Bio-Rad Laboratories Inc, Hercules, Calif, has announced its continued expansion into the molecular diagnostics testing market with the launch of the Amplichek I quality control, for which FDA recently issued a premarket notification (510(k)) clearance. The control is the second in a series of infectious disease controls that Bio-Rad has introduced for the molecular diagnostic testing market this year.
“We are pleased to expand our offering of controls for the molecular diagnostics testing market,” says John Hertia, president of the clinical diagnostics group at Bio-Rad. “The introduction of Amplichek I represents Bio-Rad’s continued commitment to improve laboratory analytical performance and ultimately the quality of patient care.”
Amplichek I is an independent, multianalyte quality control for the assessment of HIV 1, hepatitis B, and hepatitis C nucleic acid tests that can help mitigate the limitations of manufacturer controls. Unlike some controls that are optimized for specific systems, Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.
For more information, visit Bio-Rad Laboratories.
