Thermo Fisher Scientific has introduced Accula SARS-CoV-2 test.
The test delivers reverse transcription polymerase chain reaction (RT-PCR) detection of SARS-CoV-2 in a point-of-care format in 30 minutes, according to the company.
The Accula SARS-CoV-2 Test has received Emergency Use Authorisation (EUA) from the United States (U.S.) Food and Drug Administration (FDA) for the detection of SARS-CoV-2 in clinical laboratory improvement amendments (CLIA)–waived environments, the company said.
“Thermo Fisher’s new testing platform combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays,” said Amit Chopra, MD, India and South Asia.
“The Accula SARS-CoV-2 Test is natural extension to our existing offerings and will significantly help to meet the continuing demands for rapid and reliable COVID-19 testing in India,” he said.
RT-PCR testing is streamlined from start to finish using a fully integrated, single-use microfluidic test cassette and the reusable, palm-sized Accula Dock which will cost about ₹60,000 without taxes. The device will be imported from the U.S. The user will need to buy cassettes for testing which cost cost about ₹5,000 per per test. The final pricing will be announced by labs and entities which will undertake these tests.
“The test uses nasal swab samples and provides reliable, qualitative results in approximately 30 minutes,” the company said.
The Accula SARS-CoV-2 Test is enabled by proprietary PCR technology that allows for reduced absolute temperatures and reduced temperature differentials—resulting in rapid exponential amplification while reducing overall thermocycling times.
“The rapid Accula point-of-care test will open new avenues of personal and public testing without compromising on accuracy,” Mr Chopra said.
In January, Thermo Fisher acquired Mesa Biotech Inc., that developed the Accula SARS-CoV-2 Test to provide accurate and faster results at the point of care.
The device can be used at airports, sports events and VVIP meetings for quick screening of guests and visitors for a a COVID- free environment, the company said.
