Inova Diagnostics gets FDA approval for automated ANCA IFA assays
Inova Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new immunofluorescence assays (IFA).
The FDA approved Nova Lite DAPI ANCA (ethanol) and Nova Lite DAPI ANCA (formalin) kits for use with Nova View digital IFA microscope.
Nova Lite DAPI ANCA kits are claimed to be the first FDA cleared reagents to detect anti-neutrophil cytoplasmic antibodies (ANCA) on an automated digital IFA microscope.
ANCA are a group of autoantibodies associated with diseases such as granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA)
Nova View will automate the interpretation and reporting of IFA antinuclear antibody (ANA) and ANCA testing.
It will acquire, interpret, present and archive digital IFA images for operator review and confirmation.
Nova View will also determine the result and carry out pattern interpretation. It will predict a pattern specific endpoint titer, after result and pattern confirmation by the operator.
Results will be recorded electronically in a transcription free and paperless work environment, and all digital images are archived for future review
Nova View will improve assay integrity through using Nova Lite barcoded IFA slides, in addition to enabling full patient sample traceability.
Northwell Laboratories technical automated laboratory Laurel Tria said: “It marks a significant step forward in automating and standardizing the ANCA IFA test while providing clinicians with a highly reliable test result.”
Inova Diagnostics research and development vice president Dr Michael Mahler said: “Inova Diagnostics is pleased to launch these newly FDA cleared ANCA assays, expanding the number of assays available on NOVA View to three.”
Image: Nova View automated digital IFA microscope for Nova Lite DAPI ANCA (ethanol), Nova Lite DAPI ANCA (Formalin), and Nova Lite DAPI HEp-2. Photo: courtesy of PRNewsFoto / Inova Diagnostics.