A review of testing and assurance methods for Trichinella surveillance programs.
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ABSTRACT:
SUBMITTER: Barlow A
PROVIDER: S-EPMC8379475 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Effective performance of digestion testing methods for Trichinella, and their use for the detection of infected animals and the prevention of human trichinellosis require system-wide incorporation of appropriate quality assurance (QA) practices. The recommendations of the International Commission on Trichinellosis (ICT) aim to facilitate reliable test results when laboratories operate within a quality management system (QMS) which includes: 1) a quality manual (or similar documentation of the QMS); 2) a validated test method with identified critical control points; 3) a training program; 4) procedures utilizing proficiency testing and other methods to confirm technical capability of analysts; 5) equipment calibration and maintenance; 6) standard operating procedures, related documentation and reporting; 7) procedures to enable continuous monitoring and improvements; and 8) regular internal and third party audits. The quality manual or similar documentation describes the QMS within a testing laboratory, and lists the QA policies and good laboratory practices. Quality assurance goals contained in such documentation are the foundation of an effective QA program and must be explicit, measurable, and expressed in terms of performance criteria for the test method based on purpose for testing. The digestion method is capable of consistently detecting Trichinella larvae in meat at a level of sensitivity that is recognized to be effective for use in controlling animal infection and preventing human disease. However, consistent performance of the assay is assured only when parameters of the test method have been defined, scientifically validated as fit for purpose, and used within an effective QMS. The essential components of a digestion assay, specifically the critical control points and minimum standards for test performance are described. Reliable proficiency samples and their appropriate use in a quality system are key factors for certifying and maintaining an effective testing laboratory, including qualifying, re-qualifying and disqualifying of analysts as appropriate. Thus recommendations are included for the preparation and use of proficiency samples in a Trichinella digestion testing laboratory. The minimum training requirements for analysts performing a quality assured digestion assay, as well as suggested requirements for the content of a training manual, are also outlined. Finally, these ICT recommendations include essential components and minimum standards for maintaining and achieving certification and maintenance of a laboratory performing digestion testing for Trichinella. The certification program for the laboratory, including qualifying analysts, may be administered by a National Reference Laboratory or an authorized third party certifying body, under the auspices of the appropriate competent authority.
| S-EPMC7033998 | biostudies-literature
Project description:Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate.
| S-EPMC4047169 | biostudies-literature
Project description:Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.
| S-EPMC4023973 | biostudies-literature
Project description:An increasing number of U.S. emergency departments (EDs) have implemented ED-based HIV testing programs since the Centers for Disease Control and Prevention issued revised HIV testing recommendations for clinical settings in 2006. In 2010, the National HIV/AIDS Strategy (NHAS) set an linkage-to-care (LTC) rate goal of 85% within 90 days of HIV diagnosis. LTC rates for newly diagnosed HIV-infected patients vary markedly by site, and many are suboptimal. The optimal approach for LTC in the ED setting remains unknown.The objective was to perform a brief descriptive analysis of the LTC methods practiced in EDs across the United States to determine the overall linkage rate of ED-based HIV testing programs.We conducted a systematic review of literature related to U.S. ED HIV testing in the adult population using PubMed, Embase, Web of Science, Scopus, and Cochrane. There were 333 articles were identified; 31 articles were selected after a multiphasic screening process. We analyzed data from the 31 articles to assess LTC methods and rates. LTC methods that involved physical escort of the newly diagnosed patient to an HIV/infectious disease (ID) clinic or interaction with a specialist health care provider at the ED were operationally defined as "intensive" LTC protocol. "Mixed" LTC protocol was defined as a program that employed intensive linkage only part of the coverage hours. All other forms of linkage was defined as "nonintensive" LTC protocol. An LTC rate of ?85% was used to identify characteristics of ED-based HIV testing program associated with a higher LTC rate.There were 37 ED-based HIV testing programs in the 31 articles. The overall LTC rate was 74.4%. Regarding type of protocol, nine (24.3%) employed intensive LTC protocols, 25 (67.6%) nonintensive, two (5.4%) mixed, and one (2.7%) with unclear protocols. LTC rates for programs with intensive and nonintensive LTC protocols were 80.0 and 72.7%, respectively. Four (44.4%) with intensive protocols and nine (36.0%) with the nonintensive protocols had LTC rates > 85%. The linkage staff employed was different between ED programs. Among them, 25 (67.6%) programs used exogenous staff, 10 (27.0%) used the ED staff, and two had no information. All the programs in the nonintensive group utilized drop-in HIV/ID clinic or medical appointments while seven of nine of the programs in the intensive group physically escorted the patients to the initial medical intake appointment. There were no significant differences in characteristics of ED-based HIV testing programs between those with ?85% LTC rate versus those with <85% within the intensive or nonintensive group.Intensive LTC protocols had a higher LTC rate and a higher proportion of programs that surpassed the >85% NHAS goal compared to nonintensive methods, suggesting that, when possible, ED-based HIV testing programs should adopt intensive LTC strategies to improve LTC outcomes. However, intensive LTC protocols most often required involvement of multidisciplinary non-ED professionals and external research funding. Our findings provide a foundation for developing best practices for ED-based HIV LTC programs.
| S-EPMC4938722 | biostudies-other
Project description:The first step in SARS-CoV-2 genomic surveillance is testing to identify infected people. However, global testing rates are falling as we emerge from the acute health emergency and remain low in many low- and middle-income countries (LMICs) (mean = 27 tests/100,000 people/day). We simulated COVID-19 epidemics in a prototypical LMIC to investigate how testing rates, sampling strategies, and sequencing proportions jointly impact surveillance outcomes and showed that low testing rates and spatiotemporal biases delay time-to-detection of new variants by weeks-to-months and can lead to unreliable estimates of variant prevalence even when the proportion of samples sequenced is increased. Accordingly, investments in wider access to diagnostics to support testing rates of ~100 tests/100,000 people/day could enable more timely detection of new variants and reliable estimates of variant prevalence. The performance of global SARS-CoV-2 genomic surveillance programs is fundamentally limited by access to diagnostic testing.
| S-EPMC9164450 | biostudies-literature
Project description:The first step in SARS-CoV-2 genomic surveillance is testing to identify people who are infected. However, global testing rates are falling as we emerge from the acute health emergency and remain low in many low- and middle-income countries (mean = 27 tests per 100,000 people per day). We simulated COVID-19 epidemics in a prototypical low- and middle-income country to investigate how testing rates, sampling strategies and sequencing proportions jointly impact surveillance outcomes, and showed that low testing rates and spatiotemporal biases delay time to detection of new variants by weeks to months and can lead to unreliable estimates of variant prevalence, even when the proportion of samples sequenced is increased. Accordingly, investments in wider access to diagnostics to support testing rates of approximately 100 tests per 100,000 people per day could enable more timely detection of new variants and reliable estimates of variant prevalence. The performance of global SARS-CoV-2 genomic surveillance programs is fundamentally limited by access to diagnostic testing.
| S-EPMC9839449 | biostudies-literature
Project description:BACKGROUND:Web-based developmental surveillance programs may be an innovative solution to improving the early detection of childhood developmental difficulties, especially within disadvantaged populations. OBJECTIVE:This review aimed to identify the acceptability and effectiveness of web-based developmental surveillance programs for children aged 0 to 6 years. METHODS:A total of 6 databases and gray literature were searched using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses-informed protocol. Data extraction included variables related to health equity. RESULTS:In total, 20 studies were identified. Most papers implemented web-based versions of the Modified Checklist for Autism in Toddlers, Revised with Follow-Up screener for autism spectrum disorder or Parent Evaluation of Developmental Status screeners for broad developmental delay. Caregivers and practitioners indicated a preference for web-based screeners, primarily for user-friendliness, improved follow-up accuracy, time, and training efficiencies. CONCLUSIONS:Although evidence is limited as to the necessity of web- versus face-to-face-based developmental screening, there are clear efficiencies in its use. TRIAL REGISTRATION:PROSPERO CRD42019127894; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=127894.
| S-EPMC7206511 | biostudies-literature
Project description:BackgroundScreening and surveillance approaches for workers exposed to nanomaterials could aid in early detection of health effects, provide data for epidemiological studies and inform action to decrease exposure. The aim of this review is to identify such screening and surveillance approaches, in order to extract available data regarding (i) the studies that have successfully been implemented in present day, (ii) identification of the most common and/or toxic nano-related health hazards for workers and (iii) possible exposure surveillance markers. This review contributes to the current understanding of the risk associated with nanomaterials by determining the knowledge gap and making recommendations based on current findings.MethodsA systematic review was conducted. PubMed and Embase were searched to identify articles reporting on any surveillance-related study that described both exposure to nanomaterials and the health indicators that were measured. Four reviewers worked in pairs to independently assess the eligibility of studies and risk of bias before extraction of data. Studies were categorised according to the type of study and the medical surveillance performed, which included the type of nanomaterial, any exposure details provided, as well as health indicators and biomarkers tested.ResultsInitially 92 studies were identified, from which 84 full texts were assessed for eligibility. Seven studies met all the inclusion criteria, i.e. those performed in Taiwan, Korea, Czech Republic and the US. Of these, six compared health indicators between exposed and unexposed workers and one study described a surveillance program. All studies were at a high risk of bias. Workers were exposed to a mix of nanomaterials in three studies, carbon-based nanomaterials in two studies, nano-silver in one study and nano-titanium oxide in the other study. Two studies did not find a difference in biomarkers between exposed and unexposed workers. In addition, differences in early effects on pulmonary function or neurobehavioral tests were not observed. One study found an increased prevalence of allergic dermatitis and "sneezing" in the exposed group.ConclusionsThis review of recently published data on surveillance studies proves that there is a gap in the current knowledge, where most of the surveillance-related studies reported do not follow a set format that provides the required information on ENM characterisation, the type of exposure and the measured indicators/biomarkers. Hence, there is very low quality evidence that screening and surveillance might detect adverse health effects associated with workplace exposure. This systematic review is relevant because it proves that, although surveillance programs have been initiated and preliminary results are being published, the current studies are actually not answering the important questions or solving the overall problem regarding what the potential health hazards are among workers either handling or potentially exposed to ENMs. The recommendations, thus proposed, are based on an obvious need for (i) exposure registries, where longitudinal follow-up studies should inform surveillance, (ii) known exposure measurements or summary indices for ENMs as a reference (iii) validation of candidate biomarkers and (iv) studies that compare the effects of these surveillance approaches to usual care, e.g. those commonly followed for bulk-size hazardous materials.
| S-EPMC5102462 | biostudies-literature
Project description:BackgroundThe European Community recommends the implementation of population-based screening programmes for cervical, breast, and colorectal cancers. This recommendation is supported by many observational studies showing that organised programmes effectively reduce mortality and control the inappropriate use of screening tests. We conducted a systematic review of studies assessing the efficacy of interventions to increase participation in organised population-based screening programs.MethodsWe included all studies on interventions aimed at increasing screening participation published between 1/1999 and 7/2012. For those published before 1999, we considered the Jepson et al. (2000) review (Health Technol Assess 4:1-133, 2000).ResultsIncluding studies from the Jepson review, we found 69 with quantitative information on interventions in organised screening: 19 for cervical, 26 for breast, 20 colorectal cancers, and 4 for cervical and breast cancer together.Effective interventions were: postal (breast RR = 1,37 95% Confidence Interval (95% CI): 1.25-1.51; cervical RR = 1.71 95% CI: 1.60-1.83; colorectal RR = 1.33 95% CI: 1.17-1.51) and telephone reminders (with heterogeneous methods for implementation); GP's signature on invitation letter (breast RR = 1.13 95% CI: 1.11-1.16; cervical RR = 1.20 95% CI: 1.10-1.30; colorectal RR = 1.15 95% CI: 1.07-1.24); scheduled appointment instead of open appointment (breast RR = 1.26 95% CI: 1.02-1.55; cervical RR = 1.49 95% CI: 1.27-1.75; colorectal RR = 1.79 95% CI: 1.65-1.93). Mailing a kit for self-sampling cervical specimens increased participation in non-responders (RR = 2.37 95% CI: 1.44-3.90).ConclusionAlthough some interventions did prove to be effective, some specific variables may influence their effectiveness in and applicability to organised population-based screening programs.
| S-EPMC3686655 | biostudies-literature
Project description:Global surveillance of antimicrobial resistance (AMR) is a key component of the 68th World Health Assembly Global Action Plan on AMR. Laboratory-based surveillance is inherently biased and lacks local relevance due to aggregation of data. We assessed the feasibility, sensitivity, and affordability of a population-based AMR survey using lot quality assurance sampling (LQAS), which classifies a population as having a high or low prevalence of AMR based on a priori defined criteria. Three studies were carried out in Medan and Bandung, Indonesia, between April 2014 and June 2017. LQAS classifications for 15 antibiotics were compared with AMR estimates from a conventional population-based survey, with an assessment of the cost of a single LQAS classification using microcosting methodology, among patients suspected of urinary tract infection at 11 sites in Indonesia. The sensitivity of LQAS was above 98%. The approach detected local variation in the prevalence of AMR across sites. Time to reach LQAS results ranged from 47 to 138 days. The average cost of an LQAS classification in a single facility was US$466. The findings indicate that LQAS-based AMR survey is a feasible, sensitive, and affordable strategy for population-based AMR surveys, providing essential data to inform local empirical treatment guidelines and antimicrobial stewardship efforts.
| S-EPMC6438814 | biostudies-literature