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Papillomavirus Research (Amsterdam,... Jun 2019Effective screening for pre-cancerous lesions of the cervix is the only protective intervention that can be offered to women that have not had the opportunity to be... (Review)
Review
Effective screening for pre-cancerous lesions of the cervix is the only protective intervention that can be offered to women that have not had the opportunity to be vaccinated. Elimination goals are being developed so that by 2030, 70% of women aged 35-45 years should have been screened at least once in a lifetime and 90% of all detected lesions should have been treated. These goals focus on a substantial reduction of cervical cancer burden in low- and middle-income countries (LMICs). Scaling-up screening in these settings may be substantially improved by using self-sampling (SS), human papillomavirus (HPV) testing, and managing screened-positive women with accessible treatment. The implementation of these tools requires minimal health information data for traceability, provider training, community education, operational management and quality control. Cost-effective algorithms tailored to country needs can greatly impact the burden of disease in a limited number of years.
Topics: Adult; Diagnostic Services; Disease Eradication; Early Detection of Cancer; Female; Humans; Middle Aged; Papillomaviridae; Papillomavirus Infections; Precancerous Conditions; Uterine Cervical Neoplasms
PubMed: 31002883
DOI: 10.1016/j.pvr.2019.04.011 -
Clinical Microbiology Reviews Jun 2021The variety and complexity of ocular infections have increased significantly in the last decade since the publication of , (L. D. Gray, P. H. Gilligan, and W. C.... (Review)
Review
The variety and complexity of ocular infections have increased significantly in the last decade since the publication of , (L. D. Gray, P. H. Gilligan, and W. C. Fowler, , , 2010). The purpose of this practical guidance document is to review, for individuals working in clinical microbiology laboratories, current tools used in the laboratory diagnosis of ocular infections. This document begins by describing the complex, delicate anatomy of the eye, which often leads to limitations in specimen quantity, requiring a close working bond between laboratorians and ophthalmologists to ensure high-quality diagnostic care. Descriptions are provided of common ocular infections in developed nations and neglected ocular infections seen in developing nations. Subsequently, preanalytic, analytic, and postanalytic aspects of laboratory diagnosis and antimicrobial susceptibility testing are explored in depth.
Topics: Clinical Laboratory Services; Clinical Laboratory Techniques; Eye Infections; Humans; Laboratories
PubMed: 34076493
DOI: 10.1128/CMR.00070-19 -
The Journal of Molecular Diagnostics :... Apr 2022Coronavirus disease 2019 (COVID-19) undermines control of other infectious diseases. Diagnostics are critical in health care. This opinion paper explores approaches for... (Review)
Review
Coronavirus disease 2019 (COVID-19) undermines control of other infectious diseases. Diagnostics are critical in health care. This opinion paper explores approaches for leveraging diagnostics for COVID-19 while retaining diagnostics for other infectious diseases, including tuberculosis (TB) and HIV. The authors reflect on experiences with GeneXpert technology for TB detection and opportunities for integration with other diseases. They also reflect on benefits and risks of integration. Placement of diagnostics in laboratory networks is largely nonintegrated and designated for specific diseases. Restricting the use of diagnostics leaves gaps in detection of TB, HIV, malaria, and COVID-19. Integrated laboratory systems can lead to more efficient testing while increasing access to critical diagnostics. However, the authors have observed that HIV diagnosis within the TB diagnostic network displaced TB diagnosis. Subsequently, COVID-19 disrupted both TB and HIV diagnosis. The World Health Organization recommended rapid molecular diagnostic networks for infectious diseases and there is a need for more investment to achieve diagnostic capacity for TB, HIV, COVID-19, and other emerging infectious diseases. Integrated laboratory systems require mapping laboratory networks, assessing needs for each infectious disease, and identifying resources. Otherwise, diagnostic capacity for one infectious disease may displace another. Further, not all aspects of optimal diagnostic networks fit all infectious diseases, but many efficiencies can be gained where integration is possible.
Topics: COVID-19; Developing Countries; Diagnostic Services; HIV Infections; Humans; Tuberculosis
PubMed: 35123038
DOI: 10.1016/j.jmoldx.2021.12.008 -
Archives of Pathology & Laboratory... Oct 2020Convenience, avoidance of doctor's appointments, curiosity, and the desire to take control of one's health are driving interest toward direct-to-consumer (DTC) testing....
CONTEXT.—
Convenience, avoidance of doctor's appointments, curiosity, and the desire to take control of one's health are driving interest toward direct-to-consumer (DTC) testing. DTC is laboratory testing that is initiated by the consumer without a physician order. The results are reported back directly to the consumer. DTC testing is an exciting addition to the traditional healthcare model for consumers who want knowledge of their health status and disease risk, ancestry, and their body's expected response to certain medications based on their genotype.
OBJECTIVES.—
To discuss the perceived and potential benefits and risks involved in DTC testing.
DATA SOURCES.—
Recent published literature on DTC testing.
CONCLUSIONS.—
The benefits of DTC testing are enticing and are driving the DTC testing market. Consumers must weigh the perceived benefits with the potential risks, including privacy concerns, the possibility of receiving confusing health information, and/or information that could generate unexpected emotions, misdiagnosis, and over-testing.
Topics: Confidentiality; Direct-To-Consumer Screening and Testing; Genetic Testing; Humans; Risk Assessment
PubMed: 33002154
DOI: 10.5858/arpa.2020-0078-RA -
Genetics and Molecular Research : GMR Feb 2017The aim of this review is to describe a series of ten genetic diseases with Mendelian inheritance pattern in people of low- or middle-income countries, which can be... (Review)
Review
The aim of this review is to describe a series of ten genetic diseases with Mendelian inheritance pattern in people of low- or middle-income countries, which can be easily identified with simple and affordable methods. Recent information shows that although genetic diseases account for more than 10% of infant mortality in such countries, testing, counseling, and treatment of genetic diseases is not a priority. The selection criteria for the genetic tests that are discussed in this review are: i) the frequency of the genetic disease in the general population, ii) the cost and ease of execution, and iii) the report of validated methods in the literature for the diagnosis of these diseases. The goal is to promote diagnosis of genetic diseases at low-cost and with relative ease, thereby enabling appropriate treatments, reducing mortality, and preventing genetic diseases in high-risk families.
Topics: Developing Countries; Genetic Diseases, Inborn; Genetic Testing; Humans; Mass Screening; Population Surveillance; Socioeconomic Factors
PubMed: 28198508
DOI: 10.4238/gmr16019466 -
Frontiers in Oncology 2020Quality assured pathology services are integral to provision of optimal management for patients with head and neck cancer. Pathology services vary globally and are... (Review)
Review
Quality assured pathology services are integral to provision of optimal management for patients with head and neck cancer. Pathology services vary globally and are dependent on resources in terms of both laboratory provision and availability of a highly trained and accredited workforce. Ensuring a high-quality pathology service depends largely on close working and effective communication between the clinical team providing treatment and the pathologists providing laboratory input. Laboratory services should be quality assured by achieving external accreditation, most often by conforming to International Organization for Standardization (ISO) standards such as ISO15189 sometimes with ISO17025 or alternatively ISO17020. Quality of diagnostic reporting can be assured by the ISO but clinical teams should endeavor to work with pathologists who engage in continuing professional development, external quality assurance and audit. Research also contributes to diagnostic reporting quality. A number of initiatives in the UK such as the EPSRC/MRC funded Molecular Pathology Nodes and the National Cancer Research Institute Cellular-Molecular Pathology initiative (C-M Path), for example, have linked pathologists, industry and researchers. This has resulted in centers leading in digital innovation, artificial intelligence, translational research and clinical trials supported by pathologists. For rare tumors and contemporary molecular diagnostics, biopsy material can increasingly be shared with expert specialist pathologists working in specialist centers, particularly by using digital pathology platforms with potentially global reach. High quality services for the majority of diagnostic processes required for head and neck cancer management is best provided by local pathologists where communication with the treating team is more effective than with pathologists working in remote centers. Quality assurance is an increasingly important aspect of pathology, assuring not only effective turnaround times and accuracy for the diagnostic service but also high quality consistent reporting for clinical trials where even small pathology errors can potentially produce a significant bias and in the worst case negate the value of a completed trial. Better outcomes have been associated with centers engaged in clinical trials than in non-participating centers. Provision of a quality assured pathology service should extend to both the research and diagnostic services.
PubMed: 32266144
DOI: 10.3389/fonc.2020.00364 -
Biochemistry and Cell Biology =... Dec 2022Direct-to-consumer (DTC) genetic testing is cheaper and more accessible than ever before; however, the intention to combine, reuse, and resell this genetic information...
Direct-to-consumer (DTC) genetic testing is cheaper and more accessible than ever before; however, the intention to combine, reuse, and resell this genetic information as powerful data sets is generally hidden from the consumer. This financial gain is creating a competitive DTC market, reducing the price of whole-genome sequencing (WGS) to under 300 USD. Entering this transition from single-nucleotide polymorphism-based DTC testing to WGS DTC testing, individuals looking for access to their whole-genomic information face new privacy and security risks. Differences between WGS and other methods of consumer genetic tests are left unexplored by regulation, leading to the application of legal data anonymization methods on whole-genome data, and questionable consent methods. Large representative genomic data sets are important for research and improve the standard of medicine and personalized care. However, these data can also be used by market players, law enforcement, and governments for surveillance, population analyses, marketing purposes, and discrimination. Here, we present a summary of the state of WGS DTC genetic testing and its current regulation, through a community-based lens to expose dual-use risks in consumer-facing biotechnologies.
Topics: Humans; Direct-To-Consumer Screening and Testing; Genetic Testing; Genomics; Risk Assessment
PubMed: 35939839
DOI: 10.1139/bcb-2021-0506 -
Journal of Clinical Virology : the... Aug 2021In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon... (Review)
Review
In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon (Republican-Indiana) and Diana DeGette, (Democrat-Colorado). The VALID Act attempts to create a new framework for the oversight and regulations of both laboratory-developed testing procedures (commonly known as laboratory-developed tests) and In vitro diagnostic tests by the U.S. Food and Drug Administration. The potential impact of this new law if passed may be significant for clinical laboratories in terms of diagnostic test development and implementation. In this report, we review the background and key information that every clinical virologist should know about the VALID Act.
Topics: Clinical Laboratory Services; Colorado; Diagnostic Tests, Routine; Humans; Laboratories; United States; United States Food and Drug Administration
PubMed: 34243115
DOI: 10.1016/j.jcv.2021.104875 -
African Health Sciences Sep 2019Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) are global public health problems. TB and HIV diagnostic services linkage is imperative for the fight against...
BACKGROUND
Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) are global public health problems. TB and HIV diagnostic services linkage is imperative for the fight against the two diseases.
OBJECTIVE
To assess the diagnostic service linkage and testing of TB-HIV diagnostic services and identify predictors in Public hospitals of Northern Ethiopia.
METHODS
A cross-sectional study was conducted in five hospitals of Northern Ethiopia. Study subjects' socio-demographic, household and clinical variables were assessed. Data was analyzed using SPSS. Logistic regressions were used to determine the predictors of uptake of TB and HIV testing among HIV and TB patients, respectively.
RESULT
The level of HIV testing among TB patients was 94.4% and of TB screening among HIV patients was 90.5%. Factors that independently predict HIV testing among TB patients were Residence AOR=0.187(95% CI 0.05-0.76), being 9 grade and above AOR=13.17 (95%CI 2.67-65.03) and drinking alcohol AOR=0.03(95% CI 0.002-0.475). Likewise, being grade 9 and above AOR=6.92 (95% CI 1.75-27.4) and having chronic cough AOR=0.23 (95% CI 0.06-0.92) were predictor variables for having TB screening among HIV patients.
CONCLUSION
The levels of TB-HIV linkages and testing are high. Moreover, educational status is a strong predictor of TB screening among HIV patients and HIV testing among TB cases. The regional health bureau has to continue supporting its TB and HIV case teams in every health facility.
Topics: Delivery of Health Care, Integrated; Diagnostic Services; Female; HIV Infections; Hospitals, Public; Humans; Male; Mass Screening; Tuberculosis
PubMed: 32127802
DOI: 10.4314/ahs.v19i3.5 -
Genetics in Medicine : Official Journal... Nov 2023To assess the relative cost-effectiveness of genomic testing compared with standard non-genomic diagnostic investigations in patients with suspected monogenic kidney...
PURPOSE
To assess the relative cost-effectiveness of genomic testing compared with standard non-genomic diagnostic investigations in patients with suspected monogenic kidney disease from an Australian health care system perspective.
METHODS
Diagnostic and clinical information was used from a national cohort of 349 participants. Simulation modelling captured diagnostic, health, and economic outcomes during a time horizon from clinical presentation until 3 months post-test results based on the outcome of cost per additional diagnosis and lifetime horizon based on cost per quality-adjusted life-year (QALY) gained.
RESULTS
Genomic testing was Australian dollars (AU$) 1600 more costly per patient and led to an additional 27 diagnoses out of a 100 individuals tested, resulting in an incremental cost-effectiveness ratio of AU$5991 per additional diagnosis. Using a lifetime horizon, genomic testing resulted in an additional cost of AU$438 and 0.04 QALYs gained per individual compared with standard diagnostic investigations, corresponding to an incremental cost-effectiveness ratio of AU$10,823 per QALY gained. Sub-group analyses identified that the results were largely driven by the cost-effectiveness in glomerular diseases.
CONCLUSION
Based on established or expected thresholds of cost-effectiveness, our evidence suggests that genomic testing is very likely to be cost saving for individuals with suspected glomerular diseases, whereas no evidence of cost-effectiveness was found for non-glomerular diseases.
Topics: Humans; Child; Adult; Cost-Benefit Analysis; Australia; Quality-Adjusted Life Years; Computer Simulation; Genetic Testing
PubMed: 37489581
DOI: 10.1016/j.gim.2023.100942