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1、Hemoglobin A1c in Blood, DCA 2000+ RL.22.03 Michigan Regional Laboratory SystemJuly 2008Hemoglobin A1c in Blood, DCA 2000+ I.Purpose: Hemoglobin A1c is a quantitative method for measuring the percent concentration of hemoglobin A1c in blood. The term glycosylated hemoglobin (A1c) refers collectively
2、 to a series of stable compounds that are formed between hemoglobin and sugars. Their concentrations are increased within erythrocytes of patients with diabetes mellitus. The level of hemoglobin A1C is proportional to the level of serum glucose over a period of two months. Thus, hemoglobin A1C is co
3、nsidered to be an indicator of the mean daily blood glucose concentration over the preceding two months.The measurement of hemoglobin A1c concentration is recommended for monitoring the long-term care of persons with diabetes. The American Diabetes Association recommends measurement of hemoglobin A1
4、c levels two to four times per year, less frequently in patients with stable control. The aim of therapy by clinicians is to maintain patient glucose levels at constant normal or near normal levels in the blood.II.Specimen: Whole blood may be obtained from a finger prick or venipuncture. Acceptable
5、anticoagulants are EDTA, heparin, citrate and fluoride/oxalate. Clotted specimens are unacceptable. Reject the clotted specimen and request a new sample from the client for analysis.The provided glass capillary (within plastic capillary holder) holds 1l of blood. This system must be used for this pr
6、ocedure. NOTE: Once the glass capillary is filled with the sample, analysis must begin within 5 minutes.EDTA, heparin, fluoride/oxalate and citrate preserved whole blood may be stored at -70 degrees C to -5 degrees C for two weeks, or up to 25 degrees C for one week. Do not refreeze previously froze
7、n samples or store in a self-defrosting freezer. Allow blood sample to reach room temperature. Mix blood sample thoroughly before use. III.Materials and Equipment: A.DCA 2000 Hemoglobin A1C Reagent Kit, Bayer HealthCare, Cat. No. 5035. Materials Supplied With Kit 1.Capillary holders 2.Calibration ca
8、rd 3. Reagent cartridges B.Materials not Supplied with Kit 1.Kimwipes or gauze 2.Disposal exam gloves latex or equivalent 3.Biohazard sharps/waste container 4.Disinfectant for work areaHemoglobin A1c in Blood, DCA 2000+ RL.22.03 Michigan Regional Laboratory SystemJuly 20085.QC Log Sheet 6.Daily Pati
9、ent Log Sheet 7.DCA 2000+ Analyzer C.Shipping and handling 1.Upon receipt of the kit, check the temperature indicator located on the inside of the top lid of the carton. If the indicator has turned red, the reagent cartridges should not be used. Note time and date received, and for assistance in obt
10、aining a replacement kit, refer to the instructions given on the carton. 2.Storage Conditions: Store reagent cartridges refrigerated at 2-8 degrees C (36-46 degrees F). Capillary holders may be stored refrigerated or at room temperature. Reagent cartridges can be kept for up to three months at room
11、temperature anytime before the expiration date. Do not use reagent cartridges after the last day of the expiration month. 3.Handling Cartridges: To open, tear down from corner notch (until entire long side of pouch is open). Discard the reagent cartridge if the cartridge is damaged, the pull-tab is
12、loose or missing, the desiccant is missing, or if loose desiccant particles are found inside the foil pouch. Upon removal from refrigerated storage, allow the reagent cartridge to warm up at room temperature for 10 minutes (in unopened foil pouch) or five minutes (if removed from foil pouch). After
13、opening foil pouch, the reagent cartridge must be used within 1 hour. 4.Handling Capillary Holders: Unused capillary holders may be stored and used with any lot of reagent cartridges. Each capillary holder is packaged separately in a blister package. To remove the capillary holder, remove the white
14、plastic film from the clear plastic blister. DO NOT PUSH the capillary holder out of or through the plastic. Discard the plastic capillary holder if any of the following are missing from the holder: absorbent pad, glass capillary, latching mechanism. D.Maintenance (to be done quarterly) 1.Check the
15、air filter and change when needed. 2.Clean the cartridge compartment 3.Run the optical test cartridge. III.SAFETY Wear disposable examination gloves and a lab coat for personal protective equipment. . Use universal precautions when handling all blood and blood products. Treat all specimens as if the
16、y contained an etiologic agentHemoglobin A1c in Blood, DCA 2000+ RL.22.03 Michigan Regional Laboratory SystemJuly 2008IV.Quality Control: A.A control kit that includes 2 normal and 2 abnormal blood controls can be purchased through Bayer, product number 5068. The instructions for preparation of these controls are as follows: B.Reconstitution of Controls: 1.Remove the control bottle(s) from refrigerator just prior t
