Quantitation of residual trypsin in cell-based therapeutics using immobilized α-1-antitrypsin or SBTI in an ELISA format.

An Enzyme-Linked Immunosorbent Assay (ELISA) has been developed for the quantitation of porcine trypsin as a process residual in cell therapy products based on its capture by either of two immobilized anti-trypsins, α-1-antitrypsin (α1AT) or soybean trypsin inhibitor (SBTI) followed by detection with a polyclonal goat anti-porcine trypsin-IgG conjugated with peroxidase. It was demonstrated that an extended range of antigen quantitation could be achieved that covered nearly three orders of magnitude of trypsin concentration. The utility of the assay was demonstrated by its application to samples generated in a cell-based therapeutic manufacturing setting.

Making evidence work for communities: the role of nongovernmental organizations in translating science to programs.

Evidence-informed public health refers to the process of applying proven interventions within the context of community preferences in order to achieve positive health impacts. A key role for nongovernmental organizations (NGOs) in evidence-informed public health is to use and expand on research to help shape appropriate interventions for diverse communities. This article suggests that NGOs are particularly well positioned for this role for a number of reasons, including their geographic reach, their engagement with diverse stakeholders, and their extragovernmental position, which enables them to develop and advocate for innovative, scientifically sound solutions to long-standing health challenges. Three case studies are presented that highlight how NGOs can harness these advantages to shape evidence-informed policies and programs to improve women's health: PATH's multicountry HPV Vaccines project, the International Consortium for Emergency Contraception, and a collaborative effort to combat maternal mortality in Mali.

Health innovation networks to help developing countries address neglected diseases.

Gross inequities in disease burden between developed and developing countries are now the subject of intense global attention. Public and private donors have marshaled resources and created organizational structures to accelerate the development of new health products and to procure and distribute drugs and vaccines for the poor. Despite these encouraging efforts directed primarily from and funded by industrialized countries, sufficiency and sustainability remain enormous challenges because of the sheer magnitude of the problem. Here we highlight a complementary and increasingly important means to improve health equity: the growing ability of some developing countries to undertake health innovation.

Knowledge and perceptions of HIV among peripartum women and among men whose wives are of reproductive age, northern Thailand.

To investigate knowledge and perceptions of HIV transmission risk and interest in vaginal microbicides in northern Thailand, we conducted 14 focus group discussions and 80 interviews with men and women in Chiang Rai province. Women were recruited from antenatal or postpartum clinics, and men from various work sites. Participants evinced substantial knowledge about HIV, with two exceptions important for prevention campaigns: (a) confusion about the window period between a new infection and positive HIV-test result and (b) overestimation of the safety of extramarital sex with partners who are not sex workers. Most participants reported no personal HIV risk. Participants described Thai women as generally vulnerable to HIV infection because of the unlikelihood of condom use with their husbands and because women cannot control their husbands' extramarital behavior. Women apparently face particular risk after childbearing; peripartum abstinence averages 6-9 months, during which time some Thai men may have alternative sex partners. Women, and to a lesser degree, men were interested in potential microbicides, although they voiced many thoughtful questions about the products and about efficacy trials.

The prevalence of reproductive tract infections in Hue, Vietnam.

A study was conducted in central Vietnam to measure the prevalence of reproductive tract infections among clients of a family planning clinic, and to determine the usefulness of simple, clinic-based diagnostic tests. The prevalence of such infections was moderate, with the majority being endogenous. Few cases of cervical infection were identified, and no clinical or sociodemographic variables proved to be good predictors of such infection. Most vaginal infections could be identified through simple, clinic-based diagnostic tests, although further research into the cost-effectiveness of establishing and maintaining these services would be useful. Comparison of the results from laboratory tests and the presumptive diagnosis of the clinician indicate that the current practice of presumptive treatment is leading to significant overtreatment. Use of the World Health Organization flowcharts would reduce the overtreatment of vaginal infection but not of cervical infection. The importance of adapting the flowcharts to local epidemiology is highlighted.