Beckman Coulter COULTER LH 750 System, Reference, Page: 57 / 120

PN 4277248DD
4-3
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE SPECIFICATIONS--LH 700 Series
4
*Due to the effect of temperature on red cell size, the specification applies to a temperature
range of 70 to 80 degrees F.
Accuracy, WBC Differential
Accuracy of the WBC differential should be determined by comparison against either or both
of two comparator methods. Accuracy can be tested against the manual differential reference
method (NCCLS* H20-A [n = 400]). Accuracy was tested against a predicate hematology
analyzer. When the LH 700 Series is compared to either method, using non-flagged,
morphological normal samples, expect results within tolerance limits listed in Table 4.3.
Accuracy, Reticulocyte
Accuracy was tested against a predicate hematology analyzer. See Table 4.4
Linearity
When tested using a stable material having no interfering substances, the LH 700 Series value
should be equal to the expected value within the limits given in Table 4.5. To minimize the
effects of imprecision, take multiple readings at each dilution point. Subtract the background
count from the values obtained.
Hgb ±0.2 ±3.0%
MCV* N/A ±2.0%
RDW ±0.5 ±5.0%
Plt ±10 ±7.0%
MPV N/A ±5.0%
Table 4.3 Accuracy Tolerance Limits, WBC Differential
Cell Type
Mean Difference %
using NCCLS H20-A Mean Difference %
using predicate analyzer
Lymphocyte% ±3.0 ±1.5
Monocyte% ±3.0 ±1.0
Neutrophil% ±2.0 ±2.0
Eosinophil% ±1.0 ±0.5
Basophil% ±1.0 ±0.5
Table 4.4 Accuracy, Reticulocyte, using a predicate hematology analyzer
Parameter/Population Mean Difference
RET% ±0.5
Table 4.2 Accuracy, CBC