|Home | About | Journals | Submit | Contact Us | Français|
During the last ten years Point-of-Care Testing (PoCT) has been shown to be among the fastest growing areas of laboratory medicine. The primary reason for this growth has been a demand for faster turnaround times to facilitate improvements in patient management. While in the past we were interested in providing STAT services for critical analytes such as in blood gas analysis, our focus now is on areas that will allow a more efficient way to manage patients as they encounter the healthcare system. Examples include patients self-managing their own INR, creatinine-based triage of patients undergoing radiological investigations, and the monitoring of diabetic patients using glucose, HbA1c, and albumin/creatinine ratio measurements.
Such clinical demands have dictated PoCT needs and directed instrument design by manufacturers who must take into consideration requirements such as ensuring that quality control (QC) of the system can be maintained in the hands of non-clinical laboratory professionals by automating processes as much as possible. Barcode technology coupled with connectivity of the various PoCT devices to a central laboratory information system is now a reality, ensuring accurate documentation of the patient, the test, the time and the result reported. A key contribution of the In Vitro Diagnostics (IVD) industry which has a direct impact on the implementation of PoCT is in instrument design. If the design of the PoCT device meets the needs of the clinician and patient as well as providing an overall cost benefit, there is clear evidence that barriers to implementation are lowered significantly.
One thing is certain: PoCT is here to stay, a fact that most laboratories now recognise as an opportunity rather than a threat. The clinical laboratory professional is the best positioned health care provider able to utilise the potential benefits of PoCT to their fullest. Recent advances in the technology used in PoCT and target analytes measured will require even more understanding of pre-analytical variables, QC and quality assurance (QA). This is indeed the speciality of the clinical laboratory. The clinical laboratory must also be the principal adviser when a question arises as to whether it would be better to offer PoCT rather than perform the test in the laboratory.
Some clinical laboratory professionals are hesitant to take on the role as mentor to a provider of PoCT in addition to their normal duties because of workload and lack of resources. However, this extra responsibility can be shared by working in a partnership with all the PoCT stakeholders. In order to enjoy the potential benefits of PoCT, all relevant stakeholders must be partners in its implementation. Healthcare professionals such as doctors and nurses directly involved with the PoCT deliverables must understand and establish how PoCT results are used to manage the patient. Similarly, the laboratory is in the best position to assist with device selection through a critical appraisal of the analytical characteristics of PoCT devices, highlighting any potentially problematic pre-analytical and analytical areas that should be considered. In addition, ensuring that the PoCT devices continue to function as intended through sound QC and QA programmes can be achieved through a partnership between the laboratory and the end users. What then is the role of the PoCT supplier in this partnership?
The days are gone when the only contact with the PoCT supplier was at the point of sale with the purchasing of the devices and consumables from a company representative. The PoCT supplier in 2010 is a specialist for their PoCT product and possibly best able to provide advice on product functionality, its limitations and benefits. It must be appreciated that the supplier is a holder of significantly more information about the device than what is shown in the glossy brochure and the package insert. Unless the user is made aware of this fact, such information will never be passed on and used to meet local clinical and analytical needs. There are many areas where the supplier can now assist in an effective PoCT implementation:
In summary, at a hospital/clinic level, the contribution of the industry is in design of appropriate instrumentation, providing information, value-added services and playing an ongoing liaison/consultation role between users, professional bodies, regulators, standards committees and patient groups.
When we were asked to contribute to this PoCT edition of The Clinical Biochemist Reviews, we were encouraged to see confirmation of our belief that the manufacturer and supplier should be part of the PoCT partnership. The professional approach to this continuously expanding area of clinical medicine by bodies such as the AACB will ensure that the supplier and other medical teams as partners in PoCT settings deliver more efficient and effective patient care and management.
Dr George Koumantakis and Mr Les Watkinson are both members of the AACB PoCT Working Party Committee.
Competing Interests: Dr George Koumantakis has declared that he is an employee of Roche Diagnostics Australia. Mr Les Watkinson declares no competing interests.