Bayer HealthCare ADVIA 60, Руководство оператора

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3. SPECIFICATIONS
Page 3/4 075D0002-01
- Carryover : Carry-over was tested by analyzing samples with high concentrations of WBC's,
RBC's, HGB and PLT's. Each sample was run in triplicate, followed by three background cycles.
The % carryover is calculated using the following formula :
Background 1 - Background 3
Carryover = --------------------------------------------- X 100
Sample 3 - Background 3
3.1.1. Expected Values
Normal ranges were established at a study performed in Tarrytown (NY, USA). The results were
derived from the central 95% of the values in the distribution of 50 apparently healthy individuals.
PCT and PDW have not been established as indications in the United States for this product.
Their use should be restricted to research or investigational use only.
Expected values vary with sample population and/or geographic location. It is recommended that
each laboratory establish its own normal ranges based on the local population.
Table 3.5
Table 3.6
WBC RBC HGB PLT
Level 63.0 7.58 23.4 988
%Carryover (actual) 0.3 0.00 0.0 0.0
%Carryover (claim) <0.5% <0.5% <0.5% <0.5%
MALE (N=25) FEMALE (N=25)
WBC (x 10
3
/mm
3
) 4.5 - 10.8 4.3 - 10.4
LYM (%) 20 - 47 19 - 48
MON (%) 3 - 9 3 - 9
GRA (%) 46 - 72 48 - 71
RBC (x 10
6
/mm
3
) 4.7 - 6.1 4.2 - 5.4
HGB (g/dL) 13.8 - 17.0 11.3 - 15.5
HCT (%) 42 - 50 36 - 46
MCV (µm 3 ) 80 - 94 81 - 99
MCH (pg) 27 - 32 27 - 32
MCHC (g/dL) 31 - 34 31 - 34
RDW (%) 13 - 16 13 - 15
PLT (x 10 3 /mm 3 ) 185 - 402 132 - 440
MPV (µm 3 ) 7.1 - 9.5 7.8 - 9.3