figure 2 shows the five-weekly moving average for the number of people for HBsAg and the percentage between July 2010 and June 2011 inclusive, for 22 participating sentinel centres. Testing has remained relatively stable over the last year with a trough during the Christmas, New Year and Easter holiday period. Conversely there was an increase in the proportion of individuals testing during Christmas and the New Year. Overall, the proportion has increased slightly during the last 12 months.

12 Figure 2. Five-weekly moving average of number of people, and percentage, for HBsAg between July 2010 and June 2011 (excluding antenatal testing)* (Note difference in scale of axes compared with figures 1 and 3) * Excludes reference testing and testing from hospitals referring all samples. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. 3. Hepatitis C testing During the second quarter of 2011, excluding dried blood spot testing, a total of 38,023 individuals were at least once for hepatitis C-specific antibodies (anti-hcv). Overall, 2.6% (n=981) of individuals, although this varied by region. The highest proportion of tests were from the East of England region (table 6). In previous quarters the North West has consistently had the highest proportion of tests [1]. This may reflect a change in testing patterns and/or in the prevalence of hepatitis C in people being in these regions. It is important to note that no laboratory methods are currently available to distinguish between acute or chronic hepatitis C virus infections. These anti-hcv results do not therefore necessarily represent incident infections.

13 Table 6. of individuals, and testing, for anti-hcv in participating centres, April June 2011* Region (number of centres) East Midlands (1) 2, (2.1) East of England (1) 1, (4.3) London (6) 12, (2.5) North East (6) 2, (1.8) North West (5) 6, (2.8) South Central (1) 9,68 13 (1.3) South East Coast (2) 2, (2.9) South West (1) 3, (2.9) Wales 13 (0.0) West Midlands (1) (1.9) Yorkshire & the Humber (2) 3, (2.9) Total, all regions (22) 38, (2.6) * Excludes dried blood spot, oral fluid, reference testing and testing from hospitals referring all samples. Excludes individuals aged less than one year, in whom tests may reflect the presence of passively-acquired maternal antibody rather than true infection. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. 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 981 individuals testing for anti-hcv during the second quarter of 2011, 631 (64.3%) were also for HCV RNA by PCR (qualitative and/or quantitative). Of these individuals, 417 were PCR (66.1%). Table 7 shows the age and gender of individuals, and testing, for anti-hcv in sentinel laboratories between April and June Gender and age were reported for the majority of individuals (>98%), and where available, there was a slightly higher proportion of males compared to females (55.9 % and 44.1% respectively). As reported previously [1], the proportion testing was also higher among men than women (3.2% vs. 1.8%). The mean age of individuals was 40.8 (range ) and of those testing was 42.1 (range ). The largest age-group were aged with the percentage of individuals testing highest among year olds (4.1%). Individuals with unknown gender and age had a higher proportion testing when compared to those of known gender and age. This may reflect testing of individuals in settings such as prisons, drug services and GUM clinics where fewer demographic details on patients are routinely available. Table 7. Age and gender of individuals for anti-hcv in participating centres, April June 2011* Age group Female Male Unknown Total (0.8) (1.9) 7 (0.0) (1.4) 2, (0.8) 2, (1.0) (1.5) 5, (0.9) 4, (1.9) 5, (2.8) (4.2) 10, (2.4) 3, (2.5) 4, (4.5) (5.7) 8, (3.7) , (2.4) 2, (5.2) 38 4 (10.5) 5, (4.1)

14 , (2.0) 1, (2.9) 17 1 (5.9) 3, (2.5) 65 1, (1.5) 2, (1.6) 15 (0.0) 4, (1.6) Unknown 25 1 (4.0) 36 2 (5.6) 105 (0.0) (1.8) Total, all age groups 16, (1.8) 20, (3.2) (3.3) 38, (2.6) * Excludes dried blood spot, oral fluid reference testing and testing from hospitals referring all samples. Individuals aged less than one year are excluded since tests in this age group may reflect the presence of passively-acquired maternal antibody rather than true infection. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. To provide an indication of trends in testing, data for the period April to June 2011 (2.6%; 981/ 38,023) were compared to data received for the same time periods of 2010 and These show a reduction in the number of people over time, while a similar proportion in both 2010 (2.5%; 1,012 / 39,826) and 2009 (2.8%; 1,185 / 41,804). Figure 3 shows the five-weekly moving average for number of people for anti-hcv and percentage between July 2010 and June 2011 inclusive, for 22 participating sentinel centres. Apart from troughs during the Christmas, Easter and late summer holiday periods, testing remained relatively consistent. There has been a slight increase in the number of individuals testing. Figure 3. Five-weekly moving average of number of people, and percentage, for anti-hcv between July 2010 and June 2011* (Note difference in scales to figures 1 and 2) * Excludes dried blood spot, oral fluid, reference testing and testing from hospitals referring all samples. Data are deduplicated subject to availability of date of birth, soundex and first initial. Individuals aged less than one year are excluded since tests in this age group may reflect the presence of passively-acquired maternal antibody rather than true infection. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional.

15 4. Hepatitis D testing The sentinel surveillance study collects data on testing for hepatitis D-specific total antibody (HDV TA). Three sentinel laboratories provide HDV TA testing facilities. A HDV result does not necessarily represent an incident infection and these data should be interpreted accordingly. The data are described here are shown by region of the requesting clinician. During the second quarter of 2011, a total of 438 individuals were at least once for HDV TA. Overall 5.5% (n=24) of individuals, although this varied by region (table 8). Gender and age were reported for the majority of people (>97%), and where available, there was a slightly higher proportion of men (52.0%) than women. The mean age of individuals was 37.0 (range ), whereas the mean age of those testing was 37.3 (range ). Table 8. of individuals, and testing, for HDV TA in participating centres, April to June 2011* Region of test request East Midlands 31 (0.0) East of England 60 3 (5.0) London (7.0) North East 10 (0.0) North West 31 (0.0) Northern Ireland 2 (0.0) South Central 8 (0.0) South East Coast 22 3 (13.6) South West 11 1 (9.1) Wales 7 1 (14.3) West Midlands 15 (0.0) Yorkshire & the Humber 26 1 (3.8) Total, all regions (5.5) * Excludes reference testing. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisionall. Although all sentinel centres are in England, a small amount of first-line testing from Wales, Northern Ireland and the Channel Islands are carried out by sentinel laboratories 5. Hepatitis E IgM testing The sentinel surveillance study collects data on testing for hepatitis E-specific IgM antibody (anti-hev IgM), a marker of acute hepatitis E infection. Six sentinel laboratories provide anti-hev IgM testing facilities. Data are shown by region of the requesting clinician. During the second quarter of 2011, a total of 1,251 individuals were at least once for anti-hev IgM. Overall, 6.9% (n=1,251) of individuals, although this varied by region. Gender and age were reported for the majority of people (>92%), and where available, a higher proportion of men ( 53.2 %) were than women. The mean age of individuals was 47.3 (range ), where as the mean age of those testing was 53.6 (range ).

16 Table 9. of individuals, and testing, for anti-hev IgM in participating centres, April to June 2011* Region of test request Channel Islands 2 (0.0) East Midlands 69 8 (11.6) East of England (8.0) London (7.7) North East 43 2 (4.7) North West (2.8) Northern Ireland 15 (0.0) South Central 73 8 (11.0) South East Coast 56 4 (7.1) South West (11.3) Wales (2.9) West Midlands (5.6) Yorkshire & the Humber 43 1 (2.3) Total, all regions 1, (6.9) * Excludes reference testing. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisionall. Although all sentinel centres are in England, a small amount of first-line testing from Wales, Northern Ireland and the Channel Islands are carried out by sentinel laboratories. 6. 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. Data are shown by region of the requesting clinician. a) HBsAg testing During the second quarter of 2011, a total of 798 individuals were at least once for HBsAg by dried blood spot testing. Overall, 0.8% (n=6) of individuals, although this varied by region (table 10). Table10. of individuals, and testing, for HBsAg by dried blood spot (sentinel surveillance laboratories only), April to June 2011* Region of test request East Midlands 2 (0.0) East of England 67 (0.0) London 60 (0.0) North East (0.6) North West (0.8) South Central 3 (0.0) South East Coast (1.2) South West (1.0) West Midlands (0.0) Yorkshire & the Humber 34 (0.0) Total, all regions (0.8) * Dried blood spot testing only. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional.

17 b) Anti-HCV testing During the second of 2011, a combined total of 1,526 individuals were at least once for hepatitis C- specific antibodies (anti-hcv) by dried blood spot testing (table 11). Concateno Plc 499 individuals from drug action teams (DAT) of whom 28.3% (n=141) had a reactive test result. A further 1,027 individuals were by sentinel laboratories, of whom 18.8% (n=193). The comparatively lower proportion of test results 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 11. of individuals, and testing, for anti-hcv by dried blood spot, April to June 2011* Region of test request Data from sentinel surveillance Data from Concateno Plc reactive Total reactive East Midlands 2 (0.0) (32.1) (31.0) East of England (23.9) (0.0) (23.9) London (18.3) 44 4 (9.1) (14.4) North East (14.9) 35 2 (5.7) (13.2) North West (26.2) (0.0) (26.2) South Central 3 (0.0) 16 1 (6.3) 19 1 (5.3) South East Coast (6.0) (30.3) (14.0) South West (29.0) (28.0) (28.6) West Midlands 13 (0.0) (43.3) (100.0) Yorkshire & the Humber 34 7 (20.6) (43.7) (36.2) Total, all regions 1, (18.8) (28.3) 1, (21.9) * Dried blood spot testing only. Data excludes individuals aged less than one year, in whom tests may reflect the presence of passively-acquired maternal antibody rather than true infection. Data are de-duplicated subject to availability of date of birth, soundex and first initial. All data are provisional. It should be noted that testing data provided by Concanteno Plc represent indicative results only and are not intended to be used for diagnosis.

18 7. Anti-HCV oral fluid testing Aggregate oral fluid testing data have been provided by Concateno Plc. Data are shown by region of the requesting clinician. During the second quarter of 2011, 1,002 individuals were at least once for hepatitis C-specific antibodies (anti-hcv) by oral fluid, of whom 15.9% (n=159) had a reactive test result (table 12). Table 12. of individuals, and testing reactive, for anti-hcv by oral fluid April to June 2011* Region of test request reactive East Midlands (11.5) East of England (15.4) London (23.5) North East 49 6 (12.2) North West 12 2 (16.7) South Central 42 8 (19.0) South East Coast 36 6 (16.7) South West 11 1 (9.1) West Midlands 54 3 (5.6) Yorkshire & the Humber (19.3) Total, all regions 1, (15.9) * Oral fluid testing only. Some duplication of patients may occur as only aggregate numbers are supplied by Concateno plc. therefore duplication checks could not be made and some patients may have been more than once during the time period. All data are provisional. Testing data, provided by Concanteno plc, represent indicative results only and are not intended to be used for diagnosis References 1. Health Protection Agency. Quarterly report from the sentinel surveillance study of hepatitis testing in England: data for January to March 2011 (quarter 1). Health Protection Report 2011, 5(29): immunisation. Available at: 2. 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)

19 Laboratory reports of hepatitis A and C (England & Wales), April-June 2011 Laboratory reports of hepatitis A in England & Wales (April-June 2011) There were a total of 51 laboratory reports of hepatitis A virus reported to the Health Protection Agency during the second quarter of 2011 (April-June). This constituted a 7.3% decrease on the previous quarter (n=55), and a 29.2% decrease on the same quarter of 2010 (n=72). Between April and June 2011, two reports were from individuals of unknown age (3.9%). Where known, 24 reports were among year olds (49.0%), a further 20 reports were from those aged over 45 (36.7%), and seven reports were from the under 15 year old age-group (14.3%). Males accounted for 70.2% of all reports and 85.7% of reports among those aged under 15 old. Laboratory reports of hepatitis A in England and Wales, April-June 2011 Age group Male Female Unknown Total <1 year Unnknown 2 2 All ages

20 Laboratory reports of hepatitis A by age group and sex (England and Wales): January 2002 June 2011 Laboratory reports of hepatitis C in England & Wales (April-June 2011) There were a total of 2,465 laboratory reports of hepatitis C virus reported to the Health Protection Agency between April and June This was similar to the number of reports during quarter 1 (n=2,586), and a 32.0% increase on the same quarter in 2010 (n= 1,867). Age-group and sex were well reported (>98% complete). Consistent with previous quarters, 66.6% of reports were among males (n=1,610/2,417). Those aged accounted for 58.8% of the total number of reports (n=1,411/2,447). Laboratory reports of hepatitis C in England and Wales, April-June 2011 Age group Male Female Unknown Total <1 year Unnknown All ages 1, ,465

21 Invasive meningococcal infections (England and Wales), laboratory reports, weeks 27-39/2011 Invasive meningococcal infections, England and Wales: laboratory reports, weeks 27-39/2011 (27-39/2010) CSF and blood Culture Method of diagnosis Nonculture Other sites Cumulative totals to week / /2010 Group A 1 B C W X Y Z/29E Nongroupable Ungrouped Total Source: HPA Meningococcal Reference Unit.