
viii Rev. C, 715003738IVD
Audience and purpose
This guide is intended for use only by professionally trained and qualified
laboratory personnel who operate and maintain ACQUITY UPLC I-Class IVD
column heaters.
Intended use of the column heater
Waters designed the ACQUITY UPLC I-Class IVD column heater for use with
the ACQUITY UPLC I-Class IVD system to perform ultra-performance liquid
chromatography for in vitro diagnostic use.
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 mass spectrometers, consult the instrument’s online Help
system for instructions.
Quality control
Routinely run three QC samples that represent subnormal, normal, and
above-normal levels of a compound. If trays are the same or very similar, vary
the location of the QC samples in the trays.
Ensure that QC sample results fall within an acceptable range 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.
When analyzing samples from a complex matrix such as soil, tissue,
serum/plasma, whole blood, and other sources, note that the matrix
components can adversely affect LC/MS results, enhancing or suppressing
ionization. To minimize these matrix effects, Waters recommends you adopt
the following measures:
• Prior to the instrumental analysis, use appropriate sample
pretreatment such as protein precipitation, liquid/liquid extraction
(LLE), or solid phase extraction (SPE) to remove matrix interferences.