{品质管理质量认证}ACL9000ClotCurveRevC5某某某

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1、ACL 8000, 9000, and 10000,Clot Curves and D-Dimer Reaction Curves,Hemostasis Technical Marketing,1,Objectives,Review Nephelometry Discuss how clot curves are developed Review normal clot curves Understand why abnormal clot curves occur Review abnormal clot curves,2,What is a clot curve?,3,Tilt Tube

2、Method vs. Instrumentation,Operator adds reagents and incubates Visually determines end point or clot,Tilt Tube,Instrumentation,Test is automated Instrument takes optical readings Uses formula or algorithm to convert optical readings to endpoint,4,Nephelometric Optic Detection,Nephelometry is the me

3、asurement of light scattered by a particulate solution.,5,Algorithm: A formula or process used to convert the raw optical measurements into a clot time,Defined in the Test Definition Screen Smoothes the data to display a visible line Checks for clot integrity Raw data that does not pass all criteria

4、 will be displayed with an error,6,Threshold Plot,Light Scatter Reading,(S/R)*100,Baseline,7,Light Scatter Reading,TIME (Seconds),(S/R)*100,2nd Derivative Plot,8,Centrifugal Analysis,One LED 19 samples may be processed in one run Samples and Reagents loaded into rotor simultaneously Bridge allows se

5、parate incubation Mixed by Centrifugal force,9,Clot Signature Curve Creation,Increasing Light Scatter,Increasing Time (seconds),10,Light Scatter Reading,TIME (Seconds),Acceleration,Plateau,0,(S/R)*100,The parts of a Clot Curve,Baseline,11,Baseline,Acceleration,Plateau,12,Acceleration,Baseline,Platea

6、u,13,14,15,How do I know when I have an abnormal curve?,16,Flagging Limits,Results that are within the normal range Results that are outside of normal range Results that are outside of test range Results outside scale range,No flags * Bold *,Black,Printout,Computer,Violet,Red,No results,17,Error Cod

7、es,R Data Reduction Errors E Instrument Errors Q QC Errors Q Calibration Errors Q Analytical Reference Errors,18,Revision C 5/2004 PN 9000PPT09/26/03,19,20,Reaction Curve Errors,Error code 5: Optical failure. Error code 6: First threshold not passed. Error code 7: Second threshold not passed. Error

8、code 8: Delta time between thresholds is too long. Error code 9: Initial slope of reaction is too high. Error code 10: Final slope of reaction is too high. Error code 11: Final delta of curve is too high. Error code 12: Maximum peak of 1st derivative is below limit. Error code 13: Maximum peak of 2n

9、d derivative is below limit. Error code 14: Offset error.,21,Revision C 5/2004 PN 9000PPT09/26/03,22,23,24,25,26,27,28,29,30,Revision C 5/2004 PN 9000PPT09/26/03,31,Revision A June 2003,Revision C 5/2004 PN 9000PPT09/26/03,32,33,34,35,D-Dimer Reaction Curve Interpretation,36,Interpreting D-Dimer Rea

10、ction Curveson the ACL 9000,Immuno Assay relies on formation of antigen-antibody complexes to affect light transmission Principle: Latex particles coated with a monoclonal antibody directed towards the D-Dimer domain As antibody complexes agglutinate, the agglutination will affect the amount of ligh

11、t absorbed Analyzed using the Chromogenic Channel measures absorbance of light with 405 nm channel,37,38,39,40,41,42,43,44,45,1.29,1.26,46,Abnormal D-Dimer Reaction Curves,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,Any questions?,62,Clot Curves (Reaction curves) are a great tool.,This technology provides a better way to assure more reliable results while saving time and money,In Conclusion,63,

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