QuikRead go HbA1c

The quantitative HbA1c result can be used in monitoring the long-term blood glucose control in individuals with diabetes mellitus, as an aid in diagnosis of diabetes and in identifying patients at risk of developing diabetes mellitus. QuikRead go HbA1c is an in vitro diagnostic test for quantitative measurement of glycated hemoglobin (HbA1c) from a finger prick capillary blood or anticoagulated (EDTA or heparin) venous whole blood sample.

QuikRead go HbA1c provides you with

Improved management of diabetes^1,2  – Reliable HbA1c results at the point of care

• IFCC certified
  
• Solid QuikRead go –quality 
• HbA1c results available during patient consultation
  

Correct result at the point of care  – Easy sample collection and test procedur

• One-step sample collector
  
• 1 µl sample volume
  
• 5 minutes sample stability in the cuvette
  
• Automated QuikRead go Instrument
  

Efficiency  – One system, many tests

• Now HbA1c on QuikRead go
  
• Portable and flexible QuikRead go system
  
• Test portfolio designed for primary care 
• Enhanced bi-directional connectivity features
  

Test results should never be used alone, without a complete clinical evaluation.
QuikRead go HbA1c is not registered in the USA.

References:

1. Miller CD, Barnes CS, Phillips LS, et al. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26(4): 1158-1163.
   
2. Schnell O, Crocker JB, Weng J. Impact of HbA1c Testing at Point of Care on Diabetes Management. J Diabetes Sci Technol 2017; 11(3):611-617.

Regular use of QuikRead go HbA1c Control Set is recommended. 

The control set includes

• QuikRead go HbA1c Control, approx. 37-48 mmol/mol
  
• QuikRead go HbA1c Control High approx. 69-80 mmol/mol

HbA1c (glycated hemoglobin A1) is a well-known analyte and it is standardized by the National and International Federation of Clinical Chemistry (IFCC). Because the value of HbA1c has high significance for treatment, reliable and accurate measurement is important.¹

HbA1c gives estimate of long-term blood glucose levels

• Hemoglobin A1 is the most common hemoglobin type in red blood cells.
• Glycated hemoglobin A1 (HbA1c) forms when blood glucose binds non-enzymatically the hemoglobin A1 in a normal physiological process. Increased glucose levels increase the levels of HbA1c.²
• The glucose stays bound on the hemoglobin over the lifespan of red blood cells. Therefore, HbA1c represents the average blood glucose levels of the past two to three months.^2,3

HbA1c is convenient tool to support effective diabetes care

• Convenience for the patient: It does not require fasting and finger prick and venous sample work equally well⁴.
• Reproducible testing: It is preanalytically more stable than glucose⁵.
• Testing can be done anytime: It has lower day-to-day variation than glucose^4,6,7.
  

References

1. Lenters-Westra et al. Haemoglobin A1c: Historical overview and current concepts. Diabetes Res Clin Pract. 2013 Feb;99(2):75-84.
2. Sherwani SI, Khan HA, Ekhzaimy A, Masood A, Sakharkar MK. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights 2016; 11: 95-104.
3. Khera PK, Smith EP, Lindsell CJ, et al. Use of an oral stable isotope label to confirm variation in red blood cell mean age that influences HbA1c interpretation. Am J Hematol 2015; 90(1): 50-55.
4. Weykamp C. HbA1c: a review of analytical and clinical aspects. Ann Lab Med 2013; 33(6): 393-400.
5. Rohlfing C, Wiedmeyer HM, Little R, et al. Biological variation of glycohemoglobin. Clin Chem 2002; 48(7): 1116-1118.
6. Ollerton RL, Playle R, Ahmed K, Dunstan FD, Luzio SD, Owens DR. Day-to-day variability of fasting plasma glucose in newly diagnosed type 2 diabetic subjects. Diabetes Care 1999; 22(3): 394-398.
7. Petersen PH, Jorgensen LG, Brandslund I, De Fine Olivarius N, Stahl M. Consequences of bias and imprecision in measurements of glucose and hba1c for the diagnosis and prognosis of diabetes mellitus. Scand J Clin Lab Invest Suppl 2005; 240: 51-60.

Improved treatment results

Point of care HbA1c testing has shown to improve diabetes management, patient’s commitment to treatment and patient satisfaction. These are leading to improved glycemic control and reduced risk of harmful and expensive comorbidities. It also has potential to reduce the health care costs. ^1-5

Earlier identification of diabetes

Standardized HbA1c tests are increasingly recommended as an option to screen patients for type 2 diabetes or hyperglycemia^6-8. Nearly half of people with type 2 diabetes are undiagnosed⁷. Point of care HbA1c tests can help identification of patients and starting the appropriate treatment as early as possible⁹.

Point of care HbA1c testing can make an impact

Person with diabetes chooses POC HbA1c for^2,10

• Immediate test result, plan for treatment and support for lifestyle changes
• Avoiding excessive lab visits
  
• Finger prick sample
  
• No fasting needed
  

Healthcare provider chooses POC HbA1c for^1,2,11

• Better patient commitment Reaching all patients
  
• Timely adjustment of treatment
  
• Efficient working processes
  
• Patient satisfaction

References

1. Miller CD, Barnes CS, Phillips LS, et al. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26(4): 1158-1163.
2. Schnell O, Crocker JB, Weng J. Impact of HbA1c Testing at Point of Care on Diabetes Management. J Diabetes Sci Technol 2017; 11(3):611-617.
3. American Diabetes Association. Diabetes Care 2020; 43(Supplement 1): S66-S76
4. Egbunike V, Gerard S. The impact of point-of-care A1C testing on provider compliance and A1C levels in a primary setting. Diabetes Educ. 2013;39(1):66-73.
5. Lian J, Lang Y. Diabetes management in the real world and the impact of adherence to guideline recommendations. Curr Med Res Opin. 2014;30(11):2233-40.
6. American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care 2019; 42(Suppl 1): S13-28.
7. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels,Belgium: 2019. Available at: https://www.diabetesatlas.org, accessed 30.4.2020
8. World Health Organization (WHO). Use of glycated haemoglobin (‎HbA1c)‎ in diagnosis of diabetes mellitus: abbreviated report of a WHO consultation. 2011.
9. Clark SR, Wilson ML. Original Research: Early Diabetes Screening in the Urgent Care, Part 2. J Urg Care Med. October 2016. https://www.jucm.com/original-research-early-diabetes-screening-urgent-care-part-2/, accessed 30.4.2020
10. Weykamp C. HbA1c: a review of analytical and clinical aspects. Ann Lab Med 2013; 33(6): 393-400.
11. Patzer KH, Ardjomand P, Göhring K, et al. Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction. J
    Diabetes Sci Technol. 2018; 12(3):687-694.

Marketing and sales materials

QuikRead go HbA1c Brief Instructions (EN)

QuikRead go HbA1c Flyer (EN)

QuikRead go Family Brochure (EN)

QuikRead go Technical Specifications (EN)

Instructions for use

(For informative use only. Kindly always refer to the latest package insert in the kit.)

QuikRead go HbA1c IFU (GB, DE, FR, NL), 154470

QuikRead go HbA1c IFU (FI, SE, NO, DK), 154563

QuikRead go HbA1c IFU (CZ, SK, HU, PL), 154581

QuikRead go HbA1c IFU (IT, ES, EE, LT), 154580

QuikRead go HbA1c Control Set IFU (GB, DE, FR, ES, IT, CZ, HU, PL, SK, NL, EE, LT, SE, NO, DK, FI), 154523

Safety Data Sheet

QuikRead go HbA1c SDS (EN)

QuikRead go HbA1c Control Set SDS (EN)

I would like to start using the QuikRead go HbA1c test. Which instrument software version I need on my QuikRead go instrument?

You should have the version 8.1.1. or newer. This software is suitable also for all of the other test kits that we provide.

Which sample collector is suitable for the QuikRead go HbA1c test?

QuikRead go Sample Collectors 1µl, which are included in the QuikRead go HbA1c test kit, must be used for sample collection and transferring the sample or control into the QuikRead go HbA1c cuvettes.

Which sample types are suitable for QuikRead go HbA1c test?

Suitable sample types for QuikRead go HbA1c test are a finger prick capillary blood and anticoagulated venous whole blood sample. Only 1 µl of blood is required for the test. When taking the sample from finger prick, remember to wipe off the first drop.