A positive test, however, should be confirmed with a Polymerase Chain Reaction test
The United States Food and Drug Administration (FDA) gave emergency use approval (EUA) for the first-ever COVID-19 diagnostic test April 14, 2022. The test uses breath samples and yields results in under three minutes.
The test will finally put an end to invasive, repeated and often painful poking of swabs in the nose and throat that has been in use since the last two years to test for the SARS-CoV-2 virus.
The poking was followed by at least hours, if not days, of wait for the result to come out.
“The test can be performed in environments where the patient specimen is both collected and analysed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage,” the regulatory body noted.
It added that a “qualified, trained operator under the supervision of a health care provider licensed or authorised by state law” is needed. The test was found to be effective in a study which included 2,409 individuals — both symptomatic and asymptomatic.
The results were promising, with 91.2 per cent sensitivity — positive samples identified correctly — and 99.3 per cent specificity — negative samples identified correctly.
A positive test, however, should be confirmed with a Polymerase Chain Reaction (PCR) test.
Accuracy has been the critical hurdle in COVID-19 testing. The company that produced this instrument had, in May 2020, noted:
Accuracy has been an issue with COVID-19 testing since the beginning of the crisis. Our device is specifically designed for trace detection in the high part-per-trillion. We believe it will provide the most accurate results on the market. There are few viable non-invasive detection tools available today.
The method also successfully detected positive cases in areas of low prevalence, recording a negative predictive value of 99.6 per cent in a population where only 4.2 per cent of the people were infected.
“Today’s authorisation is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19. The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said.
The breathalyser instrument — the size of a carry-on luggage — is developed by InspectIR, a research, development and device company focused on portable COVID-19, opioid and cannabis detection solutions.
The company expects to produce an estimated 100 instruments per week each of which has a daily testing capacity of 160 samples. If this level of production is maintained, 64,000 samples per month can be tested.
The instrument uses gas chromatography-mass spectrometry, an analytical method which separates chemical mixtures to identify particular molecules.
It has been used to monitor food contamination, detect pollutants in the air, detect narcotics and alcohol in body fluids and even the atmosphere of Venus.
Other methods are also being explored to test for the presence of SARS-CoV-2. In August 2020, the FDA had issued a EUA to Yale University’s SalivaDirect which uses saliva samples to detect the virus.
The test’s affordability — an open source model — has made it an extremely attractive option with 174 American labs administered a variation of the test.
“We determined that saliva, when processed properly, can be more sensitive than NP swabs when run through a RT-qPCR machine and that we didn’t need the RNA extraction step,” Anne Wyllie, a research scientist at the Yale School of Public Health was quoted as saying in a university daily.
In May 2021, the FDA also gave EUA to NOWDiagnostics, Inc for their finger prick test of COVID-19.
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