Glucose EQA for use with Hemocue Glucose analysers
Description
 


External Quality Assessment Scheme for Blood Glucose


EQA (External Quality Assessment) Schemes provide essential information regarding the precision and accuracy of analytical systems on a regular basis. (An analytical system comprises the analyser, analytical reagents and, of course, the operator).

All data is collated and entered onto the EuroTrol interactive website before a predetermined deadline. Thereafter summary reports can be downloaded and redistributed to participants by conventional means or where possible and convenient, reviewed via individually password protected access to the website. Prospect Diagnostic’s EQA team will co-ordinate all aspects of the scheme including data acquisition and summary report distribution for all participants who do not have internet access themselves.

This EQA Scheme has been originated and developed as a minimal cost additional service for HemoCue users throughout the UK. We trust that you will appreciate the benefits of becoming a subscriber.

If you require any further explanation, information or assistance, I would encourage you to contact Vanessa Silk on 01246 292955 or by e-mail vanessa.whitworth@prospectdiagnostics.co.uk
.


Intended Purpose

EQAS for Glucose is an External Quality Assessment Scheme intended for professional use in the verification of the precision and accuracy of hand-held glucose meters.

IVD Medical Device

The EQAS for Glucose control complies with the IVD Directive 98/79/EC for Medical Devices and carries the CE mark.

Summary

Eurotrol EQAS for Glucose is an external quality control with a certain glucose concentration. EQAS for Glucose has been prepared from fresh pooled human whole blood, to which glucose and preservatives have been added. It is intended that EQAS for Glucose should be used in the periodic verification of the precision and accuracy of hand-held glucose meters, with the use of the website
www.eurotrol.com. The EQAS databse on this site offers the opportunity to obtain real-time information about the performance of your meter.

Reagents

Eurotrol EQAS for Glucose provides each month a different level, each vial holding 0.5mL fresh human whole blood. The clinically relevant range will be covered throughout the year.

Storage and Stability

Eurotrol EQAS for Glucose controls should be stored unopened at room temperature (15-30°C). Stored unopened at this temperature it is guaranteed stable for five days until the expiry date, as indicated on the vials and outer box. After opening the vial, the material should be used within 1 hour.

Procedures

1. Treat the material as a fresh patient sample.
2. Gently mix the vial 8-10 tomes before sampling.
3. Open the vial.
4. Discard the first drop.
5. Apply the next drop of the quality control material to the microcuvette according to the instuctions in the appropriate manual of the glucose meter.
6. This product may only be used once with one glucose meter.
7. Book your result into the EQAS database at the web page
www.eurotrol.com and click the EQAS button.

Precautions

EQAS for Glucose is an External Quality Assessment Scheme intended for professional use in the verification of the precision and accuracy of hand-held glucose meters.

1. For in vitro diagnostic use only.
2. Human Blood Product. Human based material is tested on HbsAg, a-HCV, a-HIV, HIV-NAT, a-HTLV, TPPA and found negative.
3. This product should not be disposed of in general waste. Consult local environmental authorities for proper disposal.

Reference Values

Accuarcy can be validated versus the following Reference Methods: Hexokinase, YSI and Glucose Dehydrogenase. These reference values are determined by the reference laboratory at Isala Klinieken, The Netherlands. The reference values are available on the EQAS database of
www.eurotrol.com. Also a detailed description of how these reference methods are carried out is given on the FAQ section of the webiste. Participants can also specify Group Median/Average or a custom value as a reference method.