COULTER HmX Hematology Analyzer, Справочное руководство

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PN 4237523A 4-8
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER
Limits over the clinical range for a minimum of 50 specimens from a general hospital
population of no more than 30% specimens with abnormally elevated Reticulocyte values
(Retic >4%) are:
Limits over the clinical range for a minimum of 50 specimens with the following
characteristics are:
r
Greater than 50% abnormally elevated Retic values (Retic >4%).
r
No greater than 5 of 50 specimens have Retic values >20%.
* Both requirements must be met.
Reportable Range
Table 4.7 shows the reportable range for the HmX Hematology Analyzer with Reticulocyte
method.
Operating Range
The operating range is 0 - 100 percent reticulocytes.
Flagging
Samples above or below the reportable range are flagged accordingly. Instrument conditions
that may interfere with the identification of reticulocytes are also flagged. Refer to the
Parameter Codes table in the Operator's Guide.
Limitations
Prepare samples at ambient temperatures between 16 and 30°C (61 and 86°F). Use air
displacement pipettes to pipet whole blood and to transfer the blood/stain mixture. Repeated
aspiration of Reagent A can cause pipette discoloration. Also see Heading 4.8, INTERFERING
SUBSTANCES.
4.5 PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER
Precision of the CBC Parameters
The tests described in this section were performed on the WBC differential and CBC
subsystems as separate, noninteractive entities. This test condition is dictated, in part, by the
need to use separately validated reference methods for evaluation of instrument accuracy and
Parameter Mean Difference* SD of Difference*
RET% ±1.0
≤
1.5
Parameter % Mean Difference* SD of Difference*
0.00 - 30.00 ±1.5
≤
3.0
Table 4.7 Reportable Range
Parameter Range Mean Difference
Reticulocyte % 0.2 - 30.0 ±0.3