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Swelab Alfa Performance

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Patricio Maturana
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42 views1 page

Swelab Alfa Performance

Uploaded by

Patricio Maturana
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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11.

3 Parameter Ranges

Linearity-Regression Linearity measured according to Boule I-1040 Section 8, based on Standard


and Linear Range EP6-A.

Parameter Difference (whichever is greater) Linearity Range


WBC ± 0.4 x 109/L or 3% 0.5 – 99.9 x 109/L
RBC ± 0.05 x 1012/L or 2% 0.30 – 7.00 x 1012/L
PLT ± 10 x 109/L or 3% 20 – 1800 x 109/L
HGB ± 0.2 g/dL or 2% 2.0 – 24.0 g/dL

Displayed Range Total range where results are reported, also outside of linearity range.

Parameter Displayed range


WBC 0 - 119.9 x109/L
RBC 0.00 – 14.00 x1012/L
MCV 15.0 – 250.0 fL
PLT 0 - 1999 x109/L
HGB 0.0 – 35.0 g/dL

Correlation Correlation was performed, using an Advia 120 as references. Data derived from
965 normal and abnormal fresh blood samples.

Parameter Correlation Coefficients (R2), Advia


WBC •
RBC •
MCV •
PLT •
HGB •

Reproducibility Measured as an average of 10 measurements each on 9 different vein K2-EDTA


collected normal samples, on 3 instruments, in OT, MCI, Cap Piercer, and Auto
Sampler modes.

Parameter OT CV (%) MCI CV (%)


WBC 7.0 x109/L ≤1.8 ≤2.5
RBC 4.59 x1012/L ≤0.9 ≤1.5
MCV 86.8 fL ≤0.5 ≤0.5
PLT 239 x109/L ≤3.0 ≤3.0
HGB 14.3 g/dL ≤0.8 ≤1.3

Total System Typical value from QC testing (n=10), using Boule Con. Calculations are based
Precision on 380 instruments, using the highest moving average value of 50 instruments
as a typical value for each parameter.

Parameter CV (%)
WBC ≤ 1.8
RBC ≤ 1.1
MCV ≤ 0.3
PLT ≤ 3.3
HGB ≤ 1.0

83

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