PerkinElmer Inc, Waltham, Mass, has announced that its Euroimmun Crithidia luciliae immunofluorescence test (CLIFT) and CLIFT-sensitive assays have received FDA 510(k) clearance.
CLIFT is critical for supporting the detection of anti-double stranded DNA (anti-dsDNA), one of the exclusive markers for systemic lupus erythematosus, 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.1
While other immunological tests, including enzyme-linked immunosorbent assays and radioimmunoassays, routinely detect anti-dsDNA antibodies, these methods historically only provide sensitivities around 20%. The CLIFT-sensitive assay, performed on the fully-automated EuroPattern microscope and software system, improves sensitivity by 30% versus other serological tests, thereby minimizing false negative results.2 The system simultaneously maintains specificity, thus helping clinical labs avoid false positive results and 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, enables CLIFT 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,” says Prahlad Singh, executive vice president and president for diagnostics at PerkinElmer. “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.”
To learn more, visit PerkinElmer.
- Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15–25; doi: 10.1002/art.23177.
- Gerlach S, Affeldt K, Pototzki L, et al. Automated evaluation of Crithidia luciliae based indirect immunofluorescence tests: a novel application of the EuroPattern-suite technology. J Immunol Res. 2015;2015:742402; doi: 10.1155/2015/742402.