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FDA authorizes Abbott's monkeypox PCR test for emergency use

The FDA has issued an emergency use authorization to Abbott Molecular for its real-time PCR test for monkeypox using lesion swab specimens from those with suspected virus infection. The PCR test (Alinity m MPXV) is the first commercial test to be authorized for detection of monkeypox and is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, according ....

Erik Swain , Clinical Laboratory Improvement Amendments , Human Services , Department Of Health , Abbott Molecular ,

FDA Roundup: October 7, 2022

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an. ....

United States , Celiam Witten , Jeff Shuren , Donald Prater , Julie Moss , Hilary Marston , Ann Meeker Oconnell , Abbott Molecular Inc , Drug Administration , Office Of Clinical , Office Of Media Affairs , Digital Health Center , Critical Path Institute , Clinical Laboratory Improvement Amendments , Radiological Health , Office Of International Engagement , Emergency Use Authorization , Abbott Molecular , Drug Evaluation , Biologics Evaluation , Further Harmonize Clinical Research Regulations , Chief Medical Officer , Ann Meekero Connell , Federal Food , Cosmetic Act , Work Underway ,

The performance of using dried blood spot specimens for HIV-1 viral load testing: A systematic review and meta-analysis

Lara Vojnov and co-workers report on the use of dried blood spots for HIV viral load testing. ....

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The performance of using dried blood spot specimens for HIV-1 viral load testing: A systematic review and meta-analysis

Lara Vojnov and co-workers report on the use of dried blood spots for HIV viral load testing. ....

United States , North Carolina , United Kingdom , Abbott Park , Provence Alpes Côd Azur , Hologic Aptima , Marie Louise Newell , Us Centers For Disease Control , University Of Southampton , Chesapeake Institutional Research Review Board Columbia , World Health Organization , International Conference , Creative Commons , Supporting Information , Emergency Plan , Disease Control , Opportunistic Infections , Preferred Reporting Items , Systematic Reviews , Quality Assessment , Diagnostic Accuracy Studies , Reporting Studies , Google Scholar , Abbott Realtime , Abbott Molecular , Roche Amplicor ,

Kovacs joins HeartcoR Solutions

Schaumburg-based HeartcoR Solutions said Xenia Kovacs has joined the organization as associate director of project management. ....

John Icardi , Xenia Kovacs , Abbott Abbvie , University Of Pecs School Law , Core Lab , Heartcor Solutions , Nagy Lajos College In Pecs , Schaumburg Heartcor Solutions , Abbott Molecular , Nagy Lajos College , Pecs School , Suburban People On The Move ,