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 human HNE 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)

1:100

Average %

89

Range %

82-96

1:200

Average %

90

Range %

85-96

1:400

Average %

85

Range %

81-92

1:800

Average %

98

Range %

91-104

The recovery of human HNE 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)

94

87-101

EDTA plasma (n=4)

98

91-104

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

pg/ml

OD1

OD2

Average

2500

0.175

0.170

0.173

1250

0.261

0.273

0.267

625

0.383

0.408

0.396

312.5

0.669

0.629

0.649

156.25

1.008

1.021

1.014

78

1.345

1.353

1.349

39

1.879

1.784

1.832

0

2.611

2.525

2.568