Monday, November 15, 2010

WHO endorses MODS, NRI and CRI to assess TB in resource-limited settings

In a policy statement by the World Health Organization on July 2010, MODS, CRI, and NRA assays have been given the vote of confidence by the international agency for use by laboratory officials and health care providers for diagnosis of MDR-TB (multi-drug resistant tuberculosis) cases.

Colorimetric redox indicator (CRI) methods comprise growing Mycobacterium tuberculosis isolates in conventional culture. A microscopically observed drug susceptibility (MODS) assay comprises observing micro-colony growth and typical cord-formation of M. tuberculosis in sealed microtitre plates containing liquid culture medium, through an inverted microscope. Nitrate reductase assay (NRA), on the other hand, involves a direct test on smear-positive sputum specimens and an indirect test on M. tuberculosis isolates grown from conventional solid culture.

All three methods exhibit high specificity and sensitivity. These criteria, among others, have led the WHO to recommend the use of selected non-commercial culture and DST methods as an interim solution in resource-constrained settings, under clearly defined programmatic and operational conditions, while capacity for genotypic and/or automated liquid culture and DST are still being developed.



Reference: World Health Organization. 2010, July. Non-Commercial Culture And Drug-Susceptibility Testing Methods For Screening Of Patients At Risk Of Multi-Drug Resistant Tuberculosis: Policy Statement. Retrieved November 15, 2010. Accessed at http://www.who.int/tb/dots/laboratory/whopolicy_noncommercialculture_and_dstmethods_july10.pdf.

Mixed success in science for developing world, says UNESCO

Developing countries more than doubled their output of scientific publications between 2002 and 2008, but their share of patent applications remained extremely low. Mico Tatalovic reports on SciDev.Net.

The developing world's share of science publications rose from a fifth to nearly a third during this time, according to the 'UNESCO Science Report 2010: Current Status of Science around the World'.

The report, published today (10 November), assessed the number of publications recorded in Thomson Reuters' Science Citation Index between 2002 and 2008, during which the total number of global science publications increased by around 35 per cent.

Much of the increase in the developing world is because of the growth of Brazil, China and India. The report found that least developed countries (LDCs), a subset of developing countries, have also increased their publications output — by 80 per cent. But this is from the starting point of 2,000 papers a year, compared with the total developing country output of 165,000 papers, and thus represents only 0.4 per cent of the world's total output.

Why has the Global Forum for Health Research collapsed?

Poor countries striving to improve their health systems deserve better than the unexplained implosion of the Global Forum for Health Research. Beverly Peterson Stearns reports on SciDev.Net.

Barely a year ago nearly 1,000 people from 80 countries gathered enthusiastically at the Palacio de Convenciones in Havana, Cuba, under the banner 'Innovating for the health of all'. More than half came from low- and middle-income countries. They were attending the annual meeting  of the non-profit organisation the Global Forum for Health Research (GFHR), eager to hear about inventive and effective ways to conduct research, and urgently seeking to improve health in their countries.

Now, less than a year after taking office, the forum's executive director, Anthony Mbewu, has resigned, and the forum itself is in failing health. The prognosis is poor. Very few remain in its Geneva secretariat. Many employees have quit, been fired, or have retired early.

Time for explanations

Why did this international organisation, set up in 1998, founder so spectacularly and so quickly when the need for health research remains so great? More importantly, what now are the prospects for ordinary people in developing countries? They pinned their hopes on local leaders in health and research who, in turn, sought guidance from experts at the annual forums.

South Africa's Sunday Times, which reported Mbewu's resignation on 31 October, said that his appointment as head of the forum had drawn criticism from HIV/AIDS activists. They had charged Mbewu, the former president of South Africa's Medical Research Council, with supporting the Mbeki government's denial of HIV and AIDS.

But in Havana the controversy was largely unrecognised. Mbewu responded to a reporter's question about the criticisms saying, "I'm a researcher, not an activist." At the time, that seemed a sufficient answer for his fellow health researchers too. They seemed satisfied that Mbewu's appointment by the forum — a respected organisation originally set up under the auspices of the WHO — meant his qualifications had been well-vetted.

A year on, many of the health leaders and researchers who gathered in Havana will convene in Montreux, Switzerland, at the First Global Symposium on Health Systems Research (16–19 November).  Will any of them probe the GFHR's collapse — or will they politely not mention it?

The Foundation Council, the forum's policy- and decision-making body, should bear responsibility for explaining what has happened to this small but once-vibrant organisation, to which so many from developing countries looked for guidance. But the responsibility is not theirs alone. The entire health research community has a duty to not turn a blind eye to the forum's failure.

A betrayal of trust?

I was in Havana as a freelance writer drafting a report on that meeting, similar to others I wrote for the Forum about  previous meetings in Mexico City (2004), Mumbai (2005), Cairo, (2006), Beijing (2007) and Bamako (2008). The great strength of these annual meetings was making well-known health researchers, public health experts, economists and innovators accessible to the people who need their help the most.

The meetings were moved each year to a new venue. That allowed field workers, students, community physicians and academics in some of the world's poorest countries to attend. There were a few large plenary sessions and many small group sessions that encouraged interaction. Even people without computers could be part of this network.

Impressive young people from poor countries sat in discussion groups next to rich entrepreneurs, respected academics and government decision-makers, all talking about problems held in common. I listened with growing optimism that progress in global health could come through collaboration that reached across the divides of poverty, borders, and politics.

The meetings' official programmes highlighted the Millennium Development Goals; combating disease and poverty; equitable access; capacity building and health systems; and innovation.

But discussions ranged much further and deeper, covering subjects some countries would rather not have highlighted: an obesity epidemic in Mexico, crushing poverty in India, female genital mutilation in Egypt, HIV/AIDS in China, counterfeit drugs in Africa, and embargoes and naturopathic medicines in Cuba. Each annual meeting was, in the fullest sense of the word, a forum.

I was astonished by how quickly and quietly the health of the GFAR deteriorated.  I heard reports as the staff diminished.  I read that employees were bringing lawsuits alleging unfair dismissal.  Gill Samuels, chair of the forum's 20-member foundation council, confirmed in an email to me that Mbewu had resigned. But she denied that there are legal cases pending. "Nothing else to add at the moment," she wrote in answer to my query.

Nothing to add? I hope there will soon be a considerable amount to add. Samuels, who comes from the pharmaceutical industry, and the others who sit on the council and come from foundations, universities, governments and institutes, are responsible for appointing the director and overseeing the forum's budget and plan of action.

Their explanations — or lack of them — will affect the credibility not only of the forum, but of any existing or future organisation seeking the trust of researchers and of those depending on them.

Beverly Peterson Stearns is a freelance writer and author. She lives in the United States.


Reference: Stearns, B. 2010. Why has the Global Forum for Health Research collapsed? Retrieved November 15, 2010. Accessed at SciDev.Net's website at: http://www.scidev.net/en/opinions/why-has-the-global-forum-for-health-research-collapsed-.html.

Wednesday, October 20, 2010

AIDS Vaccine for Asia Network (AVAN): Expanding the Regional Role in Developing HIV Vaccines

Kent SJ, Cooper DA, Chhi Vun M, Shao Y, Zhang L, et al. (2010) AIDS Vaccine for Asia Network (AVAN): Expanding the Regional Role in Developing HIV Vaccines. PLoS Med 7(9): e1000331. doi:10.1371/journal.pmed.1000331


The HIV/AIDS pandemic continues to spread and an AIDS vaccine is urgently needed. While facing unprecedented challenges, AIDS vaccine development activities are continuing around the globe. Recent results of the Thai Phase III vaccine trial are renewing such efforts. In accordance with the goals of the Global HIV Vaccine Enterprise, there is now clear recognition of the role that regional alliances can play in fostering and facilitating AIDS vaccine development, and there is broad agreement that international collaborations are the most effective way forward to develop and evaluate the next generation of AIDS vaccine candidates.

In response to these challenges, the Asian region has recently formed the AIDS Vaccine for Asia Network (AVAN).

AVAN has been initiated to meet these needs and actively facilitate the development of a regional AIDS vaccine strategy that accelerates research and development of an AIDS vaccine through government advocacy, improved coordination and harmonization of research; develops clinical trial and manufacturing capacity; supports ethical and regulatory frameworks; and ensures community participation.

Wednesday, October 6, 2010

Scripps researchers develop new detection test for river blindness parasite

Innovation will help eliminate tropical malady

In a press release by the Scripps Research Institute in La Jolla, california, the institute announced that its scientists have developed the first screening method that rapidly identifies individuals with active river blindness, a parasitic disease that afflicts an estimated 37 million people. The test could change the current strategy of mass treatment in areas where river blindness, also known as onchocerciasis, is suspected.

The study was published online on October 5, 2010, by the journal PLOS Neglected Tropical Diseases.

"A sensitive and reproducible diagnostic test for this disease is crucial for the success of worldwide control and elimination programs," said Kim Janda, Ph.D., a professor in the Departments of Chemistry and Immunology and Microbial Science, member of The Skaggs Institute for Chemical Biology, and director of The Worm Institute for Research and Medicine (WIRM) at Scripps Research. "This diagnostic tool could be a game-changer for how the disease will be treated in the future."

Judith Denery, Ph.D., a senior research associate in the Janda laboratory and the paper's first author, adds, "Because current tests often give false negatives, they are unreliable indicators of infection. For organizations such as the World Health Organization and others working to eliminate the disease, this lack of accuracy is frustrating, time-consuming, and costly."


Enhanced Detection, Diagnosis of Leishmaniasis in Bangladesh

Mondal D, Nasrin KN, Huda MM, Kabir M, Hossain MS, et al. (2010) Enhanced Case Detection and Improved Diagnosis of PKDL in a Kala-azar-Endemic Area of Bangladesh. PLoS Negl Trop Dis 4(10): e832. doi:10.1371/journal.pntd.0000832

To support the Bangladesh National Kala-azar Elimination Programme (NKEP), the group investigated the feasibility of using trained village volunteers for detecting post-kala-azar dermal leishmaniasis (PKDL) cases, using polymerase chain reaction (PCR) for confirmation of diagnosis and treatment compliance by PKDL patients in Kanthal union of Trishal sub-district, Mymensingh, Bangladesh.

Methods
In this cross-sectional study, Field Research Assistants (FRAs) conducted census in the study area, and the research team trained village volunteers on how to look for PKDL suspects. The trained village volunteers (TVVs) visited each household in the study area for PKDL suspects and referred the suspected PKDL cases to the study clinic. The suspected cases underwent physical examinations by a qualified doctor and rK39 strip testing by the FRAs and, if positive, slit skin examination (SSE), culture, and PCR of skin specimens and peripheral buffy coat were done. Those with evidence of Leishmania donovani (LD) were referred for treatment. All the cases were followed for one year.

Results
The total population of the study area was 29,226 from 6,566 households. The TVVs referred 52 PKDL suspects. Probable PKDL was diagnosed in 18 of the 52 PKDL suspect cases, and PKDL was confirmed in 9 of the 18 probable PKDL cases. The prevalence of probable PKDL was 6.2 per 10,000 people in the study area. Thirteen PKDL suspects self-reported from outside the study area, and probable and confirmed PKDL was diagnosed in 10 of the 13 suspects and in 5 of 10 probable PKDL cases respectively. All probable PKDL cases had hypopigmented macules. The median time for PKDL development was 36 months (IQR, 24–48). Evidence of the LD parasite was documented by SSE and PCR in 3.6% and 64.3% of the cases, respectively. PCR positivity was associated with gender and severity of disease. Those who were untreated had an increased risk (odds ratio = 3.33, 95%CI 1.29–8.59) of having persistent skin lesions compared to those who were treated. Patients' treatment-seeking behavior and treatment compliance were poor.

Conclusion
Improved detection of PKDL cases by TVVs is feasible and useful. The NKEP should promote PCR for the diagnosis of PKDL and should find ways for improving treatment compliance by patients.

External Quality Control Assessment for the Molecular Diagnosis of Dengue Infections

Domingo C, Niedrig M, Teichmann A, Kaiser M, Rumer L, et al. (2010) 2nd International External Quality Control Assessment for the Molecular Diagnosis of Dengue Infections. PLoS Negl Trop Dis 4(10): e833. doi:10.1371/journal.pntd.0000833

Currently dengue viruses (DENV) pose an increasing threat to over 2.5 billion people in over 100 tropical and sub-tropical countries worldwide. International air travel is facilitating rapid global movement of DENV, increasing the risk of severe dengue epidemics by introducing different serotypes. Accurate diagnosis is critical for early initiation of preventive measures. Different reverse transcriptase PCR (RT-PCR) methods are available, which should be evaluated and standardized. Epidemiological and laboratory-based surveillance is required to monitor and guide dengue prevention and control programmes, i.e., by mosquito control or possible vaccination (as soon as an effective and safe vaccine becomes available).

Objective
The purpose of the external quality assurance (EQA) study described is to assess the efficiency and accuracy of dengue molecular diagnosis methods applied by expert laboratories.

Study Design
A panel of 12 human plasma samples was distributed and tested for DENV-specific RNA. The panel comprised 9 samples spiked with different DENV serotypes (DENV-1 to DENV-4), including 10-fold dilution series of DENV-1 and DENV-3. Two specificity controls consisted of a sample with a pool of 4 other flaviviruses and a sample with chikungunya virus. A negative control sample was also included.

Results
Thirty-seven laboratories (from Europe, Middle East Asia, Asia, the Americas/Caribbean, and Africa) participated in this EQA study, and reports including 46 sets of results were returned. Performance among laboratories varied according to methodologies used. Only 5 (10.9%) data sets met all criteria with optimal performance, and 4 (8.7%) with acceptable performance, while 37 (80.4%) reported results showed the need for improvement regarding accomplishment of dengue molecular diagnosis. Failures were mainly due to lack of sensitivity and the presence of false positives.

Conclusions
The EQA provides information on each laboratory's efficacy of RT-PCR techniques for dengue diagnosis and indicates for most laboratories an urgent need to improve sensitivity and specificity.