COVID-19 testing firm LabX Corp. has donated the first Food and Drug Administration-approved antigen test Sofia 2 SARS Antigen Fluorescent Immunoassay analyzer machine to the Research Institute for Tropical Medicine (RITM).
Aside from the machine, LabX Corp. handed over 300 testing kits and demonstrated how to use it before RITM Chief Laboratory Research Amado Tandoc III and RITM Assistant Director Beatriz Quiambao at the facility in Muntinlupa City.
The machine is approved by the FDA of both the United States and Philippines, the firm said in a statement.
Quidel Corp., a California-based diagnostic healthcare firm that produces the machine, has announced that it has updated the performance data for its Sofia SARS Antigen FIA antigen test on its package insert to 96.7% using direct nasal swab versus PCR (polymerase chain reaction) tests.
This is a result of further studies included in Quidel's amended Emergency Use Authorization (EUA) that were submitted to the US FDA.
“Quidel announced that they have increase the sensitivity to 96.7 percent. This is basically two additional points from the previous 93.8 percent rating that US FDA has given Quidel,” LabX Corp. CEO Thomas Navasero said.
"This new generation of antigen test will continue to play a critical role as an effective first line of defense against COVID-19 in the country, because it is faster and more accurate than the old gold standard," Navasero added.
“Further studies have validated that our Sofia SARS Antigen FIA offers sensitivity that is comparable to PCR within this 5-day window, providing healthcare workers with confidence in their ability to accurately diagnose their patients,” he said.
The US Department of Health and Human Services has indicated its intent to purchase both Sofia 2 instruments and the Sofia SARS Antigen FIA for distribution and use in nursing homes.
“I’m looking forward how COVID-19 testing game changer is in the Philippines through LabX Corp. Through Sofia 2 antigen test, we can up the testing exponentially, and we can easily mitigate virus transmission in the country,” said Norman Bungubung, LabX Corp. Chief Operating Officer.
The Sofia 2 SARS Antigen FIA is also the first rapid point-of-care test to be grantedan EUA by the US FDA, wherein it can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity through painless swabs.
The antigen test, with a specificity of 100 percent, provides automated and objective results in just 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
Sofia 2 also uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2.