WALTHAM, Mass.--(BUSINESS WIRE)--PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today 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 percent in lupus patients with exceptional specificity.1
While other immunological tests, including ELISA and RIA, routinely detect anti-dsDNA antibodies, these methods historically only provide sensitivities around 20 percent. The EUROIMMUN CLIFT sensitive assay—performed on the fully-automated EUROPattern microscope and software system—improves sensitivity by 30 percent versus other serological tests, helping minimize false negative results.2 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,” said Prahlad Singh, Executive Vice President and President, Diagnostics, PerkinElmer. “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.”
EUROIMMUN, a PerkinElmer company, is widely recognized as a global leader in autoimmune testing and an emerging force in infectious disease and allergy testing. It has extensive expertise and capabilities across immunology, cell biology, histology, biochemistry and molecular biology.
PerkinElmer, Inc. is a global leader committed to innovating for a healthier world. Our dedicated team of about 11,000 employees worldwide is passionate about providing customers with an unmatched experience as they help solve critical issues especially impacting the diagnostics, discovery and analytical solutions markets. Our innovative detection, imaging, informatics and service capabilities, combined with deep market knowledge and expertise, help customers gain earlier and more accurate insights to improve lives and the world around us. The Company reported revenue of approximately $2.3 billion in 2017, serves customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
1 Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R,
Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, et al. Estimates of
the prevalence of arthritis and other rheumatic conditions in the United
States. Part I. Arthritis Rheum 58 (2008) 15-25.
2 Gerlach S, Affeldt K, Pototzki L, Krause C, Voigt J, Fraune J, and Fechner K. Automated Evaluation of Crithidia luciliae Based Indirect Immunofluorescence Tests: A Novel Application of the EUROPattern-Suite Technology. J. Immunol Res 2015 (2015) 742402.