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

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