UK-based company Intelligent Fingerprinting has created a user-friendly, saliva-based lateral flow VSS-GP test for quick SARS-CoV-2 antigen detection.
As compared to current Covid-19 tests, which need invasive nose and throat swabs, the latest test requires a simple swab to obtain a saliva sample from the inside of the cheek.
The new saliva sample collection method makes the test appropriate for testing vulnerable individuals as well as children. It further enables regular testing in multiple applications such as schools, airports and workplaces.
The test can deliver results in 20 minutes, which is faster than several of the nose and throat lateral flow tests currently in use.
With a simple design, the testing strip reduces plastic usage as it does not have the plastic casing present in other lateral flow tests, the company noted.
In an independent analysis, the test showed a sensitivity of 100%, in assessing 150 positive clinical samples (Ct range 18 to 28), and specificity of 100%, on testing with 250 reverse transcription-polymerase chain reaction (RT-PCR)-confirmed negative saliva samples.
Intelligent Fingerprinting executive chairman Philip Hand said: “In developing our new Covid-19 saliva test, we have successfully combined the benefits of much simpler sample collection with high levels of accuracy using our existing technology.
“Manufacturing capacity at our Cambridge plant, utilising existing equipment and ISO 13485 quality control, is ready to support the production of millions of tests per month, and we also anticipate we will be working with existing and new distribution partners to make this test available across multiple markets.”
A molecular diagnostic assay, Aptima is indicated to identify the genetic material of the SARS-CoV-2 virus.
The assay has already received CE mark for the use of nasopharyngeal and nasal swabs as well as other specimen types.
Hologic has scaled up production capacity to manufacture Aptima tests in huge quantities and shipped approximately 100 million tests across the world so far.