SeraCare Expands Women’s Health Portfolio with New ACCURUN® Controls

SeraCare Life Sciences, a provider of high-quality biological materials that help optimize diagnostic performance, reliability and repeatability across the IVD lifecycle, has announced the launch of two new ACCURUN® products – the first HPV mRNA positive and Ct/Ng negative controls for the company.

“Today women’s health assays present unique sample challenges which require dependable, whole cell controls. At SeraCare, we provide our customers with full-process controls that challenge their assays from extraction through amplification and detection,” says Chris Long, Product Manager at SeraCare. “Our new HPV mRNA positive and Ct/Ng negative controls reduce the risk of repeat testing and, as a result, give our customers greater confidence in their assay results.”

ACCURUN 381 HPV Type 16 and 18 mRNA Positive Controls
The new HPV type 16 and 18 mRNA positive control includes the full length episomal genome and targets RNA-based assays. This product is manufactured from cultured human cells infected with HPV Type 16 or Type 18 that have integrated into the cellular genome. The cells bear the mRNA transcribed from the viral genes and are preserved in a buffered methanol solution. The control is “ready to use” in assays that detect high risk HPV mRNA of E6 and E7 viral genes.

ACCURUN 841 Chlamydia trachomatis Neisseria gonorrhea Negative Control
Our ACCURUN 841 Chlamydia trachomatis Neisseria gonorrhea Negative Control is formulated for use with in vitro diagnostic amplified test methods that detect Chlamydia trachomatis Neisseria gonorrhea nucleic acid. This product is manufactured in a proprietary buffer simulating specimen transport media that contains the human cellular components required to obtain valid negative results on assay platforms. The Ct/Ng negative control closely mimics human samples as a result of its whole organism design.

SeraCare is also one of the first companies to offer researchers insight into establishing quality control best practices for their molecular labs. A recent white paper entitled, “Assessing Quality Using ACCURUN Controls for Quantitative Viral Loads” highlights how to design a molecular QC program for maximum lab efficiency. “Consistent accuracy in reporting quantitative viral load results is critically important to patients, physicians and the clinical laboratory,” says Long. “It is our goal to provide researchers with a better understanding of how solid their current systems are and how they might be improved upon.”

SeraCare’s new ACCURUN® 381 and 841 products are available immediately in the U.S. and internationally.