Evaluating a Novel Ex Vivo Point-of-Care Testing Device or Blood Gas and Electrolyte Measurement for Acceptance by the Point-of-Care Testing Committee
This article describes the complex processes encountered by a point-of-care testing (POCT) committee evaluating a novel ex vivo device for measuring blood gases, potassium, and hematocrit that would be of value in the monitoring of patients in critical care, enabling regular monitoring without the requirement for blood loss using existing point-of-care devices. With many important potential advantages to clinical management including a significant reduction in preanalytical errors and blood loss, it, however, cannot be compared directly with an existing analytical process in the laboratory. Although without an option for r...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Articles Source Type: research

Evaluation of the Roche Cobas b 101 Glycosylated Hemoglobin Point-of-Care Analyzer
Background: Glycosylated hemoglobin (HbA1c) is a biomarker to assess long-term glycemic control in diabetic patients and has recently been recommended for diagnosis of diabetes. An evaluation of the Roche Cobas b 101 point-of-care (POC) HbA1c analyzer was conducted to assess its analytical performance. Methods: Precision and accuracy were estimated by analyzing 2 control samples 11 times for the within-run experiment and over 11 days for the between-batch precision. Agreement was correlated to the laboratory method, Tosoh Biosciences G8 HbA1c analyzer (n = 51; range of results, 4.7%–15.1%), and a POC method, the Siemens...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Articles Source Type: research

Point-of-Care Lactate for Sepsis Detection: Reconsidering Accuracy, Precision, and Concordance Criteria
Abstract: Point-of-care (POC) lactate is widely used in hospital “bundles” for the early detection of sepsis. There is evidence that rapid measurement of lactate in this context improves patient outcome. Many POC lactate methods have acceptable accuracy, precision, and clinical concordance for use in sepsis screening. Point-of-care whole-blood lactate demonstrates systematic negative bias compared with plasma lactate, and therefore POC whole-blood and plasma lactate should not be used interchangeably in patients with elevated lactate levels. (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Articles Source Type: research

Evaluation of the HemoCue HbA1c 501 System in Primary Care Settings
Abstract: The routine measurement of hemoglobin A1c (HbA1c) is recommended by major clinical diabetes organizations. By providing results rapidly with point-of-care devices, more timely decisions regarding optimal treatment can be made, and studies have confirmed that immediate feedback of HbA1c results improves glycemic control in patients with type 1 and insulin-treated type 2 diabetes mellitus. The aim of this study was to evaluate the performance of the HemoCue HbA1c 501 during regular use in primary care settings. The results verify that the HemoCue HbA1c 501 system is accurate and easy to use in the hands of the inte...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Articles Source Type: research

Direct-to-Consumer Testing: The Business With Lifestyle Tests
Abstract: Medical treatment by a physician consists of diagnosing the disease of a patient and choosing the right treatment for the disease. In most cases, medical diagnosing uses laboratory testing, and in most countries, laboratory testing is regarded as an integral part of health care. Certain country-specific regulations even restrict the access only to physicians such as for the test kits or prohibit to addressing the patient directly with the laboratory report. The idea behind these regulations originates from patient safety issues with the special situation in health care with, for example, the asymmetric situation ...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Articles Source Type: research

Direct-to-Consumer Genetic Testing in the Personalized Medicine Era
Abstract: Direct-to-consumer (DTC) genetic testing is playing an increasing role in medicine as more and more consumers are interested in probing their own genetic information. Direct-to-consumer genetic testing has evolved in content and deliverables since its introduction into the consumer marketplace in 2007. Regulatory body scrutiny, such as that of the US Food and Drug Administration, has influenced the evolution of DTC genetic testing; however, many questions still exist regarding both the clinical and research practices of DTC genetic testing companies. Furthermore, whether consumers truly understand DTC genetic tes...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Review Article Source Type: research

Point-of-Care Testing in an Acute Tertiary Care Hospital in Singapore: Planning for the Future After 10 Years of Implementation
Abstract: Point-of-care testing (POCT) in our tertiary care hospital is embedded in the daily clinical processes. In 2005, the central laboratory was tasked with POCT oversight to align compliance to hospital accreditation standards. With 10 years that has since ensued, the hospital signalled a fresh relook at the agenda to ensure needs in the next lap of the hospital's reorganization are met. A multidisciplinary POCT committee was formed, and it implemented an executive framework and updated processes for current and new point-of-care (POC) tests/devices. A central repository of standardized operating procedures and quali...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Article Source Type: research

Challenges in Primary Care Delivery and the Opportunities for Point-of-Care Testing: A UK Perspective
Abstract: Health care systems around the world are changing to improve access and quality, as well as seeking to contain costs. These changes are being sought against a backcloth of improvements in both diagnosis and treatment, and increased patient life expectancy. Health care delivery for the past few decades has become very hospital centric and with consolidation of facilities to manage increasing specialization of care, as well as promoting efficiency—including in the field of diagnostics. However, these latter developments have had an adverse impact on patient access to care, with increasing pressure on primary care...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Review Articles Source Type: research

Direct-to-Consumer Testing: A New Paradigm for Point-of-Care Testing
Abstract: 2016 CPOCT International Symposium Review. This is an invited submission for the March issue covering the 2016 CPOCT International Symposium. Session 2: Direct to Consumer Testing—the New Face of Point-of-Care? (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Review Articles Source Type: research

Evaluation of 3 Point-of-Care Testing Hematology Analyzers for White Blood Count
Abstract: In the past few years, several small hematology analyzers were introduced for point-of-care testing (POCT) purposes. The POCT hematology analyzers can be used for the same purposes as centralized systems, but the possibility to use capillary blood from a fingerprick is a major advantage in several situations. The 3 tested POCT systems were the WBC DIFF system of Hemocue (Sweden), the Microsemi C-reactive protein of Horiba (Japan), and the Norma Icon hematology analyzer (Austria). The Microsemi and WBC DIFF were evaluated simultaneously. For the agreement with the laboratory method, 125 patient samples (EDTA blo...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 23, 2017 Category: Pathology Tags: Original Article Source Type: research

Evaluation of the Abaxis Piccolo Point-of-Care Chemistry Analyzer: Comparison to the Roche Cobas C501
In this study, we performed method validations for the Abaxis Piccolo Xpress assays for total protein, albumin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, calcium, creatinine, urea nitrogen, and glucose compared with the Roche Cobas c501 analyzer. The validation included linear reportable range, imprecision, and assessment of accuracy and bias by method crossover. Although some biases between the methods were observed, these could be reconciled by adjustments to the normal reference ranges. Overall, we found that these assays performed at an accepted level for clinical use....
Source: Point of Care: The Journal of Near-Patient Testing and Technology - May 31, 2017 Category: Pathology Tags: Original Articles Source Type: research

Three-Dimensional–Printed Laboratory-on-a-Chip With Microelectronics and Silicon Integration
The objective was to achieve low resistance and high reliability with low cost for manufacturing 3D-printed point-of-care diagnostic devices. (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - May 31, 2017 Category: Pathology Tags: Original Articles Source Type: research

An Evaluation of the Point-of-Care Test i-CHROMA Prostate-Specific Antigen Method for Screening in the Community
Conclusions: The i-CHROMA POCT PSA method showed good correlation with the Abbott Architect PSA method. Higher numbers of raised and abnormal PSA were identified by the i-CHROMA POCT PSA method due to the positive bias observed. The i-CHROMA POCT PSA method is a reliable method for total PSA within its limitations. (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - May 31, 2017 Category: Pathology Tags: Original Articles Source Type: research

A Comparison Between the HORIBA Yumizen H500 Point-of-Care Hematology Analyzer With a 5-Part White Cell Differential and the HORIBA Pentra 120
In conclusion, the Yumizen H500 provides reproducible, precise, and accurate results compared with our institute's mainline laboratory analyzers. (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - May 31, 2017 Category: Pathology Tags: Original Articles Source Type: research

Bio-Innovation in Taiwan, the First Survey of Point-of-Care Professional Needs, and Geospatially Enhanced Resilience in At-Risk Settings
Conclusions: Bio-innovators are enthusiastically creating POC technologies in Taiwan, including low marginal cost assay modules capable of transforming public health paradigms. Geospatial analysis showed that POCT can speed acute response in rural areas of Hualien County. At a national convocation of the Taiwan Association of Medical Technologists, P&G receptivity and support were strong, suggesting Taiwan will publish national POCT P&G. Priorities include rural areas and vulnerable populations. (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - May 31, 2017 Category: Pathology Tags: Original Articles Source Type: research