Metabolic & Diabetes Testing
Clinical chemistry solutions for metabolic health and diabetes-related laboratory investigations.
View application
Quality Control Materials
AV-QCHBA1C AV-QC HbA1c Multi-level (Liquid / Lyophilized Control)
Multi-level quality control material for HbA1c (glycated hemoglobin) assays. Available in liquid ready-to-use or lyophilized format with assayed values at clinically relevant levels (normal, intermediate and high). Designed by Aurevant Medical for reliable precision monitoring of enzymatic, immunoassay and HPLC-based HbA1c methods.
No approved datasheet is available for this product yet.
Product Overview
Overview
The Aurevant AV-QC HbA1c Multi-level is a dedicated quality control material for the quantitative determination of glycated hemoglobin (HbA1c). It is intended to monitor the precision and analytical performance of HbA1c assays used in the diagnosis and monitoring of diabetes mellitus.
The control is supplied in multiple concentration levels that cover the clinically important range from normal through intermediate to elevated HbA1c values. Depending on the specific presentation, the material is available as a liquid ready-to-use control or as a lyophilized product that is reconstituted with the supplied diluent. Both formats are prepared to provide good commutability with patient whole-blood samples.
Assayed target values and acceptable ranges are provided on a lot-specific value sheet and are suitable for use with enzymatic, immunoassay and many HPLC/ion-exchange methods after laboratory verification. The control supports daily or periodic quality-control practices, Levey-Jennings charting and compliance with laboratory accreditation requirements for HbA1c testing.
This product is an original Aurevant Medical quality control material manufactured under controlled conditions and intended for professional laboratory use by trained personnel.
The control is supplied in multiple concentration levels that cover the clinically important range from normal through intermediate to elevated HbA1c values. Depending on the specific presentation, the material is available as a liquid ready-to-use control or as a lyophilized product that is reconstituted with the supplied diluent. Both formats are prepared to provide good commutability with patient whole-blood samples.
Assayed target values and acceptable ranges are provided on a lot-specific value sheet and are suitable for use with enzymatic, immunoassay and many HPLC/ion-exchange methods after laboratory verification. The control supports daily or periodic quality-control practices, Levey-Jennings charting and compliance with laboratory accreditation requirements for HbA1c testing.
This product is an original Aurevant Medical quality control material manufactured under controlled conditions and intended for professional laboratory use by trained personnel.
Product name and code identify the record only; they are not a substitute for current manufacturer documentation. Confirm intended use, configuration, availability, supported applications, and all technical and commercial terms in writing before procurement.
Key Features
Features
- •Multi-level control covering normal, intermediate and elevated HbA1c concentrations
- •Human whole-blood / hemolysate matrix for good commutability with patient samples
- •Available in liquid ready-to-use or lyophilized presentations
- •Assayed values suitable for enzymatic, immunoassay and many HPLC methods
- •Values provided in both NGSP (%) and IFCC (mmol/mol) units where applicable
- •Extended open-vial or reconstituted stability at 2–8 °C
- •Lot-specific target values and acceptable ranges supplied
- •Supports daily or periodic QC, Levey-Jennings charting and accreditation requirements
- •Compatible with Aurevant chemistry systems and other open HbA1c platforms after validation
Key advantages
- •Multi-level design allows monitoring across the full clinical decision range for diabetes diagnosis and monitoring
- •Human whole-blood / hemolysate matrix improves commutability compared with some artificial controls
- •Choice of liquid or lyophilized format provides flexibility for different laboratory workflows
- •Assayed values in both NGSP and IFCC units support laboratories reporting in either system
- •Good open-vial / reconstituted stability reduces waste and supports consistent QC practices
- •Suitable companion control for laboratories running HbA1c alongside routine chemistry panels
Sample Types
- →Not applicable (quality control material)
Safety
Safety Information
For in-vitro diagnostic use only. This product contains human-source material. Although donor units were tested and found non-reactive for common infectious disease markers, handle as potentially infectious. Wear appropriate personal protective equipment (gloves, lab coat, eye protection). Store at 2–8 °C; do not freeze. Do not use after the expiry date. After opening or reconstitution, observe the stated stability period and discard if contamination, turbidity or hemolysis beyond normal appearance is observed. Dispose of according to local laboratory and environmental regulations. Consult the package insert and Safety Data Sheet (SDS) before use.
Instructions
Directions for Use
Remove the control from refrigerated storage (2–8 °C).
Technical Data
Specifications
Specifications
Research Status
verified_product_identity_and_approved_supply
Publication Approval
approved_for_publication
Technical Specification Status
verified_against_current_product_documentation
Specification
Aurevant AV-QC HbA1c Multi-level – multi-level quality control for glycated hemoglobin assays. Liquid or lyophilized, human-matrix, assayed for enzymatic, immunoassay and HPLC methods. Values in % and mmol/mol.
Use Cases
Applications
- →Daily or periodic quality control of HbA1c assays
- →Monitoring of precision and accuracy of enzymatic HbA1c methods
- →QC of immunoassay and HPLC/ion-exchange HbA1c systems
- →Support for laboratory accreditation and external quality assessment programs
- →Levey-Jennings charting and application of Westgard or laboratory-specific QC rules
Approved documentation
Downloads
No approved documents are currently associated with this product.
Product questions
Frequently Asked Questions
How many levels are included?
The product is supplied as a multi-level control, typically covering normal, intermediate and/or high HbA1c concentrations. Exact configuration is stated on the product label and value sheet.
Is it liquid or lyophilized?
Both presentations may be available. Check the specific product packaging – liquid ready-to-use or lyophilized with diluent.
Which HbA1c methods is it suitable for?
The control is assayed for use with enzymatic, immunoassay and many HPLC/ion-exchange methods. Always verify suitability with the specific method in use.
Are values provided in both NGSP and IFCC units?
Yes, where applicable the lot-specific value sheet provides target values in both % HbA1c (NGSP) and mmol/mol (IFCC).
What is the stability after opening or reconstitution?
Liquid controls typically remain stable for 14–30 days at 2–8 °C after opening. Lyophilized controls typically remain stable for 5–14 days after reconstitution when stored at 2–8 °C. Exact claims are stated on the package insert.
Can it be used on non-Aurevant HbA1c systems?
Yes, after the laboratory has verified the commutability and assigned values for the specific HbA1c method in use.
How should lyophilized controls be reconstituted?
Reconstitute each vial with the exact volume of the supplied diluent. Mix gently by inversion until fully dissolved and allow the recommended standing time before use.
Product enquiry
Request a Quote
Request model-specific availability, configuration, delivery, warranty, training, and service information.