Features Advantages Product Data Sheet 32 …...Features, Advantages, and Bene˜ts DS-H7546-01 06/18...
Transcript of Features Advantages Product Data Sheet 32 …...Features, Advantages, and Bene˜ts DS-H7546-01 06/18...
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 32
The healthcare industry is undergoing significant changes and a key example is the consolidation of clinical laboratories. The consolidation of existing laboratories into one is creating a crucial need for high volume and convenient analyzers. Working with an analyzer that reduces operating costs while increasing convenience is a must to succeed in this changing environment.
Product
The MedTest Dx BA-800M Automated Clinical Analyzer is a versatile, high-volume platform with a built-in Sample Delivery Module (SDM). The SDM is capable of handling up to 440 sample positions and automatically delivers samples to the analytical unit by means
Regulatory and Certification
• 510(k) Cleared
Market: High Volume Clinical Laboratory Testing
MedTest Dx BA-800M High Throughput Automated Clinical Analyzer: Increasing operator walk-away time and overall laboratory efficiency
Figure 1:
800.445.9853(International) +1.734.487.8300 www.medtestdx.com
of color coded sample racks, which are shown in Figure 1. The BA-800M can deliver throughputs of 800 tests/ hr. without ISE and 1200 tests/ hr. with ISE. The system is capable of running Drugs of Abuse screening reagents, general chemistries and ISE’s. This innovative analyzer is equipped with conventional software and an intuitive user interface with a sleek design, making it the ideal solution for today’s fast-paced laboratory environments.
1. Control Rack2. Calibrator Rack3. Manual Return Rack4. STAT Sample Rack5. Routine Sample Rack
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Features, Advantages, and Benefits
DS-M1114-01.2
Features
MTBF 3 years
800 photometric tests / hour without ISE
1200 photometric test / hour with ISE
Largest Sample Delivery Module (SDM) among the same class of
analyzers
100 uL minimum reaction volume
R1 ~ R4 Reagent Format
Advantages
A robust system that is manufactured with high quality
components
A high performance and through-put clinical system
Capable of processing up to a total of 440 samples at a time
Less reagent consumed per test
Increase capability of running different assays, e.g. Vitamin D
Benefits
Get the highest percent ROI on your purchase
Quicker turn-around-time for test results, dramatically shortening the
waiting time for lab results
Longer walk-away time, frees up operators’ time to perform other
tasks
Lowers the cost per tests, allowing for higher financial returns
Eliminates the need for standalone specialty testing analyzers
Built-in carryover protection
Intuitive software with built-in operation commands
Lessen reagent cross reactivity
Logical, easy to navigate software
Highly reliable patient results
Save time and money in operator training
Product Number
80-BA800M
80-BA800M-ISE
115-022798-00
Description
BA-800M Analyzer without ISE, 220V, Barcode Reader, Glass Cuvettes, Drainage
Tubing BA-800M ISE Module (Optional)
DI Water Supply Module (Optional)
ORDERING INFORMATION
Product Data Sheet 23
As shown in figure 1, diabetes on a global basis is increasing at an exponential rate. To diagnose and 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 diagnosis of diabetes.
Product
The Pointe Scientific two-part HbA1c assay is a stabilized modification of the previous, innovative HbA1c three-part reagent that was first introduced in 2003. The improved reagent maintains the same antibodies and buffers but includes additional stabilizers in the R2 to allow it to become a single component as opposed to two separate components that required mixing prior to use.
Regulatory and Certification
• 510(k) Cleared• CE Mark• NGSP Certified• Referenced to IFCC Standard• Health Canada Medical Device Licensed
Market: Diabetes Testing
Pointe Scientific 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