Beckman Coulter TQ-Prep, Reference

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PN 4237395AA
4-3
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE SPECIFICATIONS
4
4.2 PERFORMANCE SPECIFICATIONS
Accuracy of Delivery Volume of Distilled Water
r
Volume delivery of syringe for Reagent A: 600 µL ±5%
Lysing time: 8 seconds ±1 second
r
Volume delivery of syringe for Reagent B: 265 µL ±5%
Stabilizing time: 10 seconds ±1 second
r
Volume delivery of syringe for Reagent C: 100 µL ±5%
Fixative time: 10 seconds ±1 second
r
Volume delivery of syringe for OPTION reagent: 500 µL ±10%
Mixing time: 8 seconds ±1 second
Precision (Reproducibility)
The precision (reproducibility) of the reagent delivery volumes is the coefficient of variation
(CV%) as listed below:
r
Reagent A = 5%
r
Reagent B = 5%
r
Reagent C = 5%
r
OPTION Reagent =15%
Calibration
Gravimetric measurement of delivery volumes (*density of distilled or deionized water = 1.0
g/mL).
* The density of ImmunoPrep A and C is insignificantly different from distilled water. The
density of ImmunoPrep B is 1.04 g/mL
4.3 PERFORMANCE CHARACTERISTICS
The TQ-Prep system was tested with normal and abnormal specimens in comparison to the
COULTER Multi-Q-Prep system and substantially equivalent results were observed.
The precision (reproducibility) of the unit based on 32 replicate samples tested for CD4 have
a coefficient of variation (CV) of 1.2%.