The clinical effect of glucose meter selection upon the detection of neonatal hypoglycemia

2021 ◽  
Author(s):  
Kayla Parker ◽  
Martha E Lyon ◽  
Barry D Kyle ◽  
Lannae Strueby ◽  
Mark Inman
Keyword(s):  
Clinical Effect ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Adult Population ◽  
Unintended Consequences ◽  
Point Of Care Testing ◽  
Neonatal Hypoglycemia ◽  
Neurodevelopmental Outcomes ◽  
Glucose Meter ◽  
Effect Of Glucose

Abstract Neonatal hypoglycemia is a common, transitional metabolic state that may lead to poor neurodevelopmental outcomes if unrecognized or managed inadequately. Given its frequency of presentation and immense clinical significance, a myriad of clinical practice guidelines have been published outlining appropriate screening, diagnosis, and treatment principles—many endorsing the use of glucose point-of-care testing (POCT). Unfortunately, the well-intended ‘march’ toward POCT, with bedside glucose meters as screening devices in the NICU, has resulted in unintended consequences with critical implications: a lack of international traceability to the ‘gold’ standard glucose method by POCT devices, under-recognition of POCT limitations, and a reliance upon a technology primarily driven to detect hyperglycemia in the adult population as opposed to neonatal hypoglycemia. As providers continue to advocate for improved POCT, there must be robust communication between providers and the clinical laboratory in the selection, standardization, and interpretation of glucose POCT to ensure optimal neonatal glucose detection.

Point-of-care testing: inspection preparedness

Perfusion ◽  
2000 ◽  
Vol 15 (2) ◽  
pp. 137-142 ◽  
Author(s):  
John Bennett ◽  
Cindy Cervantes ◽  
Scott Pacheco
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Health Care Financing ◽  
Well Being ◽  
Regulatory Agencies ◽  
Human Beings ◽  
Point Of Care Testing ◽  
Human Specimen ◽  
Testing Site ◽  
Clinical Laboratory Improvement Amendments

Point-of-care testing (POCT) in the operating room has changed dramatically since the implementation of the Clinical Laboratory Improvement Amendments (CLIA ‘88), which became effective in September 1992. With the implementation of CLIA ‘88, the Health Care Financing Administration (HCFA) mandated that human specimen testing ‘for the purpose of diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings’, must be performed by a certified laboratory or testing site. To attain and maintain accreditation, the need for more stringent and comprehensive documentation has become imperative. The Joint Commission for the Accreditation of Hospitals (JCAHO), the College of American Pathologists (CAPS), HCFA, and state regulatory agencies require data such as staff credentialling, staff training/competency, procedure manuals, quality control logs, quality assurance/corrective action plans, correlation studies, proficiency testing results, and equipment maintenance logs to assure specimens are analyzed in a reliable manner by competent personnel so as not to jeopardize the safety and well being of the patient. Developing a comprehensive, ongoing survey readiness plan that includes a pre-survey checklist of all the documentation required and having this documentation in order and up to date well in advance of the survey will greatly enhance the probability of a successful survey conducted by the various regulatory agencies.

scholarly journals Thermal Stress and Point-of-Care Testing Performance: Suitability of Glucose Test Strips and Blood Gas Cartridges for Disaster Response

2009 ◽  
Vol 3 (1) ◽  
pp. 13-17 ◽  
Author(s):  
Richard F. Louie ◽  
Stephanie L. Sumner ◽  
Shaunyé Belcher ◽  
Ron Mathew ◽  
Nam K. Tran ◽  
...  
Keyword(s):  
Thermal Stresses ◽  
Point Of Care ◽  
Blood Gas ◽  
Point Of Care Testing ◽  
Medical Assistance ◽  
Test Strips ◽  
Glucose Test ◽  
Glucose Meter ◽  
Glucose Test Strips ◽  
Blood Gas Analyzer

ABSTRACTObjective: 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. Glucose test strips were cold-stressed (–21°C) and heat-stressed (40°C) for up to 4 weeks. Blood gas cartridges were stressed at –21°C, 2°C, and 40°C for up to 72 hours. Test strip and cartridge performance was evaluated using aqueous quality control solutions. Results were compared with those obtained with unstressed POCT strips and cartridges.Results: Heated glucose test strips and blood gas cartridges yielded elevated results. Frozen test strips and cooled cartridges yielded depressed glucose and blood gas results, respectively. Frozen cartridges failed.Conclusions: The performance of glucose test strips and blood gas cartridges was affected adversely by thermal stresses. Heating generated elevated results, and cooling depressed results. Disaster medical assistance teams and emergency medical responders should be aware of these risks. Field POCT devices must be robust to withstand adverse conditions. We recommend that industry produce POCT devices and reagents suitable for disaster medical assistance teams. (Disaster Med Public Health Preparedness. 2009;3:13–17)

scholarly journals Point-of-care testing in the cardiovascular operating theatre

2006 ◽  
Vol 44 (9) ◽  
Author(s):  
Urs E. Nydegger ◽  
Erich Gygax ◽  
Thierry Carrel
Keyword(s):  
Healthcare Professionals ◽  
Cardiovascular Surgery ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Operating Table ◽  
Standard Laboratory ◽  
Rapid Progress ◽  
Point Of Care Testing ◽  
Laboratory Procedures ◽  
Major Equipment

AbstractPoint-of-care testing (POCT) remains under scrutiny by healthcare professionals because of its ill-tried, young history. POCT methods are being developed by a few major equipment companies based on rapid progress in informatics and nanotechnology. Issues as POCT quality control, comparability with standard laboratory procedures, standardisation, traceability and round robin testing are being left to hospitals. As a result, the clinical and operational benefits of POCT were first evident for patients on the operating table. For the management of cardiovascular surgery patients, POCT technology is an indispensable aid. Improvement of the technology has meant that clinical laboratory pathologists now recognise the need for POCT beyond their high-throughput areas.Clin Chem Lab Med 2006;44:1060–5.

scholarly journals Postmarket Surveillance of Point-of-Care Glucose Meters through Analysis of Electronic Medical Records

2016 ◽  
Vol 62 (5) ◽  
pp. 716-724 ◽  
Author(s):  
Lee F Schroeder ◽  
Don Giacherio ◽  
Roma Gianchandani ◽  
Milo Engoren ◽  
Nigam H Shah
Keyword(s):  
Data Mining ◽  
Validation Study ◽  
Random Error ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Central Laboratory ◽  
Average Bias ◽  
Time Period ◽  
Glucose Meter ◽  
Promising Source

Abstract BACKGROUND The electronic medical record (EMR) holds a promising source of data for active postmarket surveillance of diagnostic accuracy, particularly for point-of-care (POC) devices. Through a comparison with prospective bedside and laboratory accuracy studies, we demonstrate the validity of active surveillance via an EMR data mining method [Data Mining EMRs to Evaluate Coincident Testing (DETECT)], comparing POC glucose results to near-in-time central laboratory glucose results. METHODS The Roche ACCU-CHEK Inform II® POC glucose meter was evaluated in a laboratory validation study (n = 73), a prospective bedside intensive care unit (ICU) study (n = 124), and with DETECT (n = 852–27 503). For DETECT, the EMR was queried for POC and central laboratory glucose results with filtering based on of bedside collection timestamps, central laboratory time delays, patient location, time period, absence of repeat testing, and presence of peripheral lines. RESULTS DETECT and the bedside ICU study produced similar estimates of average bias (4.5 vs 5.0 mg/dL) and relative random error (6.3% vs 5.6%), with overlapping CIs. For glucose <100 mg/dL, the laboratory validation study estimated a lower relative random error of 3.6%. POC average bias correlated with central laboratory turnaround times, consistent with 4.8 mg · dL−1 · h−1 glycolysis. After glycolysis adjustment, average bias was estimated by the bedside ICU study at −0.4 mg/dL (CI, −1.6 to 0.9) and DETECT at −0.7 (CI, −1.3 to 0.2), and percentage POC results occurring outside Clinical Laboratory Standards Institute quality goals were 2.4% and 4.8%, respectively. CONCLUSIONS This study validates DETECT for estimating POC glucose meter accuracy compared with a prospective bedside ICU study and establishes it as a reliable postmarket surveillance methodology.

Evaluation of point-of-care testing in critically unwell patients: comparison with clinical laboratory analysers and applicability to patients with Ebolavirus infection

Pathology ◽  
2015 ◽  
Vol 47 (5) ◽  
pp. 405-409 ◽  
Author(s):  
Jen Kok ◽  
Jimmy Ng ◽  
Stephen C. Li ◽  
John Giannoutsos ◽  
Vineet Nayyar ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Point Of Care Testing

scholarly journals Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

2021 ◽  
Vol 11 ◽  
Author(s):  
Xi Mo ◽  
Xueliang Wang ◽  
Zhaoqin Zhu ◽  
Yuetian Yu ◽  
Dong Chang ◽  
...  
Keyword(s):  
Public Health ◽  
Nucleic Acid ◽  
Quality Management ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Conventional Polymerase Chain Reaction ◽  
Laboratory Medicine ◽  
Expert Consensus ◽  
Nucleic Acid Detection ◽  
Point Of Care Testing

COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

scholarly journals Types of Assays for SARS-CoV-2 Testing: A Review

2020 ◽  
Vol 51 (5) ◽  
pp. e59-e65 ◽  
Author(s):  
Marie C Smithgall ◽  
Mitra Dowlatshahi ◽  
Steven L Spitalnik ◽  
Eldad A Hod ◽  
Alex J Rai
Keyword(s):  
Patient Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Direct Patient Care ◽  
Point Of Care Testing ◽  
Clinical Laboratories ◽  
Novel Coronavirus ◽  
Outpatient Settings ◽  
Clinical Laboratory Testing

Abstract Clinical laboratory testing routinely provides actionable results, which help direct patient care in the inpatient and outpatient settings. Since December 2019, a novel coronavirus (SARS-CoV-2) has been causing disease (COVID-19 [coronavirus disease 2019]) in patients, beginning in China and now extending worldwide. In this context of a novel viral pandemic, clinical laboratories have developed multiple novel assays for SARS-CoV-2 diagnosis and for managing patients afflicted with this illness. These include molecular and serologic-based tests, some with point-of-care testing capabilities. Herein, we present an overview of the types of testing available for managing patients with COVID-19, as well as for screening of potential plasma donors who have recovered from COVID-19.

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