PerkinElmer announced that its EUROIMMUN Crithidia luciliae immunofluorescence test (CLIFT) and CLIFT sensitive assays have received FDA 510(k) clearance.
CLIFT testing is critical in supporting the detection of anti-double stranded DNA (anti-dsDNA)—one of the exclusive markers for systemic lupus erythematosus (SLE), a severe rheumatic autoimmune disease commonly known as lupus. The prevalence of anti-dsDNA ranges from 40 to 90% in lupus patients with exceptional specificity.
While other immunological tests, including ELISA and RIA, routinely detect anti-dsDNA antibodies, these methods historically only provide sensitivities around 20%. The EUROIMMUN CLIFT sensitive assay—performed on the fully-automated EUROPattern microscope and software system—improves sensitivity by 30% versus other serological tests, helping minimize false negative results. Specificity is maintained simultaneously, helping clinical labs to avoid false positive results, thus enabling rheumatologists or primary care physicians to diagnose lupus with greater confidence.
The EUROPattern microscope’s fully-automated workflow, which renders digital images within 13 seconds per field, allows the EUROIMMUN CLIFT assays to improve result turnaround time during the screening process. EUROIMMUN’s proprietary BIOCHIP technology further enhances efficiency and cost savings by requiring less sample and reagents.
“Correct diagnosis is a prerequisite to determining effective treatment,” Prahlad Singh, Executive Vice President and President of Diagnostics at PerkinElmer, said in a press release. “The FDA’s clearance of the EUROIMMUN CLIFT assays represents a significant milestone in helping clinicians more quickly and accurately detect autoimmune disorders and provide personalized care for those with lupus.”
