Prealbumin KAI-053 (K-ASSAY)

For In Vitro Diagnostic Use
CE

Kit composition

Reagent 1 (R-1) Buffer Reagent 4 × 20 ml
Reagent 2 (R-2) Antiserum Reagent 2 × 8 ml

Precision

The precision for the K-ASSAY Prealbumin assay was determined using packaged reagents, pooled human serum, and a Hitachi 717 analyzer.

Precision Assay: Within Run

Sample I Sample II Sample III
N = 20
Mean = 11.2
SD = 0.145
CV = 1.29%
N = 20
Mean = 24.9
SD = 0.289
CV = 1.16%
N = 20
Mean = 57.0
SD = 0.767
CV = 1.35%

Correlation

A comparison of the K-ASSAY Prealbumin assay and a similar Prealbumin assay was performed on a Hitachi 717. The test results provided the following data.

Y = 0.9164x + -0.332
r = 0.9924
n = 50
X = Similar Prealbumin assay
Y = K-ASSAY Prealbumin assay
X min = 5.7
max = 43.2
mean = 22.89
Y min = 4.2
max = 38.4
mean = 20.64

Interference

Bilirubin F and C No interference up to 22 mg/dl
Hemoglobin No interference up to 470 mg/dl
Lipemia No interference up to 5%