NEW YORK (GenomeWeb News) – Becton Dickinson segment BD Diagnostics said today its BD Max MRSA molecular test has received a Moderate Complexity rating under the Clinical Laboratory Improvement Amendments of 1988.
The rating allows the test to be performed by a qualified laboratory technician.
The assay was cleared by the US Food and Drug Administration last month for marketing in the US. It runs on the fully automated BD Max System and was developed to rapidly identify patients with methicillin-resistant Staphylococcus aureus.
"Healthcare institutions can now simplify and optimize their MRSA active surveillance testing in less than a minute of hands-on time per specimen with true walk-away automation," Tom Polen, president of BD Diagnostics, said in a statement.