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This document provides guidelines for validating a turbidimetric assay for transferrin on an ARCHITECT C8000 instrument. It outlines the instrument settings, reaction definition, reagent preparation, calibrator levels and volumes, calibration intervals, and validity checks required to validate the transferrin reagent. The reagent is ready to use and the assay measures transferrin concentration in mg/dL using a logarithmic calibration with 5 calibrator levels over a range of 0-700 mg/dL.

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Enrique Duarte
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35 views

Trans

This document provides guidelines for validating a turbidimetric assay for transferrin on an ARCHITECT C8000 instrument. It outlines the instrument settings, reaction definition, reagent preparation, calibrator levels and volumes, calibration intervals, and validity checks required to validate the transferrin reagent. The reagent is ready to use and the assay measures transferrin concentration in mg/dL using a logarithmic calibration with 5 calibrator levels over a range of 0-700 mg/dL.

Uploaded by

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

Turbidimetry

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
Reagent is ready to use.

Instrument settings

General Conventional Units


Assay TF Type Photometric Results Unit mg/dL
Number ... Version 1 Assay Defaults Low Linearity 4.8
High Linearity 700
Reaction Definition
Reaction Mode End Up Read Times Gender and Age specific Ranges
Wavelength 340 / 700 Main 14 -- 16 GENDER AGE (Y) NORMAL
Last Required Read 16 Flex __ -- __ Male 0-130 200 - 360
Absorbance Range … / … Color Correction __ -- __ Female 0-130 200 - 360
Sample Blank Type None Either 0-130 200 - 360

Reagent / Sample R1 R2 Reults Units mg/dL


Reagent TF 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 2 1:1.00

Validity Checks
Reaction definition None
Rate Linearity % ___
Calibration
Method Logit - 4

Calibrators and Volumes


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

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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