Point of care testing in clinical trials
Mike Wickham, Dave McComas and Charlotte Wickham
Woodley Equipment Company
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 20141.
Looking back through history, POC testing has been around from the very start. In Ancient Egypt, patients’ urine was analysed at the bedside for abnormalities, and in India around the same time, the practice of tasting urine to detect glucose first arose. Later in the 1600s, this technique reoccurred when Thomas Willis associated sweet-tasting urine with diabetes. During the 1960s, as technology advanced, it became necessary for samples to be sent to centralised laboratories for analysis by qualified scientists using large analytical equipment and a variety of complicated scientific procedures. Now however, with further advancement of analytical technologies, such as solid phase chemistry and integration of microprocessors, analysers are becoming smaller and more compact, meaning we can take diagnosis back to the patient’s bedside, to the point of care.
“In Ancient Egypt, patients’ urine was analysed at the bedside for abnormalities…”
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, and covers a variety of fields including biochemistry, haematology and virology.
What’s driving the growth of POC testing?
The recent resurgence of interest in POC diagnostics is being driven by a number of factors where it offers benefits over traditional laboratory testing. Here are some of the key drivers we see of this market (summarised in 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.
• Reduced 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.
• Analyte viability: In many instances it is necessary for sample integrity that analysis takes place within a short time of the sample being withdrawn, for example blood gases and certain cardiac markers. Currently POC analysis is the only realistic solution in these cases.
• 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.
Figure 1: Benefits of POC testing
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 laboratory 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 Coles2. 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. In particular the Carter Report calls for POC testing to be covered by CPA regulations3. In addition the IBMS (Institute of Biomedical Science) 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 technologies4,5. The guidelines advise that POC testing should be overseen by a CPA accredited laboratory that would have the relevant knowledge and experience to ensure quality assurance is implemented correctly. It is essential to monitor POC testing, ensuring devices are well maintained by qualified Biomedical Scientists. The operators of POC testing devices are required to be adequately trained using SOPs (standard operating procedures) to maintain a high-quality service. It is also important to keep the user’s skills up to date with Continuing Professional Development (CPD). The SOPs 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
Application to 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 now 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 and use appropriate qualified personnel to provide an efficient and reliable service as this is a highly specialised area of expertise.
The POC equipment available for use in clinical trials covers a wide range of drug applications including, diabetes, cardiac, cardiovascular, coagulation, haematological conditions, respiratory, infectious diseases, parasitic infection, and women’s health. Whatever the disease area, the sponsor company/CRO must work in conjunction with the provider of the POC devices and the centralized laboratory to provide the most appropriate data in accordance with the study protocol.
“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.”
The essentials of a POC supplier include expertise in a number of areas. 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. Compliance with these key features will maintain data acceptance and ensure that the study runs smoothly over the shortest possible time.
With the right combination of equipment, expertise and logistics, POC testing is a powerful tool for improving the efficiency of clinical trials in the 21st Century.
1. Worldwide Markets and Emerging Technologies for Point of Care Testing, Life Science Intelligence, 2009
2. Chaired by Lord Carter of Coles, (2008) Report of the second phase of the review of NHS pathology services in England, Department of Health.
3. Clinical Pathology Accreditation (UK) Ltd (2007). The Conduct of CPA (UK) Ltd Medical Laboratory Assessments. CPA Ltd, Sheffield UK.
4. Cramb, R. (2004) Guidelines on Point-of-Care testing, The Royal College of Pathologists. http://www.rcpath.org/resources/pdf/Point-of-CareTesting-updatedOct04.pdf
5. Institute of Biomedical Science (2000) Point of care testing (near patient testing). Guidance on the involvement of the clinical laboratory.
About the authors:
Mike Wickham CSci FIBMS is the Managing Director of Woodley Equipment Company. Mike is a Chartered Scientist and Fellow of the Institute of Biomedical Sciences with 36 years experience specialising in Haematology, Blood Transfusion and Point of Care devices for all disciplines. Email: firstname.lastname@example.org
Dave McComas BSc MSc FIBMS is the Biomedical Technical Manager at Woodley Equipment Company. Dave is a Biomedical Scientist and Fellow of the Institute of Biomedical Sciences with a BSc in Biology and an MSc in Biomedical Sciences specialising in Haematology, Blood Transfusion and Point of Care devices for all disciplines. Email: email@example.com
Charlotte Wickham BSc MSc is a Biomedical Specialist in the Technical Service Department at Woodley Equipment. Charlotte is a trainee Biomedical Scientist with an MSc and BSc in Biomedical Sciences with Forensic studies, specialising in Haematology, Biochemistry and Point of Care devices for all disciplines. Email: firstname.lastname@example.org
For further information on the Point Of Care range Woodley Equipment can offer, including its supporting services, Biomedical Scientists, logistics management, medical electronics and technical support, please visit www.woodleyequipment.com or contact the authors on +44 (0)8456 777001.
How is POC testing being utilised in your clinical trials?