Difficult Demands

1. Diabetes, the Global Challenge

415 million people are estimated to have diabetes, with its treatment & management costing at least 673 billion USD in 2015. The worldwide prevalence of diabetes is expected to rise by 35% to 642 million by 20401.

Requirement: Cope with ever increasing workloads.

 

2. Increasing Laboratory Demands

With pressure to consolidate workloads & reduce costs, the speed, performance and ease of analysis becomes ever more important.

Requirement: Provide fast HbA1c results with minimal user intervention.

 

3. HbA1c as a Diabetic Marker

The use of an HbA1c result, increasingly in two decimal places, for diabetes diagnosis, monitoring & identification of high risk patients demands an extremely high level of precision.

Requirement: Accurately & precisely report HbA1c in IFCC & NGSP units

 

4. Abnormal Haemoglobins

Abnormal hemoglobins are the most prevalent monogenic disorder, with HbS present in up to 788,000 newborns annually.2 The importance of minimizing interference with the HbA1c result, common with ion-exchange HPLC, has risen with increased global migration.

Requirement: Report a precise and accurate HbA1c result in the presence of abnormal hemoglobins.

 

 

A Clear Solution

With a range of methodologies available & increasing demands from clinicians for a fast, accurate HbA1c result, it does not need to be difficult to choose the best instrument for your laboratory.

 

Insist on boronate affinity HPLC to meet all of your essential requirements:

	Boronate Affinity HPLC	Immunoassay	Capillary Electrophoresis	Ion-Exchange HPLC
1. Speed	✔	✔	✔	✔
2. Capacity	✔	✔	✘	✘
3. Precision	✔	✘	✔	✔
4. Accuracy	✔	?	✔	✔
5. Lack of Interference	✔	?	✔	✘
6. Operator Friendly	✔	✔	✘	✘
7. Cost Effective	✔	✔	?	?

 

Real World Performance

When instruments are used in a clinical environment accuracy claims need to be reflected in EQA and evaluation performance. The clean separation of boronate affinity and the reliability of HPLC is a standard other platforms strive to match.

 

“On the basis of the accuracy data and ease-of-use as determined by the technologists, the Premier Hb9210 was selected for HbA1c testing at GMH.”

Prof. Koch et al. - Grady Memorial Hospital, Atlanta. AACC 2013 Poster Presentation

 

“HbA1c% values measured using the Premier Hb9210 are accurate and precise as demonstrated by the excellent correlation between assays and the imprecision studies performed. The TAT and cost per reportable test showed a significant decrease.”

Arias-Stella et al. - Henry Ford Hospital, Detroit. AACC 2013 Poster Presentation

 

“For GH2-06, values were assigned by only two NGSP SRLs (boronate affinity HPLC only) due to presence of HbS trait. Three methods showed a clear positive bias due to HbS.”

Dr. R. Little, NGSP Steering Committee. CAP 2012 GH2-B Report.

 

Software & Connectivity

The Premier Hb9210 software combines operator ease-of-use with advanced data management facilities & LIS integration.

The icon based touch-screen interface enables instant access to instrument operation, options, results & reagent options.

Barcode entry of reagent, QC & sample data eliminates transcription errors and speed of data entry. A full audit trail allows for maximum quality assurance and regulatory compliance.

 

Reagents & Consumables

Reagents for the Premier Hb9210™ are provided in a pack format, with a different pack available for low, medium & high workloads.

Each pack contains all of the reagents and analytical columns required to perform the requisite number of patient tests, with sufficient reagents for your calibration & quality control program. Calibrator & control materials are available separately.

Together this allows for simplified inventory management & transparent pricing based on a guaranteed number of patient samples.

OPERATION:
Intended Use	For in vitro diagnostic quantitative determination of hemoglobin A1c (HbA1c) in whole blood from venous draw and finger stick. For in vitro diagnostic use only.
Elements of Analysis	Quantification of glycated hemoglobins
Principle	Patented Boronate Affinity HPLC
Automation	Completely Automated
Operation	Continuous
Test Time	75 seconds
Instrumentation Control	Windows Operating System with Proprietary Assay Software
Results Output	Display and Print
Printout	Automatic, User Select

SAMPLING:
Sample capacity	210 samples, with continuous sample loading capabilities
Sample Types	Whole blood, hemolysates made from whole blood or packed red blood cells. Blood can be fresh or thawed from frozen state. Venous EDTA, Heparin or Sodium Fluoride or Finger Stick
Minimum readable division	IFCC: One decimal place. NGSP Two decimal places.
Minimum sample requirement	10 μL (whole blood to make 1:150 hemolysate dilution) 0.5mL (whole blood to make direct injection)
Sample ID	Operator Input or Bar Code Reader

PERFORMANCE:
Standards / Traceability	IFCC, NGSP
Reporting Units	% HbA1c (NGSP / DCCT) & mmol/mol (IFCC)
Equation Used for Final HbA1c Value	%HbA1c = 0.588 * %GHb + 1.706 mmol/mol = (%HbA1c – 2.15) / 0.0915
Calibration	Previous IFCC/NGSP calibration used for each sample
Controls	With each run per clinical laboratory policies
C.V.	<2.0%

METHODOLOGY:
Column	Boronate Affinity Matrix
Column Matrix	Replenished, Re-Used
Reagents	Boronate Affinity Chemistry
Column temperature	55.0⁰C
Detector	LED single wavelength detector 413 ± 2nm
Solution Phases	2
Optical Phases	1
Chromatography Integration	Peak Separation and Area Determination
Detector UV Wavelength	413 nM
Detector UV Light	LED

ENVIRONMENTAL:
Safety Standards for Electrical Equipment for Lab and IVD Use	IEC61010 Certified
Electromagnetic Compatibility	74cm (H) x 54cm (W) x 66cm (D)
Dimensions	74cm (H) x 54cm (W) x 66cm (D)
Weight	62kgs
Laboratory Interface	ASTM

Trinity Biotech Premier HB 9210