Point-of-care testing inches closer

Point-of-care testing (PoCT) by general practitioners, or even within the home, is certainly not a new concept. In fact, many PoCT tests have been used for decades, such as the ECG, dipstick urinalysis, pregnancy and blood glucose testing.

What has changed is the type of testing which can now be done by a GP or home user. The inevitable forward march of technology means that many sophisticated tests that were once the domain of the pathology laboratory have been developed in more portable versions.

But just because the technology exists, it does not mean that all such tests are, or should be, instantly accessible, according to the Department of Health and Ageing.

In 2001, the Department of Health and Ageing released details of a report that indicated a "lack of evidence around the clinical and economic benefits of PoCT". The recommendations of this report were that further information be collected on the diagnostic performance of PoCT in the community setting.

It took a while for this recommendation to be implemented, but mid 2005 finally saw the beginning of a long-term Point-of-care Testing Trial that is due to finish up in early 2007.

The trial has not been designed to validate the technology itself, but rather to determine whether or not "PoCT in general practice should be funded by the Australian government".

Secondary issues that will be evaluated as part of the trial include:

• Is the effectiveness of PoCT at least as good as for the same tests using pathology laboratory testing?
• Is it the same or more cost effective to perform PoCT compared with pathology laboratory testing?
• Are patients and other stakeholders more satisfied with PoCT than with pathology laboratory testing?
• What would the appropriate MBS fees be for the PoCT tests selected to be in the trial?

By its conclusion, more than 6000 patients are expected to have participated in the trial, which is being conducted by 60 general practices.

Before the trial even began, its Steering Group had a list of expected outcomes, including potential advantages and disadvantages of PoCT in general practice.

These advantages included: enhanced clinical management; greater patient compliance with pathology requests; greater convenience and satisfaction for patients; better health outcomes to the patient; greater satisfaction for the GP; savings in cost and time to the patient; and improvement in the doctor/patient relationship.

The potential disadvantages included: inappropriate testing, leading to increased costs with no benefits to patient or society; inaccurate results, which leads to less than optimal health outcomes for the patient; and possible increased consultation and waiting times.

Most of Australia's GPs embrace the concept of PoCT. Some have even questioned the necessity for such a trial, viewing it as delay in the implementation of the technology for all Australians.

Many GPs are already using some PoCT testing in their practices, but many tests are only part of the Pathology Services Table (PST) when performed in a laboratory environment. This means that patients are eligible for a rebate through Medicare when their tests are sent off to a pathology laboratory, but not when the same test is performed in a general practice.

In September 2005, the three GPs who were representing the profession on the committees overseeing the trial withdrew from the process when their funding was cut. This removal of general practice representation to the trial prompted Victorian GP, Dr Jonathan Cohen to submit an abrupt opinion piece to the Medical Observer.

In this article, Cohen indicated that the government was being swayed into dragging its heels on the subject by suggestions that pathology costs will blow out if tests are available at the point of care due to misuse and overtesting.

"Since PoCT is already in place in general practice here and internationally, it is well past the time to conduct trials to assess the place of 'specialist' pathology testing within the medical system," he wrote in his article.

"It is time to allow patients the choice of having their tests performed with their GP, during the consultation and at lower cost to them and Medicare."

The Australian Institute of Medical Scientists (AIMS) released its own position statement on the subject of point-of-care testing well before the trial began.

In this position statement, AIMS points out that the dissemination of point-of-care technology in diagnostics is being fuelled by the need for immediate diagnostic information.

The representative body also states that PoCT is growing due to the emergence of new technologies which do not require trained laboratory personnel or complex equipment.

And while AIMS supports the ongoing development of high quality, sensitive and specific PoCT, the institute says that "PoCT is a supplement to, and not a replacement for, high quality reference laboratory services".

AIMS maintains that medical scientists should continue to be involved in:

• The introduction of new technology for PoCT
• The calibration and maintenance of equipment
• The training of users of PoCT devices
• Reviews of quality control
• Reviews of the cost-effectiveness of the use of the new technology

The institute "does not support introduction of technology for the sake of technology". Rather, it suggests "there must be a significant clinical or cost benefit to the community with the introduction of any new technology".

Marketing coordinator at Point of Care Diagnostics, Jacqui Goodall says that only when rebates are comparable for tests done in a laboratory, and at the point of care, will patients be able to decide for themselves on the benefits of PoCT.

However, she is quick to praise the Commonwealth government for not rushing in to change Medicare. "As you would hope, the Commonwealth does not change Medicare without significant evidence," she told What's New in Lab Technology.

"Although point-of-care diagnostics are now the standard for many tests, there are virtually no studies on the overall benefits to society from these changes either medically or economically.

"The trial comes to an end later this year, and we are hopeful that the results will clearly show the benefits of point-of-care testing. Australia has really taken a lead on this issue by actually identifying the issue and determining that we will get the facts before rushing in."

She says the most common PoC tests currently available test for: sexually transmitted diseases, troponin, substance abuse, fertility, urinary tract infection, infectious diseases, PSA, cholesterol, a1C, Haemoglobin, blood sugar and INR.

She uses the following example.

"A patient needs their INR levels tested at least once a week so their dosage of warfarin can be prescribed. This means the patient will present to the surgery, have a venous sample collected, wait at least 24 hours (longer if they were considered to be located in a remote area) and then return to the surgery to discuss the results with their doctor.

"The PoCT alternative would be to use a handheld device which requires a smaller blood sample and gives the results within a few minutes. The advantage is that the result can be discussed with the doctor in the first consultation and the warfarin levels can be adjusted accordingly."

Goodall doesn't believe that point-of-care testing in general practice will have a negative impact on pathology laboratories, but will redefine the roles of the two. She also points out that there will always be tests that cannot be done economically at the point of care.

"A decentralisation of testing will not harm the laboratories, however it may change the way in which they operate. It will open many opportunities to them as they begin to offer point-of-care testing in GP offices and collection centres."

As for the big question on Medicare rebates and the availability of PoCT to all Australians, the jury will remain out until all of the results of the yet-to-finish trial have been collected, compiled and analysed.