Multiplex Analytical Control Introduced for Cystic Fibrosis Testing

A multiplex analytical control for cystic fibrosis testing is now labeled for in vitro diagnostic use.

The Accurun 644 cystic fibrosis control is available to clinical pathologists in the European market. The synthetic, multiplex control is an effective mechanism for identifying mutations in the cystic fibrosis CFTR gene, covering all mutations in the Luminex (Austin, TX, USA) xTag cystic fibrosis 39 kit v2 IVD assay. The kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.

By covering the largest number of mutations in a single vial of any commercial control, the Accurun 644 control offers labs advantages in terms of both quality control and cost. Using the multiplex control allows for detection of significant errors missed or more difficult to identify using rotating genomic DNA controls— enabling labs to improve error detection with fewer controls, reducing costs, improving throughput, and increasing revenue potential.

A product of SeraCare (Milford, MA, USA), the Accurun 644 control for cystic fibrosis testing with CE marking is available in Europe for IVD testing after serving as a highly effective tool for research purposes in the United States for two years.

Cystic Fibrosis (CF) is a multisystem disease that can affect the respiratory tract, pancreas, sweat glands, intestine, male genital tract, and liver. Pulmonary disease is one of the most notable characteristics of CF and is the leading cause of death in CF patients.

SeraCare's portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking, and contract research services.

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