Point-of-Care Testing in the Private Sector

Point-of-care testing (POCT) refers to analytical tests performed by qualified health professionals outside recognized and accredited public or private laboratories and outside health and social services institutions (as defined by law). This area of activity is not currently regulated.  Faced with the growing reliance on POCT and the need to ensure that these tests are of high quality, safe and technically effective, the Ministère de la Santé et des Services sociaux (MSSS) decided to review the legislation and regulations applicable to POCT and to assess the need for governance oversight in this area. In that context, the MSSS asked AETMIS to support this review process by performing an exhaustive literature review that would help provide an appropriate defi nition for POCT, draw up a list of Canada approved kits and instruments, flag the major issues associated with POCT, and identify the quality-control and quality-assurance measures proposed in Canada and around the world.

This report is not an in-depth analysis of each test but a descriptive analysis of the situation characterizing the use of POCT. Given that the MSSS basically wanted background information, this is a factual report based on observations of the POCT situation outside Québec and a literature review on this issue in general. Note that tests self-administered by patients are not included in our analysis.

• Rapid access to point-of-care tests and their results raises the issue of their appropriateness and frequency. Some believe that POCT should be performed only when justifi ed by the need for a rapid response and in situations requiring immediate test results. These tests seems more appropriate for patient monitoring than for disease detection or diagnosis.

• Accountability lines should be clearly identifi ed in policies and procedures on the different tests. Before any test is used, its benefi ts must be weighed against the disadvantages associated with its result. It must always be kept in mind that the aim of POCT is to contribute to improving patients’ care and quality of life and that it must complement, not replace, central laboratory services.

• The wide availability of POCT in contexts as varied as superstores raises serious concerns about the trivialization of medical conditions “diagnosed” in this way. There is also the fear that this type of testing might be performed by unqualifi ed staff. To mitigate this problem, some propose that professional laboratory technicians take part in selecting and maintaining the test devices, training operators, and regularly verifying their competence and the accuracy of the documentation provided to patients (in accordancewith the requirements issued by regulatory bodies).

• Since it has become necessary to develop and adopt statutory measures governing the use of POCT in Québec, the legislator could base them on the regulations in place in other countries in order to adapt and reinforce existing regulatory mechanisms or to provide for new ones. This type of governance oversight could help make point-of-care tests as effective and safe as those performed in central laboratories.

• Lastly, any decision with regard to prioritizing these tests must be based on a comprehensive analysis of each test, including an economic component to ensure that its benefi ts outweigh its disadvantages and costs.