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Development of Control Material for Erythrocyte Sedimentation Rate (ESR)
The erythrocyte sedimentation rate (ESR) remains the most widely used laboratory test for monitoring the course of infections, inflammatory diseases, and some types of cancer. In an era of quality assurance and accreditation of medical laboratories, great attention should be given to quality control and quality assurance for ESR measurement. In clinical laboratories, the use of appropriate control materials is required for monitoring the accuracy and precision of the routine method. Clearly, there is a need to develop a control material for ESR measurement with increased the accuracy and stability. The present invention is a ESR control material designed to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens.
Technology Features, Specifications and Advantages
The aim of this intervention is to develop and evaluate control material for the quality control and the External Quality Assessment (EQA) of ESR in clinical laboratories.
The technology comprises a two-phase suspension suitable for use as an ESR control, the suspension possessing the following two components:
- A synthetic plasma base comprises a carrying buffer that, in conjunction with the aggregating agent, high molecular weight polymer or combination of high molecular weight polymers, produces predictable and reproducible red blood cell sedimentation rate values for a given ESR testing apparatus and method
- Chemical fixing of the red blood cells that provides the ESR control with the capability of providing useful results in the presence of citrate and/or saline.
The technology provider reports their ESR control material can be analyzed by both Westergren method and automated machine. Based on ISO13528:2015, homogeneity of the material was verified by the duplicate analysis of ten random samples. The results also proved that the inter-sample variation was negligible. Moreover, after storage for up to 4 weeks at 2-8 °C, the ESR control material showed similar patterns to the initial value.
Advantages of the current ESR control material
- Compatible with all diluents including 3.8% sodium citrate, normal saline buffer
- Provides sedimentation of red blood cells at a substantially constant
- Predictable and reproducible sedimentation rates
This ESR control material will be used for IQC and EQA program to monitor the accuracy and precision of the ESR measurement
The technology provider has established the EQA program to support clinical laboratories including hospital laboratories, lab company, private clinical laboratory, laboratories of institute in Thailand.
Benefits of the technology:
- Help laboratories determine their performance
- Troubleshoot and resolve any problem areas by assessing instruments and reagents using the ESR control material