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Trig

This document provides instructions for validating an enzymatic-spectrophotometric assay for triglycerides on an ARCHITECT C8000 instrument. It outlines the instrument settings, reaction definition, reagent and sample details, validity checks, calibration method and intervals, and expected results. The validation ensures proper performance when software or reagent versions change.

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Enrique Duarte
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52 views

Trig

This document provides instructions for validating an enzymatic-spectrophotometric assay for triglycerides on an ARCHITECT C8000 instrument. It outlines the instrument settings, reaction definition, reagent and sample details, validity checks, calibration method and intervals, and expected results. The validation ensures proper performance when software or reagent versions change.

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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TRIGLYCERIDES

Enzymatic-spectrophotometric
GLYCEROL PHOSPHATE OXIDASE/PEROXIDASE

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 TRIG Type Photometric Results Unit mg/dL
Number ... Version 1 Assay Defaults Low Linearity 1.6
High Linearity 600
Reaction Definition
Reaction Mode End Up Read Times Gender and Age specific Ranges
Wavelength 500 / 700 Main 16 -- 18 GENDER AGE (Y) NORMAL
Last Required Read 18 Flex __ -- __ Male 0-130 0 - 150
Absorbance Range … / … Color Correction __ -- __ Female 0-130 0 - 150
Sample Blank Type None Blank Read Time __ -- __ Either 0-130 0 – 150

Reagent / Sample R1 R2 Reults Units mg/dL


Reagent TRIG Reagent Volume 300 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 3 1:1.00

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

Calibrators and Volumes


Calibrator Set Standard Calibrator Level Concentration Volume
Blank 0.00 3
Std. 1 (*) 3
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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