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.

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.

Abstract 13313: First Report of the New Point-of-Care TEG: a Multicenter Validation Study of the CORA® System

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Paul A Gurbel ◽  
Kevin P Bliden ◽  
Amy L Monroe ◽  
Wendi L Slusser ◽  
Martin Gesheff ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Validation Study ◽  
Strong Correlation ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Coronary Revascularization ◽  
Ease Of Use ◽  
Trauma Patients ◽  
Roc Curve Analysis ◽  
Thrombotic Risk

Background: Thrombelastography (TEG) is an established but labor intensive method for assessing global hemostasis for the management of bleeding and thrombotic risk in surgical, cardiovascular, and trauma patients. We performed the initial validation study of the first true point-of-care TEG, the CORA® (COagulation Resonance Analyzer or TEG-6S system). CORA uses resonance-frequency viscoelasticity measurements and a disposable multi-channel microfluidic cartridge to assess hemostasis and response to antiplatelet therapy. Methods: TEG assays (n=5,100) were performed from the blood of healthy volunteers (n=160) and patients undergoing coronary revascularization (n=300) collected at 3 hospitals. Quality controls were also assayed. The performance of the TEG-6S system was compared with the conventional TEG 5000 system in accordance with Clinical Laboratory Standards Institute Guidelines. Results: Regression analysis demonstrated a strong correlation (R) between the two systems by all standard measures and a lower coefficient of variation (CV %) with the CORA system at all hospitals (Table). Receiver operating characteristic (ROC) curve analysis showed an excellent correlation between platelet mapping methods (AUC≥0.90, p<0.001) and there was a substantial agreement for measuring antiplatelet response to aspirin (k=0.67, agreement=87%) and P2Y12 inhibitors (k=0.69, agreement=86%). Conclusion: The new point-of-care TEG-6S system is associated with improved precision, greater ease of use, and a strong correlation as compared to the conventional TEG 5000 system. The TEG-6S will facilitate future trials of personalized antiplatelet therapy and improve the assessment of bleeding and thrombotic risk in cardiovascular, surgical, and trauma patients.

scholarly journals ASSESSMENT OF PERFORMANCE AND IMPLEMENTATION CHARACTERISTICS OF RAPID POINT OF CARE SARS-CoV-2 ANTIGEN TESTING IN KENYA

2021 ◽  
Author(s):  
Jesse Gitaka ◽  
Eva Muthamia ◽  
Samuel Mbugua ◽  
Mary Mungai ◽  
Gama Bandawe ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Test Performance ◽  
Gold Standard ◽  
Point Of Care ◽  
Turnaround Time ◽  
Ease Of Use ◽  
Control Measures ◽  
Antigen Test ◽  
Rt Pcr ◽  
Predictive Values

Abstract Background: The COVID-19 pandemic has resulted in a need for rapid identification of infectious cases. Testing barriers have prohibited adequate screening for SARS COV2, resulting in significant delays in treatment provision and commencement of outbreak control measures. This study aimed to generate evidence on the performance and implementation characteristics of the BD Veritor rapid antigen test as compared to the gold standard test for diagnosis of SARS COV2 in Kenya. Methods: This was a field test performance evaluation in symptomatic and asymptomatic adults undergoing testing for SARS COV2. Recruited participants were classified as SARS-CoV2-positive based on the locally implemented gold standard reverse transcription polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swabs. 272 antigen tests were performed with simultaneous gold standard testing, allowing us to estimate sensitivity, specificity, positive and negative predictive values for the BD Veritor rapid antigen test platform. Implementation characteristics were assessed using the Consolidated Framework for Implementation Research for feasibility, acceptability, turn-around time, and ease-of-use metrics. Results and Discussion: We enrolled 97 PCR negative symptomatic and 128 PCR negative asymptomatic, and 28 PCR positive symptomatic and 19 PCR positive asymptomatic participants. Compared to the gold standard, the sensitivity of the BD Veritor antigen test was 94% (95% confidence interval [CI] 86.6 to 100.0) while the specificity was 98% (95% confidence interval [CI] 96 to 100). The sensitivity of BD Veritor antigen test was higher among symptomatic (100%) compared to asymptomatic (84%) participants, although this difference was not statistically significant. There was also a lack of association between cycle threshold value and sensitivity of BD Veritor test. The BD Veritor test had quick turnaround time and minimal resource requirements, and laboratory personnel conducting testing felt that it was easier to use than the gold standard RT-PCR. Conclusion: The BD Veritor rapid antigen test exhibited excellent sensitivity and specificity when used to detect SARS-CoV-2 infection among both symptomatic and asymptomatic individuals in varied population settings in Kenya. It was feasible to implement and easy to use, with rapid turnaround time.

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.

scholarly journals ASCLS Annual Meeting 2017: Official Abstracts of Submitted Papers, Case Studies and PostersEffective Incorporation of Performance Standards in Quality Control SystemsSubmandibular ZygomycosisRisk Management and Quality Control in Mass SpectrometryThe Significance of the Laboratory in the Work Up and Monitoring of Seemingly Independent Illnesses That In Fact Were InterrelatedThe Education Gap in Clinical MicrobiologyValidation of an Allelic Discrimination Assay for Drug MetabolismDevelopment of a High Resolution Melt Curve Assay to Detect Sickle Cell DiseasePhytochemical Effects on Bacterial BiofilmField Evaluation of Onsite Monitors for Surface Contamination by 5-fluorouracilComparison of Test Results for IHC, FISH and NGS when Screening for Molecular MarkersSevere Factor VII Deficiency in a NewbornValidation of Vysis LSI ALK and ROS1 Break Apart FISH ProbesA Prospective Study of Patients Diagnosed with Sarcoidosis: Nutrition, Health Assessment and Environmental ExposuresAssessment of Intake of Cinnamon Supplements on Hemoglobin A1c Levels in Pre-DiabeticsNGS Testing Helps to Identify New Treatment Opportunities for Advanced Solid Tumor Cancers Driven by Molecular AlterationsCause and Concern for Patients with B- cell Lymphoproliferative DisordersOral Presentation AbstractsInpatient Utilization of Point of Care Glucose Concomitant TestingWhat is That Bug in My Blood?Effects of Blood Banking Advanced Technology Practice Prior to Clinical Rotations on Clinical Laboratory Science Student OutcomesPlanting Your Lab Garden with Your OWN Seeds: A Novel Approach to the Laboratory Professional Shortage

2017 ◽  
Vol 30 (3) ◽  
pp. 161-170
Author(s):  
Selom Agboyi ◽  
Sean Ahrens ◽  
Zoe C. Brooks ◽  
Demetra Castillo ◽  
Ryan Cordner ◽  
...  
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Health Assessment ◽  
Performance Standards ◽  
Advanced Technology ◽  
Factor Vii ◽  
High Resolution Melt ◽  
Allelic Discrimination Assay ◽  
Allelic Discrimination

Simplified formats of modern biosensors: 60 years of using immunochromatographic test systems in laboratory diagnostics

2020 ◽  
Vol 65 (10) ◽  
pp. 611-618
Author(s):  
Boris Georgievich Andryukov ◽  
I. N. Lyapun ◽  
M. P. Bynina ◽  
E. V. Matosova
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Diagnostic Tools ◽  
Modern World ◽  
Laboratory Diagnostics ◽  
Analytical Sensitivity ◽  
Immunochromatographic Test ◽  
Emergency Situations ◽  
Advantages And Disadvantages ◽  
Test Systems

Immunochromatographic test systems known to foreign laboratory diagnostic experts as lateral flow immunoassay (LFIA) are simplified tape formats of modern biosensors. For 60 years, they have been widely used for the rapid detection of target molecules (ligands) in biosubstrates and the diagnosis of many diseases and conditions. The growing popularity of these test systems for providing medical care or diagnostics in developing countries, medical facilities, in emergency situations, as well as for individual home use by patients while monitoring their health are the main factors contributing to the continuous development and improvement of these methods, the emergence of a new generation of formats. The attractiveness and popularity of these fast, easy-to-use, inexpensive and portable diagnostic tools is associated primarily with their high analytical sensitivity and specificity, as well as the ease of interpretation of the results. These qualities have passed the test of time, and today LFIA test systems are fully consistent with the modern world concept of «point-of-care testing», finding wide application not only in medicine, but also in ecology, veterinary medicine, and agriculture. This review will highlight the modern principles of designing the most widely used formats of immunochromatographic test systems for clinical laboratory diagnostics, summarize the main advantages and disadvantages of the method, as well as current achievements and prospects of LFIA technology. Modern innovations aimed at improving the analytical characteristics of LFIA technology are interesting, promising and can bring additional benefits to immunochromatographic platforms that have gained popularity and attractiveness for six decades.

scholarly journals Unique Approach to Quality Assurance in Viscoelastic Testing

2020 ◽  
Vol 5 (6) ◽  
pp. 1228-1241 ◽  
Author(s):  
Nicole H Leadbetter ◽  
Thomas B Givens ◽  
Francesco Viola
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Central Laboratory ◽  
Control Plan ◽  
Coagulation Function ◽  
Core Technology ◽  
Unique Approach ◽  
New Generation ◽  
Precision Testing

Abstract Background The Quantra QPlus System is a novel viscoelastic testing (VET) device designed for the management of coagulation function in critical care settings. The system is indicated and approved for use at the point-of-care and designed for use by nonlaboratory personnel. Methods We describe the comprehensive set of internal QC checks implemented in the Quantra and demonstrate the system’s unique capabilities made possible by its ultrasound core technology. Single- and multisite precision testing were performed following Clinical Laboratory Standards Institute guidelines and included multiple days of testing, multiple instruments, multiple lots of cartridges and controls, and multiple operators. Results Percent CVs for total imprecision were 3.6% to 8.0% for all measured parameters. CVs for replicate imprecision (“repeatability”) were 2.7% to 7.7% for all measured parameters. Replicate imprecision was the largest component of variability for most parameters. Conclusions The Quantra QPlus System is a new-generation cartridge-based VET device that can operate with reduced oversight from the central laboratory while easily integrating into the Individualized Quality Control Plan framework.

scholarly journals Clinical Test Performance of a Rapid Point-of-Care Syphilis Treponemal Antibody Test: A Systematic Review and Meta-analysis

2020 ◽  
Vol 71 (Supplement_1) ◽  
pp. S52-S57
Author(s):  
Claire C Bristow ◽  
Jeffrey D Klausner ◽  
Anthony Tran
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Test Performance ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Meta Analysis ◽  
Treponema Pallidum ◽  
Antibody Test ◽  
Health Check ◽  
Clinical Test

Abstract We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, “What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum.” The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1–100%), while pooled specificity was 95.9% (81.5–100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8–97.2%), while pooled specificity was 96.7% (91.9–99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8–98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.

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.

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