Product Info for Alpha-1 Microglobulin Reagent

Serum and Plasma:
When a calibrator containing 17.1 mg/L alpha-1 microglobulin is measured, the range of the absorbance change per minute at a wavelength of 570 nm is
0.016 – 0.030.

Urine:
When a calibrator containing 3.4 mg/L alpha-1 microglobulin is measured, the range of the absorbance change per minute at a wavelength of 570 nm is
0.010 – 0.020.

Specificity

When a sample containing a known level of alpha-1 microglobulin was measured, the value obtained for the sample was in the range of the known concentration, +/- 10%.

Precision

When a sample containing a known level of alpha-1 microglobulin is tested 10 times, the CV of the test should typically be under 10%.

Precision Assay: Within Run

Serum (Within Run)

Sample I Sample II Sample III

N=10
Mean=7.1
SD=0.145
CV=2.04% N=10
Mean=32.1
SD=0.263
CV=0.82% N=10
Mean=66.1
SD=0.540
CV=0.82%

Urine (Within Run)

Sample I Sample II Sample III

N=10
Mean=0.7
SD=0.029
CV=3.93% N=10
Mean=3.3
SD=0.012
CV=0.37% N=10
Mean=17.4
SD=0.059
CV=0.34%

Precision Assay: Between Days

Serum (Between Days)
Sample I	Sample II	Sample III
N=15 Mean=7.5 SD=0.15 CV=2.0%	N=15 Mean=32.3 SD=0.31 CV=0.9%	N=15 Mean=67.1 SD=1.27 CV=1.9%

Urine (Between Days)
Sample I	Sample II	Sample III
N=15 Mean=0.72 SD=0.046 CV=6.3%	N=15 Mean=3.3 SD=0.04 CV=1.2%	N=15 Mean=17.2 SD=0.31 CV=1.8%

Assay Range

Serum / Plasma:
1.5 to 200.0 mg/L (or value of highest calibration point)

Urine:
0.3 to 50.0 mg/L (or value of highest calibration point)

Correlation

Correlation between the K-ASSAY Alpha-1 Microglobulin test and the latex agglutination method of another company is given below:

Serum Sample

y
r
n
x
y
= 1.00x + 2.83
= 1.00
= 55
= Company A’s latex reagent
= K-ASSAY Alpha-1 Microglobulin Assay

Urine Sample

y
r
n
x
y
= 1.00x - 0.52
= 1.00
= 55
= Company A’s latex reagent
= K-ASSAY Alpha-1 Microglobulin Assay

INTERFERENCE - Serum & Urine Samples

Hemoglobin	No interference up to 500 mg/dL
Bilirubin C	No interference up to 31 mg/dL

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