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Direct Bilirubin: Instrument

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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Enrique Duarte
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91 views1 page

Direct Bilirubin: Instrument

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.

Uploaded by

Enrique Duarte
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on 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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