Declaration of traceability and uncertainty for Myt-3D, Myt-5D and Myt-CAL

Assignment of reference values to fresh whole blood Myt-CAL values are traceable to standard reference methods. Myt-3D and Myt-5D are traceable through the Myt-CAL to the standard reference methods. Haematology analyzers in are whole blood calibrated to values obtained using the following standard reference methods. Whole blood samples drawn from normal, healthy donors are collected in EDTA anticoagulant and analyzed within six hours of collection. The White Blood Cell (WBC) and Red Blood Cell (RBC) are analyzed on a Coulter Counter Z series instrument. All counts are corrected for coincidence. Haemoglobin is measured using the Clinical Laboratory Standards Institute (CLSI) recommended reagent for (1) the haemoglobincyanide (cyanmethaemoglobin) method . Readings are made at 540 nm in a (1) colorimeter/spectrophotometer calibrated according to CLSI H15-A3 and ICSH recommendations . The hematocrit (packed cell volume) is measured using plain glass microhematocrit tubes (not coated with anticoagulant) centrifuged for 5 minutes in a microhaematocrit centrifuge according to the CLSI H7-A3 (2) document . No correction is made for trapped plasma. Platelets are assayed using a haemocytometer and phase contrast optics. Determination of uncertainty Uncertainty is an estimate of the range in which the true value of a reported result may occur. The uncertainty associated with the calibration of the Orphe analyzers using the Myt-CAL calibrator has been estimated by adding the following sources of uncertainty: uncertainty of the equipment used to determine the reference values: flask, pipette, single aperture impedance counter (WBC, RBC), Hemocytometer by phase-contrast (PLT), spectrophotometer (HGB), and ruler (HCT). uncertainty of the haematology analyzer when calibrating with the Myt-CAL.
Table 1. Expanded uncertainty based on a standard uncertainty multiplied by a coverage factor of k=2 providing a level of confidence of approximately 95%. Mythic 18 Mythic 22 Absolute Absolute Percent Percent Measured uncertainty Measured uncertainty uncertainty Parameter uncertainty of value of value of of measurement measurement measurement measurement 9.0 0.19 2.08 9.0 0.20 2.20 WBC (103/uL) 4.50 0.10 2.13 4.50 0.08 1.79 RBC (106/uL) 13.8 0.21 1.49 13.8 0.21 1.55 HGB (g/dL) 40 0.95 2.38 40 0.80 2.01 HCT (%) 250 14.1 5.62 250 13.5 5.42 PLT (103/uL)
1. National Committee for Clinical Laboratory Standards (now Clinical Laboratory Standards Institute.) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood: Approved Standard-Third Edition. NCCLS document H15-A3. Wayne, PA: NCCLS, 2000. National Committee for Clinical Laboratory Standards (now Clinical Laboratory Standards Institute.) Procedure for Determining Packed Cell Volume by the Microhematocrit Method: Approved Standard, NCCLS document H7-A3. NCCLS, Wayne, PA: NCCLS, 2001.

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