A | B |
calibration | process of setting an instrument to accurately respond to the test reagents or devices |
certificate of waiver (CoW) | CLIA document that allows a facility to perform only waived tests |
CLIA-waived tests | tests that provide simple, unwavering results and require a minimum amount of judgment and interpretation |
control sample | a manufactured specimen that has a known value of the analyte being tested |
external controls | liquid positive and negative controls that are tested before the patient specimen to check the reliability of the instrument and testing technique |
internal control | built-in positive control used in qualitative tests to prove the device or kit is working |
kit | all components of the test packaged together |
Levy-Jennings chart | a graph used to plot and visualize the results of control samples over time |
mean | the average test result of a series of control tests |
optics check | confirming that the light source and light sensor in optical analyzers are working properly |
precision | reproduciblity- ability to produce the same test result each time a test is performed |
PHI | protected health information |
qualitative test | test that simply looks for the presence or absence of a substance |
QA | quality assurance |
QC | quality control |
quanititative | test that produces a numerical value indicating the amount of a substance present |
reagent | substance or ingredient used in a laboratory test to detect, measure, examine, or produce a reaction |
reliability | when both accuracy and precision are accomplished |
standard deviation (SD) | statistical term describing the amount of variation fromt he mean in a data set |
CLIA | Clinical Laboratory Improvement Amendments |