Dataset Information

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials.

ABSTRACT: Global Pharma Health Fund (GPHF) Minilab™, a semi-quantitative thin-layer chromatography (TLC)-based commercially available test kit, is widely used in drug quality surveillance globally, but its diagnostic accuracy is unclear. We investigated the diagnostic accuracy of Minilab system for antimicrobials, using high-performance liquid chromatography (HPLC) as reference standard. Following the Minilab protocols and the Pharmacopoeia of the People's Republic of China protocols, Minilab-TLC and HPLC were used to test five common antimicrobials (506 batches) for relative concentration of active pharmaceutical ingredients. The prevalence of poor-quality antimicrobials determined, respectively, by Minilab TLC and HPLC was amoxicillin (0% versus 14.9%), azithromycin (0% versus 17.4%), cefuroxime axetil (14.3% versus 0%), levofloxacin (0% versus 3.0%), and metronidazole (0% versus 38.0%). The Minilab TLC had false-positive and false-negative detection rates of 2.6% (13/506) and 15.2% (77/506) accordingly, resulting in the following test characteristics: sensitivity 0%, specificity 97.0%, positive predictive value 0, negative predictive value 0.8, positive likelihood ratio 0, negative likelihood ratio 1.0, diagnostic odds ratio 0, and adjusted diagnostic odds ratio 0.2. This study demonstrates unsatisfying diagnostic accuracy of Minilab system in screening poor-quality antimicrobials of common use. Using Minilab as a stand-alone system for monitoring drug quality should be reconsidered.

SUBMITTER: Pan H

PROVIDER: S-EPMC5928700 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials.

Pan Hui H Ba-Thein William W

The American journal of tropical medicine and hygiene 20180101 1

Global Pharma Health Fund (GPHF) Minilab™, a semi-quantitative thin-layer chromatography (TLC)-based commercially available test kit, is widely used in drug quality surveillance globally, but its diagnostic accuracy is unclear. We investigated the diagnostic accuracy of Minilab system for antimicrobials, using high-performance liquid chromatography (HPLC) as reference standard. Following the Minilab protocols and the Pharmacopoeia of the People's Republic of China protocols, Minilab-TLC and HPLC ...[more]

PMID: 29141717

Similar Datasets

Project description:BackgroundRapid diagnostic tests (RDTs) for malaria are a vital part of global malaria control. Over the past decade, RDT prices have declined, and quality has improved. However, the relationship between price and product quality and their larger implications on the market have yet to be characterized. This analysis used purchase data from the Global Fund together with product quality data from the World Health Organization (WHO) and Foundation for Innovative New Diagnostics (FIND) Malaria RDT Product Testing Programme to understand three unanswered questions: (1) Has the market share by quality of RDTs in the Global Fund's procurement orders changed over time? (2) What is the relationship between unit price and RDT quality? (3) Has the market for RDTs financed by the Global Fund become more concentrated over time?MethodsData from 10,075 procurement transactions in the Global Fund's database, which includes year, product, volume, and price, was merged with product quality data from all eight rounds of the WHO-FIND programme, which evaluated 227 unique RDT products. To describe trends in market share by quality level of RDT, descriptive statistics were used to analyse trends in market share from 2009 to 2018. A generalized linear regression model was then applied to characterize the relationship between price and panel detection score (PDS), adjusting for order volume, year purchased, product type, and manufacturer. Third, a Herfindahl-Hirschman Index (HHI) score was calculated to characterize the degree of market concentration.ResultsLower-quality RDTs have lost market share between 2009 and 2018, as have the highest-quality RDTs. No statistically significant relationship between price per test and PDS was found when adjusting for order volume, product type, and year of purchase. The HHI was 3,570, indicating a highly concentrated market.ConclusionsAdvancements in RDT affordability, quality, and access over the past decade risk stagnation if health of the RDT market as a whole is neglected. These results suggest that from 2009 to 2018, this market was highly concentrated and that quality was not a distinguishing feature between RDTs. This information adds to previous reports noting concerns about the long-term sustainability of this market. Further research is needed to understand the causes and implications of these trends.

Project description:BackgroundMillions of dollars are invested annually under the umbrella of national health systems strengthening. Global health initiatives provide funding for low- and middle-income countries through disease-oriented programmes while maintaining that the interventions simultaneously strengthen systems. However, it is as yet unclear which, and to what extent, system-level interventions are being funded by these initiatives, nor is it clear how much funding they allocate to disease-specific activities - through conventional 'vertical-programming' approach. Such funding can be channelled to one or more of the health system building blocks while targeting disease(s) or explicitly to system-wide activities.MethodsWe operationalized the World Health Organization health system framework of the six building blocks to conduct a detailed assessment of Global Fund health system investments. Our application of this framework framework provides a comprehensive quantification of system-level interventions. We applied this systematically to a random subset of 52 of the 139 grants funded in Round 8 of the Global Fund to Fight AIDS, Tuberculosis and Malaria (totalling approximately US$1 billion).ResultsAccording to the analysis, 37% (US$ 362 million) of the Global Fund Round 8 funding was allocated to health systems strengthening. Of that, 38% (US$ 139 million) was for generic system-level interventions, rather than disease-specific system support. Around 82% of health systems strengthening funding (US$ 296 million) was allocated to service delivery, human resources, and medicines & technology, and within each of these to two to three interventions. Governance, financing, and information building blocks received relatively low funding.ConclusionsThis study shows that a substantial portion of Global Fund's Round 8 funds was devoted to health systems strengthening. Dramatic skewing among the health system building blocks suggests opportunities for more balanced investments with regard to governance, financing, and information system related interventions. There is also a need for agreement, by researchers, recipients, and donors, on keystone interventions that have the greatest system-level impacts for the cost-effective use of funds. Effective health system strengthening depends on inter-agency collaboration and country commitment along with concerted partnership among all the stakeholders working in the health system.

Project description:The impact of donors, such as national government (bi-lateral), private sector, and individual financial (philanthropic) contributions, on domestic health policies of developing nations has been the subject of scholarly discourse. Little is known, however, about the impact of global financial initiatives, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria, on policies and health governance of countries receiving funding from such initiatives.This study employs a qualitative methodological design based on a single case study: Brazil. Analysis at national, inter-governmental and community levels is based on in-depth interviews with the Global Fund and the Brazilian Ministry of Health and civil societal activists. Primary research is complemented with information from printed media, reports, journal articles, and books, which were used to deepen our analysis while providing supporting evidence.Our analysis suggests that in Brazil, Global Fund financing has helped to positively transform health governance at three tiers of analysis: the national-level, inter-governmental-level, and community-level. At the national-level, Global Fund financing has helped to increased political attention and commitment to relatively neglected diseases, such as tuberculosis, while harmonizing intra-bureaucratic relationships; at the inter-governmental-level, Global Fund financing has motivated the National Tuberculosis Programme to strengthen its ties with state and municipal health departments, and non-governmental organisations (NGOs); while at the community-level, the Global Fund's financing of civil societal institutions has encouraged the emergence of new civic movements, participation, and the creation of new municipal participatory institutions designed to monitor the disbursement of funds for Global Fund grants.Global Fund financing can help deepen health governance at multiple levels. Future work will need to explore how the financing of civil society by the Global Fund and other donors influence policy agenda-setting and institutional innovations for increased civic participation in health governance and accountability to citizens.

Project description:BackgroundSensitive diagnostic tools are required for an accurate assessment of prevalence and intensity of helminth infections in areas undergoing regular deworming, and for monitoring anthelmintic drug efficacy. We compared the diagnostic accuracy of the Kato-Katz and FLOTAC techniques in the frame of a drug efficacy trial.Methodology/principal findingsStool samples from 343 Zanzibari children were subjected to duplicate Kato-Katz thick smears and the FLOTAC basic technique in a baseline screening in early 2009. The FLOTAC showed a higher sensitivity than the Kato-Katz method for the diagnosis of Trichuris trichiura (95% vs. 88%, p = 0.012) and Ascaris lumbricoides (88% vs. 68%, p = 0.098), but a lower sensitivity for hookworm diagnosis (54% vs. 81%, p = 0.006). Considering the combined results from both methods as 'gold' standard, the prevalences of T. trichiura, hookworm and A. lumbricoides were 71% (95% confidence interval (CI): 66-75%), 22% (95% CI: 17-26%) and 12% (95% CI: 8-15%), respectively. At follow-up, 3-5 weeks after 174 among the 269 re-examined children were administered anthelmintic drugs, we observed cure rates (CRs) against A. lumbricoides, hookworm and T. trichiura of 91% (95% CI: 80-100%), 61% (95% CI: 48-75%) and 41% (95% CI: 34-49%), respectively, when using the Kato-Katz method. FLOTAC revealed lower CRs against A. lumbricoides (83%, 95% CI: 67-98%) and T. trichiura (36%, 95% CI: 29-43%), but a higher CR against hookworm (69%, 95% CI: 57-82%). These differences, however, lacked statistical significance. Considerable differences were observed in the geometric mean fecal egg counts between the two methods with lower egg reduction rates (ERRs) determined by FLOTAC.Conclusion/significanceOur results suggest that the FLOTAC technique, following further optimization, might become a viable alternative to the Kato-Katz method for anthelmintic drug efficacy studies and for monitoring and evaluation of deworming programs. The lower CRs and ERRs determined by FLOTAC warrant consideration and could strategically impact future helminth control programs.

Dataset Information

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials.

Publications

Diagnostic Accuracy of Global Pharma Health Fund Minilab™ in Assessing Pharmacopoeial Quality of Antimicrobials.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure