The purpose of a Point of Care Test (PoCT) is to yield a faster result closer to the time it is clinically required. Advancing technology, particularly in the molecular diagnostics field, is assisting clinicians in their diagnosis by providing a faster result from microbiology diagnostic laboratories. Provided they have adequate sensitivity and specificity, PoCT assays are likely to be endorsed by clinicians.
Currently there are few regulations stipulated for QA requirements for PoCT used outside the laboratory environment. The majority of PoCT designed for use as an integral part of an infectious disease diagnostic algorithm have good specicifity, sensitivty can be variable.
In addition, a consistent internal and external Quality Control (QC) program should be in place and monitored. This will demonstrate the effectiveness of the test over an appropriate period of time, on a specimen by specimen basis, at intervals that satisfy the accuracy of an individual patient result for that test. Patients and doctors should expect quality laboratory results, regardless of where, when or who does the testing [1].
Standards and Guidelines currently underway which are related to Infectious Diseases in Australia include;- WHO- training and quality systems for HIV and malaria in developing countries, ASHM - national testing policies for HIV and HBV?HCV, AIMS - Guidelines and recommendation for quality- assured conduct of PoCT for Infectious Diseases in Australia regulations.
With only a few exceptions, PoCTs currently available in infectious diseases offer a level of performance that is still inferior to molecular diagnostic tests available in a quality controlled environment using highly trained personnel. PoCT are less efficient and more error prone when performed by non-trained personnel [1]. Quality assurance measures are required [2]. Most PoCTs are intended for qualitative detection of an antigen or antibody [2].
PoCT performed outside a NATA registered facility needs staff to br trained in how to provide a quality assured result. This process should be overseen by a NATA registered laboratory.