Procleix TIGRIS - Sample Requirements

INTRODUCTION AND PRODUCT DESCRIPTION
PROCLEIX
®
TIGRIS System Operator’s Manual 1-25
Volume I: Operating the Instrument
Part # 902649EN Rev. A
Sample Requirements
Sample Quality
All sample tubes must contain sufficient liquid for processing, and must be free of undissolved
particles, clots, and foam. Specimens with visible precipitates or fibrinous material should be
clarified according to instructions in the appropriate PROCLEIX
®
Assay package insert.
Volume Requirements
The minimum specimen pipetting volume is 500 μL. Up to ten replicates can be tested from
each sample tube; each replicate is a 500 μL aliquot. Calibrators and PROCLEIX
®
TIGRIS
Controls have a fixed number of replicates that is set in the software. Attempts to pipette from
the sample tube beyond what is described here can lead to insufficient volume errors.
Processing a sample with less than the minimum sample volume may result in errors. The
minimum sample volume includes both the sample pipetting volume and the dead volume.
Dead Space Volume Requirement
For samples in tubes that do not contain red cells or a gel separator, the dead space volume
requirements must be taken into account. Dead space volume is defined as the volume of
sample in a tube that must be present in order for the system to initiate pipetting.
For example, the dead space volume for a 12 mm or 13 mm diameter round-bottom tube is
500 µL. Each sample of this type must have at least the required specimen pipetting volume of
500 µL, plus the dead space volume of 500 µL of plasma. Refer to the table below for minimum
specimen volume requirements.
Buffer Zone Requirement
For samples in tubes that contain cells, a layer of debris after centrifugation, or a gel separator,
a minimum volume of plasma defined as a buffer zone volume must exist between the cell,
debris, or gel interface and the PROCLEIX TIGRIS System’s pipette tip.
For example, the buffer zone required for a 12 mm or 13 mm diameter round-bottom tube is
200 µL. Each sample of this type must have at least the required specimen volume of 500 µL
plus the buffer zone volume of 200 µL of plasma. Refer to the table below for minimum
specimen volume requirements.
Tube Diameter Dead Space Volume Total Volume Requirement
12 mm - 13 mm 500 µL 1000 µL
16 mm 1000 µL 1500 µL
Tube Diameter Buffer Zone Volume Total Volume Requirement
12 mm - 13 mm 200 µL 700 µL
16 mm 400 µL 900 µL