March 2019—Quidel has received the CE mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of vitamin D sufficiency and is the first quantitative assay on the Sofia.
The company also received the CE mark for its point-of-care Sofia 2 Lyme+ FIA to be used with the Sofia 2 fluorescent immunoassay analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi, Borrelia garinii, and Borrelia afzelii from serum and plasma specimens.
Quidel also reported that the manufacturing of its CE-marked Quidel Triage PLGF Test is set to resume and will be commercially available outside the United States for clinical use in the first quarter of 2019. In the company’s acquisition of Alere’s Triage business, ownership of the Triage placental growth factor product transferred to Quidel.
Quidel, 858-552-1100