Module 3f: Point of Care Testing

Other terms used to describe POCT are

Diagnostic testing at or near the site of patient care rather than in the clinical laboratory.

Persons performing POCTs are called

tests which are subject to the lowest level of regulation and are cleared by the FDA for home use

Accurate as to render the likelihood of erroneous results negligible, as well as pose no reasonable risk of harm to the patient if the test is performed incorrectly.

These tests require no special training or educational background for operation, and require only minimum quality control

more difficult to perform than waived tests but usually employ hand-held automated methodology

Operators for these tests have relatively more stringent set of requirements. Facilities should acquire a Certificate of Registration from authorizing and accrediting bodies, and are subjected to proficiency testing and on-site inspections.

Tests under moderate complexity tests that involve the use of a microscope, limited to bright-field or phase-contrast microscope, for slide examinations of freshly collected body fluid

Tests that can only be performed by physician’s assistants, nurse practitioners, midwives, physicians, and dentists during a patient’s examination.

These tests require sophisticated instrumentation and a high degree of interpretation by testing personnel

Personnel performing these tests must have a formal education in laboratory science.