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Aspartate Aminotransferase (Ast/Got) : Instrument

This document provides guidelines for validating reagents for measuring aspartate aminotransferase (AST/GOT) using a continuous spectrophotometric assay on an ARCHITECT C8000 instrument. It specifies reagent preparation and storage, instrument settings, reaction definitions, calibrator levels and volumes, validity checks, and calibration intervals. The validation ensures proper performance when software or reagent versions change.

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Enrique Duarte
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108 views

Aspartate Aminotransferase (Ast/Got) : Instrument

This document provides guidelines for validating reagents for measuring aspartate aminotransferase (AST/GOT) using a continuous spectrophotometric assay on an ARCHITECT C8000 instrument. It specifies reagent preparation and storage, instrument settings, reaction definitions, calibrator levels and volumes, validity checks, and calibration intervals. 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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ASPARTATE AMINOTRANSFERASE (AST/GOT)

Continuous-spectrophotometric
IFCC

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: Pour the contents of a Reagent B bottle into a Reagent A bottle. Mix gently.
Stable for 2 months at 2-8ºC.
Instrument settings

General Conventional Units


Assay AST Type Photometric Results Unit U/L
Number ... Version 1 Assay Defaults Low Linearity 1,1
High Linearity 500
Reaction Definition
Reaction Mode Rate Down Read Times Gender and Age specific Ranges
Wavelength 340 / 0 Main 3 -- 13 GENDER AGE (Y) NORMAL
Last Required Read 13 Flex __ -- __ Male 0-130 0 - 40
Absorbance Range … / … Color Correction __ -- __ Female 0-130 0 - 40
Sample Blank Type None Blank Read Time __ -- __ Either 0-130 0 - 40

Reagent / Sample R1 R2 Reults Units U/L


Reagent AST 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 10 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 10
Std. 1 (*) 10
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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