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News items for the in vitro diagnostics industry for the week of March 30, 2020.
Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.
The ID Now COVID-19 test is the second assay from the company to receive EUA from the FDA, following the same designation issued to the Abbott RealTime SARS CoV-2.
The test will run on the m2000 RealTime molecular system, and the company said it will be shipping 150,000 tests immediately.
Labs are using specific protocols to mitigate the effects of biotin, a vitamin supplement that can interfere with test results.
Abbott received five separate clearances associated with its i-Stat Chem8+ cartridge running on the company's iStat 1 system.
The researchers are studying use of pharmacy testing to monitor hypertension and cholesterol as well as for detecting and managing various infectious diseases.
A recent study established high sensitivity and specificity for three CLIA waived point-of-care molecular flu tests in pediatric samples.
Abbott said the increase in diagnostics revenue was driven by adoption of the company's Alinity family of diagnostic instruments.
The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.