Decentralisation of diagnostics through Point of Care Tests – The way forward.

Modern medicine relies heavily on laboratory results and the analysers that produce them.

Thanks to modern engineering, these analysers are becoming more and more automated with greater throughput (ability to conduct more tests per minute) than ever before. The benefits of these analysers inherently come with greater engineering complexity, and as such they require highly skilled personnel, not only at their design and manufacturing stage, but also during their transport, installation, and post-installation operation and maintenance and repairs. These complexities can easily undermine the usefulness of these analysers in a setting like PNG where the numbers of qualified personnel is relatively extremely scarce.

Due to this lack of local expertise most hospitals rely on local third party suppliers for the transportation, installation, reagent supplies and service maintenance. This situation, unfortunately, has many times over the years resulted in unacceptable delays in supply of reagents and maintenance and repair of the equipment, with obvious detrimental effects on patient-care.

 

Current trends in Diagnostic Technology

Worldwide there has been an explosion in research and development into Point of Care Tests (POCT) technologies in recent years.  This explosion has been fuelled by the trend towards the decentralization of healthcare away from the large specialist hospitals and towards healthcare that is more accessible outside this hospital setting .

The term distributed diagnostics and home healthcare (D2H2) describes the concepts of the distribution of diagnostic services away from centralized laboratories, utilising appropriate information technology and Point of Care Testing (P.O.C.T) technologies; to make the practice of modern medicine available outside the hospital setting.

The forces, acting on the health system of the developed nations (Fig 1) giving rise to the above trend are similar but even more powerful in countries such as Papua New Guinea.

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Fig 1: Forces acting on the Western Medical System, pushing and pulling towards D2H2 (Distributed Diagnostics and Home Healthcare). 

A change in direction towards decentralization of diagnostic services is intensely relevant and appropriate for our PNG setting. One of the advantages of most POCTs is

that they require minimal expertise and most often the test procedure and interpretation can be performed by nonmedical personnel and often by the patients themselves.  In the USA more and more of these POCTs are categorised as waived tests by Clinical Laboratory Improvement Act (CLIA) ‘88 – meaning that there are no formal qualification requirements for their usage.

Initiatives from private foundations and institutions, for example, The Gate’s Grand Challenges in Global Health Initiative, have created more interest in global health and a funding climate conducive to the research and development of specific diagnostics for the developing countries.   

The field of microfluidics and its application to diagnostics through miniaturisation of complex laboratory functions has the potential of making diagnostic capabilities, now only available in well-resourced laboratories of the developed world, available to the rest of the world.

An example is the Alere PIMA CD4 counter for the measurement of CD4 white cells for the monitoring and care of HIV patients.  The PIMA is currently being rolled out in PNG by the Clinton foundation. 

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Fig 2 The Alere PIMA CD4 Cell Counter – being rolled out by The Clinton Foundation.

Three other such appropriate POCT which are already being used in PNG at the Paradise Private Hospital (aka Mola’s Clinic) are the:

  1. Epoc analyser, capable of measuring – Atrial blood gasses, electrolytes, lactate and glucose.
  2. The Triage MeterPro – Troponin I (Next Generation).
  3. The Afinion Analyser – HbA1c, Lipids profile, CRP and Albumin Creatinin ratio(ACR).

These POCT analysers have proven very useful, the Epoc and Triage MeterPro especially for critically ill patients where quick turn-around-time and clinical decision of utmost importance in improving patient outcomes.  And the Afinion for the long term management of diabetic and other clients with high cardiovascular risks.

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Fig 3. The Epoc Analyser

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Fig 4: The Triage MeterPro – Troponin, CK-MB, BNP.

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Fig 5: The Afinion analyser – HbA1c, Lipids profile, ACR and CRP

The emergence of these new technologies into the market will assist greatly in our efforts to deliver healthcare services to both the urban and rural areas of PNG through “distributed  diagnostics”. They will enable, Doctors, Health Extension Officer, Nurse, and other health-workers working anywhere in PNG to make correct, reliable diagnosis and provide appropriate treatment to their patients in a timely manner.

There are however, some special considerations that must be kept in mind, if we are to achieve maximum benefit from the use of POCTs. These include, appropriate selection, safety, maintenance, training of end user and proper Quality control and assurance and documentation. If these considerations are neglected, and mere availability and distribution of these tests are seen as the “silver bullet” to our health problems, we are likely to fall short of the great promise with these tests.

About Dr. Poyap J Rooney

Dr. Rooney is a medical doctor who has gained both his undergraduate medical degree and more recently his post graduate masters degree in clinical biochemistry at the University of Papua New Guinea.
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