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ارزیابی دستگاه شمارشگر سلولهای خونی

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ارزیابی دستگاه شمارشگر سلولهای خونی. دکتر آتوسا شریعت تربقانی آزمایشگاه مرجع سلامت. Cell count techniques. Electrical Optical. Outlet. Light Source Beam. Aperture. Photodiode. Inlet. Optical Principle. Constant Current Source. Vacuum Pump. 9% NaCl Electrolyte. Electrodes. Aperture. - PowerPoint PPT Presentation

Text of ارزیابی دستگاه شمارشگر سلولهای خونی

  • ElectricalOptical

  • CoincidenceCarry overPost aperture recirculation

  • Inadequate mixingPipetting faultInappropriate dilutionDelay in transferring suspension to counting chamberElectric interferenceExternal noiseAperture blockageAspiration failureContaminated diluentAir bobblesResidual lysic agentInadequate drainage

  • RBC/ WBC imprecision linearity WBC incomplete lysis

    Platelet solution with dust imprecision

    CV%Calibration stability

  • 5 SET UP

  • 1-4

  • RBC < 0.03 10 12/lWBC < 0.04 10 9/lHGB < 0.2 g/lPLT < 5 10 9/l

  • 5-3 20

  • Each step in triplicate (each dilution read in duplicate)10-20 normal individuals Hct can be corrected 1.5-3% 2% for 0.440.442%=0.0088 .44-.0088=0.43

    CF(coefficient factor)= [(manual-analyzer) / (analyzer )]100

  • Sample manual mean cell counter mean 1 11,11.5,11 11.7 12,12,12 12 2 12,12.8,13 12.6 13,12.8,12.8 12.87 3 14,14.2,13.9 14.03 14.5,14.5,14.8 14.6 4 13,13.5,13.6 13.37 13.6,13.1,13.4 13.37 5 14.3,14.6,14.5 14.47 15,15,15.1 15.03Mean(manual)=11.7+12.6+14.03+13.37+14.47 = 13.23 5Mean(cell counter)=12+12.87+14.6+13.37+15.13=13.57 5CF=(13.23 13.57 ) / 13.57 = -0.02598 X (-0.025) = -2.45 98 2.45 = 95.55

  • Concentration 1.5 mg / cc or 3 mg / 2 cc

    Solution 3% 3 gr / 100 cc or 3000 mg /100030000 mg 1000 cc 3 mg X X= 0.1 cc or 100 l

    Solution 6% 6 gr / 100 cc or 6000 mg /100060000 mg 1000 cc 3 mg X X= 0.05 cc or 50 l

  • ( 20-18 ) (MCV 100 , Hg = 10-11 gr/dl) (Bil > 30 mol/l )

  • 5 +4Sd 5

  • 20 5/5 .

  • 10 CBC 10 . 5 . SDCV Within-run Precision . 2 Between-run Precision . Precision Between-day .

  • 20 20

  • CV within-run within-day ( 0.25 TE )

    CV between-day TE) 0.33 T)

  • Test Allowable total error (TE )Within-run CVWithin-day CVWhite cell countTarget + 15%3.75%Erythrocyte countTarget + 6%1.5%HematocritTarget + 6%1.5%HemoglobinTarget + 7%1.75%Platelet countTarget + 25%6.25%

  • high (H1,H2,H3) low (L1.L2.L) . C / D E / F G / H .%carry over =

  • :6.28-6.27-6.30 0.74-0.52-0.49

    .

  • reportable range . . C E G . platelet rich plasma . CML . MCV.MCH.MCHC .

  • .

    Low poolHigh poolMixture 15 part00%Mixture23 part1 part25%Mixture32 part2 part50%Mixture41 part3 part75%

  • ( ) . R2 > 0.95 .

  • 100 . ( 20 ) ( ) : CBC ..... .

  • FDA .: CLSI

  • R2 Slop intercept-Bias . T duplicate test . flag NRBC & flag immature cell

  • . . 14 10 3 baseline . 4 . .

  • ( ) . baseline 1.5% . .

    RBC1Run14.1Run24.12Run34.11Average4.114h Unmixed4.094h Premixed4.13Change unmixed%0.49Change premixed %-0.49

  • 4.1+4.12+4.11 / 3 = 4.11 4.09 . 4.13

  • .

  • user friendly .

    GP19-A Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline

  • General Principles of Software Validation; Final Guidance for Industry and FDA StaffDocument issued on: January 11, 2002 U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research

    GP19-A Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline , CSLI

  • Homogenous Non-homogenous

  • . ( 5%) . .

  • XX1.1X1.2X1X2.1X2.2X2X3.1X3.2X3...

  • Duplicate test

    WtWt2X1.1X1.2X1.1-X1.2(X1.1-X1.2)2X2.1X2.2X2.1-X2.2(X2.1-X2.2)2X3.1X3.2X3.1-X3.2(X3.1-X3.2)2.....

  • Ss 0.3 sd test for program

  • StableUnstable

  • Test or Analyte Acceptable PerformanceWhite cell differentiation Target 3 SD based on percentage of different types of white cellsErythrocyte count Target 6%Hematocrit Target 6%Hemoglobin Target 7%Leukocyte count Target 15%Platelet count Target 25%

  • . ( )

  • *