EKF Diagnostics’ Glycated Serum Protein LiquiColor Assay

EKF Diagnostics’ Glycated Serum Protein (GSP) LiquiColor® Assay offers a two to three week indicator of average blood glucose. This closes the information gap between daily glucose levels and quarterly HbA1c testing.

GSP serves as an accurate intermediate marker of glycemia in instances where HbA1c may be of limited value such as pregnancy, reduced RBC lifespan and hemodialysis.

The difference between actual measured HbA1c and predicted HbA1c from glycated serum protein is called the glycation gap. Measuring HbA1c and GSP together offers improved diagnostic accuracy by more reliably predicting complications of diabetes including nephropathy and retinopathy.

GSP provides superior specificity and accuracy compared to fructosamine assays (NBT method) for monitoring and assessment of short-term to medium-term (past two to three week period) average blood glucose levels. Complementary to HbA1c in diagnosis and screening of diabetes.

Studies suggest that combining GSP results with HbA1c measurements provides a better assessment of long term risk of diabetic complications.

Specifications

Methodology

Correlation to predicate method

Linearity

On-board stability

Calibration

Sample type

Sample size

Enzymatic

N = 65

R2 = 0.9966

Slope = 0.9542

Y intercept = 14.567

Range of values = 60-1249 µmol/L GSP

 

0.0 to 1354.0 µmol/L

Four weeks

Two point

Sold separately

 

Serum

10 µL

 

Within run precision

 

Control level 1

Control level 2

Serum level 1

Serum level 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 lab precision

 

Control level 1

Control level 2

Serum level 1

Serum level 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%