Tag Archives: EUROIMMUN

July 2022—GenScript USA has reached an agreement with Euroimmun US, a Perkin­Elmer company, for the distribution of the GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit in the United States and Canada.

Oct. 13, 2021—PerkinElmer announced that the FDA has issued emergency use authorization for its PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.

August 2021—Euroimmun launched its SARS-CoV-2 NeutraLISA assay, a surrogate neutralization test intended for the detection of neutralizing antibodies against SARS-CoV-2.

February 2021—Euroimmun launched its CE-marked EuroRealTime SARS-CoV-2/Influenza A/B, which detects and differentiates genetic material from SARS-CoV-2 and influenza virus types A and B using throat swab samples of patients with acute symptoms, which can be indicative of COVID-19 or flu. The assay is compatible with common real-time PCR thermal cyclers and is available in countries that accept the CE mark. The EuroRealTime analysis software allows for standardized evaluation of test results. The company also launched its CE-marked SARS-CoV-2 Antigen ELISA, a laboratory diagnostic test for the direct detection of SARS-CoV-2 by semiquantitative determination of the virus-specific nucleocapsid protein in swab samples from the upper respiratory tract. Validation data revealed 93.6 percent sensitivity and 100 percent specificity as compared with real-time PCR tests. The assay can be automatically processed on all open ELISA platforms and is available in countries that recognize the CE mark.

May 7, 2020—PerkinElmer announced that the FDA has provided emergency use authorization for Euroimmun’s Anti-SARS-CoV-2 ELISA (IgG) serology test.

April 2016—Euroimmun, headquartered in Luebeck, Germany, has developed a system of comprehensive tests available for the serological detection and differentiation of Zika virus infections.

July 2015—Euroimmun US announced the FDA 510(k) clearance of its EuroPattern System, which consists of a fluorescent microscope (oculars included for manual interpretation) and software that acquires, interprets, archives, and displays digital images of stained IFA slides.