Point of Care最新文献

OBJECTIVES: To determine if a gap exists between sexually transmitted infection (STI) clinicians and industry professionals regarding perceptions of the ideal types and characteristics of STI point-of-care tests (POCTs). METHODS: Our online survey design contained sections on demographics; barriers of use for available STI POCTs; characteristics of an ideal POCT, including prioritizing pathogens for targets; and "building your own POCT". Practicing clinicians and academic experts from two venues, STI-related international conference attendees and U.S. STD clinic clinicians, were invited to participate in the clinician survey. Professionals from industry in the STI diagnostic field were invited to participate in the industry survey. Chi-square test and conditional logistical regression were used for data analysis. RESULTS: Clinician survey participants (n=218) identified "the time frame required" (39.9%), "complexity" (31.2%), and "interruption of work flow" (30.3%) as the top three barriers making it difficult to use STI POCTs, while the industry survey participants (n=107) identified "complexity" (65.4%), "unreliability" (53.3%), and "difficulty in reading results" (34.6%) as the top three barriers (all p values <0.05). Sensitivity was always the most important attribute to be considered for a new STI POCT by both participant groups. Participants of the clinician group chose cost as the second priority attribute, while those of the industry group chose specificity as the second priority. CONCLUSION: We identified differences in the perceptions regarding barriers and ideal attributes for STI POCTs between frontline clinical providers and industry personnel. Tailored training is warranted to inform scientists, biomedical engineers, and other industry experts about characteristics that clinicians desire for STI POCTs.

Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers' specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs.

The purpose of this article is to review current principles and criteria for obtaining Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) waiver, identify existing point-of-care (POC) coagulation and hematology technologies, and analyze regulatory challenges regarding CLIA-waiver for those and future devices. CLIA '88 documentation requires tests performed by laboratories with a Certificate of Waiver to be so simple that the likelihood of erroneous results by the user is negligible, or poses no unreasonable risk of harm to the patient if performed incorrectly as determined by the Secretary of Health and Human Services. "Simple" means that the test uses unprocessed samples, has a direct read-out of test results, does not have specifications for user training, and includes instructions for confirmatory testing when advisable. Currently the CLIA-waived hematology and coagulation POC devices only test for hemoglobin (Hb), hematocrit (Hct), and prothrombin time/international normalized ratio (PT/INR). The problem with these devices is the lack of multiplexing. POC coagulation and hematology devices face challenges for obtaining a waiver. These challenges include the lack of clinical needs assessment, miniturized assays that correct for interfering substances, and assays simple enough to be combined in a multiplex platform. Several scenarios demonstrate how POC coagulation or hematology devices can improve crisis care. Industry should perform needs assessment on clinicians and emergency responders to determine which analytes to incorporate on multiplex POC coagulation and hematology devices, and produce devices that address confounding factors.

A versatile microfluidic platform for the evolving molecular diagnostics industry is described. It incorporates low cost Rheonix CARD(®) (Chemistry and Reagent Device) technology to analyze a variety of clinical specimens. A patented lamination process incorporates all pumps, valves, microchannels and reaction compartments into an inexpensive disposable plastic device. Once an untreated clinical specimen is introduced, all assay steps, including cell lysis, nucleic acid purification, multiplex PCR, and end-point analysis, are automatically performed. Three distinct CARD assays are described which utilize either a low density microarray for multiplex detection of amplicons or an integrated primer extension assay to detect single nucleotide polymorphisms of interest. The STI (Sexually Transmitted Infections) CARD(®) is able to simultaneously detect four sexually transmitted infectious agents (N. gonorrhoeae, C.trachomatis, T. pallidum and T. vaginalis). Human C33A cervical epithelial cells were spiked with different levels of genomic DNA from the four species of interest, singly or in combination, and applied to the CARD device. Using multiplex PCR amplification of the targets followed by microarray detection, the CARD device was able to correctly detect a minimum of 10 copies of each of the four pathogens. The HPV (Human Papillomavirus) CARD(®) was able to detect and distinguish 20 different clinically relevant HPV types using cloned HPV DNA. In addition, the HPV CARD could identify HPV types in vaginal specimens previously demonstrated to contain high or low risk HPV using a currently commercially available testing method. Finally, the detection of specific single nucleotide polymorphisms (SNP) associated with warfarin dosing sensitivity was achieved on the Warfarin Genotyping CARD(®) by analyzing human buccal swabs. Once multiplex PCR was completed, the SNPs were detected using a primer extension assay.

OBJECTIVE: The goal of this paper is to identify strategies for connectivity that will optimize point-of-care testing (POCT) organized as small-world networks in disaster settings. METHODS: We evaluated connectivity failures during the 2010 Haiti Earthquake, applied small-world network concepts, and reviewed literature for point-of-care (POC) connectivity systems. RESULTS: Medical teams responding to the Haiti Earthquake faced connectivity failures that affected patient outcomes. Deploying robust wireless connectivity systems can enhance the efficiency of the disaster response by improving health care delivery, medical documentation, logistics, response coordination, communication, and telemedicine. Virtual POC connectivity education and training programs can enhance readiness of disaster responders. CONCLUSIONS: The admirable humanitarian efforts of more than 4000 organizations substantially impacted the lives of earthquake victims in Haiti. However, the lack of connectivity and small-world network strategies, combined with communication failures, during early stages of the relief effort must be addressed for future disaster preparedness.

Point-of-care (POC) tests are an important strategy to address the epidemic of sexually transmitted infections (STIs) among both adolescents and young adults. While access to care and confidentiality are major barriers to STI care, POC tests allow the clinician to provide immediate and confidential test results and treatment. In addition, POC test results constitute a "teachable moment"; that is, an opportunity to provide immediate feedback to the patient that may impact his/her risk behaviors. This paper reviews published data and manufacturer's product literature describing current point-of-care STI tests, including studies of test performance as well as impact on treatment intervals and disease spread. It presents theoretical and proposed pitfalls and solutions of implementing POC tests in clinical settings, non-traditional settings, and home care venues. We reviewed the available STI tests according to the World Health Organization (WHO) criteria for judging POC tests: the "ASSURRED" criteria (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, Delivered).

Point-of-care testing is useful when caring for patients in hospital settings and in emergency and disaster situations. However, point-of-care professional practice lacks components, such as standardization, harmonization, and consistency, which would substantially improve patient care if implemented. Therefore, we propose adoption of whole-blood standards, harmonization among testing methods, and tighter quality control constraints. Granting these 3 wishes will improve quality at the point of care and ultimately will improve diagnoses, treatment decisions, and patient outcomes.

Pathogen nucleic acid detection exhibits faster turnaround times and higher sensitivity compared with blood culture. When antibiotics are present, blood cultures experience higher false-negative rates. In contrast, nucleic acid tests may detect pathogens irrespective of antimicrobial therapy. Thus, future point-of-care nucleic acid-based detection devices could play a role in revolutionizing pathogen detection in critically ill patients. To properly optimize clinical use, pathogen nucleic acid tests should have the capacity to quantitate pathogen DNA, be miniaturized with simplified preanalytical and postanalytical processing components, and reduce net operating costs or provide clear-cut clinical outcome benefits. These 3 elements will foster a new generation of nucleic acid tests for use at the point of need and facilitate a paradigm shift to point-of-care pathogen detection with evidence-based treatment and real-time quantitative monitoring of patients with sepsis.