Last April, the US Food and Drugs Administration (FDA) gave its first Emergency Use Authorisation for saliva testing.
Five months later, it had already approved another four types of saliva-based tests for Covid-19, with the latest being the low-cost and non-invasive procedure developed by the Yale School of Public Health.
According to validation results provided to the FDA, 60 patient samples taken from saliva and swab tests yielded the same results that showed the presence of the coronavirus.
The agency also noted that independent testing by the New Jersey State Health Department of 10 samples agreed with the findings.
Following this, a research team led by Yale postdoc Chantal Vogels detailed a new tool called SalivaDirect and published it on Aug 4 on preprint server medRxiv.
Researchers found that saliva could be collected in any sterile container and that it remained largely stable even when warm, negating the need for special tubes or preservatives.
“This is a huge step forward to make testing more accessible,” Vogels said in a recent press release.
“This started off as an idea in our lab soon after we found saliva to be a promising sample type in the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health.”
Traditional Covid-19 testing is a two-part process: once the sample is collected, the virus’ RNA must be extracted before it can be detected by sensitive, PCR-based methods.
SalivaDirect removes the extraction step, replacing it with something that’s really simple.
“You add an enzyme, you heat it up, so you lose the most expensive, most time consuming and the most skilled [steps],” explained Nathan Grubaugh, an epidemiologist at Yale and a co-author on the study.
Yale is offering SalivaDirect’s protocol open-source, meaning researchers worldwide can take and adapt the method for use in their own labs – depending on what resources they have available.
The authors said they engineered their protocol to be as adaptive as possible to different PCR kits already in the market.
This same flexibility and relatively streamlined protocol also make SalivaDirect a cheaper alternative to traditional PCR tests, the authors stated.
The total cost needed for one test is roughly US$5, meaning it could be offered to the public for much less, perhaps as little as US$10.
“This could be one the first major game changers in fighting the pandemic,” Andy Slavitt, a former acting administrator of the Centers for Medicare and Medicaid Services, tweeted in response to news of SalivaDirect.
“Rarely am I this enthusiastic . . . [With] a US$10 test, you can test every day or every couple days,” he added.
To put it simply, saliva tests require minimal processing and largely retains the accuracy of traditional nasopharyngeal swabs.
Now, the race is on to provide a cheaper and friendlier Covid-19 test kit in Malaysia.
Testing for Covid-19, at the moment, involves a healthcare professional inserting a swab into one nostril, to the nasopharynx at the back of the nasal cavity, quickly scraping the tissue to collect material, and sending it off for analysis.
This method is cumbersome as it needs to be done by a qualified worker wearing fresh gloves and personal protective equipment (PPE), which are dangerously hot in Malaysia’s tropical climate.
However, the collection of a saliva sample requires spitting into a tube, resulting in a much less invasive procedure without tying up large amounts of PPE.
Per FDA’s instructions, the testing would still occur in a healthcare setting under the supervision of a qualified professional.
“Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples,” explained Andrew Brooks, the chief operating officer of biorepository RUCDR Infinite Biologics, in a statement.
Brooks also said that in addition to identifying carriers of the virus, this form of testing could also make it easier to re-test people who have recovered, so they can end their isolation.
This new saliva test should be available in Malaysia by March 2021, at an approximate cost of RM40, and the result can be obtained within three hours.
It is understood at least one Malaysian company has already submitted test kits to the Ministry of Health for approval – a process which usually takes three months under an emergency use situation, said a medical industry professional who declined to be named.
Once it is approved, we can expect to see a boost in the ride-hailing industry, because people are still hesitant to take public transport now – out of fear of contagion.
But with the availability of non-invasive and lower-cost testing, more drivers can take the test at a weekly frequency.
The introduction of this low cost and uncomplicated Covid-19 test kit would then serve as a call for the leaders in the industry like Grab, Foodpanda, Lalamove and the rest to subsidise the cost of tests for gig workers with outstanding performance and safety records.
Yamin Vong has been a journalist for 40 years and has covered the Tokyo Show almost consecutively since the early 1980s, driven thousands of test cars and met numerous auto industry chiefs. Currently, he’s focussed on the motoring industry’s land transport issues. He blogs at MotorMouth.
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