Stay ahead of the curve

The race is on to provide a cheaper and more friendly Covid-19 test kit in Malaysia.

Testing the saliva for the virus that causes Covid-19 should be available within March at an approximate cost of RM40. The result can be obtained within three hours.

It is understood at least one Malaysian company has already submitted its S. Korean test kit 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.

The U.S. Food and Drugs Administration (FDA) gave its first Emergency Use Authorization for saliva testing last April. Five months later, it had already approved another 4 types of saliva-based test for COVID-19, with the latest being the low-cost and non-invasive procedure developed by the Yale School of Public Health.

Saliva tests require minimal processing and largely retains the accuracy of traditional nasopharyngeal swabs.

The saliva test kit will be a boost for the ride-hailing industry. What’s happening now is that many people are hesitant to take public transport because of fear of contagion.

With a non-invasive and lower-cost testing, more drivers can take the test at a more meaningful, weekly frequency.

One of the factors supporting the momentum of the Malaysia economy is the navigational app, Waze. Waze enables motorcyclists and drivers to be gainfully employed, if not well renumerated.

The introduction of a low cost and friendly Covid-19 test kit is a call for the leaders in the industry like Grab, Food Panda, Lalamove and the rest to subsidise the cost of tests for those gig workers with outstanding performance and safety records.

Currently, testing for COVID-19 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 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 the tropical climate.

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 the Food and Drug Administration’s (FDA) 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,” Andrew Brooks, the chief operating officer of RUCDR Infinite Biologics, a biorepository backed by Rutgers University that developed the spit test, explains in a statement.

The saliva test builds on the existing TaqPath SARS-CoV-2 Assay used in existing COVID-19 testing to identify RNA from the virus.

Brooks explains 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. 

According to validation results provided to the FDA, 60 patient samples taken from saliva and swab tests were in agreement as to the presence of the coronavirus. The agency notes that independent testing by the New Jersey State Health Department of 10 samples agreed with RUCDR’s findings.

In a recent paper, published August 4 on the preprint server medRxiv, a team led by Yale postdoc Chantal Vogels detailed the new tool called SalivaDirect. A team composed of many of the same researchers had previously shown that saliva could be collected in any sterile container and that the saliva 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 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.”

Traditional COVID-19 testing is a two-part process: once the sample is collected, the virus’s 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 step and the most time consuming and the most skilled [steps],” says Nathan Grubaugh, an epidemiologist at Yale and a coauthor 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 say they engineered their protocol to be as adaptive as possible to different PCR kits already on the market.

“Providing 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,” Food and Drug Administration (FDA) Commissioner Stephen Hahn says in a press release announcing the emergency use authorization.

This same flexibility and relatively streamlined protocol also make SalivaDirect a cheaper alternative to traditional PCR tests, the authors say. The total cost of the reagents needed for one test is roughly $5, meaning it could be offered to the public for much less, perhaps as little as $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 the news. “Rarely am I this enthusiastic . . . [With] a $10 test, you can test every day or every couple days.”