Jahnavi Sarma
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Written By: Jahnavi Sarma | Updated : August 18, 2020 9:25 AM IST
The key component of SalivaDirect is that the method has been validated with reagents and instruments from multiple vendors. @Shutterstock
Testing for SARS-CoV-2 has been a major stumbling block in the fight against the pandemic, with long delays and shortages of testing. There are many tests that are used to detect COVID-19. Since The start of the pandemic, many tests have been developed. Some are better than others, a few gives results in record time.
Now the FDA has authorised the emergency use of a new and less expensive saliva-based laboratory diagnostic test for COVID-19 that could be a game-changer in the diagnosis of the infection as it will enable rapid testing amongst more people easily and prevent transmission. This new test would increase efficiency and avoid shortage of crucial test components like reagents. This type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents. The FDA had previously authorised four other tests that use saliva for sampling, but these yielded varying results. Authorisation of the new test occurs amid ongoing disarray over COVID-19 testing.
The SalivaDirect test was developed by researchers at Yale School of Public Health. It is being further validated as a test for asymptomatic individuals through a programme that tests players and staff from the National Basketball Association (NBA). It is simpler, less expensive and less invasive than the traditional method for such testing known as nasopharyngeal (NP) swabbing. Results so far have found that this test is highly sensitive and yields similar outcomes as NP swabbing. With the FDA's emergency use authorisation, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation and, perhaps, beyond in the coming weeks.
The key component of SalivaDirect is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues as experienced early in the pandemic. According to the Yale researchers, this is a huge step forward to make testing more accessible. They say that this started off as an idea soon after they found saliva to be a promising sample type of the detection of SARS-CoV-2. Now it has the potential to be used on a large scale to help protect public health. With saliva being quick and easy to collect, it could be a game-changer in COVID-19 diagnostics, they added.
With testing urgently needed, the Yale team was determined to decrease both testing times and costs, to make testing widely accessible. Wide-spread testing is critical to containment efforts. The test was simplified so that it only costs a couple of dollars for reagents and labs are likely to charge about USD 10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, they pandemic may finally be controlled even before a vaccine. Researchers say that they are not seeking to commercialise the method. Instead they want the simplified testing method to help those most in need. Some experts have said that up to 4 million tests are needed per day and SalivaDirect provides one pathway toward that goal.
(With inputs from Agencies)
