Pooling serum samples may lead to loss of potential biomarkers in SELDI-ToF MS proteomic profiling

BACKGROUND: High throughput proteomic technology offers promise for the detection of disease biomarkers and proteomic signature patterns but biomarker discovery studies can be limited by cost factors when large sample size numbers are required. Pooling sera or plasma samples from disease cases potentially offers a solution to cost implications by reducing the standard errors of mass to charge values. Surface enhanced laser desorption/ionization time of flight (SELDI-ToF) mass spectra obtained from individual and pooled sera from invasive aspergillosis cases and controls were compared. RESULTS: Pooling resulted in 50% loss of peak clusters detected in individual samples. Overall, loss was greatest for low intensity clusters. Peak intensities and case:control intensity ratios, among clusters not lost, demonstrated good reproducibility. CONCLUSION: Pooling sera results in significant potential biomarker loss when using SELDI-ToF MS

Genetic dysbiosis: the role of microbial insults in chronic inflammatory diseases

This review was undertaken at UCL, which received a proportion of funding from the Department of Health’s National Institute of Health Research (NIHR) Biomedical Research Centres funding scheme

Near patient chlamydia and gonorrhoea screening and treatment in further education/technical colleges : a cost analysis of the 'Test n Treat' feasibility trial

Background Community-based screening may be one solution to increase testing and treatment of sexually transmitted infections in sexually active teenagers, but there are few data on the practicalities and cost of running such a service. We estimate the cost of running a ‘Test n Treat’ service providing rapid chlamydia (CT) and gonorrhoea (NG) testing and same day on-site CT treatment in technical colleges. Methods Process data from a 2016/17 cluster randomised feasibility trial were used to estimate total costs and service uptake. Pathway mapping was used to model different uptake scenarios. Participants, from six London colleges, provided self-taken genitourinary samples in the nearest toilet. Included in the study were 509 sexually active students (mean 85/college): median age 17.9 years, 49% male, 50% black ethnicity, with a baseline CT and NG prevalence of 6 and 0.5%, respectively. All participants received information about CT and NG infections at recruitment. When the Test n Treat team visited, participants were texted/emailed invitations to attend for confidential testing. Three colleges were randomly allocated the intervention, to host (non-incentivised) Test n Treat one and four months after baseline. All six colleges hosted follow-up Test n Treat seven months after baseline when students received a £10 incentive (to participate). Results The mean non-incentivised daily uptake per college was 5 students (range 1 to 17), which cost £237 (range £1082 to £88) per student screened, and £4657 (range £21,281 to £1723) per CT infection detected, or £13,970 (range £63,842 to £5169) per NG infection detected. The mean incentivised daily uptake was 19 students which cost £91 per student screened, and £1408/CT infection or £7042/NG infection detected. If daily capacity for screening were achieved (49 students/day), costs including incentives would be £47 per person screened and £925/CT infection or £2774/NG infection detected. Conclusions Delivering non-incentivised Test n Treat in technical colleges is more expensive per person screened than CT and NG screening in clinics. Targeting areas with high infection rates, combined with high, incentivised uptake could make costs comparable

Antimicrobial resistance point-of-care testing for gonorrhoea treatment regimens: cost-effectiveness and impact on ceftriaxone use of five hypothetical strategies compared with standard care in England sexual health clinics.

BackgroundWidespread ceftriaxone antimicrobial resistance (AMR) threatens Neisseria gonorrhoeae (NG) treatment, with few alternatives available. AMR point-of-care tests (AMR POCT) may enable alternative treatments, including abandoned regimens, sparing ceftriaxone use. We assessed cost-effectiveness of five hypothetical AMR POCT strategies: A-C included a second antibiotic alongside ceftriaxone; and D and E consisted of a single antibiotic alternative, compared with standard care (SC: ceftriaxone and azithromycin).AimAssess costs and effectiveness of AMR POCT strategies that optimise NG treatment and reduce ceftriaxone use.MethodsThe five AMR POCT treatment strategies were compared using a decision tree model simulating 38,870 NG-diagnosed England sexual health clinic (SHC) attendees; A micro-costing approach, representing cost to the SHC (for 2015/16), was employed. Primary outcomes were: total costs; percentage of patients given optimal treatment (regimens curing NG, without AMR); percentage of patients given non-ceftriaxone optimal treatment; cost-effectiveness (cost per optimal treatment gained).ResultsAll strategies cost more than SC. Strategy B (azithromycin and ciprofloxacin (azithromycin preferred); dual therapy) avoided most suboptimal treatments (n = 48) but cost most to implement (GBP 4,093,844 (EUR 5,474,656)). Strategy D (azithromycin AMR POCT; monotherapy) was most cost-effective for both cost per optimal treatments gained (GBP 414.67 (EUR 554.53)) and per ceftriaxone-sparing treatment (GBP 11.29 (EUR 15.09)) but with treatment failures (n = 34) and suboptimal treatments (n = 706).ConclusionsAMR POCT may enable improved antibiotic stewardship, but require net health system investment. A small reduction in test cost would enable monotherapy AMR POCT strategies to be cost-saving

Frequency and risk factors for prevalent, incident, and persistent genital carcinogenic human papillomavirus infection in sexually active women: community based cohort study

Objective To investigate frequency and risk factors for prevalent, incident, and persistent carcinogenic human papillomavirus (HPV) in young women before the introduction of immunisation against HPV types 16 and 18 for schoolgirls

Nigella Sativa's Effect on Biochemical as well as Anthropometric Parameters in Diabetic Rats on High Fat Diet

Objective: Black cumin (Nigella sativa L.) seeds and its crude extract or essential oils have been widely used traditionally for nutritional and medicinal applications in Asian countries. Its effects on diabetics with high fat diet consumption have not been adequately studied. This study was undertaken to study its effects on body weight, abdominal girth, lipid profile and plasma glucose levels in diabetic high fat diet fed rats. Materials and Methods : Streptozotocin induced male Wistar rats were fed high fat diet [5130 kcal] for 4 weeks after which they were given vehicle, Nigella sativa ethanolic extract (300mg/kg), Nigella sativa ethanolic extract (600 mg) or metformin (100 mg). Lipid profile, blood glucose, body weight & abdominal girth were measured. Results: Nigella sativa ethanolic extract (600 mg) caused significant reduction in blood glucose, total cholesterol, triglycerides, VLDL and non HDL cholesterol comparable to metformin. Conclusion : Nigella sativa shows anti-hyperglycemic effects and improvement in lipid profile in diabetic high fat diet fed rats which is comparable to metformin. Further studies are required to advocate its use in patients with diabetes and dyslipidemias. Keywords: Nigella sativa, diabetes mellitus, antihyperlipidemic, antihyperglycemic, high fa

Mixed-methods evaluation of a novel online STI results service.

OBJECTIVES: Evidence on optimal methods for providing STI test results is lacking. We evaluated an online results service, developed as part of an eSexual Health Clinic (eSHC). METHODS: We evaluated the online results service using a mixed-methods approach within large exploratory studies of the eSHC. Participants were chlamydia- positive and negative users of online postal self-sampling services in six National Chlamydia Screening Programme (NCSP) areas and chlamydia-positive patients from two genitourinary medicine (GUM) clinics between 21 July 2014 and 13 March 2015. Participants received a discreetly worded National Health Service 'NHS no-reply' text message (SMS) informing them that their test results were ready and providing a weblink to a secure website. Participants logged in with their date of birth and mobile telephone or clinic number. Chlamydia-positive patients were offered online management. All interactions with the eSHC system were automatically logged and their timing recorded. Post-treatment, a service evaluation survey (n=152) and qualitative interviews (n=36) were conducted by telephone. Chlamydia-negative patients were offered a short online survey (n=274). Data were integrated. RESULTS: 92% (134/146) of NCSP chlamydia-positive patients, 82% (161/197) of GUM chlamydia-positive patients and 89% (1776/1997) of NCSP chlamydia-negative participants accessed test results within 7 days. 91% of chlamydia-positive patients were happy with the results service; 64% of those who had tested previously found the results service better or much better than previous experiences. 90% of chlamydia-negative survey participants agreed they would be happy to receive results this way in the future. Interviewees described accessing results with ease and appreciated the privacy and control the two-step process gave them. CONCLUSION: A discreet SMS to alert users/patients that results are available, followed by provision of results via a secure website, was highly acceptable, irrespective of test result and testing history. The eSHC results service afforded users privacy and control over when they viewed results without compromising access

‘Can you recommend any good STI apps?’ A review of content, accuracy and comprehensiveness of current mobile medical applications for STIs and related genital infections

Objective Seeking sexual health information online is common, and provision of mobile medical applications (apps) for STIs is increasing. Young people, inherently at higher risk of STIs, are avid users of technology, and apps could be appealing sources of information. We undertook a comprehensive review of content and accuracy of apps for people seeking information about STIs. Methods Search of Google Play and iTunes stores using general and specific search terms for apps regarding STIs and genital infections (except HIV), testing, diagnosis and management, 10 September 2014 to 16 September 2014. We assessed eligible apps against (1) 19 modified Health on The Net (HON) Foundation principles; and (2) comprehensiveness and accuracy of information on STIs/genital infections, and their diagnosis and management, compared with corresponding National Health Service STI information webpage content. Results 144/6642 apps were eligible. 57 were excluded after downloading. 87 were analysed. Only 29% of apps met ≥6 HON criteria. Content was highly variable: 34/87 (39%) covered one or two infections; 40 (46%) covered multiple STIs; 5 (6%) focused on accessing STI testing. 13 (15%) were fully, 46 (53%) mostly and 28 (32%) partially accurate. 25 (29%) contained ≥1 piece of potentially harmful information. Apps available on both iOS and Android were more accurate than single-platform apps. Only one app provided fully accurate and comprehensive information on chlamydia. Conclusions Marked variation in content, quality and accuracy of available apps combined with the nearly one-third containing potentially harmful information risks undermining potential benefits of an e-Health approach to sexual health and well-being.The Electronic Self-Testing Instruments for Sexually Transmitted Infection (eSTI2) Consortium is funded under the UKCRC Translational Infection Research (TIR) Initiative supported by the Medical Research Council (Grant Number G0901608) with contributions to the Grant from the Biotechnology and Biological Sciences Research Council, the National Institute for Health Research on behalf of the Department of Health, the Chief Scientist Office of the Scottish Government Health Directorates and the Wellcome Trust

Impact of deploying multiple point-of-care tests with a 'sample first' approach on a sexual health clinical care pathway. A service evaluation.

OBJECTIVES: To assess clinical service value of STI point-of-care test (POCT) use in a 'sample first' clinical pathway (patients providing samples on arrival at clinic, before clinician consultation). Specific outcomes were: patient acceptability; whether a rapid nucleic acid amplification test (NAAT) for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) could be used as a POCT in practice; feasibility of non-NAAT POCT implementation for Trichomonas vaginalis (TV) and bacterial vaginosis (BV); impact on patient diagnosis and treatment. METHODS: Service evaluation in a south London sexual health clinic. Symptomatic female and male patients and sexual contacts of CT/NG-positive individuals provided samples for diagnostic testing on clinic arrival, prior to clinical consultation. Tests included routine culture and microscopy; CT/NG (GeneXpert) NAAT; non-NAAT POCTs for TV and BV. RESULTS: All 70 (35 males, 35 females) patients approached participated. The 'sample first' pathway was acceptable, with >90% reporting they were happy to give samples on arrival and receive results in the same visit. Non-NAAT POCT results were available for all patients prior to leaving clinic; rapid CT/NG results were available for only 21.4% (15/70; 5 males, 10 females) of patients prior to leaving clinic. Known negative CT/NG results led to two females avoiding presumptive treatment, and one male receiving treatment directed at possible Mycoplasma genitalium infection causing non-gonococcal urethritis. Non-NAAT POCTs detected more positives than routine microscopy (TV 3 vs 2; BV 24 vs 7), resulting in more patients receiving treatment. CONCLUSIONS: A 'sample first' clinical pathway to enable multiple POCT use was acceptable to patients and feasible in a busy sexual health clinic, but rapid CT/NG processing time was too long to enable POCT use. There is need for further development to improve test processing times to enable POC use of rapid NAATs

‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial

Background Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low. We will conduct a cluster randomised feasibility trial of frequent, rapid, on-site chlamydia testing and same-day treatment (Test and Treat (TnT)) in six FE colleges (with parallel qualitative and economic assessments) to assess the feasibility of conducting a future trial to investigate if TnT reduces chlamydia rates. Methods We will recruit 80 sexually active students aged 16–24 years from public areas at each of six colleges. All participants (total n = 480) will be asked to provide samples (urine for males, self-taken vaginal swabs for females) and complete questionnaires on sexual lifestyle and healthcare use at baseline and after 7 months. Participants will be informed that baseline samples will not be tested for 7 months and be advised to get screened separately. Colleges will be randomly allocated to the intervention (TnT) or the control group (no TnT). One and 4 months after recruitment, participants at each intervention college (n = 3) will be texted and invited for on-site chlamydia tests using the 90-min Cepheid GeneXpert system. Students with positive results will be asked to see a visiting nurse health adviser for same-day treatment and partner notification, (backed by genitourinary medicine follow-up). Participants in control colleges (n = 3) will receive ‘thank you’ texts 1 and 4 months after recruitment. Seven months after recruitment, participants from both groups will be invited to complete questionnaires and provide samples for TnT. All samples will be tested, and same-day treatment offered to students with positive results. Acceptability of TnT will be assessed by qualitative interviews of purposively sampled students (n = 30) and college staff (n = 12). We will collect data on costs of TnT and usual healthcare. Discussion Findings will provide key values to inform feasibility, sample size and timescales of a future definitive trial of TnT in FE colleges, including: Recruitment rates TnT uptake rates Follow-up rates Prevalence of chlamydia in participants at baseline and 7 months Acceptability of TnT to students and college staff Estimate of the cost per person screened/treated in TnT versus usual care Trial registration International Standard Randomised Controlled Trials Registry, ID: ISRCTN58038795, Registered on 31 August 2016