L–000867(A) 5–35 – Performance and LimitationsParameterCor-relationCoeffi -cientSlope Inter-ceptQBCMeanCellCounterMeanRange ofValuesNumberof Sam-plesHematocrit (%) 0.983 0.973 2.572 36.5 34.8 15.7– 61.7 646Hemoglobin (g/dL) 0.984 0.982 0.387 12.1 12.0 5.2– 18.5 638Platelet (x 109/L) 0.962 0.935 17.701 244 242 23 – 913 558WBC (x 109/L) 0.974 1.124 –0.936 10.4 10.1 1.6– 92.9 535Granulocyte (x109/L) 0.972 0.991 0.152 7.0 7.0 0.8– 45.0 535Lymph/Mono(x109/L) 0.987 1.206 –0.419 3.3 3.1 0.8– 89.9 535The hematocrit results shown above reflect the calibration methods of the Coulter or Sysmex analyzers used in the correlationstudy. The QBC STAR software has been calibrated to match the international reference standard for microhematocrit (MHCT)technology. The data shown in the table below were obtained by comparing the QBC STAR results against the microhematocritreference method.12Interfering Substances• Hemolysis: Do not perform tests on visibly hemolyzed blood specimens.• Bilirubin: No effects on test results have been observed at bilirubin concentrations up to 20 mg/dL.8• Triglycerides: No effects on test results have been observed at triglyceride concentrations up to 1,800 mg/dL.8• Coumadin: Anticoagulant therapy has been shown to have no clinically signifi cant effect on performance.8• Doxorubicin: Treatment with the anthracyclic drug Doxorubicin does not appear to interfere with the QBC testmethod.8• Other Drugs: The effects of other potentially interfering drugs and their metabolites on QBC tests have not beenestablished.9, 10Parameter CorrelationCoeffi cient Slope Intercept QBCMeanCellCounterMeanRange ofValuesNumber ofSamplesMicrohematocrit(%) 0.986 1.023 –0.650 36.5 36.3 15.7– 61.9 646* Products of Coulter Electronics, Hialeah, FL and TOA Medical Electronics, Kyoto, Japan.