Quo Test A1C Analyser
Simple, Accurate and Reliable HbA1c measurement for the management of diabetes.
The Quo-Test HbA1c Analyser uses a patented boronate fluorescence quenching technology to measure glycated hemoglobin (HbA1c) from a 4ul sample taken from a finger prick or venous whole blood.
| Product and Data integration available.
SIMPLE, ACCURATE & RELIABLE
Collect 4µl blood sample
Insert sample collector into the Quo-Test cartridge.
Insert cartridge into analyser. Results available within 4 minutes.
FAST & ACCURATE
- Results within 4 minutes.
- Measuring range: 4-17% A1c.
- Unaffected by Hb variants which do not result in reduced erythrocyte life span.
EASY TO USE
- User-friendly features minimise training time.
- Just 4µl blood required from finger prick or venous sample.
“The Quo-Test HbA1c analyzer; the right choice in a point-of-care setting.”
-Dr Andreas Müller
Quo-Test vs 2 Market Leading Competitors
The aim of this study was to compare different HbA1c POCT devices and established HbA1c laboratory methods. The advantage of POCT methods over traditional laboratory testing is the real-time estimation of the results, which enables a clinician to give patients their test results immediately during a single consultation. This type of testing has significant clinical implications for the patient, allowing them to take control of their disease management in a quicker and more effective manner.
Competitor A – low-cost point-of-care instrument designed for rapid and reliable measurements of HbA1c as well as three other biomarkers. The analyzer uses boronate affinity reflectance technology with either capillary or venous blood.
Competitor B – simple and fast POC analyzer suitable for use with whole blood, plasma, serum and urine. The analyzer provides measurements of HbA1c as well as three other parameters based on boronate affinity chromatography methodology.
Quo-Test (EKF Diagnostics) – dedicated fully automated HbA1c analyzer that uses patented boronate fluorescence quenching technology. A 4µl sample taken from a finger prick or venous whole blood is required and results are available in four minutes.
Each test was performed using EDTA treated whole blood samples provided with known HbA1c levels by a local medical laboratory (Dr. Heuchel, Saalfeld, Germany). Measurement of HbA1c levels in the laboratory by HPLC was performed using a Variant II (Bio-Rad Lab, Hercules, USA) under standard operating conditions. Levels of HbA1c were also determined immunologically in the laboratory using the HbA1c Beckman Coulter/AU480 (Beckman Coulter, USA), performed on site in parallel to the tests with the POCT systems. HPLC analysis was carried out using 100 different EDTA blood samples ranging from 4.4 to 14.6% DCCT. The below table shows the coefficient of correlation and average difference (%DCCT) of each POCT device when compared to the HPLC laboratory method.
Summary of statistical data of the three POCT systems compared to the HPLC laboratory method.
The Bland-Altman graph in figure. 1 demonstrates the variation in calculated HbA1c level from the HPLC to the Quo-Test device.
System accuracy of the three POCT systems compared to the HPLC lab method.
In addition to being tested against HPLC laboratory testing each device was also tested against a leading immunoassay large scale laboratory analyzer to assess how each compares in the estimation of HbA1c levels from whole blood samples.
As with the HPLC comparison, 100 different EDTA blood samples were assessed using the immunological laboratory method covering a range of 4.9 to 14.1% DCCT HbA1c.
Summary of statistical data for within-run precision examination of HbA1c determination with four POCT systems.
Summary statistical data of the POCT systems compared to the immunological laboratory method.
Comparison of Quo-Test with the HPLC laboratory method.
It can be seen that both Competitor A and the Quo-Test compare well with 63% of results within 6% of the determined mean HPLC values and all results are within 12% of the HPLC values for the Quo-Test.
Figure.3 Comparison Quo-Test with the immunological laboratory method (Bland-Altman graph)
Evaluation of repeatability of the three POCT methods was carried out using three EDTA blood samples at three different HbA1c concentrations (L1 to L3), with 20 repetitions for each concentration level.
Table 4 contains the single test results, as well as the averages in % DCCT, standard deviation (SD) in % DCCT and the coefficients of variations in %.
Since POCT is often based in the clinical or primary care setting it is important that non-laboratory trained users can easily handle and correctly operate the analyzers. In Germany the requirements of the German Medical Association guidelines for quality assurance of laboratory medical tests must be fulfilled.
Competitor B and Quo-Test stood out as being the most suitable choice for a point-of-care setting given their ease of use, since they both use simple cassette-based technology.
All systems demonstrated satisfactory system accuracy. Except for two outliers (once each Competitor A and Competitor B) all systems show an accordance with both lab methods within a +18%-range. The maximum deviation of the Quo-Test compared to both laboratory methods is notably below 12%. The Quo-Test was, therefore, found to have the best agreement with the two laboratory methods.
The results of the intra-run precision examination demonstrate good repeatability for all the POCT systems. The coefficients of variation (CV) between
1.6 and 2.2% (Competitor A), 1.6 and 2.8% (Competitor B), 1.2 and 1.9 % (Quo-Test), display only marginal differences between all systems. Regarding the assessment of the precision between the days with control material, only data from five study days was collected with the POCT systems and four days with the laboratory methods. Within this short period all systems demonstrated CVs between 0.5 and 4.5% which represents satisfactory precision. All control test results were within the targets given by the manufacturer.
The Quo-Test system tends to report higher values at low concentrations, but within the maximum range of +12%, fulfilling the requirements of the guidelines of the German Medical Association.
In summary, it can be stated that all POCT systems meet the requirements of HbA1c determination in practice and those set by the German Medical Association. Competitor B and Quo-Test were particularly easy to use and represent the best choice for a point-of-care setting. Regarding analyzer accuracy, it was found that the best agreement with both laboratory methods was achieved when using the Quo-Test analyser.
QUEStIONS & ANSWERS
How long does it take to perform a glycated hemoglobin (HbA1c) test?
Once a blood sample has been introduced into the Quo-Test results are reported within 4 minutes.
How much blood is required?
Just 4μL is required from a finger prick, capillary or venous sample.
What technology is being used?
Quo-Test uses a patented Boronate Fluorescence Quenching Technology (BFQT) associated with simple yet powerful multiple optical measurements.
What is the benefit of BFQT?
Based on well documented boronate affinity for glycated hemoglobin, the BFQT has similar performances as the boronate affinity chromatography systems used in reference laboratories. However, as it does not require physical separation it assures a simple, fast and accurate measurement. The Quo-Test system using the BFQT has the advantage of not being affected by hemoglobin variants (which do not result in reduced erythrocyte life span), labile glycated hemoglobin or hematocrit levels.
How are results reported?
Results are displayed on the digital display and reported in mmol/mol IFCC, % DCCT, % JDS, eAG mg/dl and eAG mmol/l values.
Does it store patient results?
Yes, the Quo-Test can store up to 7,000 results which can be downloaded to a PC via a USB cable.
Does the instrument have a NGSP and IFCC certification?
Yes, the Quo-Test analyser has been certified to the NGSP and IFCC standard.
What is NGSP and IFCC certification?
In an effort to standardize glycated haemoglobin results the AACC has set up the “National Glycohemoglobin Standardization Program” (NGSP) in 1996. In parallel the International Federation of Clinical Chemistry (IFCC) developed reference methods for glycated haemoglobin. In 2006 and 2007, an international consensus between IFCC and AACC was agreed upon. The calibration and certification of laboratories and manufacturers to the same standards have improved the conformity of the results. However, in practice differences can still be observed among technologies as well as between individual systems either because of the heterogeneity of haemoglobines, underlying different technologies (e.g. ion exchange, boronate affinity, Immunoassay due to calibration drifts, or lot to lot variability. This may result in differences in reported values. EKF Diagnostics follows the recommendations of the IFCC and NGSP to ensure that our instruments and reagents are accurately aligned and traceable to the reference method. See www.ngsp.org for more information.
Can the Quo-Test be used in laboratories?
Yes, although the Quo-Test has been developed to be used in a point of care setting, it is a professional product providing laboratory level accuracy.
Is there a warranty period?
Yes, all Quo-Test analysers carry a 12-month worldwide warranty.
What languages are featured on the device?
Quo-Test can be set up in English, Czech, Danish, Dutch, Finnish, French, German, Italian, Spanish, Russian, Polish, Romanian, Portuguese, Bosnian, Bulgarian, Croatian, Estonian, Greek, Kazakh, Latvian, Lithuanian, Serbian, Slovakian, Swedish, Turkish, and Chinese. Ask your EKF representative for details.
Where is the EKF Quo-Test HbA1c analyser produced?
It is assembled at EKF Diagnostics’ ISO 13485:2012/2003 accredited manufacturing facility in Germany on behalf of Quotient Diagnostics.