HbA1c Whole Blood Controls

Streck’s HbA1c product line includes a control and linearity with intact red blood cells to challenge the entire HbA1c procedure, including the lysing of the red blood cells - a step omitted with other controls.

Daily use of these whole blood controls provides quality control data for confirming the precision and accuracy of your laboratory’s instruments. Laboratories should validate test methods at least every six months or following changes in lots of critical reagents or system components.

HbA1c is an important marker in the management of diabetes. However, many of the current commercial controls available only provide quality assurance of the HbA1c measurement component of the patient result.

This is because these reagents are lyophilised and hence do not control the lysis step that patient samples have to undergo. As a result the full patient pathway is not controlled.

Streck A1c Cellular® controls, are the first HbA1c controls available with intact red blood cells.

This is an important consideration for laboratories looking to achieve ISO 15189 accreditation which requires more stringent application of Quality Assurance.

Applications

Like all of the Streck control products, the HbA1C controls enhance compliance with ISO15189 guidelines on Quality Assurance since they are true cellular controls that follow all aspects of the patient pathway, including the lysing step. This confirms accuracy across the complete test system and hence reliability of patient results.

Both control kits contain whole intact blood controls, made with true cellular material. They look just like normal patient samples and can be used for immunoassay or ion-exchange HPLC methods. Users can have complete confidence in results because the controls go through exactly the same processes as the patient sample.

A1c-Cellular is a two level control. The linearity product is a five level set that assesses the accuracy and linear reportable range of the HbA1c procedure.

Benefits

  • Ready to use liquid controls - saves the laboratory time and eliminates reconstitution errors.

  • Cap-piercable plastic vials, allowing autosampling

  • Complete testing

  • Convenient packaging

  • Does not require reconstitution

  • Free participation in STATS® - evaluate performance against peers to demonstrate compliance