Home HIV tests hit the market

Scientists have developed a prototype for an ultra-sensitive sensor that allows doctors to detect early stages of diseases with the naked eye, according to a paper published in the medical journal Nature Nanotechnology. These findings have already found their way into commercial use, although this availability is not universal.

The team who conducted the research reported that the sensitivity of their visual sensor technology is tenfold that of the current methods for measuring biomarkers. In tests, the sensors have been able to detect even very low viral loads in samples, detection that has previously been impossible.  The test uses nanotechnology that works by turning a sample solution a distinctive red or blue color, easily detectable by the naked eye.

The greatest impact of this research is expected to impact HIV diagnoses, especially in developing countries, which have fewer economic resources per capita and a greater rate of infection relative to the rest of the world. However, it is hoped that the test can be adapted to detect other diseases such as tuberculosis, malaria, sepsis and leishmaniasis.

“Unfortunately, the existing gold standard detection methods can be too expensive to be implemented in parts of the world where resources are scarce. Our approach affords for improved sensitivity, does not require sophisticated instrumentation, and it is ten times cheaper, which could allow more tests to be performed for better screening of many diseases,” Professor Molly Stevens of the Departments of Materials and Bioengineering at Imperial College London told Medical News Today.

The OraSure HIV test, approved by the FDA this summer for use in the United States allows people to test for HIV in their own homes, detecting the virus within twenty minutes through a simple mouth swab. The test costs about $40 and, as of September, is available in American stores.

A trial for OraSure showed that the home test only detected HIV 92 per cent of the time for people carrying the virus, leading some to conclude that although the test is convenient, it may be lack degree efficacy.

Prior to saliva HIV tests, at home HIV test kits required blood samples, which had to be sent to a laboratory to be tested–taking longer and reducing the privacy of at-home testing.

Researchers for the new HIV diagnostic test intend to collaborate with global NGOs to help manufacture and distribute the new diagnostic technology in developing countries, helping to decrease the spread of the disease

Undoubtedly, the manufacture and distribution of this diagnostic test will make an impact globally. While the impact on underdeveloped countries – where medical resources relative to the population are low – may be the most noticeable, there is still a need for diagnostic tools like these in Canada.

While the OraSure test was passed by the FDA this summer, it has yet to be approved by Health Canada.

Sarah O’Dacre of Health Canada confirmed in an email that “the OraSure Rapid Test (HIV test kit) is not approved for sale in Canada.”

When The Daily spoke with Dr. Nikita Pant Pai, a clinical epidemiologist at the McGill University Health Centre who has been involved in evaluating Point of Care HIV tests, she emphasized the increasing role that diagnostic kits like these might play. “I am aware that there is a lot of interest in proactive communities to get them into Canada…Approval of [the] HIV self test will pave the way for several other self tests (other key infectious and chronic diseases)….it is a concept whose time has come.”

The number of newly HIV-infected Canadians in 2008 was between 2,300 and 4,300 people, indicating that, while incidence of the disease is higher in other nations, Canada still has room for improvement, and OraSure tests may help.

Pai also mentioned the importance of creating support systems for those diagnosed with HIV outside of the doctors office. “It is important to set up counselling systems in place before we consider self tests for Canada,” she emphasized. This concern was also raised in the FDA approval process, leading OraSure to add a telephone counseling number on the side of the kits.

While there is great hope for this technology, there is also great concern. There are still roadblocks to its Canadian implementation, which might take some time to resolve. However, a focus on the Global South for the product may provide greater returns through lowered costs and increased accessibility for HIV diagnosis.

With files from Peter Shyba