Related Experiment Video

Updated: Oct 21, 2025

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
05:58

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes

Published on: March 22, 2022

4.2K

Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT

Anders Abildgaard1,2, Cindy Søndersø Knudsen3, Lise Nørkjær Bjerg4

  • 1Department of Clinical Biochemistry, Regional Hospital Horsens, Horsens, Denmark.

Clinical Chemistry and Laboratory Medicine
|September 4, 2021
PubMed

Insights

Point-of-care testing (POCT) for glycated haemoglobin A1c (HbA1c) using the Siemens DCA Vantage™ shows analytical imprecision and variability due to reagent lots and instruments. This highlights the need for rigorous validation and collaboration in POCT for diabetes management.

Area of Science:

  • Clinical Chemistry
  • Point-of-Care Testing (POCT)
  • Diabetes Mellitus Management

Background:

  • Glycated haemoglobin A1c (HbA1c) is crucial for diabetes management.
  • Siemens DCA Vantage™ offers rapid HbA1c results via POCT.
  • Concerns exist regarding the analytical performance of POCT HbA1c methods.

Purpose of the Study:

  • To compare the analytical performance of the Siemens DCA Vantage™ POCT instrument with established routine methods (Tosoh G8/G11 HPLC).
  • To evaluate the impact of reagent lot, instrument, and operator on DCA Vantage™ HbA1c results in a clinical setting.

Main Methods:

  • Retrospective analysis of 960 routine clinical HbA1c results from the same patient within 48 hours.
  • Prospective method comparison with 97 patients in a diabetes out-patient clinic.
  • Evaluation of reagent lot, operator, and instrument effects on DCA Vantage™ performance.

Main Results:

  • The critical difference (CD) for DCA Vantage™ HbA1c results ranged from 5.14 to 6.61 mmol/mol (0.47-0.55%).
  • Analytical imprecision (CVA) of the DCA Vantage™ exceeded 3%.
  • Significant effects of reagent lot and inter-instrument variability were observed; operator had no significant effect.

Conclusions:

  • The DCA Vantage™ HbA1c assay does not meet current analytical performance specifications.
  • Rigorous validation of new reagent lots and instrument recalibration are essential for improving precision.
  • Close collaboration between clinicians and laboratory professionals is vital for effective POCT implementation.
  • POCT HbA1c results require careful interpretation alongside other glycemic control measures to prevent treatment errors.
Abstract

Keywords:
clinical laboratory techniquesglycated haemoglobin Apoint-of-care testing

More Related Videos

A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy07:24

A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy

1.8K
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model23:56

Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model

Published on: October 31, 2010

16.9K

Related Concept Videos

Variability: Analysis01:11

Variability: Analysis

Measures of variability are statistical metrics that reveal the dispersion pattern within a dataset. They are pivotal in biostatistics, providing insights into the heterogeneity within health and biological data. Variability signifies the degree to which data points diverge from one another, helping researchers understand the potential range of values and associated uncertainty within the data.
The range is a simple measure of variability, indicating the difference between the highest and...
235
Difference from Background: Limit of Detection01:05

Difference from Background: Limit of Detection

The limit of detection (LOD) is the smallest amount of analyte that can be distinguished from the background noise. The LOD value corresponds to the concentration at which the analyte signal is three times larger than the standard deviation of the blank signal. Below this value, the analyte signal cannot be differentiated from the background noise. It is calculated by dividing the calibration slope by 3 times the standard deviation of the blank signals.
The LOD indicates the presence or absence...
7.4K
Errors occurring during blood pressure monitoring01:25

Errors occurring during blood pressure monitoring

Blood pressure monitoring is a crucial clinical procedure in diagnosing and managing various cardiovascular conditions. Despite its significance, the accuracy of blood pressure measurements can be compromised by multiple factors, potentially leading to either falsely high or low readings. These inaccuracies are critical as they can significantly impact patient care. So, it is vital to understand these challenges deeply and adopt strategic approaches to minimize errors.
Several factors...
1.0K
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
19
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
41
Volume of Distribution01:20

Volume of Distribution

The apparent volume of distribution (Vd) is a crucial pharmacokinetic parameter representing the hypothetical body fluid volume into which a drug disperses. It is calculated based on the total amount of drug in the body (estimated from the administered dose and bioavailability) divided by the plasma drug concentration. The total amount of drug in the body does not directly refer to the dose given but is derived by accounting for absorption, distribution, metabolism, and excretion processes.
632