The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring.

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems.

Point-of-care testing: state-of-the art and perspectives.

Point-of-care testing (POCT) is becoming an increasingly popular way to perform laboratory tests closer to the patient. This option has several recognized advantages, such as accessibility, portability, speed, convenience, ease of use, ever-growing test panels, lower cumulative healthcare costs when used within appropriate clinical pathways, better patient empowerment and engagement, and reduction of certain pre-analytical errors, especially those related to specimen transportation. On the other hand, POCT also poses some limitations and risks, namely the risk of lower accuracy and reliability compared to traditional laboratory tests, quality control and connectivity issues, high dependence on operators (with varying levels of expertise or training), challenges related to patient data management, higher costs per individual test, regulatory and compliance issues such as the need for appropriate validation prior to clinical use (especially for rapid diagnostic tests; RDTs), as well as additional preanalytical sources of error that may remain undetected in this type of testing, which is usually based on whole blood samples (i.

Evaluation of a Rapid Drug Test Device for Urine Fentanyl Compared to Mass Spectrometry and 2 Urine Fentanyl Assays.

Background: A new Rapid Drug Test Device (RDTD) is available for analysis of urine fentanyl. With the rise in fentanyl abuse in the United States, we evaluated the analytical performance of the RDTD test strip compared to mass spectrometry and 2 urine fentanyl immunoassays.

Methods: Leftover, deidentified urine samples collected from inpatients and outpatients from our psychiatric hospital and other clinics were frozen at <-70°C, thawed at room temperature, and centrifuged.

Validation and verification framework and data integration of biosensors and diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division.

Advances in technology have transformed healthcare and laboratory medicine. Biosensors have emerged as a promising technology in healthcare, providing a way to monitor human physiological parameters in a continuous, real-time, and non-intrusive manner and offering value and benefits in a wide range of applications. This position statement aims to present the current situation around biosensors, their perspectives and importantly the need to set the framework for their validation and safe use.

Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems.

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC) that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing.

Implementing Individualized quality control plans and managing risk at the point-of-care for molecular diagnostics.

Introduction: Faster turnaround times can lead to rapid patient treatment. Implementing a point-of-care (POC) molecular COVID-19 test requires careful planning. In the POC setting, there are numerous operators and regular monitoring of their activities is key to the successful implementation of a POC molecular test.

Reliability of Handheld Blood Glucose Monitors in Neonates: Trustworthy Arterial Readings but Capillary Results Warrant Caution for Hypoglycemia.

Background: Accurate glucose monitoring is vitally important in neonatal intensive care units (NICUs) and clinicians use blood glucose monitors (BGM), such as the Inform II, for bedside glucose monitoring. Studies on BGM use in neonates have demonstrated good reliability; however, most studies only included healthy-term neonates. Therefore, the applicability of results to the preterm and/or ill neonate is limited.

Comparison of Hb A1c Quantification in the Presence of Hemoglobin Variants of an HPLC Assay with an Enzymatic Assay.

Background: In this study, we evaluated the impact of hemoglobin (Hb) variants on the performance of the Abbott Alinity c and Bio-Rad Variant II Turbo 2.0 HPLC Hb A1c assays.

Methods: The analytical performance of the Abbott Alinity c Hb A1c (enzymatic) assay was compared to the Bio-Rad Variant II Turbo 2.

Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting.

The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022.

Time to address quality control processes applied to antibody testing for infectious diseases.

As testing for infectious diseases moves from manual, biological testing such as complement fixation to high throughput automated autoanalyzer, the methods for controlling these assays have also changed to reflect those used in clinical chemistry. However, there are many differences between infectious disease serology and clinical chemistry testing, and these differences have not been considered when applying traditional quality control methods to serology. Infectious disease serology, which is highly regulated, detects antibodies of varying classes and to multiple and different antigens that change according to the organisms' genotype/serotype and stage of disease.

AACC Guidance Document on the Use of Point-of-Care Testing in Fertility and Reproduction.

Background: The AACC Academy revised the reproductive testing section of the Laboratory Medicine Practice Guidelines: Evidence-Based Practice for Point-of-Care Testing (POCT) published in 2007.

Methods: A panel of Academy members with expertise in POCT and laboratory medicine was formed to develop guidance for the use of POCT in reproductive health, specifically ovulation, pregnancy, premature rupture of membranes (PROM), and high-risk deliveries. The committee was supplemented with clinicians having Emergency Medicine and Obstetrics/Gynecology training.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.

Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia.

Continuous Ketone Monitoring Consensus Report 2021.

This article is the work product of the Continuous Ketone Monitoring Consensus Panel, which was organized by Diabetes Technology Society and met virtually on April 20, 2021. The panel consisted of 20 US-based experts in the use of diabetes technology, representing adult endocrinology, pediatric endocrinology, advanced practice nursing, diabetes care and education, clinical chemistry, and bioengineering. The panelists were from universities, hospitals, freestanding research institutes, government, and private practice.

Utilizing Point-of-Care Testing to Optimize Patient Care.

Background: Point-of-Care Testing (POCT) is clinical laboratory testing conducted close to the site of patient care. POCT provides rapid turnaround of test results with the potential for fast clinical action that can improve patient outcomes compared to laboratory testing.

Methods: Review the advantages of POCT and discuss the factors that are driving the expansion of POCT in modern healthcare.

Clinical Validation of a Novel Quality Management System for Blood Gas, Electrolytes, Metabolites, and CO-Oximetry.

Background: Quality management of point-of-care (POC) blood gas testing focuses on verifying instrument accuracy and precision, in addition to performing daily quality control (QC) checks every 8 h and with each patient test (unless internal calibration is verified every 30 min). At the POC, a risk-based approach is suitable to address both systemic and transient sample-specific errors that may negatively impact patient care.

Methods: We evaluated the performance of the GEM® Premier™ 5000 with next generation Intelligent Quality Management 2 (iQM®2) (Instrumentation Laboratory, Bedford, MA), from the analysis of approximately 84,000 patient samples across 4 sites.

A Survey of Sigma Metrics across Three Academic Medical Centers.

Background: Sigma metric calculations provide laboratories an objective means to assess analytical method performance. Methods with higher sigma values are desirable because they are more reliable and may use less frequent quality control in order to maintain optimal performance. Sigma metrics can also serve as a tool when comparing method performance across assay and manufacturer platforms.

Digital Diagnostics and Mobile Health in Laboratory Medicine: An International Federation of Clinical Chemistry and Laboratory Medicine Survey on Current Practice and Future Perspectives.

Background: A survey of IFCC members was conducted to determine current and future perspectives on digital innovations within laboratory medicine and healthcare sectors.

Methods: Questions focused on the relevance of digital diagnostic solutions, implementation and barriers to adopting digital technologies, and supplier roles in supporting innovation. Digital diagnostic market segments were defined by solution recipient (laboratory, clinician, patient/consumer, payor) and proximity to core laboratory operations.

A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients.

Background: Our purpose was to evaluate the performance of the ACCU-CHEK® Inform II blood glucose monitoring system (Roche Diagnostics GmbH) compared with the perchloric acid hexokinase (PCA-HK) comparator method on the cobas® 6000 analyzer (Roche Diagnostics International Ltd) in critically ill patients.

Methods: Overall, 476 arterial (376 pediatric/adult, 100 neonate), 375 venous, and 100 neonatal heel-stick whole-blood samples were collected and evaluated from critical care settings at 10 US hospitals, including the emergency department, medical and surgical intensive care units (ICUs), and neonatal and pediatric ICUs. The ACCU-CHEK Inform II system was evaluated at 2 cutoff boundaries: boundary 1 was ≥95% of results within ±12 mg/dL of the reference (samples with blood glucose <75 mg/dL) or ±12% of the reference (glucose ≥75 mg/dL), and boundary 2 was ≥98% of results within ±15 mg/dL or ±15% of the reference.

Standardization process of continuous glucose monitoring: Traceability and performance.

People with diabetes are required to regularly check their glucose to make therapy decisions. So far, systems for self-monitoring of blood glucose were used, but nowadays minimally invasive continuous glucose monitoring (CGM) systems are increasingly more often employed, sometimes to partially replace self-monitoring of blood glucose. Most CGM systems on the market measure glucose concentrations continuously in the interstitial fluid of the subcutaneous fatty tissue.