Quidel and Life Technologies have received 510(k) approval from US FDA to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments.
The Quidel Molecular Direct C. difficile Assay kit comprises an extraction-free, three-step sample preparation process that does not need heat step, timed step, and centrifugation.
Due to the fast and easy direct-to-amplification procedure, the assay can produce result in less than 70 minutes by an efficient method.
This Quidel Molecular Direct C. difficile Assay is part of Quidel's line of molecular diagnostics products.
The QuantStudio Dx Real-Time PCR instrument's touch screen, reagent and sample tracking, and Laboratory Information Management Systems interface are meant for ease of use, and the six-color feature allows for a multiplex of six targets in one reaction.
The 7500 Fast Dx Real-time PCR Instrument system is a five-color real-time PCR instrument that offers the performance required for high-quality results in a 96-well format.
Clostridium difficile bacterial infections are life-threatening, especially for the elderly, immunocompromised populations, and for patients on a prolonged antibiotic regimen. C. difficile infection (CDI) is frequently linked with antibiotic therapy.
Quidel President and CEO Douglas Bryant noted that according to the Centers for Disease Control and Prevention, 14,000 deaths are attributed to CDI in the US each year.
"For this reason, a fast and accurate diagnosis is vital to the patient's proper treatment and speedy recovery.
"With the clearance of our C. difficile assay, we extend our Quidel Molecular product line beyond respiratory infections with products that address the needs of hospital laboratories in higher-volume settings," Bryant added.
