Unlike the charge-based separation of ion exchange HPLC, which doesn’t detect all glycated haemoglobin (Hb) species, the Premier Hb9210™ uses the glycation specific binding of boronate affinity to detect all of the glycated Hb species present.
This allows the final result to be determined based on a simple peak area fraction of two species of Hb, making result interpretation extremely straightforward as there are only two peaks on the chromatogram:
- one glycated (directly correlated to the HbA1c result)
- one non-glycated (all other haemoglobin types)
With a worldwide increase in diabetes testing combined with increasing ethnic diversity, being completely free of interference from Hb variants gives you complete reassurance that the patient’s HbA1c result is being measured correctly.
With a sample analysis time of just 66 seconds and results needing minimal interpretation, the Premier Hb9210™ provides the fastest HbA1c analysis time currently available with a CV below 2%.
A capacity of 210 patient samples, which can be processed in batch or continuous loading mode, plus a STAT sample position gives flexibility & capacity to all medium & high throughput laboratories.
Together these combine to rapidly diagnose & monitor diabetic HbA1c levels, allowing the laboratory to meet any compliance targets and freeing up patient queues in busy clinic areas.
Racked tubes allow the operator to quickly add samples, prior to the instrument aspirating them directly from closed whole blood sample tubes using a self-cleaning syringe mechanism. This minimises blood contact & eliminates any manual pre-analytical preparation for the user.
The use of colour- and bar-coded reagents with excellent onboard stability, electronic level sensing and a continuous display of reagent status ensures sufficient reagents are onboard at all times. Less intervention as a user also allows for maximum instrument uptime.
Unique to the world of HbA1c testing, controls can be loaded onto the instrument each day where they are always available for analysis. You simply choose the control frequency for your workload & the Premier Hb9210 will analyse & log QC results at the respective intervals. Remain QA compliant with ease.
Accurate & Precise
The combination of the consistency of HPLC with the clearly defined separation of boronate affinity gives you repeatable, accurate results every time. In line with the ADA/EASD/IDF Working Group on HbA1c recent guidelines for reporting HbA1c, the Premier Hb9210™ is certified to report in the following units:
- IFCC (mMol HbA1c/mol Hb)
- NGSP (% HbA1c)
You can also rely on best in class precision, linearity & specificity:
- Precision: Intra-run CVs below 2% guarantee a reliable, repeatable result.
- Linearity: r² = 0.9958 (for 3.8%HbA1c to 18.5%HbA1c) ensure accuracy for the whole diabetic population.
- Specificity: minimal interference from variants, interferents, matrix effects & sample freezing.
- Correlation: vs Trinity Biotech Ultra2 – r² = 0.9962 allowing you to upgrade with confidence.
The instrument is also an IFCC Reference Method and as a NGSP Certification Reference Method can even be used for the correlation of other devices for NGSP certification.
Software & Connectivity
Premier Hb9210™ Affinity™ software combines operator ease-of-use with the advanced data management facilities demanded by modern hospital IT policies.
Accessible via the integrated colour touch-screen, the familiar icon based interface enables instant access to instrument operation, run parameters, previous results & maintenance duties etc , letting you quickly setup patient runs.
Relevant reagent, QC & sample data is all entered using barcode readers, to eliminate transcription errors and speed data entry. The logging of this data with clear data presentation and excellent storage capacity ensures a full audit trail for maximum quality assurance and regulatory compliance.
As is now practically essential in the modern laboratory, the instrument fully integrates with your laboratory or hospital information systems (LIS & HIS) , providing complete data synchronisation and accessible results to all relevant departments.
In summary the Premier Hb9210™ offers you fast, reliable & safe HbA1c diagnosis in a compact, high-capacity platform. Rely on patented Boronate Affinity technology and the precise, accurate performance of HPLC to give you complete reassurance in your results.