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Tag: test

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

• Immunocompromised transplant patients are at risk of major complications when infected with BK virus • cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions • New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus […]

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

• First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample • As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients • […]

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

• Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions • Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status • Affordable and small, instrument-free testing kit enables convenient use for healthcare professionals at […]

Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

• Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy • Supports rapid molecular detection of acute HIV infection, which is critical in curbing further disease transmission • Combines confirmatory HIV testing and […]

FDA: Certain COVID-19 Serology/Antibody Tests Should Not Be Used

Letter to Clinical Laboratory Staff and Health Care Providers The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The “removed” test list includes tests where significant […]

First COVID-19 ‘stress test’ passed, Food logistics in times of COVID-19

The Nagel-Group is used to respond flexible to fluctuating demand in retail. The panic buying at the beginning of the COVID-19 pandemic nevertheless presented an enormous challenge for Germany’s biggest food logistics company. Nobody was prepared for the sudden surge. Nonetheless, the supply for people remained consistently secure. Nagel supplies discounters and supermarkets on behalf […]

Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home […]