A New York fertility doctor has developed a rapid, non-invasive coronavirus test that, according to a preliminary study, can yield accurate results in 30 minutes or less.
A test developed by Dr. Zev Williams, a reproductive endocrinologist who runs the Fertility Center in Columbia, uses a person’s saliva to screen for COVID-19.
A small sample of saliva is placed in a tube containing the enzymes and the compound that causes the chemical reaction, then the tube is heated with a heat block. The liquid in the tube turns yellow when it is positive for the virus or red when it is negative.
“We wanted to design a one-step test in which all work is done by enzymes and chemicals rather than cartridges and components,”; said Williams, adding that enzymes and chemicals are easy to scale and distribute.
According to a preliminary study published by Williams on MedRxiv, a one-step rapid test detected only one or two copies of SARs-CoV-2 virus in a microliter of saliva, which means that it can determine if a person is infected even if they have only a low concentration of the virus.
“Low detection limits help ensure that you can detect the virus in infected individuals, even if they are asymptomatic,” Williams explained.
The study, which was not reviewed, also noted a sensitivity of 97% and a specificity of 100%.
Sensitivity refers to the ability of a test to correctly identify infected patients, while specificity is the ability of a test to correctly identify those who are not sick. In this case, when the sample was negative, the saliva test did not give a false positive result, whereas when the sample was positive, 97 percent of the time it was correctly detected.
“This test is very, very simple, very fast and very accurate,” said Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, a partnership with Columbia University that licenses the test.
“Currently there is no accuracy in other tests.”
If the test proves successful in further testing, Williams hopes it can help reduce the spread of the disease by monitoring contracts.
“Getting the results back quickly will allow the individual to be quarantined so that they do not spread it, and it will also allow you to find contact,” Williams said.
“If you get results a week later, good luck trying to make contacts if they use the subway system after you’ve lost.”
Current COVID-19 testing involves nasal swabs and specialized laboratories and machines that slow down testing and result in delays of days or even weeks in achieving results.
“The problem is the delay between testing and achieving results,” said Dr. Alexis Nahama, Head of Regulatory Affairs at Sorrento.
“We need to bring testing to people as opposed to taking people samples and taking them to the lab, because it’s falling apart today.”
Sorrento is conducting a larger saliva study next month before applying for an FDA emergency permit.
The cost of the test is expected to be less than $ 15, Williams said.