Intra-assay Precision (Precision within an assay): CV%<8%

Three samples of known concentration were tested twenty times on one plate to assess.

Inter-assay Precision (Precision between assays): CV%<10%

Three samples of known concentration were tested in twenty assays to assess.

To assess the linearity of the assay, samples were spiked with high concentrations of horse fibrinogen in various matrices and diluted with the Sample Diluent to produce samples with values within the dynamic range of the assay.

Sample

Serum(n=4)

1:5000

Average %

93

Range %

88-99

1:10000

Average %

97

Range %

91-105

1:20000

Average %

89

Range %

82-96

1:40000

Average %

96

Range %

90-102

The recovery of horse fibrinogen spiked to levels throughout the range of the assay in various matrices was evaluated. Samples were diluted prior to assay as directed in the Sample Preparation section.

Sample Type

Average % Recovery

Range

Serum (n=5)

95

89-98

EDTA plasma (n=4)

98

93-103

These standard curves are provided for demonstration only. A standard curve should be generated for each set of samples assayed.

ng/ml

OD1

OD2

Average

1500

0.149

0.154

0.151

750

0.226

0.237

0.231

375

0.301

0.320

0.310

187.5

0.436

0.429

0.432

93.75

0.597

0.611

0.604

46.8

0.876

0.853

0.865

23.4

1.294

1.284

1.289

0

2.338

2.225

2.282