How should the Afinion HbA1c test cartridge be stored before use?
The Afinion HbA1c Test Cartridge must reach a temperature of 18-30°C (64-86°F) before use. Upon removal from the refrigerator, leave the test cartridge in the unopened foil pouch for at least 15 minutes. No test result will be obtained if the test cartridge is too cold when used. An information code will be displayed. Do not freeze.
What is the CPT code for Afinion HbA1c?
E-Learning webcast presented by the American Diabetes Association (1 credit) Afinion™ System Tests Code Afinion HbA1c, 15 test 1116974 (US) Afinion HbA1c, 15 test 1116797 (NO, SE, DK, FL, IS) Afinion HbA1c, 15 test 1116796 (JP) Afinion HbA1c, 15 test 1116798 (IN) 3 more rows ...
How long should the test cartridge cool before use?
• Allow 15 minutes for the test cartridge to reach operating temperature 18-30°C (64-86°F) before use. • Open the pouch just before use. Hold the test cartridge by the handle.
Which hemoglobin variants do not affect the Afinion HbA1c test result?
The following hemoglobin (Hb) variants have been analyzed and found not to affect the Afinion HbA1c test result: HVAC, HbAD, HbAE, HbF, HbAJ, and HbAS6. Carbamylated hemoglobin does not affect the Afinion HbA1c test result6.
What is the operating temperature for the Afinion analyzer?
The Alere Afinion™ AS100 Analyzer/Afinion™ 2 Analyzer must be placed on a flat level surface avoiding any equipment which may emit vibrations. Operating temperature is 15-32°C or 59-89°F.
Do a1c cartridges need to be refrigerated?
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 temperature anytime before the expiration date.
Can Alere afinion HbA1c controls be stored at room temperature?
Reagents and Storage 1. Afinion™ HbA1c Test Cartridges can be stored unopened at room temperature (15°-25°C or 59°-77°F) for 90 days. 2. Once opened, control vials are stable for 60 days when stored refrigerated, 2°- 8°C (36°- 46°F).
How do you use afinion HbA1c?
Test procedure overview Switch on the Afinion™ AS100 Analyzer. Allow the Afinion™ HbA1c Test Cartridge to reach operating temperature (64-86ºF). Open the foil pouch just before use. Be sure to properly label the Test Cartridge with sample ID.
What is the minimum amount of time a Refrigeated cartridge must sit at room temperature before using?
Preparation for Use An individual cartridge may be used after standing 5 minutes, in its pouch, at room temperature. An entire box should stand at room temperature for one hour before cartridges are used.
How long are A1c controls good for?
If your result is normal but you're over 45, have risk factors, or have ever had gestational diabetes, repeat the A1C test every 3 years. If your result shows you have prediabetes, talk to your doctor about taking steps now to improve your health and lower your risk for type 2 diabetes.
How often should Alere afinion HbA1c controls be run as per the manufacturer's recommendations?
every 30 daysAt least every 30 days. When training new operators in correct use of the Alere Afinion™ HbA1c Dx and the Alere Afinion™ AS100 Analyzer.
What is the Alere afinion HbA1c measuring range?
4.00-15.00% HbA1cReportable range The Afinion HbA1c Dx measuring range is 4.00-15.00% HbA1c. The HbA1c results are displayed in 0.01% intervals. The hemoglobin measuring range is 6.0-20.0 g/dL.
What are the acceptable sample types for the Afinion HbA1c assay?
The following sample materials can be used with the Afinion™ HbA1c test: • Capillary blood sample (from finger prick). Venous whole blood with anticoagulants (ethylenediamine tetra-acetic acid (EDTA), heparin or citrate). Capillary blood samples cannot be stored.
What is the sample size for Alere afinion HbA1c assay?
120 blood samples(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method.
What is the sample size for the HbA1c assay?
When run alone, HbA1c tests require very low blood volumes (1-5ul)3 that are typically achieved with thin lancets at shallow puncture depth (i.e., 30G x 1.5mm or 28G x 1.8mm). If performing multiple tests or testing on an individual with thicker skin, it may be necessary to use a larger lancet and puncture deeper.
What is afinion used for?
The Afinion™ HbA1c assay is a test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used to monitor metabolic control in patients with diabetes. It provides the immediate test results you need for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies.
How long can novolin n be left unrefrigerated?
If not in use or unopened, the Novolin N vials can be stored in a refrigerator until the expiration date, or at room temperature for 42 days. If currently in use, opened vials can be stored at room temperature for 42 days. Do not refrigerate opened vials.
How do you store insulin without refrigeration?
News that various insulins can be stored at oscillating temperatures ranging between 25 and 37°C for 4 weeks without becoming less effective is positive and reassuring for people with diabetes who live in places without reliable access to refrigeration, such as refugee camps.
Should insulin be kept in the fridge?
According to the product labels from all three U.S. insulin manufacturers, it is recommended that insulin be stored in a refrigerator at approximately 36°F to 46°F. Unopened and stored in this manner, these products maintain potency until the expiration date on the package.
How do you travel with an insulin pen?
Yes. TSA specifically states that diabetes-related supplies, equipment and medications, including liquids, are allowed through the checkpoint once they have been properly screened by X-ray or hand inspection. Passengers should declare these items and separate them from other belongings before screening begins.
Simply More Efficient
Immediate point of care HbA1c results for efficient monitoring of glycemic control.
Short assay time in 3 minutes
The CLIA-Waived Afinion™ HbA1c test gives you reliable, high quality results conveniently available when and where you need them.
Timely treatment changes
Diabetes can be treated and managed by healthful eating, regular physical activity, and medications to lower blood glucose levels. Lowering the HbA1c has been shown to reduce microvascular complications of diabetes and is also associated with long-term reduction in macrovascular disease.
Long shelf life of reagents
Patient consultations can be carried out with confidence. The HbA1c Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin. The test has 3 months room temperature storage.
How long does it take to get a HBA1C test?
Finally — an HbA1c test that can be used as an aid to diagnose and monitor your patients with diabetes or pre-diabetes at the point of care in just 3 minutes.
Does HBA1C decrease microvascular complications?
Lowering the HbA1c has been shown to reduce microvascular complications of diabetes and, if implemented soon after the diagnosis of diabetes, is associated with long-term reduction in macrovascular disease. 1-2.
Hemoglobin A1c Test For Use with Afinion ™ 2 and Alere Afinion™ AS100 Analyzer
- Please consult the Afinion™ Analyzer User Manual for the operation of the analyzer and general handling of the test cartridge. Technical Support The manufacturer provides a toll-free line for technical support. Call 1-866-216-9505 (available for use only in the United States of America) 1…
Product Description
- Intended use Afinion HbA1c is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human capillary and venous whole blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus 1. Summary and explanation of the test The human erythrocyte i…
Storage and Stability
- Refrigerated storage 2-8°C (36-46°F) 1. The Afinion HbA1c Test Cartridges are stable until the expiration date only when stored refrigerated. The expiration date is stated on each foil pouch and on the kit box. 2. The Afinion HbA1c Test Cartridge must reach a temperature of 18-30°C (64-86°F) before use. Upon removal from the refrigerator, leave the test cartridge in the unopened fo…
Sample Materials and Storage
- The following sample materials can be used with the Afinion HbA1c test: 1. Capillary blood sample (from a finger prick). 2. Venous whole blood with anticoagulants (ethylene diamine tetra-acetic acid (EDTA), heparin or citrate). Sample storage 1. Capillary blood samples cannot be stored. 2. Venous whole blood with anticoagulants (EDTA, heparin or citrate) can be stored – refrigerated f…
Test Result Reporting
- Afinion HbA1c measures the total glycated hemoglobin and the total hemoglobin concentration. The ratio between them is proportional to the % HbA1c of the sample. The analyzer calculates the ratio, and the test result is displayed as % HbA1c. Reportable range The Afinion HbA1c measuring range is 4.0-15.0% HbA1c. The HbA1c results are displayed in 0.1% intervals. The hemoglobin …
Quality Control
- Quality control testing should be done to confirm that your Afinion Analyzer System is working properly and providing reliable results. Only when controls are used routinely and the values are within acceptable ranges can accurate results be assured for patient samples. Each laboratory site can benefit from establishing a quality control plan. The laboratory director should determin…
Troubleshooting
- To ensure that correct HbA1c results are reported, the Afinion The analyzer performs optical, electronic, and mechanical controls. The capillary, the test cartridge, and all individual processing steps are checked during the course of each analysis. When problems are detected, the analyzer terminates the test and displays an information code. The table below contains the assay-specifi…
Performance Characteristics
- The performance data presented in this section are representative data from internal and external studies. Results obtained in individual laboratories may vary. Linearity The linearity of the Afinion HbA1c Assay was verified using two fresh EDTA blood samples. Varying amounts of sample 1 (17.9% HbA1c) and sample 9 (5.3% HbA1c) were mixed in different proportions to obtain a total …
Bibliography
- Lenzi S et al., The Clinical Usefulness of Glycated Hemoglobin in Monitoring Diabetes Mellitus: A long-Term Study. Clin Chem 1987; 33:55-56.
- Frantzen F, Studies on glycated hemoglobin and new analytical methods for its determination. Dr. Philos. thesis. NTNU, Trondheim 1998. ISBN 82- 7861-116-5.
- The Diabetes Control and Complications Trial Research Group, The Effect of Intensive Treat…
- Lenzi S et al., The Clinical Usefulness of Glycated Hemoglobin in Monitoring Diabetes Mellitus: A long-Term Study. Clin Chem 1987; 33:55-56.
- Frantzen F, Studies on glycated hemoglobin and new analytical methods for its determination. Dr. Philos. thesis. NTNU, Trondheim 1998. ISBN 82- 7861-116-5.
- The Diabetes Control and Complications Trial Research Group, The Effect of Intensive Treatment of Diabetes on the Development and Progression of LongTerm Complications in Insulin-Dependent Diabetes...
- Sacks DB et al., Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus. Clin Chem 2011; 57(6):e1-e47.
