bioMérieux endotoxin detection assay documents

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bioMérieux endotoxin detection assay
.... Name
.... Date
.... Documentation
........ Operator
............ Alternatives
................ Operator name
................ Operator reference
.................... Config
........................ Update mode
............ Role
........ Incubation
............ Duration
............ Temperature
........ Excitation
............ Wavelength
............ Bandwidth
........ Emission
............ Wavelength
............ Bandwidth
........ Instrument
............ Name
............ Serial number
............ Gain
........ Time of initial measurement
........ Time of final measurement
........ Batch/lot number
.... Setup
........ Assay elements
............ Standard
................ Name
................ Geometric sequence
.................... Number of steps
.................... Initial working concentration
.................... Base
................ Number of replicates
................ Observation group ID
............ Test
................ Name
................ Dilution factor
................ Endotoxin limit
................ PPC spike
................ Number of replicates
................ Observation group ID
................ Exclude from analysis / invalid assay element
............ Blank control
................ Name
................ Number of replicates
................ Observation group ID
................ Exclude from analysis / invalid assay element
............ PPC control
................ Name
................ PPC control spike
................ Number of replicates
................ Observation group ID
................ Exclude from analysis / invalid assay element
........ Observation data
............ Column: Observation group
............ Column: Sequence step
............ Column: Initial response value
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
............ Column: Final response value
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
............ Column: Positive product control flag
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
............ Column: Technical-outlier flag
............ Column: Position factor
.... Analysis
........ Alternatives
............ 4-parameter logistic model
................ Weight
............ Linear model
................ Control for adjustment
........ Coefficient of variation mode
........ Final activity rounding
........ Gain optimization
............ Used standard step
............ Current gain
............ Optimum dRFU value
............ Scaling factor
............ Test: Maximum CV (%) of the standard responses
................ Upper margin (%)
................ Result if test value equals margin
................ Rounding
........ Test system
............ Test: Coefficient of determination (|r|)
................ Lower margin
................ Result if test value equals margin
................ Rounding
............ Test: Upper asymptote
................ Alternatives
.................... Lower margin (based on highest dose response)
.................... Lower margin (fixed)
................ Result if test value equals margin
................ Rounding
............ Test: Slope (linear model)
................ Upper margin
................ Lower margin
................ Result if test value equals margin
................ Rounding
............ Test: Intercept (linear model)
................ Upper margin
................ Lower margin
................ Result if test value equals margin
................ Rounding
............ Test: B parameter (4PL)
................ Upper margin
................ Lower margin
................ Result if test value equals margin
................ Rounding
............ Test: Inflection point
................ Upper margin
................ Lower margin
................ Result if test value equals margin
................ Rounding
............ Test: Lower asymptote
................ Alternatives
.................... Upper margin (based on lowest dose response)
.................... Upper margin (fixed)
................ Result if test value equals margin
................ Rounding
............ Test: PPC recovery rate
................ Upper margin (%)
................ Lower margin (%)
................ Result if test value equals margin
................ Rounding
............ Test: Maximum CV (%) of the standard
................ Upper margin (%)
................ Result if test value equals margin
................ Rounding
............ Test: Maximum CV (%) of samples
................ Upper margin (%)
................ Result if test value equals margin
................ Rounding
............ Test: Maximum CV (%) of PPCs
................ Upper margin (%)
................ Result if test value equals margin
................ Rounding
............ Test: Blank relative development
................ Upper margin (%)
................ Lower margin (%)
................ Result if test value equals margin
................ Rounding
............ Test: Blank concentration
................ Alternatives
.................... Upper margin (based on lowest dose standard)
.................... Upper margin (fixed)
................ Result if test value equals margin
................ Rounding
............ Test: Maximum number of missing standard responses
................ Upper margin
................ Result if test value equals margin
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author