Advertisement

Topics

Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany.

08:00 EDT 14th September 2018 | BioPortfolio

Summary of "Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany."

Measurement of HbA1c is an essential laboratory measure for the follow-up and therapy decision-making in patients with diabetes. HbA1c is one of the measurands in laboratory medicine that have to be successfully checked according to the criteria of the guidelines of the German Medical Association (Rili-BAEK) in external quality assurance using the reference method value concept, when applied in patient care. The allowed deviation of ±18% in external quality assessment (EQA) and ± 10% in internal quality control has been ultimately met by virtually all the different manufacturers and methods. However, such broad limits for permissible deviations are not suitable in view of medical requirements in patient care. The low-level acceptance criteria also depends on the previously used EQA materials used in Germany. In fact, HbA1c measurement results that are imprecisely measured or come from incorrectly calibrated devices are difficult to identify. With implementation of unprocessed fresh EDTA blood, the situation has changed. Until now systems with unit use reagents for point-of-care testing (POCT) of HbA1c are not mandatory to participate in EQA schemes in Germany. This paper outlines why there was a need to narrow the acceptance limits listed within the Rili-BAEK for HbA1c's internal (to ± 3%) and external (to ± 8%) quality controls in EQA schemes for Germany, which will take place after a transition period in the next years. Higher quality in HbA1c measurements will help to avoid misdiagnosis of diabetes as well as potential over- or undertreatment of patients at risk for diabetes.

Affiliation

Journal Details

This article was published in the following journal.

Name: Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme
ISSN: 1439-4286
Pages:

Links

DeepDyve research library

PubMed Articles [27726 Associated PubMed Articles listed on BioPortfolio]

Correction: Higher HbA1c Measurement Quality Standards are Needed for Follow-Up and Diagnosis: Experience and Analyses from Germany.

Performance evaluation of HbA1c measurement systems with sigma metric for 1066 laboratories in China.

This study aimed to evaluate the performance of HbA1c measurement systems quantitatively with sigma metric and promote the quality improvement.

Anemia modifies the prognostic value of glycated hemoglobin in patients with diabetic chronic kidney disease.

A common complication of chronic kidney disease (CKD), anemia can influence glycated hemoglobin (HbA1c) levels. In diabetic patients, anemia occurs earlier and with higher severity over the course of ...

How Do You Measure Up: Quality Measurement for Improving Patient Care and Establishing the Value of Infectious Diseases Specialists.

The shift from volume-based to value-based reimbursement has created a need for quantifying clinical performance of ID physicians. Nationally recognized ID specialty-specific quality measures will all...

Evidence for the utility of antenatal HbA1c to predict early postpartum diabetes after gestational diabetes in South Africa.

Aim To evaluate antenatal HbA1c at diagnosis and in the 4 weeks preceding delivery to predict early postpartum diabetes mellitus (DM) in women with Gestational Diabetes Mellitus (GDM). Methods Seventy...

Clinical Trials [13063 Associated Clinical Trials listed on BioPortfolio]

Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites: ...

Determination of Cut-off Value of AGEsP and HbA1c in Type 2 Diabetes Diagnosis in China

Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China

Transplants With Unlicensed Preserved Cord Blood

Background: - Cord blood transplants can treat cancers and other diseases in children and adults. The U.S. Food and Drug Administration (FDA) requires cord blood to be collected and store...

Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers

Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophre...

BIO REsponse Adapted Combination Therapy Pilot Study

Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, ...

Medical and Biotech [MESH] Definitions

A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.

Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.

Norms, criteria, standards, and other direct qualitative and quantitative measures used in determining the quality of health care.

The levels of excellence which characterize the health service or health care provided based on accepted standards of quality.

Measurement of parameters of the speech product such as vocal tone, loudness, pitch, voice quality, articulation, resonance, phonation, phonetic structure and prosody.

Advertisement
Quick Search
Advertisement
Advertisement

 


DeepDyve research library

Searches Linking to this Article