Beckman Coulter COULTER LH 750 System, Reference

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PN 4277248DD
4-10
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS
NRBC Accuracy Characteristics
NRBC Accuracy Characteristics was defined as the agreement between the LH 700 Series and
the results given by the reference method (NCCLS H20A) and a predicate hematology
analyzer.
All NRBC % results > 2 and < 15 will be flagged with an R symbol. Beckman Coulter, Inc.
recommends a slide review as per your individual laboratory protocol. The presence of this
flag does not affect the correction of the white blood cell count in the presence of NRBC's.
Table 4.21 shows the NRBC results for whole blood specimens with and without NRBC
collected in a salt of EDTA.
* NCCLS
** predicate hematology analyzer
Platelet Accuracy Characteristics
Table 4.22 shows the Plt results for whole blood specimens collected in a salt of EDTA.
Reference Ranges
A Normal Range study was conducted to assess the Reference Ranges for the LH 700 Series.
Whole-blood samples were collected from 131 donors (males and females). The selection of
donors was consistent with guidelines stated in NCCLS, C28-A.
Table 4.21 NRBC Accuracy Characteristics, Compared Samples
Parameter Units N
Population
Minimum Population
Maximum Mean
Difference
NRBC
* % 496 0.0 344.00 -0.84
NRBC
**
% 56 0.0 178.00 4.00
Table 4.22 Plt Accuracy Characteristics vs ICSH/ISLH Platelet Method
Parameter Units N
Population
Minimum Population
Maximum Mean
Difference Mean %
Difference
PLT
x 10
3
cells/L
104 0.37 1138.00 -4.38 19.43
Table 4.23 Normal Population Study
Parameter Units Mean
95% Confidence
Low Limit 95% Confidence
High Limit
WBC
x 10
3
cells/µL
6.03 3.53 9.57
RBC
x 10
6
cells/µL
4.64 3.96 5.50
Hgb g/dL 13.83 12.14 16.27
Hct % 40.22 35.39 47.19
MCV fL 87.0 76.9 94.7
MCH pg 29.98 25.69 32.95
MCHC g/dL 34.42 33.34 35.47