Handheld and small benchtop chemistry analyzers represent methods that produce quantitative results for POCT. Most handheld glucose meters use electrochemical analysis principles. Testing methods vary and include electromechanical, photometric, electrochemical, and chemiluminescence technology. Test principles vary by instrument and specific assay. Many POC analyzers have onboard instrument QC monitored daily for instrument function validation. As with all test kits, the manufacturer's instructions must be followed for proper operation and to maintain the FDA-approved level of complexity of the instrument.
Appropriate procedures and operating instructions must be in place for the test kits, instruments, and methodologies in each POCT location. Manufacturers often provide procedures in Clinical and Laboratory Standards Institute (CLSI) format and package inserts for all kits and test methodologies. Either of these formats may serve as instructions for end users. The documents do not have to be rewritten or recreated. The laboratory director must approve the use of the documents as test instructions. The laboratory director's approval must be noted with a signature and in use date on the written procedures.
