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Hemoglobin A1c Testing Markets
Date:3/25/2013

FCC) 53
4.3.3 New NGSP Certification Criteria Beginning in September 53
4.3.4 ADAG (A1c Derived Average Glucose) 53
4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c 53
4.3.6 College of American Pathologists (CAP) Proficiency Program 54
4.3.7 Certifications and Selecting HbA1c Assays 54
4.4 Advantages and Disadvantages of HbA1c Assessment 54
4.5 HbA1c Testing Recommendations 56
4.5.1 Frequency of HbA1c Testing 56
4.5.2 Diagnostic HbA1c Testing 57
4.5.3 Screening for Pre-diabetes 59
4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals 59
4.6 Accuracy and Precision in HbA1c Testing 60
4.6.1 Biological Variation 60
4.6.2 Pre-Analytical Variation 61
4.6.3 Analytical Variation 61
4.7 Potential Interfering Variables Affecting HbA1c Testing 63
4.8 Potential Areas of Improvement in HbA1c Testing Performance 64
4.9 Optimizing of Point of Care (POC) HbA1c Testing 65
4.10 Key Issues for HbA1c Testing 65
4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools 66

5. HbA1c Testing Devices on the Market 68
5.1 HbA1c Self-Testing Devices 69
5.1.1 A1CNow SELFCHECK 69
5.1.2 DTI Laboratories, Inc. 69
5.1.3 Flexsite Diagnostics, Inc. 70
5.1.4 Heritage Labs International 70
5.2 Professional HbA1c Testing Devices 70
5.2.1 Point of Care HbA1c Testing 70
5.2.1.1 Axis-Shield (now part of Alere) 70
5.2.1.2 Bio-Rad 71
5.2.1.3 DiaSys Diagnostic Systems 71
5.2.1.4 Diazyme Laboratories 71
5.2.1.5 EKF Diagnostics 72
5.2.1.6 Infopia 72
5.2.1.7 Siemens Healthcare Diagnostics 72
5.2.2 HbA1c Laboratory Testing 73
5.2.2.1 Abbott 73
5.2.2.2 Arkray 73
5.2.2.3 Beckman Coulter 73
5.2.2.4 Bio-Rad 74
5.2.2.5 Diazyme Laboratories 75
5.2.2.6 EKF Diagnostics 75
5.2.2.7 Ortho Clinical Diagnostics (part of Johnson & Johnson) 75
5.2.2.8 Pointe Scientific, Inc
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