Performing a Hemoglobin A1c Test Job Aid

SIEMENS Performing a Hemoglobin A1c Test on the DCA Vantagem Analyzer DCA Vantage Analyzer READ THIS GUIDE BEFORE PERFORMING A TEST. TEST QUALITY CONTROLS AS DIRECTED ON REVERSE SIDE. For the quantitative measurement of the percent concentration of Hemoglobin A1c in blood. Note information regarding CLIA waiver on reverse side. .... .... Getting Started . If the screen saver is on, select any part of the touchscreen. . If an error message displays, select OK and follow the messages. SIEMENS . No special skills are required. Testing Materials DCA Systems . A Calibration Card is provided with each Reagent Kit. · DCA Systems HbA1c cartridge CE . Refer to the Operator's Guide and Package Inserts for more LOT . Capillary holder 9544 information on entering calibration, analyzing controls, handling Tissue and disposal of biohazardous material, and more system details. Note: _ You can select Help at any time for further assistance. STEP Collecting a Blood Sample 1 Touch the tip of the capillary to a small drop of blood until the capillary is filled. STEP Cleaning the Capillary 2 Wipe the side of the capillary tube with a tissue. A Inserting the Capillary STEP SIEMENS 3 Insert the capillary holder into a cartridge DCA Systems (flat side toward cartridge) until the holder CE snaps into place. LOT 9544 Bring the cartridge to room temperature before use, if refrigerated. Refer to the Reagent Kit package insert for product limitations, interferences, storage, and expiration date. Do not use the cartridge past the expiration date. If an error occurs, follow screen prompts or consult the DCA Vantage Operator's Guide. For technical support questions or comments, call (877) 229-3711. Continues on Reverse Side SIEMENS Performing a Hemoglobin A1c Test on the DCA Vantage Analyzer DCA Vantage® Analyzer Scanning the Cartridge 1. Hold the cartridge so that the barcode faces to the right STEP 2. Insert the cartridge into the barcode track above 4 the dot. SIEMENS CE DCA' Systems 3. Quickly and smoothly, slide the cartridge down. A beep and display change indicate a successful scan; repeat if not successful. Inserting the Cartridge 1. Hold the cartridge so that the barcode STEP faces to the right. 5 2. Open the door and insert the cartridge into the compartment until a click is heard. SIEMENS 3. Slowly and firmly pull to remove the flexible tab. 4. Close the door to start the test. Recording the Results HbA1c Test 10:45 PM 01/30/2007 1. Wait until the test is complete (approximately HbA1c Patient Test Result 6 minutes) STEP 2. To change the patient information, select Edit. . HbA1c = 6.2% 3. To return to the patient result screen, Sequence No. 001 6 select Next. Date 10:45 PM 01/30/2007 Cartridge Lot 0506 4. To print the results, select Print. Serial No. A123456 Note: 2 You can select Help at any time for further assistance. Help Print Èdia Next Removing the Cartridge 1. Select Next, then open the door. 2. Push and hold down the button on the STEP right side. 7 3. To unlock, gently push the tab on the cartridge to the right. 4. Pull out the cartridge. 5. Discard the cartridge to prevent injury or possible contamination to others. Quality Control Information Regarding CLIA Waiver It is recommended that quality control specimens be tested with each new lot of The DCA Vantagem system is CLIA-waived only when used with Siemens-branded reagents, new shipment of reagents and monthly for reagents that has been stored for DCA 2000+T™ or DCA systems HbA1c cartridges. more than 30 days. QC testing is recommended to ensure reagent storage integrity, train and confirm performance acceptability for new users, and when patients' clinical A certificate of CLIA waiver is required to perform the test in a waived setting. conditions or symptoms do not match. Additional QC intervals may be required as per To obtain a Certificate of Waiver, contact your state department of health or visit the your laboratory procedures. Liquid ready-to-use controls are available; contact technical CMS Web site for an application, form CMS-116. support for recommendations. Failure to adhere to the instructions for use, including instructions for limitations Compare QC results to those listed as acceptable by the QC manufacturer. If control or intended use, and for performing QC testing, is considered as off-label results are not acceptable, do not test patient samples until the problem is resolved. Repeat control testing until results are acceptable. use, resulting in the test being categorized as high complexity and subject to all CLIA regulations. For technical support assistance call (877) 229-3711. DCA 2000+ and DCA Vantage are trademarks of Siemens Healthcare Diagnostics. 2008 Siemens Healthcare Diagnostics Inc. All rights reserved. Siemens Healthcare Diagnostics, Tarrytown, NY 10591-5097 USA 133979 Rev. C