Overview

When you see a doctor and they order some blood tests, a specimen of your blood will be taken and the sample will go off to a laboratory to be analysed along with many other patient samples. As well as doing all the tests on your blood sample, the laboratory, depending upon its size, will generally have the capability to handle a wide range of different tests, possibly on hundreds or thousands of samples a day.

This is called central laboratory testing and it has developed in order to provide high quality testing at relatively low cost (Figure 1).

There is an alternative to this type of testing where instead of a sample of blood being taken from a vein, a smaller sample is taken from your finger and it is tested where you are located, maybe in the GP practice or even in your home. This is called Point-of-Care Testing or PoCT, and it takes various different forms as shown in Figure 2.

There are other names for this type of testing. If you are testing in your own home it might be called home testing. Sometimes it is referred to as near-patient testing. The overall aim of PoCT is to provide a test result much more quickly than when a blood sample is sent to a central laboratory.

For more explanation take a look at this animation:

How common is PoCT in Australia?

The most common form of PoCT is someone with diabetes who is taking insulin and who are measuring their blood glucose at home, sometimes several times a day, using a glucose meter (shown below) in order to guide their insulin dose. Glucose would also be measured in many different healthcare locations using similar glucose meters.

Above is an example of a typical, handheld, glucose meter used to measure glucose on a fingerstick sample. (Image courtesy of Roche Diagnostics)

Another common example is if you are taking warfarin and you need to have your INR test done to check that your prothrombin level is in the correct range. Some people will do this themselves at home but many others will go to their GP who will perform this test in their practice rather than have their patients go to a laboratory collection centre.

PoCT also takes place in hospitals themselves even where a central laboratory is located. Critical care units such as Intensive Care Units all have their own testing equipment to measure a range of critical tests such as oxygen and carbon dioxide.

As Figure 2 (Point-of-Care Testing) indicates, there are other places where PoCT may be performed, including specialist rooms and small rural hospitals that do not have an onsite laboratory. Nurses and other healthcare workers who work in very remote locations often need to be able to test on-site and you may have seen that your local pharmacist may be offering PoCT, probably for lipids and maybe HbA1C.

Around Australia it has been estimated that about eight to 10 million point-of-care tests are performed each year. This is small compared to the number of tests done by central laboratories but the volume of PoCT is expected to grow.

PoCT is considered by some to be part of what is collectively known as digital health which includes services such as the digital health record, called My Health Record, and the many health related Apps which are now available on mobile phone or tablet devices. The aim of all such services is to provide a more consumer or patient-friendly experience that in the long term will enable the patient to better manage their own health.

Why is PoCT performed?

The need for a quicker test result is one of the key aims of PoCT and this can deliver benefits for healthcare consumers and healthcare providers.

Let us start with the example of a patient who is seriously ill and being managed in a critical care unit. They may be so sick that they need to be ventilated, which requires the levels of oxygen and carbon dioxide in their blood to be measured frequently. This can only be done effectively using point-of-care testing through blood-gas instruments. These provide oxygen and carbon dioxide results in minutes after taking blood samples from the patient. The rapidly produced results can then be used to adjust the patient’s ventilation system very quickly and as such, are a vital part of critical care medicine.

Historically, one of the factors that drove the development of PoCT instruments half a century ago or more ago was the pioneering use of ventilators to manage patients with polio in the epidemics of the 1950s. The company that developed these early point-of-care instruments is still a leading manufacturer of them today.

_{One of the first point-of-care devices used to measure blood gases on critically ill patients in the 1950s. (Image courtesy of Radiometer Pty Ltd)}

PoCT is not only helpful for the acutely ill but also for those with chronic diseases such as diabetes. Glucose meters have revolutionised care for diabetics  who can now monitor their glucose without even needing to take blood samples – this might be seen as the ultimate in point-of-care testing.

People with diabetes also need to measure their HbA1C levels as well as their glucose levels, but less often – maybe up to four times a year.  Having an HbA1C test requires a diabetic to visit a pathology collection centre to have their blood taken. The sample is then sent to the laboratory, which following analysis, sends the result to the patient’s doctor.  The patient then goes to their GP or specialist to discuss the HbA1C result and possible changes to their treatment. For the patient this essentially means two trips every time their HbA1C result is measured and reviewed.

Figure 3 shows this process and also identifies where the process can occasionally go wrong when the doctor does not have a recent HbA1C result to discuss with the patient; this makes the consultation less effective.

HbA1C testing can now be measured on small point-of-care devices in doctors’ practices and a few GPs and specialists around Australia are routinely performing PoCT for HbA1C on their diabetic patients. This means one visit combines the collection (Figure 3). As well as the obvious convenience for the patient, the PoCT process avoids some of the potential problems that lead to an HbA1C result not being available at the time of the consultation.

Accurate and reliable PoCT for HbA1C has been available for some years and many trials have been conducted around the world including Australia, which have compared the PoCT process to central laboratory testing. Some of the evidence from these trials indicates that PoCT can be beneficial.

The role of PoCT is perhaps more important for consumers and patients who live in the country where access to pathology testing is not as easy and convenient as in cities or major regional centres. Testing is critically important for those with chronic health problems and regular testing such as HbA1C, together with clinical check-ups, is important in keeping people healthy and out of hospital.

In South Australia, the Integrated Cardiovascular Clinical Network (ICCNetSA) runs a dedicated PoCT program for both acute diagnosis and chronic disease monitoring program in conjunction with country GPs.  This video, provided courtesy of ICCNetSA, explains what it means for the patients, the GP and the community:

What tests are performed at point-of-care and why

There are a growing number of tests that can be performed at point-of-care although the menu of tests is far less than the range performed in the central laboratory.

Two factors should determine the need for PoCT. The first is a clear understanding of why PoCT is being conducted. In other words, what is the clinical question being asked by your healthcare provider, who is usually your GP, and how will performing the test in the practice help them answer that question more effectively than sending the test to the central pathology laboratory. In the examples described in Table 1 we describe the reasons for testing. 

The second factor to consider is whether there is a PoCT device of sufficient quality to provide a reliable result that can be used for your care. Developments in technology have produced a range of different PoCT devices some of which have a similar analytical performance to those tests carried out in the pathology laboratory. For the test examples described, devices are available that produce results of the required quality.

However, it is important to emphasise that not all PoCT tests that are available are of the required quality and consumers and patients need to be aware of this, if and when they are offered PoCT.

Table 1  shows some of the tests that are being carried out in various point-of-care locations such as in the home, general practice, the pharmacy, and other healthcare facilities including small rural hospitals or clinics. Pictures of some of the devices used to perform these tests are also shown.
Table 1. Tests performed at a range of point-of-care locations and the reasons for testing

The photographs shown here are of a selection of point-of-care devices for different tests.

The Cobas 101 device can measure Lipids, HbA1C and urinary albumin/creatinine ratio on a fingerstick sample place. It is used in general practice and outpatient clinics. (Image courtesy of Roche Diagnostics)

The Cepheid Gene-Expert device can measure a number of different infection disease viruses including COVD-19. It is being used in Aboriginal Health Clinics and some regional laboratories. (Image courtesy of Cepheid International)

How is PoCT performed?

One of the conveniences of PoCT is that in many cases the sample consists of a drop of blood usually taken from your finger-tip.

Above is shown a few millilitres of blood, collected using a device called a lancet, being directly applied to the testing slide to measure INR. (Image Courtesy of Point-of-Care Diagnostics, Sydney, Australia).

For other point-of-care devices blood may be collected into a small glass tube or similar dispensing device. This is then inserted into the point-of-care device where the testing process takes place.

If you have testing done in your GP practice then it is likely that a practice nurse will perform it. This is a less invasive procedure than having a venepuncture where the person collecting the sample needs to have special training and skill. Care must be taken to ensure a viable sample is collected.

The complete point-of-care testing process, including collection of the sample and the measurement process is shown for an INR measurement in this video which is supplied by Point-of-Care Diagnostics, Sydney, Australia:

There may be occasions when your GP or other healthcare provider will want to send a test to the pathology laboratory as well as do a test in the practice. In this case, the practice nurse may perform a conventional venepuncture to send a sample to the laboratory and keep back some of the blood collected for a PoCT.

The testing process and the time it takes, varies  according to the test and the device. For INR and glucose it only takes  one or two minutes to get a result. For tests such as HbA1C or Lipids it may take between five and 15 minutes.

Once the result is produced you will be able to see your GP who will decide on your treatment based on the result and their clinical judgement.

Ideally, all results produced by point-of-care devices would automatically go into your electronic patient record. While some GPs do have this facility, many do not and your result will be written on a piece of paper and the GP or one of the practice staff will manually enter it into your patient record.

Some pharmacies offer PoCT. The results from these tests will be given to you and it will most likely be your responsibility to ensure that you inform your GP of the results. There is no electronic connection between pharmacies and GPs, so manual result transfer, with the potential for loss of results, is the only process in place.

Advantages and disadvantages of PoCT

In the previous sections we have demonstrated some of the features of PoCT and some of the reasons why it has been developed and why it is used.

However, as well as advantages there are also disadvantages which all those involved with PoCT including consumers and patients need to be aware of before they use this type of testing. Another way to think about advantages and disadvantages is to consider the benefits of PoCT to you as a consumer and the risks.  As well as what PoCT means for you  it is also important to consider the benefits and risks for your healthcare provider, such as your GP, for the government and ultimately, the community that funds the testing.

The risks and benefits vary according to the specific test but in Table 2 we consider these benefits and risks of PoCT in general.

Table 2. Advantages and disadvantages of PoCT for different groups and explanations

Questions to ask your doctor

If your GP or another healthcare provider such as a pharmacist offers you a test using point-of-care testing, here are some questions that you might like to ask to help you decide on whether to proceed or not.

1. What type of sample do you collect for PoCT?

Background: One of the advantages of PoCT is that it usually uses a finger-prick sample taken with a device called a lancet. While more convenient than collecting a venous blood sample using a needle and syringe, it does require some skill to ensure that the sample is collected correctly. There may be occasional circumstances when a venous sample is required and some tests may require a urine or even a nasal sample.

2. Is the quality of the PoCT testing you are offering sufficient to make safe and effective clinical decisions about my healthcare?

Background: Not all PoCT devices that are available for use in Australia are of sufficient quality to make safe and effective clinical decisions. Organisations and processes are in place to try and ensure that GPs and other healthcare providers only use devices of proven performance. But the reality is that there are currently no regulations to ensure that only devices with a minimum required performance are used on patients. This situation will change and already many providers are using reliable, proved devices.

3. Do you perform quality procedures to make sure the point-of-care results are reliable and accurate?

Background: The central pathology laboratory devotes a lot of resources to ensuring that the quality of lab testing is very high, meaning that your test results are reliable and accurate. The quality processes used with PoCT are different, possibly not so extensive as in the central laboratory, but are certainly necessary. At the moment there are no regulations in place to ensure that quality processes must accompany all PoCT. It is likely that such regulations will be introduced as PoCT expands and many PoCT providers are already using quality processes to ensure the testing is safe.

4. Will the test results from a point-of-care test go into my medical record?

Background: When your tests are performed in a central laboratory the results are in most cases transmitted electronically back to your GP and into your medical record which sits on the GPs computer. In some cases the results may be uploaded into your My Health Record. With PoCT this electronic transmission of results will likely not occur and there will need to be a manual process of entering the results into your patient record. It is important that all your testing results are retained in the record to ensure that the correct decisions are made about your treatment.

Another example of PoCT results not getting into your patient record is if have testing performed at the pharmacy and the results are only provided to you on a paper report which you will have to take to your GP.

5. Will I have to pay for PoCT?

Background: At the present time PoCT is not reimbursed on the Medical Benefits Schedule (MBS). GPs may be able to use a separate MBS item number to pay for a portion of the testing. They may choose to absorb the remainder of the cost themselves or they may ask you as the patient to pay a fee. Any testing in pharmacies is likely to mean that you the patent pay although some of these charges may be reimbursed via private health insurance. Efforts are being made to include PoCT on the MBS but this has not yet been agreed.

More information

You can find out more about point-of-care testing from the organisations and sources below.

• National Pathology Accreditation Advisory Council (NPACC) Draft requirements for Point-of-Care Testing.
• Royal Australian College of General Practitioners (RACGP) Standards for Point-of-Care Testing (5th edition).
• Australasian Association of Clinical Biochemists (AACB) Point-of-Care Testing Implementation Guide.
• Australian Point-of-Care Testing Practitioners Network (APPN). 
• Integrated Cardiovascular Clinical Network South Australia (ICCNet).
• Quality Assurance for Aboriginal & Torres Strait Islander Medical Services (QAAMS).