Prod Info for CRP (2) Reagent

When a saline blank is used as a sample, the absorbance change per minute is -0.0050 to 0.0050, while a standard CRP solution containing 1000 micrograms/dl is 0.0650 to 0.1000 after subtracting the saline blank.

Specificty

When serum containing a known level of CRP (250 micrograms/dl) is measured, the assay value obtained is within 10%

Precision

Samples tested were commercial human CRP control serum.

Precision Assay: Within Run

Sample I Sample II Sample III

N = 20
Mean = 2.37
SD = 0.112
CV = 4.73% N = 20
Mean = 8.26
SD = 0.226
CV = 2.73% N = 20
Mean = 16.91
SD = 0.267
CV = 1.58%

Precision Assay: Between Run
CRP values were tested on 3 days.

Sample I	Sample II	Sample III
N = 10 Mean = 2.63 SD = 0.154 CV = 5.86%	N = 10 Mean = 8.68 SD = 0.217 CV = 2.50%	N = 10 Mean = 17.29 SD = 0.302 CV = 1.75%

Assay Range

Standard Protocol:	10.0 to 2000 mg/dl or (0.1 to 20 mg/L)
High Sensitivity Protocol:	5.0 to 1000 mg/dl or (0.05 to 10 mg/L)

Lower Limit of Detection

Standard Protocol:	10 mg/dl
High Sensitivity Protocol:	5 mg/dl

Correlation

Y	= 1.024x + 0.701
r	= 0.998
n	= 37
X	= Company A's CRP (WHO) nephelometric assay
Y	= K-ASSAY CRP (2)

INTERFERENCE

Bilirubin C/F
Hemoglobin
Lipid No interference up to 60 mg/dl
No interference up to 500 mg/dl
No interference up to 1500 mg/dl triglycerides

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