People living with hepatitis B need to undergo a viral load test (also called a hepatitis B DNA test), which is a blood test measuring the amount of the virus in a person’s body. This test helps doctors decide whether you need to start treatment, and if you are on treatment, whether it is working well.
Currently, the standard hepatitis B viral load test requires a blood sample taken from a vein, which isn’t always easy to do, particularly in remote areas or places without specialist laboratories. These tests are also expensive, making it hard for some people to get the care they need.
Our team at the Kirby Institute has conducted a study to look at a different kind of test called the “Xpert HBV Viral Load assay”. This test can be done directly where the patient is seen, like in a doctor’s office or a small clinic. This test uses a small drop of blood from a finger prick, and the results are ready in 30-60 minutes. Having the results ready soon after the test means that your doctor can explain the results to you during the same consultation as the test. This test is already used for some other infections such as hepatitis C or tuberculosis but has not yet been studied for hepatitis B.
In this study, we compared the results of this new finger prick test to the standard blood test in up to 250 people and results are available so far in 178 people.
For each person, we measured the amount of virus in the blood detected by the finger prick test and compared it with that of the standard test. Our results so far show that the difference between the results of the two tests is very small. Even when there were slight differences, these are unlikely to change the treatment decisions for patients.
In conclusion, our findings to date are very promising. If we confirm this in the final results and show that the finger prick test is just as good as the standard test, this will be an important step forward. Eventually we hope it will help more people with hepatitis B get the care they need, regardless of where they live or their access to medical resources.
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Hi @bhajari,
Thanks for sharing this study with us. If it works, this will make a huge difference in the management and care of HBV. Great work and hope the final results show effectiveness. How much do these test kits cost and are they readily available around the world? Thanks, Bright
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Hi bhajari
Thank you for your sharing with the valuable innovative HBV DNA point of care test using the gene Xpert assay. It will be the game changer in the current landscapes of CHB patients management. At present, we have Cepheid Xpert HCV RNA assay that recently approved by US FDA for test and treatment in individuals at risk for HCV as same day , one stop service treatment and linkage to care . One of the barriers for starting treatment for CHB patients is the need for HBV viral load testing, which is not available at LMICs especially in primary healthcare settings.
Recently, WHO have launched the expanded eligibility criteria for treatment in 2024 Hepatitis B guidelines , however , one of the four options criteria is HBV DNA testing, which is the most reliable to assess treatment eligibility and monitoring of treatment responses where laboratory testing is available. This Xpert HBV viral load assay can be used as HBV reflex testing that means the first pinprick blood specimen can be tested with rapid diagnostic test and the results can be read in 15-20min , if positive, then the second pinprick blood test can be done with Xpert HBV DNA assay. This innovative test can be beneficial in primary health care and resources limited settings and the patients can easily access to tests and treatments with linkage to care and be engaged in follow up periods. If this test kit pass the standard inspection , validation and commercial availability. It can be beneficial for CHB patients and may be one of the key drivers to achieve WHO hepatitisB elimination goals in 2030. I would like to give encouragement in creating innovation in the test kit for HBV DNA point of care finger prick assay. Cheers…
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Hi @Bansah1,
Thank you for your interest on our work. The test kits used in this study resemble a prototype version. If the final results demonstrate high performance, this data will support the manufacturer in developing a dedicated HBV viral load fingerstick assay for market use, including cost considerations. Thanks again for your post.
Hi @chul_chan,
Thank you for your post. You explained the utility of this test and its impact on the CHB clinical care landscape very well. It should also be noted that treatment eligibility in the WHO guidelines still requires high ALT levels. Therefore, a point-of-care HBV viral load test alone would not suffice for a same-day test and treatment model, although it would still simplify CHB clinical care. However, in the context of CHB care in pregnant women, a test and treat model is feasible since treatment eligibility can be determined based on the HBV viral load.
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Oh okay, sorry I didn’t know it was a prototype. I was thinking that it was a test that already existed and you were trying to see whether it would work in the HBV space. I hope it’s successful and effective so it can be manufactured for use around the world. I strongly believe it would make a huge difference especially in areas where those standard tests are not available or very expensive. Great work and thanks for your response. Bansah1
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