Diazyme Glycated Serum Protein Assay
The Glycated Serum Protein (GSP) Assay is an enzymatic, liquid-stable test for quantitative measurement of glycated serum proteins in serum. GSP reflects glycemic control over approximately 2–3 weeks, providing a shorter-term monitoring measure alongside blood glucose and HbA1c.
Manufactured by Diazyme Laboratories, the assay is intended for monitoring patients with diabetes and is for in vitro diagnostic use. Analyzer-specific application parameters are required.
Enzymatic Measurement
Uses fructosaminase™ and a colorimetric endpoint reaction to measure glycated serum proteins.
Ready-to-Use Reagents
Two liquid-stable reagents simplify preparation. Calibrators and controls are ordered separately.
Features and Laboratory Benefits
- Measures glycated serum proteins, including glycated albumin and fructosamine.
- Enzymatic specificity reduces susceptibility to non-glycated reducing substances associated with conventional NBT fructosamine dye methods.
- Liquid reagents R1 and R2 are supplied ready to use.
- Supports implementation on compatible automated chemistry analyzers using assay-specific applications.
- Manufacturer identifies the assay as FDA 510(k) cleared.
Interpret results with other laboratory findings and the patient’s clinical status. This assay measures GSP concentration; it should not be described as a standalone glycated-albumin percentage test.
GSP Assay Specifications
| Parameter | Specification |
|---|---|
| Method | Enzymatic colorimetric Trinder endpoint |
| Specimen | Serum |
| Sample volume | 10 µL; confirm analyzer application |
| Analytical measurement range | 21.0–1354.0 µmol/L |
| Limit of detection — LOD | 7.2 µmol/L |
| Limit of quantitation — LOQ | 13.0 µmol/L |
| Calibration | Two-point calibration using the specified GSP calibrator set |
| Reagent storage | 2–8°C; stable until labeled expiration when stored as directed |
| Refrigerated onboard stability | At least 4 weeks at 2–8°C, per manufacturer insert |
| Result units | µmol/L |
Use the current instructions for use and the application sheet for the exact analyzer. Calibration and quality-control schedules must follow the applicable documentation.
Manufacturer-Reported Assay Performance
The following data are reported in Diazyme’s product literature. Performance in individual laboratories may vary.
Method Comparison
| Measure | Reported result |
|---|---|
| Comparison | Diazyme GSP versus predicate method on Hitachi 917 |
| Serum samples | 65 |
| Slope | 0.9542 |
| Y-intercept | 14.57 |
| R² | 0.9966 |
Within-Run Precision
| Measure | Control 1 | Control 2 | Serum 1 | Serum 2 |
|---|---|---|---|---|
| N | 80 | 80 | 80 | 80 |
| Mean (µmol/L) | 204 | 751 | 251 | 373 |
| SD (µmol/L) | 2.2 | 4.9 | 1.9 | 2.4 |
| CV (%) | 1.1 | 0.7 | 0.8 | 0.6 |
Within-Laboratory Precision
| Measure | Control 1 | Control 2 | Serum 1 | Serum 2 |
|---|---|---|---|---|
| N | 80 | 80 | 80 | 80 |
| Mean (µmol/L) | 204 | 751 | 251 | 373 |
| SD (µmol/L) | 2.4 | 5.6 | 3.2 | 3.7 |
| CV (%) | 1.2 | 0.7 | 1.3 | 1.0 |
Interference Study
Diazyme reports less than 10% deviation at the concentrations below. These results do not imply freedom from interference at all concentrations.
| Substance | Tested concentration |
|---|---|
| Ascorbic acid | 5 mg/dL |
| Bilirubin | 7.5 mg/dL |
| Conjugated bilirubin | 5 mg/dL |
| Glucose | 2400 mg/dL |
| Hemoglobin | 200 mg/dL |
| Triglycerides | 2000 mg/dL |
| Uric acid | 35 mg/dL |
Analyzer Applications, Calibration and Controls
Contact Jant with your analyzer manufacturer and exact model to request GSP application information. Compatibility with one analyzer does not establish compatibility with every chemistry system.
Diazyme identifies DZ112B-CAL as the GSP calibrator set and DZ112B-CON as the recommended control set. Confirm Jant ordering references and pack sizes when requesting a quotation.
Each laboratory should establish an appropriate reference interval. Use the current product instructions and laboratory procedures for specimen handling, calibration and quality control.
Request GSP Application InformationProduct Details and Ordering
| Jant Catalog Number | Description | Reagent Configuration |
|---|---|---|
| DLDZ1128K | Diazyme Glycated Serum Protein Assay | R1: 1 × 60 mL; R2: 1 × 17 mL |
This configuration is identified in Diazyme’s insert as DZ112B-KY1. Calibrators and controls are sold separately. Contact Jant to confirm the current catalog reference, analyzer application, availability and pricing.
Request Information or a QuoteDocumentation and Resources
Download the Jant-hosted product brochure below. Request the current instructions for use and analyzer-specific application sheet before implementation.
GSP Assay Brochure (PDF) Request Instructions and Application Sheets Explore Chemistry Open-Channel ReagentsFrequently Asked Questions
GSP reflects approximately 2–3 weeks of glycemic control and provides a shorter-term measure alongside glucose and HbA1c monitoring.
The assay uses serum. Follow the current instructions for specimen collection and handling.
Applications are analyzer-specific. Contact Jant to confirm the exact instrument and required application parameters.
The listed reagent kit contains R1 and R2. Calibrators and controls are sold separately.
Results are reported as GSP concentration in µmol/L. Do not assume that the result is a glycated-albumin percentage.
Contact Jant with your catalog number, analyzer model and anticipated testing volume.
Request GSP Assay Information
Discuss analyzer applications, reagents, calibrators, controls and pricing with Jant Pharmacal.