Yale scientists develop quick, affordable saliva-based COVID-19 test

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Yale University is reporting that the United States Food and Drug Administration (FDA) has granted an emergency use authorisation to a saliva-based laboratory diagnostic test developed by Yale School of Public Health researchers to determine whether someone is infected with COVID-19.

Yale made the announcement on Saturday, a day before Jamaica’s Ministry of Health and Wellness announced that non-residents visiting Jamaica from the United States, Brazil, the Dominican Republic, and Mexico — which have all been designated as high-risk locations — are now required to obtain a COVID-19 polymerase chain reaction (PCR) test prior to arrival.

“This applies to all non-residents 12 years and older, including those who are business travellers, entering the island on or after August 20 from the locations currently designated as high-risk by the Jamaican health authorities,” the ministry said in a news release yesterday.

“They are required to do the test within 10 days prior to their intended date of travel to Jamaica,” the ministry said, adding that everyone applying to enter on visitjamaica.com from the designated high-risk locations will be required to upload their COVID-19 PCR test certificate as part of the application process.

“This requirement was already in effect for non-residents from the states of Arizona, Florida, New York, and Texas in the United States,” the ministry said.

The ministry also reminded that visitors to the island, upon arrival, will be subject to health screening and risk assessment by the local health authorities.

“All tourists will be allowed to go to their hotel under a Stay in Resilient Corridor order from their date of entry to Jamaica. Those tested will have to stay in their rooms until their result is returned,” the ministry explained, adding that “visitors who return a negative result will remain on hotel property, according to Stay in Resilient Corridor orders”.

Yesterday, a local health practitioner, who opted for anonymity, said while he understands the Government’s desire to ensure that visitors to the island are not infected by the virus, the health authorities should give serious consideration to other testing methods than the PCR, that are being developed and which provide results in a much shorter time.

“The PCR test is more sensitive because it searches samples for the virus’s genetic material. However, because the viral RNA is so small, it needs to be sent to a laboratory to be amplified. Therefore it requires a lot of time and resources,” the health expert said.

Yale University, in its announcement of the saliva-based test, which it has named SalivaDirect, explained that it is being further validated as a test for asymptomatic individuals through a programme that tests players and staff from the National Basketball Association.

“SalivaDirect 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 SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing,” the university said in an article published on its website.

Yale said the FDA’s emergency use authorisation has made the testing method immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the US and, perhaps, beyond, in the coming weeks.

The university explained that a 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,” Yale said.

“This is a huge step forward to make testing more accessible,” the article quotes Chantal Vogels, a Yale post-doctoral fellow who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor.

“This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus,” Vogels said.

Yale also said the preprint on the development and validation of SalivaDirect were recently posted on medRxiv.

“With saliva being quick and easy to collect, we realised it could be a game-changer in COVID-19 diagnostics,” the article quotes associate research scientist Anne Wyllie who, along with Assistant Professor Nathan Grubaugh spearheaded development of SalivaDirect as a means of rapidly expanding SARS-CoV-2 testing at Yale School of Public Health.

Yale said that with testing urgently needed, its team of scientists was determined to decrease both testing times and costs, to make testing widely accessible.

“Widespread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about US$10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Grubaugh.

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