Abbott Precision XceedPro Manuel de l'opérateur télécharger pdf (Page 2)

Title (with LTR): Precision Xceed Glucose Procedure (LTR19678)

Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:20:23 PM)

Purpose

This document outlines policies and procedures that deal with the test being described. In an effort to be concise

some information may be excluded from the manufacturer’s manual. It is recommended that operators familiarize

themselves with the manufacturer’s product information that accompanies each package and their manual.

Scope

Level of Personnel: All MD’s, RNs, NPs, PCAs, and

MAs, who have successfully completed initial training and

maintained annual competency.

Testing Site: All sites approved and on file with the

Pathology Service POCT Division.

Policy and Principle Statement

 To obtain a quantitative measure of blood glucose measurement that is used definitively for the purpose of care.

Test Principle

The Precision Xceed Pro System allows rapid measurement of blood glucose (D-glucose) by using an electrochemical

detection technique. This biosensor system employs a disposable dry reagent strip technology, based on the glucose

dehydrogenase method for glucose determination. Each test strip features an electrode containing the enzyme

glucose dehydrogenase (GDH-NAD). When a blood drop is applied to the target area of the test strip, the glucose

dehydrogenase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons

are transferred by a co-enzyme and an electrochemical mediator to the electrode surface. This will generate a current

that is measured by the system. The size of the current generated is proportional to the amount of glucose present in

the blood drop, thus giving an accurate reading of the blood glucose concentration.

Regulatory Requirements

1. Each testing site must have a documented quality control program, which is developed in collaboration with or

has been approved by the MGH Pathology Service.

2. All test results must be maintained in patient records with all required information for four years

Required information:

1. Patient’s name

2. MRN number

3. Patient’s gender

4. Patient’s age or date of birth

5. Date & time test collected, performed and reported

6. Ordering Physician

7. Responsible physician (if not 6)

8. Reference or Target Range

9. Test Performed

10. Test units

11. Lab name

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Abbott Precision XceedPro Manuel de l'opérateur Page 2