Novel method for rapid, reliable HIV testing

The life expectancy for a person who is diagnosed and starts antiretroviral treatment rapidly after infection with HIV today probably approaches that of the general population. Yet the European Centre for Disease Prevention and Control estimates that, depending on the country, up to 43% of people living with HIV in Europe remain undiagnosed. On average, 47% of HIV cases are diagnosed late and 28% of people have advanced HIV (CD4 cell count <200/mm³) at diagnosis. The proportion of people with HIV diagnosed late exceeds 50% in nine European countries, including Italy, Greece and Sweden.

So, Owen Mumford Ltd is delighted to attend AIDS 2018 in Amsterdam to introduce SimplitudeÔ Pro HIV, which meets the need for a reliable point-of-care diagnostic test that is simple to use and offers patients and healthcare workers confidence in reliable test results. SimplitudeÔ Pro HIV will be available to healthcare workers across Europe by early 2019

A meta-analysis of 25 studies underscores the need for innovative rapid testing. Self-testers and trained healthcare workers can reliably and accurately diagnose HIV using rapid tests. But errors can occur. Users may, for instance, choose the wrong lancet or fail to pierce the skin properly. They may collect too little blood or transfer specimens incorrectly. Some procedures involve multiple steps. Users can easily confuse components or spill solutions.

Such errors seem to be relatively common. For example, one study included in the meta-analysis found that users were unable to take blood samples or transfer specimens correctly on 56.3% of occasions. - Simplitude^™ Pro HIV addresses the issues highlighted by the meta-analysis.

Simplitude™ Pro HIV is the world's first rapid diagnostic test witha built-in safety lancet, blood collection unit and test strip. The test offers high sensitivity (99.6%) and specificity (99.6%) and the result can be read in 15 minutes. Unlike standard, multi-component rapid test kits, Simplitude™ Pro HIV integrates the features and functionality in a single handheld, easy-to-use device.

Field testing in Kenya underscores that Simplitude^™ Pro HIV offers simplicity, reliability and confidence even in resource-poor settings. A 2016 study, for instance, confirmed that Simplitude^™ Pro HIV offers high sensitivity (90.9%) and specificity (88.4%). Both parameters showed 100% concordance with the test algorithm approved for use by healthcare professionals.

Despite enrolling people with a wide-range of educational attainments, from university students to the general population living in remote villages, about 9 in 10 users: found that the test requirements were easy to understand (93%); could complete the test correctly first time without supervision (89%); and would recommended the test (94%). Further field tests in Kenya and other parts of the world confirms that Simplitude™ Pro HIV is simple to use and offers the confidence of reliable results.

"We are delighted to participate in AIDS 2018 and introduce Simplitude^™ Pro HIV to healthcare workers, patients and other stakeholders," says Tania MacKenzie Senior Product Manager for Diagnostics at Owen Mumford Ltd. "Earlier diagnosis enables people with HIV to start treatment sooner, which increases their chances of living a long and healthy life and reduces the risk of transmission. We believe that the convenience and prompt results offered by point-of-care tests, such as Simplitude^™ Pro HIV,- are critical to further improve outcomes for people living with HIV."​