QBC Diagnostics Star Operators & Service Manual
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QBC STAR™ System User’s Manual5–2 L–000867(A)In a separate precision study, intra- and inter-run precision were assessed using a dual level QBC Control (#424304). Thecontrols were assayed on multiple days at three sites using QBC STAR tubes and the QBC STAR system. The results of thisstudy are presented in the table below.Control PrecisionAccuracyThe performance of the QBC STAR system is based on data from venous blood samples collected in VACUTAINER® brand col-lection tubes containing K3EDTA anticoagulant. Venous blood samples provide a more stable test system than capillary bloodfor comparing results from multiple methods. While skin puncture samples provide clinically relevant results, they are subjectto more variation due to the nature of the sampling technique.Two QBC STAR tubes were prepared on each of approximately 323 blood samples and analyzed on both the QBC STAR systemand either the Coulter® STKS or Sysmex K1000 analyzers*. The correlation coefficients for the WBC, Gran, L/M, Hct, and Hgb,and PLT parameters were 0.95 or greater. Complete statistical results are presented below.Control Level 1 Control Level 2Intra-Day* Intra-Run** Intra-Day* Intra-Run**Parameter Site MeanValue %CV df %CV df MeanValue %CV df %CV dfHCT (%)BDPOL #1POL #230.4630.9330.710.281.370.73101091.581.661.1220201934.8735.2734.650.001.220.00101090.952.261.25202019HGB (g/dL)BDPOL #1POL #210.0710.1610.220.001.490.82101091.521.481.0020201911.6511.6911.660.001.060.14101090.992.341.18202019PLT (x 109/L)BDPOL #1POL #2443.33382.78459.370.004.060.001010910.644.0211.08202019194.55163.48204.186.502.080.001010918.863.3112.84202019WBC (x109/L)BDPOL #1POL #29.189.749.320.000.004.33101095.837.225.1720201921.3121.6719.880.001.035.61101097.455.409.57202019GRAN (x109/L)BDPOL #1POL #24.805.275.060.000.002.89101098.968.796.702020195.516.235.374.822.920.00101095.258.318.68202019LYMPH/MONO(x 109/L)BDPOL #1POL #24.384.484.261.490.005.35101095.626.526.5620201915.8115.4414.520.001.757.63101098.967.5912.61202019*Variability between runs during the same days** Variability between tubes on the same run during the same day (error) df = degrees of freedom0.00 denotes a negative variance estimate |
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