scholarly journals Analysis of a Point-of-Care HbA1c Assay: Is It Time for an HbA1c Error Grid?

2019 ◽  
Vol 14 (5) ◽  
pp. 896-897
Author(s):  
Jan S. Krouwer
Keyword(s):  
Adverse Event ◽  
Error Estimate ◽  
Hemoglobin A1c ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Total Error ◽  
User Facility ◽  
Finger Stick ◽  
Error Grid ◽  
Clinical Laboratory Improvement Amendments

In an article in Journal of Diabetes Science and Technology, Arnold et al have presented a thorough study of imprecision components for a point-of-care hemoglobin A1c (HbA1c) assay. An interesting and innovative approach is the combination of data from different studies to arrive at a total error estimate. But total error has the oxymoron feature of estimating performance for most (95%) but not all of the results. An HbA1c error grid would provide the severity for results that exceed the 6% requirement. Since this device is intended for Clinical Laboratory Improvement Amendments waived labs and allows for finger-stick samples, monitoring the Food and Drug Administration adverse event database (MAUDE, Manufacturer and User Facility Device Experience) is recommended.

scholarly journals Hemoglobin A1c Point-of-Care Assays; A New World with a Lot of Consequences!

2009 ◽  
Vol 3 (3) ◽  
pp. 418-423 ◽  
Author(s):  
Erna Lenters-Westra ◽  
Robbert J. Slingerland
Keyword(s):  
Nurse Practitioners ◽  
Hemoglobin A1c ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Care Center ◽  
Venous Blood ◽  
Coefficients Of Variation ◽  
Rapid Result ◽  
Performance Results ◽  
Clinical Laboratory Improvement Amendments

Background: Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods: The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results: At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion: Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly.

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 Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: a Paradigm Shift to Molecular Tests

2018 ◽  
Vol 56 (7) ◽  
Author(s):  
Marwan M. Azar ◽  
Marie L. Landry
Keyword(s):  
Respiratory Syncytial Virus ◽  
Antiviral Therapy ◽  
Influenza A ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Clinical Laboratory Improvement Amendments

ABSTRACT An accurate laboratory diagnosis of influenza, respiratory syncytial virus (RSV), and other respiratory viruses can help to guide patient management, antiviral therapy, infection prevention strategies, and epidemiologic monitoring. Influenza has been the primary driver of rapid laboratory testing due to its morbidity and mortality across all ages, the availability of antiviral therapy, which must be given early to have an effect, and the constant threat of new pandemic strains. Over the past 30 years, there has been an evolution in viral diagnostic testing, from viral culture to rapid antigen detection, and more recently, to highly sensitive nucleic acid amplification tests (NAAT), as well as a trend to testing at the point of care (POC). Simple rapid antigen immunoassays have long been the mainstay for POC testing for influenza A and B viruses and respiratory syncytial virus (RSV) but have been faulted for low sensitivity. In 2015, the first POC NAAT for the detection of influenza was approved by the Food and Drug Administration (FDA), ushering in a new era. In 2017, the FDA reclassified rapid influenza diagnostic tests (RIDTs) from class I to class II devices with new minimum performance standards and a requirement for annual reactivity testing. Consequently, many previously available RIDTs can no longer be purchased in the United States. In this review, recent developments in Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived testing for respiratory virus infections will be presented, with the focus on currently available FDA-cleared rapid antigen and molecular tests primarily for influenza A and B viruses and RSV.

Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care

2012 ◽  
Vol 50 (9) ◽  
Author(s):  
Snježana Kos ◽  
Arie van Meerkerk ◽  
Joke van der Linden ◽  
Theo Stiphout ◽  
Remi Wulkan
Keyword(s):  
Glycemic Control ◽  
Point Of Care ◽  
Total Error ◽  
Reference Method ◽  
Tight Glycemic Control ◽  
Insulin Dosage ◽  
Deming Regression ◽  
Clarke Error Grid ◽  
New Generation ◽  
Error Grid

AbstractPoint-of-care (POC) glucose devices are widely used for insulin-dosage decision-making although such an application is not always permitted. In this study, we have evaluated a new generation of POC glucose device, the HemoCueThis study was performed according to the CLSI/STARD criteria. The 201DMRT was compared to the laboratory hexokinase glucose method (Siemens Dimension VistaThe 201DMRT showed a good agreement with the laboratory reference method. This was examined using Deming regression analysis, percentage Bland-Altman plot and a modified Clarke-error grid. The total analytical error at the clinically critical glucose concentrations of 5.6, 7.0 and 11.1 mmol/L (101, 126 and 200 mg/dL) was 6.4%, 4.3% and 3.0%, respectively. The total error among the different POC devices and among different cuvette lot numbers was <6.5%. Glucose measurements on the 201DMRT were not affected by changes in partial pressure of oxygen, whereas changes in hematocrit had influence on the results (3.4% for every 0.10 L/L change in hematocrit).The 201DMRT device can be used for glycemic control based on analytical results presented. However, the clinical applicability for tight glycemic control must be confirmed in a clinical study.

scholarly journals Assessing the Risk of Contrast-Induced Nephropathy Using a Finger Stick Analysis in Recalls from Breast Screening: The CINFIBS Explorative Study

2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
I. P. L. Houben ◽  
C. J. L. Y. van Berlo ◽  
O. Bekers ◽  
E. C. Nijssen ◽  
M. B. I. Lobbes ◽  
...  
Keyword(s):  
Potential Risk ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Venous Blood ◽  
National Guidelines ◽  
Contrast Induced Nephropathy ◽  
Risk Patients ◽  
Finger Stick ◽  
Media Delivery

Purpose. To evaluate whether a handheld point-of-care (POC) device is able to predict and discriminate patients at potential risk of contrast-induced nephropathy (CIN) prior to iodine-based contrast media delivery. Methods and Materials. Between December 2014 and June 2016, women undergoing contrast-enhanced spectral mammography (CESM) with an iodine-based contrast agent were asked to have their risk of CIN assessed by a dedicated POC device (StatSensor CREAT) and a risk factor questionnaire based on national guidelines. Prior to contrast injection, a venous blood sample was drawn to compare the results of POC with regular laboratory testing. Results. A total of 351 patients were included; 344 were finally categorized as low risk patients by blood creatinine evaluation. Seven patients had a eGFR below 60 ml/min/1.73 m2, necessitating additional preparation prior to contrast delivery. The POC device failed to categorize six out of seven patients (86%), leading to (at that stage) unwanted contrast administration. Two patients subsequently developed CIN after 2–5 days, which was self-limiting after 30 days. Conclusion. The POC device tested was not able to reliably assess impairment of renal function in our patient cohort undergoing CESM. Consequently, we still consider classic clinical laboratory testing preferable in patients at potential risk for developing CIN.

Point-of-Care Testing in Community Pharmacies: Keys to Success From Pennsylvania Pharmacists

2017 ◽  
Vol 31 (6) ◽  
pp. 629-635 ◽  
Author(s):  
Emily A. Steltenpohl ◽  
Brandon K. Barry ◽  
Kim C. Coley ◽  
Melissa S. McGivney ◽  
Julie L. Olenak ◽  
...  
Keyword(s):  
Community Pharmacy ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Pharmacy Practice ◽  
Community Pharmacists ◽  
Improve Patient Satisfaction ◽  
State Regulations ◽  
Community Pharmacy Practice ◽  
Clinical Laboratory Improvement Amendments ◽  
Improve Patient

Background Clinical Laboratory Improvement Amendments (CLIA)-waived tests allow for quick, accurate, and noninvasive laboratory testing. Community pharmacists utilize CLIA-waived tests to provide clinical services such as point-of-care (POC) testing to help manage chronic disease and acute illness. Objective To identify key themes in the successful delivery of POC testing services by community pharmacists in Pennsylvania. Results An initial search identified 51 Pennsylvania pharmacies with a CLIA waiver. Of these, five independent pharmacies met inclusion criteria, three of which completed interviews. The remaining 38 chain pharmacies were represented by three interviews. In total, five key themes were identified as essential to POC testing services: (1) utilize state resources and professional connections to navigate federal and state regulations, (2) establish relationships with physician partners (3) offer tests that are meaningful to patients and their physicians, (4) evaluate financial impact, workflow adaptations, and marketing approaches when implementing POC testing services, and (5) focus on individualized attention and convenience of community pharmacy-based POC testing to improve patient satisfaction. Conclusion Successful POC testing services in community pharmacy practice rely on utilizing resources, partnering with known physicians, selecting meaningful tests for patients, and analyzing finances, workflow, and marketing to provide individualized attention and convenient care.

scholarly journals Accurate PCR Detection of Influenza A/B and Respiratory Syncytial Viruses by Use of Cepheid Xpert Flu+RSV Xpress Assay in Point-of-Care Settings: Comparison to Prodesse ProFlu+

2017 ◽  
Vol 56 (2) ◽  
Author(s):  
Daniel M. Cohen ◽  
Jennifer Kline ◽  
Larissa S. May ◽  
Glenn Eric Harnett ◽  
Jane Gibson ◽  
...  
Keyword(s):  
Influenza A ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Reverse Transcription Pcr ◽  
Qualitative Detection ◽  
High Concordance ◽  
Respiratory Syncytial Viruses ◽  
Syncytial Virus ◽  
Clinical Laboratory Improvement Amendments

ABSTRACT The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viruses and respiratory syncytial virus (RSV) performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to those of the Prodesse ProFlu+ real-time reverse transcription-PCR (RT-PCR) assay (ProFlu+) for the detection of influenza A and B viruses as well as RSV in a Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with results of the ProFlu+ assay in the combined CW and non-CW settings with positive percent agreements (PPA) (100%, 100%, and 97.1%) and negative percent agreements (NPA) (95.2%, 99.5%, and 99.6%) for influenza A and B viruses and RSV, respectively. In conclusion, this multicenter study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for influenza A and B viruses and RSV in ∼60 min for use at the point-of-care in the CW setting.

Quality Control of Test Systems Waived by the Clinical Laboratory Improvement Amendments of 1988

2000 ◽  
Vol 124 (8) ◽  
pp. 1122-1127 ◽  
Author(s):  
Kathleen M. LaBeau ◽  
Marianne Simon ◽  
Steven J. Steindel
Keyword(s):  
Quality Control ◽  
Home Health Care ◽  
Error Detection ◽  
Test Performance ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Ease Of Use ◽  
Test Systems ◽  
Physician Office ◽  
Clinical Laboratory Improvement Amendments

Abstract Context.—Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. Objective.—To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. Design and Setting.—Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. Results.—Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. Conclusions.—Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.

scholarly journals Cardio-Pulmonary Sequelae in Recovered COVID-19 Patients: Considerations for Primary Care

2021 ◽  
Vol 12 ◽  
pp. 215013272110237
Author(s):  
Zouina Sarfraz ◽  
Azza Sarfraz ◽  
Alanna Barrios ◽  
Radhika Garimella ◽  
Asimina Dominari ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Infection ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Case Reports ◽  
Case Series ◽  
Infectious Complications ◽  
Care Physician ◽  
Cross Sectional ◽  
Infection Period

Background: Current literature lacks characterization of the post-recovery sequelae among COVID-19 patients. This review characterizes the course of clinical, laboratory, radiological findings during the primary infection period, and the complications post-recovery. Primary care findings are presented for long-COVID care. Methods: Adhering to PRISMA guidelines, 4 databases were searched (PubMed, Embase, CINAHL Plus, Scopus) through December 5, 2020, using the keywords “COVID-19 and/or recovered and/or cardiovascular and/or long-term and/or sequelae and/or sub-acute and/or complication.” We included published peer-reviewed case reports, case series, and cross-sectional studies providing the clinical course of COVID-19 infection, and cardiopulmonary complications of patients who recovered from COVID-19, while making healthcare considerations for primary care workers. Results: We identified 29 studies across 9 countries including 37.9% Chinese and 24.1% U.S. studies, comprising 655 patients (Mean Age = 45) with various ethnical backgrounds including Asian and European. Based on the WHO COVID-19 severity classification scale, initial disease severity was mild for 377 patients and severe for 52 patients. Treatments during primary infection included corticosteroids, oxygen support, and antivirals. The mean value (in days) for complication onset after acute recovery was 28 days. Complete blood counts and RT-PCR tests were the most common laboratory results described. In 22 of the studies, patients showed signs of clinical improvement and were prescribed medications such as anticoagulants or corticosteroids. Conclusion: Post-recovery infectious complications are common in long-COVID-19 patients ranging from mild infections to life-threatening conditions. International thoracic and cardiovascular societies need to develop guidelines for patients recovering from COVID-19 pneumonia, while focused patient care by the primary care physician is crucial to curb preventable adverse events. Recommendations for real-time and lab-quality diagnostic tests are warranted to establish point-of-care testing, detect early complications, and provide timely treatment.

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