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    Direct Bilirubin: Instrument

    Uploaded by

    Enrique Duarte
    This document provides settings and parameters for validating a direct bilirubin assay on an ARCHITECT C8000 instrument. The reagent is prepared by mixing the contents of one Reagent B-T vial into a Reagent A-D bottle. The instrument is set to a wavelength of 548/700 nm, absorbance range of 0-15 mg/dL, and 3 replicates. A linear calibration method is used with a single calibrator level and validity checks including absorbance ranges and calibration factor tolerance.

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    © All Rights Reserved
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    Direct Bilirubin: Instrument

    Uploaded by

    Enrique Duarte
    52 views1 page
    This document provides settings and parameters for validating a direct bilirubin assay on an ARCHITECT C8000 instrument. The reagent is prepared by mixing the contents of one Reagent B-T vial into a Reagent A-D bottle. The instrument is set to a wavelength of 548/700 nm, absorbance range of 0-15 mg/dL, and 3 replicates. A linear calibration method is used with a single calibrator level and validity checks including absorbance ranges and calibration factor tolerance.

    Original Description:

    BILD

    Original Title

    Bil-D

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    This document provides settings and parameters for validating a direct bilirubin assay on an ARCHITECT C8000 instrument. The reagent is prepared by mixing the contents of one Reagent B-T vial into a Reagent A-D bottle. The instrument is set to a wavelength of 548/700 nm, absorbance range of 0-15 mg/dL, and 3 replicates. A linear calibration method is used with a single calibrator level and validity checks including absorbance ranges and calibration factor tolerance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    52 views1 page

    Direct Bilirubin: Instrument

    Uploaded by

    Enrique Duarte
    This document provides settings and parameters for validating a direct bilirubin assay on an ARCHITECT C8000 instrument. The reagent is prepared by mixing the contents of one Reagent B-T vial into a Reagent A-D bottle. The instrument is set to a wavelength of 548/700 nm, absorbance range of 0-15 mg/dL, and 3 replicates. A linear calibration method is used with a single calibrator level and validity checks including absorbance ranges and calibration factor tolerance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    DIRECT BILIRUBIN

    Spectrophotometric
    DIAZOTIZED SULFANILIC

    The application parameters comprised here constitute a guide to facilitate the validation of our reagents by the
    instrument. It is advisable to validate the use when there is any change in software or reagent versions.

    Instrument: ARCHITECT C8000


    Reagent preparation
    Working Reagent: Transfer the contents of one Reagent B-T vial into a Reagent A-D bottle. Mix thoroughly.
    Stable for 20 days at 2-8 ºC.
    Instrument settings

    General Conventional Units


    Assay BIL-D Type Photometric Results Unit mg/dL
    Number ... Version 1 Assay Defaults Low Linearity 0.05
    High Linearity 15
    Reaction Definition
    Reaction Mode End Up Read Times Gender and Age specific Ranges
    Wavelength 548 / 700 Main 16 -- 18 GENDER AGE (Y) NORMAL
    Last Required Read 18 Flex __ -- __ Male 0-130 0 – 0.2
    Absorbance Range … / … Color Correction __ -- __ Female 0-130 0 – 0.2
    Sample Blank Type None Blank Read Time __ -- __ Either 0-130 0 – 0.2

    Reagent / Sample R1 R2 Reults Units mg/dL


    Reagent BIL-D Reagent Volume 200 Decimal Places 1 (Range 0-4)
    Diluent Saline Water Volume __ __ Correlation Factor 1.0000
    Diluent Disp. Mode Type 0 Dispense Mode Type 0 Type 0 Intercept 0.0000

    Diluent Name Sample Water Dilution Factor


    Standard 20 1:1.00

    Validity Checks
    Reaction definition None
    Rate Linearity % ___
    Calibration
    Method Linear

    Calibrators and Volumes


    Calibrator Set Standard Calibrator Level Concentration Volume
    Blank 0.0 20
    Std. 1 (*) 20
    Std. 2 -- --
    Std. 3 -- --
    Std. 4 -- --
    Replicates 3 (Range 1-3) Std. 5 -- --

    Intervals Validity Checks


    Calibration Interval Full Interval 999 hours Blank Absorbance range: 0.0000 -- 0.0000
    Calibration Type Adjust Type None Span Absorbance Range: 0.0000 -- 0.0000
    Expected cal Factor : 0.00
    Expected Cal factor tolerance: %0
    (*) Enter the standard value
    … Values to be entered by the user
    Version 0707

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