The US Food and Drug Administration (FDA) has granted clinical laboratory improvement amendments (CLIA) waiver to Quidel's Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay (FIA).
The Sofia Analyzer and Sofia Influenza A+B FIA utilizes immunofluorescence-based chemistry and software to detect Influenza types A and B and provide result within minutes of obtaining the nasal swab and nasopharyngeal swab specimens from the patient.
Quidel president and chief executive officer Douglas Bryant said the company is pleased to receive CLIA waiver for its Sofia system because this permits to sell to the CLIA waived physician office labs, emergency departments, and other CLIA waived facilities.
"We are very proud of this achievement, and we are excited about the ability to provide physicians in any medical setting with highly accurate diagnostic solutions within minutes of the arrival of their patient," Bryant added.
The Sofia test system has received CE-mark and FDA 510(k) approvals and is available in Europe and US.