Prod Info for Fibrinogen Reagent

When a saline blank is used as a sample, the absorbance is below 0.050. When a standard having a fibrinogen concentration of around 248 mg/dl is assayed, the absorbance (after subtracting the saline blank) is within 0.050-0.150.

Specificity

When control serum with a known value is assayed, the result is within 10% of the assigned value.

Assay Range

100-900 mg/dl (multi-point calibration) or
81-729 mg/dl (using NIBSC international standard)

Precision

When a sample containing 200 mg/dl fibrinogen is assayed 20 times (within-run), the absorbance C.V. is below 5%.

Within Run	Sample A	Sample B	Sample C
N MAX MIN AVE CV%	20 152 136 142.4 2.96	20 456 429 444.7 1.48	20 763 721 739.6 1.43

Between Day	Sample A	Sample B	Sample C
N MAX MIN AVE CV%	10 170 165 167.4 0.94	10 329 316 323.6 1.06	10 571 544 554.1 1.50

Correlation

A comparison ofthe K-ASSAY Fibrinogen test and an Incstar Fibrinogen test kit were performed on a Hitachi 717. The test results provided the following data:

Y
r
n
X
Y

= 0.967x + 33.91
= 0.995
= 50
= Incstar ITA
= K-ASSAY Fibrinogen

Additional correlation sutdies on assays using the Clauss method (clotting method) are available.

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