Standards for point-of-care testing


Definitions of terms used in this document




Accuracy  Measure of how close the results of a test come to the true value. 
Adverse event  An incident in which harm resulted to a person who was receiving healthcare. 
Analyte  A chemical substance in a fluid or other specimen from the body that is undergoing analysis. 
Analytical performance  The performance of the testing system. 
Bias  A quantitative measure of inaccuracy or systematic departure from accuracy under specified conditions of analysis. 
Calibration  The process of testing and adjustment of an instrument, kit or test system, to provide a known relationship between the measurement response and the value of the substance being measured by the test procedure. 
Clinical decision limits  Specific cut-off points or limits for decision about diagnosis or well-defined specific actions, based on guidelines from expert groups. 
Consumables  Products required to perform a test, such as cartridges, reagents, calibrators.  
Controls  The material used to perform quality control testing. 
External quality assurance program  An external program in which samples are periodically sent to testing sites for analysis. 
Instrument  A testing platform, system or device. 
In vitro  Outside the body; in a clinical or research laboratory; in an artificial environment such as a test tube or petri dish. 
In-vitro diagnostic medical device (IVD)  A medical device (including a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system) used in vitro (whether alone or in combination with other diagnostic goods) to examine specimens from a human body. 
Non-conformance  Departures from standard procedures, or instances where the process or system does not comply with the predetermined specifications. 
Point-of-care testing (PoCT)  Pathology testing performed at the point or time of care that helps healthcare practitioners make immediate and informed decisions about a patient’s care. 
Point-of-care testing practitioners (PoCT practitioners)  Members of the practice team who perform PoCT who: 
  • have undertaken training 
  • participate in training and education updates. 
Post-analytical  Post-testing processes, such as reporting. 
Pre-analytical  Pre-testing processes, such as test requests. 
Precision  The measure of the closeness of results obtained after analysing the same sample more than once. 
Quality control (QC)  The set of procedures designed to monitor the test method and the results to assure test system performance. These procedures include testing control materials, charting the results and analysing them to identify sources of error, and evaluating and documenting any remedial action taken as a result of this analysis. 
Reagent  A substance that produces a chemical reaction in a sample that allows an analyte to be detected and measured. 
Reference interval  The reference interval or range for a particular test is expressed as the average value for the ‘normal’ population group together with the variation around that value (plus or minus two standard deviations from the average). In this way, ranges quoted represent the values found in 95% of individuals in the chosen non-diseased or ‘reference’ group.  
Screen  The examination of asymptomatic people to classify them as likely or unlikely to have a disease. 
Test method  A method or procedure that produces a test result.  
Transcription errors  Data entry errors that usually occur because of typographical mistakes when transferring data and results.