Computing the surveillance error grid analysis: procedure and examples.

The surveillance error grid (SEG) analysis is a tool for analysis and visualization of blood glucose monitoring (BGM) errors, based on the opinions of 206 diabetes clinicians who rated 4 distinct treatment scenarios. Resulting from this large-scale inquiry is a matrix of 337 561 risk ratings, 1 for each pair of (reference, BGM) readings ranging from 20 to 580 mg/dl. The computation of the SEG is therefore complex and in need of automation.

Short-Term Thermal-Humidity Shock Affects Point-of-Care Glucose Testing: Implications for Health Professionals and Patients.

The objective was to assess the effects of short-term (≤1 hour) static high temperature and humidity stresses on the performance of point-of-care (POC) glucose test strips and meters. Glucose meters are used by medical responders and patients in a variety of settings including hospitals, clinics, homes, and the field. Reagent test strips and instruments are potentially exposed to austere environmental conditions.

Effects of humidity on foil and vial packaging to preserve glucose and lactate test strips for disaster readiness.

Objective: Efficient emergency and disaster response is challenged by environmental conditions exceeding test reagent storage and operating specifications. We assessed the effectiveness of vial and foil packaging in preserving point-of-care (POC) glucose and lactate test strip performance in humid conditions.

Methods: Glucose and lactate test strips in both packaging were exposed to mean relative humidity of 97.

Dynamic temperature and humidity environmental profiles: impact for future emergency and disaster preparedness and response.

Introduction: During disasters and complex emergencies, environmental conditions can adversely affect the performance of point-of-care (POC) testing. Knowledge of these conditions can help device developers and operators understand the significance of temperature and humidity limits necessary for use of POC devices. First responders will benefit from improved performance for on-site decision making.

Effects of environmental conditions on point-of-care cardiac biomarker test performance during a simulated rescue: implications for emergency and disaster response.

Objective: To characterize the effects of environmental stress on point-of-care (POC) cardiac biomarker testing during a simulated rescue.

Design: Multiplex test cassettes for cardiac troponin I (cTnI), brain natriuretic peptide (BNP), CK-MB, myoglobin, and D-dimer were exposed to environmental stresses simulating a 24-hour rescue from Hawaii to the Marshall Islands and back. We used Tenney environmental chambers (T2RC and BTRC) to simulate flight conditions (20°C, 10 percent relative humidity) and ground conditions (22.

Innovations in point-of-care testing for enhanced United States disaster caches.

Objective: To describe, innovate, recommend, and foster the implementation of point-of-care (POC) testing in disaster caches to enhance crisis standards of care and to improve triage, diagnosis, monitoring, treatment, and management of victims and volunteers in complex emergencies and disasters.

Design And Settings: The authors compared POC testing in United States disaster caches to commercially available POC testing to enhance the caches and to reflect current state-of-the-art diagnostic capabilities. The authors also provided recommendations based on literature review and knowledge from newly developed POC technologies from the UC Davis Point-of-Care Technologies Center.

Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers.

Strategic integration of point-of-care (POC) diagnostic tools during crisis response can accelerate triage and improve management of victims. Timely differential diagnosis is essential wherever care is provided to rule out or rule in disease, expedite life-saving treatment, and improve utilization of limited resources. POC testing needs to be accurate in any environment in which it is used.

POINT-OF-CARE HEMATOLOGY AND COAGULATION TESTING IN PRIMARY, RURAL EMERGENCY, AND DISASTER CARE SCENARIOS.

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.

Effects of dynamic temperature and humidity stresses on point-of-care glucose testing for disaster care.

Objective: To characterize the performance of glucose meter test strips using simulated dynamic temperature and humidity disaster conditions.

Methods: Glucose oxidase- and glucose dehydrogenase-based test strips were dynamically stressed for up to 680 hours using an environmental chamber to simulate conditions during Hurricane Katrina. Paired measurements vs control were obtained using 3 aqueous reagent levels for GMS1 and 2 for GMS2.

Enhancing crisis standards of care using innovative point-of-care testing.

Objective: To identify strategies with tactics that enable point-of-care (POC) testing (medical testing at or near the site of care) to effectively improve outcomes in emergencies, disasters, and public health crises, especially where community infrastructure is compromised.

Design: Logic model-critical path-feedback identified needs for improving practices. Reverse stress analysis showed POC should be integrated, responders should be properly trained, and devices should be staged in small-world networks (SWNs).

Point-of-care testing for disasters: needs assessment, strategic planning, and future design.

Objective evidence-based national surveys serve as a first step in identifying suitable point-of-care device designs, effective test clusters, and environmental operating conditions. Preliminary survey results show the need for point-of-care testing (POCT) devices using test clusters that specifically detect pathogens found in disaster scenarios. Hurricane Katrina, the tsunami in southeast Asia, and the current influenza pandemic (H1N1, "swine flu") vividly illustrate lack of national and global preparedness.

Point-of-care testing for pandemic influenza and biothreats.

New and reemerging infectious diseases, such as pandemic viruses and resistant bacteria, pose a serious threat in the 21st century. Some of these agents represent global security threats. This review provides an overview of diagnostic challenges presented by pandemic influenza and biothreat agents.

Potential clinical utility of polymerase chain reaction in microbiological testing for sepsis.

Objectives: To evaluate the potential improvement of antimicrobial treatment by utilizing a new multiplex polymerase chain reaction (PCR) assay that identifies sepsis-relevant microorganisms in blood.

Design: Prospective, observational international multicentered trial.

Setting: University hospitals in Germany (n = 2), Spain (n = 1), and the United States (n = 1), and one Italian tertiary general hospital.

Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response.

Objective: Point-of-care testing (POCT) devices are deployed in the field for emergency on-site testing under a wide range of environmental conditions. Our objective was to evaluate the performance of glucose meter test strips and handheld blood gas analyzer cartridges following thermal stresses that simulate field conditions.

Methods: We evaluated electrochemical and spectrophotometric glucose meter systems and a handheld blood gas analyzer.

Assessing the performance of handheld glucose testing for critical care.

Background: We assessed the performance of a point-of-care (POC) glucose meter system (GMS) with multitasking test strip by using the locally-smoothed (LS) median absolute difference (MAD) curve method in conjunction with a modified Bland-Altman difference plot and superimposed International Organization for Standardization (ISO) 15197 tolerance bands. We analyzed performance for tight glycemic control (TGC).

Methods: A modified glucose oxidase enzyme with a multilayer-gold, multielectrode, four-well test strip (StatStriptrade mark, NOVA Biomedical, Waltham, MA) was used.

Standardization, Harmonization, and Realization.

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.

Multiplex polymerase chain reaction detection enhancement of bacteremia and fungemia.

Objective: To test a multiplex real-time polymerase chain reaction (PCR) method for simultaneous detection of multiple organisms in bloodstream infections.

Methods: Prospective observational study at the University of California Davis Medical Center (Sacramento, CA). Two hundred adult (>18 yrs) patients from the emergency room, intensive care units, and general medicine wards at risk of a bloodstream infection and who manifested signs of systemic inflammatory response syndrome (SIRS).

Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves.

Background: We introduce locally-smoothed (LS) median absolute difference (MAD) curves for the evaluation of hospital point-of-care (POC) glucose testing accuracy.

Methods: Arterial blood samples (613) were obtained from a university hospital blood gas laboratory. Four hospital glucose meter systems (GMS) were tested against the YSI 2300 glucose analyzer for paired reference observations.

Validation of oxygen saturation measurements in a canine model of hemoglobin-based oxygen carrier infusion.

This study was designed to validate oxygen saturation measurements from the NOVA CO-Oximeter (NOVA Biomedical Corporation, Waltham, MA), the i-STAT System (Sensor Devices, Waukesha, WI), and the Corning 170 blood gas analyzer (Bayer Corporation, East Walpole, MA) under conditions similar to the clinical application of a hemoglobin-based oxygen carrier (HBOC, hemoglobin glutamer-200 [bovine]; Oxyglobin, Biopure Corporation, Cambridge, MA). A canine model was used for both in vitro and in vivo experiments. In vivo experiments were conducted in a canine laboratory, and in vitro experiments were conducted in a tonometry laboratory.

Oxygen saturation measurements in canine blood containing hemoglobin glutamer-200 (Bovine): in vitro validation of the NOVA CO-Oximeter.

This study was designed to validate in vitro oxygen saturation (SO2) measurements with the NOVA CO-Oximeter (Nova Biomedical Corp, Waltham, Mass, USA) in canine blood containing hemoglobin (Hb) glutamer-200 bovine (Hb-200; Oxyglobin, Biopure, Cambridge, Mass, USA) as a Hb-based oxygen carrier recently introduced into clinical practice. In the first set of experiments, stored blood from 6 mixed-breed canine blood donors was used. Target PO2 levels were reached in aliquots of blood samples by tonometry.