Prod Info for High Sensitive Microalbumin Reagent

When a saline blank is used as a sample, the absorbance is below 0.05. When a calibrator containing 5 mg/dl of human albumin is assayed, the absorbance (after subtracting the absorbance value for the saline blank) is within the range of 0.131-0.525.

Specificity

When a urine sample with a known value is assayed, it is within 10% .

Precision

Precision Assay: Within Run

Sample I Sample II Sample III Sample IV

N=10
Mean=0.372
SD=0.008
CV=2.12% N=10
Mean=0.574
SD=0.010
CV=1.68% N=10
Mean=0.959
SD=0.016
CV=1.66% N=10
Mean=1.926
SD=0.023
CV=1.20%

Precision Assay: Between Runs

Sample I Sample II Sample III

N=7
Mean=1.62
SD=0.016
CV=1.01% N=7
Mean=4.93
SD=0.042
CV=0.85% N=7
Mean=11.11
SD=0.018
CV=1.62%

Assay Range

0.05-30 mg/dl (multi-point calibration)

Correlation

A comparison of the K-ASSAY High - Sensitive Microalbumin and a Beckman MA Microalbumin Test Kit was performed on a Hitachi 717 automated analyzer and on a Beckman Array. The test results provided the following data. All values are expressed in mg/dl of albumin.

Y
r
n
X
Y

= 0.8693x + 12.850
= 0.99435
= 33
= Beckman MA Test Kit
= K-ASSAY High - Sensitive Microalbumin

X min	= 2.04	Y min	= 1.4
max	= 2990	max	= 2464
mean	= 313.949	mean	= 285.77

INTERFERENCE

Bilirubin
Hemoglobin
Lipemia

No interference up to 20 mg/dl
No interference up to 500 mg/dl
No interference up to 5%

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