Point Of Care Testing in Clinical Trials
SummaryAssessing the use of Point Of Care Testing in Clinical Trials - the policies and procedures involved, the benefits Point Of Care can bring to clinical trials and the advantages over the conventional laboratory approach.
Point of Care Testing
Point of care (POC) testing is diagnostic testing performed promptly and conveniently in the vicinity of the patient, avoiding the often lengthy procedure of sending samples to be processed in a central laboratory. This gives rise to the alternative names of near-patient and bedside testing. The requirement for POC testing is increasing, with the global POC testing market predicted to rise from $12.8 billion in 2008 to $17.8 billion in 2014 (Life Science Intelligence, 2009)
POC testing can be implemented using disposable testing kits, such as dipsticks and cassettes; handheld analysers and monitors; or small benchtop analysers, all of which require little or no maintenance. This equipment can be applied to a range of different tests such as blood gases, electrolytes, coagulation, pregnancy assessment and drugs of abuse testing, covering a variety of fields including biochemistry, haematology and virology.
In certain settings POC offers many benefits and opportunities over the conventional laboratory approach, making it an exciting ever-developing alternative (Figure 1).
• SPEED - The most significant advantage of POC testing is the marked decrease in turnaround time. The testing procedures themselves can produce results in minutes and sometimes seconds. It eliminates the need for samples to be sent to centralised laboratories whereby clinicians have to wait for the specimens to be processed and results returned. A faster patient diagnosis means faster implementation of treatment and all-round better management of the patient and their condition. This is particularly important for a rapid response to critical values.
• PORTABILITY - POC devices are often small and portable and sometimes battery-powered, giving particular advantage when used out in the community or on large hospital sites. Even the larger POC analysers are small enough to be installed in areas such as GP surgeries, thus providing greater accessibility for the people who use them.
• CONVENIENCE – Clinicians, through the use of POC, spend less time organising the necessary logistics involved when sending samples to a laboratory. Time isn’t wasted filling in forms and organising the shipping of specimens or looking for results once completed.
• DECREASES LABORATORIES’ WORKLOAD - Pressure is taken from overworked laboratories as appropriately trained clinicians and other non-laboratory staff can carry out testing otherwise performed in the laboratory.
• CONNECTIVITY - Connectivity of POC devices provides even greater convenience, meaning patient and quality control results can be input into a central database where they can be collated, accessed and shared by those who need them. Several methods are implemented by different POC devices, including USB and wireless connections, this eliminates the need for manual transcription, thus reducing errors. Inputting these results into a central database also means they can be used for data mining and research purposes. Usernames and passwords can help eliminate the risk of non-authorised personnel gaining access to patient records.
• SAMPLE QUALITY - With samples being tested immediately, their quality is no longer compromised by time and environmental conditions that are exerted when a sample is transported to a central laboratory.
• QUALITY ASSURANCE - Special POC testing schemes have been set up by the Clinical Pathology Accreditation (CPA) accreditation scheme and the National External Quality Assurance Scheme (NEQAS) to ensure the quality of the results generated by the POC devices and their users.
With all the above points considered, POC testing, when used in conjunction with the traditional centralised laboratory approach, becomes a very powerful, effective tool in diagnostics.
Appropriate Governance and Quality Assurance
In taking laboratory testing outside the confines of the CPA accredited laboratory and out of the hands of the qualified laboratory staff, POC testing becomes an area that requires strict governance and application of quality assurance. This is an issue that is highlighted in the Review of NHS Pathology Services in England (The Carter Report), chaired by Lord Carter of Coles. The report represents a thorough and informed appraisal of pathology and the direction in which this key diagnostic service should develop to meet the requirement for high-quality patient care. The Carter Report calls for POC testing to be covered by CPA regulations. In response to this the CPA organisation have set out several external quality schemes for POC testing that relate to each area of testing. The Institute of Biomedical Science (IBMS) has suggested future integration of CPA and NEQAS to create an independent strengthened accreditation service, which also extends to POC testing.
The IBMS, in conjunction with The Royal College of Pathologists, have published a set of guidelines on POC testing to direct POC users in the appropriate implementation of POC technologies. The guidelines advise that POC testing should be overseen by a CPA accredited laboratory who would have the relevant knowledge and experience to ensure quality assurance is implemented correctly. To meet the needs of clinical governance it is recommended that all the laboratory disciplines are under the guidance of a POC testing committee. NHS POC testing committees typically include managers with an understanding and authority for implementing a POC program, members of the hospital laboratory such as the POC testing manager (quality manager), pathology services manager and a co-ordinator of the laboratory’s quality assurance schemes, as well as various other individuals who are using the POC testing devices in the hospital or general practice. In general practice the committee will be under the guidance of the local Primary Care Trust (PCT). The POC guidelines recommend that POC committees based in hospitals and those in local primary care involve members from both sectors to ensure an overview of POC devices across the divisions.
The Standard Operating Procedures (SOP) should be written to the standard of CPA and NEQAS and according to the IBMS guidelines, must include the following points;
• Clinical background
• Analytical principle
• Health and safety including:
o Information on COSHH (Control Of Substances Hazardous to Health)
o Safe disposal of waste
o Control of infection
o Adverse incident reporting
• Pre-analytical considerations
• Reagents, standards, controls and quality assurance
• Test procedure
• Sample analysis
• Calculation of results
• Assay performance
POC testing in Clinical Trials
Results generated by POC devices can be utilised in clinical trials as decision-makers prior to administering treatment, or results can be used as actual trial data. Companies exist that can supply POC equipment and reagents to sponsors and CROs on a global scale. It is essential that these companies are suitably equipped to provide an efficient and reliable service as this is a highly specialised area of expertise. Biomedical scientists with a high level of knowledge and experience are required to provide global training and technical support. It is important to have a well-equipped service department with qualified engineers to ensure equipment is fully calibrated and maintained. Experience in logistics is also essential to maintain the supply of sensitive reagents worldwide. Reagents need to be kept at correct stable temperatures throughout the shipping process, so it is vital to work with the correct logistics companies who can move equipment and reagents across borders and through difficult countries whilst ensuring the cold chain is maintained and documented.
Worldwide Markets and Emerging Technologies for Point of Care Testing, Life Science Intelligence, 2009