Available Uplc Inlets; Calibrating - Waters Xevo TQD IVD Overview And Maintenance Manual

Available UPLC inlets

System Inlet
ACQUITY UPLC Binary Solvent Manager (BSM)
IVD
Sample Manager (SM)
Column Heater
Sample Organizer (optional)
Column Manager (optional)
ACQUITY UPLC Binary Solvent Manager (BSM)
I-Class IVD
Sample Manager - Flow-Through-Needle
(SM - FTN)
Column Heater (CH-A) with active pre-heating

Calibrating

To calibrate LC systems, follow acceptable calibration methods using at least five standards to
generate a standard curve. The concentration range for standards must include the entire range of
QC samples, typical specimens, and atypical specimens.
When calibrating the mass spectrometer, consult the calibration section of the ACQUITY UPLC
I-Class/Xevo TQD IVD System Operator's Guide (part number 715005210IVD).
Quality control
The following quality controls are required when using Waters in vitro diagnostic (IVD) LC-MS/MS
Systems.
To prevent incorrect reporting of results, verify proper sample vial placement and positioning
against the sample list, prior to sample injection.
Routinely run three matrix-matched QC samples at the Lower and Upper Limit of Quantitation and
the mid-point of the Measuring Range for each analyte. Additionally, QCs at decision points may
speed detection of critical deviations. If sample trays are the same or very similar, vary the location
of the QC samples in the trays. Ensure that QC sample results are within acceptable ranges, and
evaluate precision from day-to-day and run-to-run. Data collected when QC samples are out of
range might not be valid. Do not report these data until you are certain that the instrument
performs satisfactorily.
TargetLynx™ processing includes calibration curve, internal standard, and quality control flagging
features. Waters recommend including these capabilities when validating quantitative clinical
methods, to automate detection of erroneous results. Nevertheless, a manual inspection of data
should be performed prior to reporting results.
To reduce the possibility of an incorrect patient result due to carryover caused by exhaustion of the
wash solvent, run appropriate blank samples during the sample analysis.
September 7, 2016, 715003560IVD Rev. C
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