What is reference range in clinical chemistry?
A reference range is usually defined as the set of values 95 percent of the normal population falls within (that is, 95% prediction interval). It is determined by collecting data from vast numbers of laboratory tests.
What are some common clinical chemistry tests?
The most common specimens used in clinical chemistry are blood and urine. Many different tests exist to detect and measure almost any type of chemical component in blood or urine. Components may include blood glucose, electrolytes, enzymes, hormones, lipids (fats), other metabolic substances, and proteins.
What is CLIA validation?
The analytical validation under CLIA looks at the performance characteristics of a test used to describe the quality of patient test results, and includes an analysis of accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference interval, and any other performance characteristics …
What are recovery experiments and why are they important in analytical chemistry?
The purpose of the recovery experiment in clinical chemistry is performed to estimate proportional systematic error. We must know all measurements have some error margin in measuring analytical performance.
Why do laboratories have different ranges?
A reference range can vary between different laboratories when a collection of people who are considered ‘normal’ are used to establish a reference range for a given blood test. Complex mathematics are applied to allow for a natural variation within this chosen collection of people and therefore the reference range.
Why Different labs have different ranges?
Every lab has different types of equipment with which they collect samples and test blood. It is bound to have a different result because the equipment affects the results. Be it from the storage container in which blood is stored or the equipment under which it is tested.
What are routine chemistry tests?
What are chemistry panels? Chemistry panels are groups of tests that are routinely ordered to determine a person’s general health status. They help evaluate, for example, the body’s electrolyte balance and/or the status of several major body organs. The tests are performed on a blood sample, usually drawn from a vein.
What is the difference between reportable range and reference range?
Reportable range is the functional range of an assay over which the concentrations of an analyte can be measured with acceptable accuracy and precision. Reportable range should not be confused with reference range. Reportable range includes analytical measurement range (AMR) and clinically reportable range (CRR).
What is an acceptable percent recovery?
The recovery for accepted range in analytical chemistry is 70-120%.
What is Spike and recovery?
In spike-and-recovery, a known amount of analyte is added (spiked) into the natural test sample matrix and its response is measured (recovered) in the assay by comparison to an identical spike in the standard diluent. A spike-and-recovery experiment is designed to assess this difference in assay response.
What is the reportable range of the analyte?
A reportable range will be established for each analyte tested. The upper limit of the reportable range will be set at the concentration of the highest standard tested which exhibited acceptable results for linearity, accuracy and precision. This concentration, however, may not exceed the manufacturer’s stated linear range.
What is the upper limit of the reportable range?
The upper limit of the reportable range will be set at the concentration of the highest standard tested which exhibited acceptable results for linearity, accuracy and precision. This concentration, however, may not exceed the manufacturer’s stated linear range.
How do you determine the reportable range of a concentration experiment?
In this experiment, a laboratory will analyze a series of samples with known concentrations, or a series of diluted samples. The measured results are plotted on the y-axis vs the expected or known values on the x-axis. The reportable range is then assessed by drawing the best straight line through the linear portion of the data.
What is the difference between reference range and reportable range?
Reportable range should not be confused with reference range. Reportable range includes analytical measurement range (AMR) and clinically reportable range (CRR). AMR is defined as the range of values an instrument can report directly without dilution or concentration.