The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The platform enables the assessment of hemoglobin levels at the point of care and quantitatively measures hemoglobin in capillary or venous whole blood.
Abbott's Alinity h-series system integrates a standalone hematology analyzer and slide maker-and-stainer module to enable high-throughput complete blood counting.
The XW-100 Automated Hematology Analyzer previously received 510(k) clearance. With the CLIA waiver, the test can be run in more types of healthcare facilities.
The method allows clinicians to more easily integrate anemia testing with testing for other underlying disorders, potentially aiding study of the condition.
The CDC received clearance for a number of influenza panels and kits. Agilent's assay for postnatal CNV detection, and Abbott's hematocrit test were also cleared.
The kit is designed to be used on the same platform as Grifols' other molecular typing platforms and can provide results within four hours of DNA extraction.