717plus Autosampler Information
Intended Use
The Waters 717plus Autosampler can be used for in-vitro diagnostic testing to analyze
many compounds, including diagnostic indicators and therapeutically monitored
compounds. When you develop methods, follow the “Protocol for the Adoption of
Analytical Methods in the Clinical Chemistry Laboratory,” American Journal of Medical
Technology, 44, 1, pages 30–37 (1978). This protocol covers good operating procedures
and techniques necessary to validate system and method performance.
Biological Hazard
When you analyze physiological fluids, take all necessary precautions and treat all
specimens as potentially infectious. Precautions are outlined in “CDC Guidelines on
Specimen Handling,” CDC – NIH Manual, 1984.
Calibration
Follow acceptable methods of calibration with pure standards to calibrate methods. Use a
minimum of five standards to generate a standard curve. The concentration range should
cover the entire range of quality-control samples, typical specimens, and atypical
specimens.
Quality Control
Routinely run three quality-control samples. Quality-control samples should represent
subnormal, normal, and above-normal levels of a compound. Ensure that quality-control
sample results are within an acceptable range, and evaluate precision from day to day and
run to run. Data collected when quality-control samples are out of range may not be valid.
Do not report this data until you ensure that chromatographic system performance is
acceptable.