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Intended Use Statement
The PowerWave is an eight-channel, automated, benchtop, general purpose,
Microplate Spectrophotometer which performs analyses of a variety of samples.
The Performance Characteristics of the data reduction software have not been
established with any laboratory diagnostic assay. The user must evaluate this
software in conjunction with the specific laboratory diagnostic assay. This re-
evaluation must include the establishment of new performance characteristics
for the specific assay.
This system is designed for use with a variety of microplate-based assays. Assay
protocol variations are addressed by the developer of the ELISA test kit, in
accordance with the test kit's procedure. A versatile curve fitting and statistical
software program is preloaded on every PowerWave. Plate templates and
formulas are automatically combined with the protocol assay setup. Data results
may be printed out, or sent to a computer running a Bio-Tek software package,
such as KC Jr. or KC4
for Windows. The software provides:
■ An easy-to-use, menu-driven interface;
■ Endpoint curvilinear regressional and statistical calculations;
■ Curve fitting, with 4-parameter, cubic, quadratic, linear, cubic-
spline, point-to-point and 2-P (Logit) methods;
■ Formula calculations for more complex mathematical operations;
■ Ability to define controls and positive and negative cutoffs;
■ Kinetic, with maximum slope, R-squared at maximum slope and
Onset OD Time analysis;
■ Scanning read mode to provide area under the curve calculations.
Specimen Preparation
Samples should be obtained, treated and stored following instructions and
recommendations contained in the package kit.
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