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Features, Advantages, and Bene�ts
DS-H7546-01 06/18
Features
Patented antibody with high specificity for HbA1c
Fully Automated
Direct measurement of HbA1c
Does not require a standalone system
NGSP Certification & Traceable to IFCC Standard
Advantages
Minimizes cross-reactivity from hemoglobin variant molecules
No offline sample pretreatment
Does not require additional channel for determination of
total hemoglobin
Eliminates the need for HbA1c specific analyzers
Standardized tests results to test methods used in clinical studies
Benefits
More precise results » no interference from hemoglobin variants / adducts; Carbamylated Hb, Acetylated Hb, HbA2, HbS, HbC, HbE and HbD
Streamline testing process with more accurate results and less
hands-on activities
Saves space on analyzer and cost of running additional test
Save laboratory space and money by the consolidation of clinical
laboratory equipment
Increase patient confidence by a NGSP certified test
Ordering Information
Product Number Analyzer Speci�c Description
H7546-40 Open Channel R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
REAGENTS
H7541-CALCALIBRATORS
H7546-120 Open Channel R1: 1 x 90 mL, R2: 1 x 30 mL
OH546-40 Beckman AU R1: 2 x 15 mL, R2: 1 x 10 mL
HBA-480 BS-480 R1: 2 x 60 mL, R2: 2 x 20 mL
HBA-600 BS-200 R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
12-H7546-40 BS-200(International)R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
H7541-CTLCONTROLS
Lyophilized
Lyophilized
1 vial each of 4 levels
2 vials each of 2 levels
Instrument Applications
• Abbot Aeroset• Alycon• ATAC 8000 • Beckman/Olympus AU400, AU640, AU2700, AU5400, CX, DxC, LX • Bayer Advia 1650, 1800, 2400• Biolis 24i• Biotecnica BT2000/3000• Chemwell• Cobas 6000, c501, Mira, Mira Plus• Envoy 500• Express• Dimension
• Hitachi - 704, 717, 747, 902, 911, 912, 914, 917• Konelab 20, 30, 60• Mindray - BS-200, BS-300, BS-400, BS-480, BA-800M • Pentra 400• Pointe 360• Prestige 24i• RA - 500, 1000• Randox Daytona• Selectra SE• Sirrus• Spectrum• Targa • Vitros 5
Product Data Sheet 23
50%
As shown in figure 1, diabetes on a global basis is increasing at an exponential rate. To monitor diabetes it is necessary to evaluate patient’s glucose and HbA1c levels. Glucose levels reflect an individual’s glycemia at a specific point in time, whereas HbA1c levels reflect the average glucose levels over the previous 2-3 months. Therefore, HbA1c has been recommended for the monitoring of diabetes.
Product
The Pointe brand HbA1c assay is an innovative two-part reagent. This reagent includes additional stabilizers in the R2, allowing it to become a single component. There are many on-board lyse applications available, eliminating off-board pretreatment of samples.
Key Product Highlights
• Streamline testing with a 2-part assay that requires no offline sample pretreatment• Generate precise results due to patented antibody that minimizes cross-reactivity • Eliminate additional tests due to the direct measurement of HbA1c• Manufactured in the USA under ISO 13485 standards• 510(k) Cleared; CE Certified
Market: Diabetes Testing
Pointe brand Hemoglobin A1c Assay:Streamlining diabetes testing with a 2-part HbA1c assay
Figure 1:
Diabetes population per IDF diabetes Atlas Eighth Edition 2017
800.445.9853(International) +1.734.487.8300 www.medtestdx.com
Made in USA
CertifiedPerformanceGuarantee
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Features, Advantages, and Benefits
DS-H7546-01.4
Features
Patented antibody with high specificity for HbA1c
Fully Automated
Direct measurement of HbA1c
Does not require a standalone system
NGSP Certification & Traceable to IFCC Standard
Advantages
Minimizes cross-reactivity from hemoglobin variant molecules
No offline sample pretreatment
Does not require additional channel for determination of total
hemoglobin
Eliminates the need for HbA1c specific analyzers
Test results standardized to test methods used in clinical studies
Benefits
More precise results » no interference from hemoglobin
variants / adducts; Carbamylated Hb, Acetylated Hb, HbA2, HbS,
HbC, HbE and HbD
Streamline testing process with more accurate results and less hands-on
activities
Saves space on analyzer and cost of running additional test
Save laboratory space and money by the consolidation of clinical
laboratory equipment
Increase customer confidence by a NGSP certified test
Product Number Analyzer Specific Description
H7546-40 Open Channel R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
H7541-CALCALIBRATORS
H7546-120 Open Channel R1: 1 x 90 mL, R2: 1 x 30 mL
H7541-CTLCONTROLS
Lyophilized
Lyophilized
1 vial each of 4 levels
2 vials each of 2 levels
REAGENTS
Applications available for wide range of analyzers
www.medtestdx.com Made in USACertified
PerformanceGuarantee
“MedTest Dx certifies that all of our products are manufactured according to specified parameters. Any product not meeting specifications through their listed expiration date will be remedied immediately without charge.”
DS-H7546-01 front FINALDS-H7546-01 b back Final