US-based in-vitro diagnostics company Inova Diagnostics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its QUANTA Flash dsDNA, Jo-1, and Scl-70 assays.
QUANTA Flash dsDNA is a highly specific marker which assists in the diagnosis of systemic lupus erythematosus (SLE) when used with clinical and other laboratory findings.
It features sensitivity and specificity while diagnosing SLE and it maintains a strong correlation with parameters hinting SLE such as SLEDAI, C3, C4, and total complement activity.
It also displays correlation to the Farr assay with a quick and safe result.
Monash University, Melbourne, Australia Professor Ban-Hock Toh said: "Anti-dsDNA antibodies measured with QUANTA Flash on the fully automated BIO-FLASH analyzer show very high agreement to Farr assay, which is often considered the reference method in spite of the labor intensive procedure and the presence of radioactivity.
“The QUANTA Flash dsDNA assay is a viable alternative for labs currently using the Farr technology."
QUANTA Flash Jo-1 plays an important role in the diagnosis of polymyositis and dermatomyositis, while the Flash Scl-70 assay acts as a classification marker to aid in the detection of systemic sclerosis.
Inova Diagnostics CEO Roger Ingles said: "The random access capabilities of BIO-FLASH delivers enhanced workflow efficiencies and improved turn-around time, making even the most specialised autoimmune tests efficient to perform.
“The addition of QUANTA Flash dsDNA and Jo-1 assays expands the BIO-FLASH CTD menu and will allow laboratories and physicians to receive accurate and timely patient results."
The Quanta Flash assays operate on the BIO-FLASH fully automated chemiluminescent platform which is used for the autoimmune laboratory.