AcroMetrix introduces the OptiQual HPV Genotype Panel

Nov 19 2009

AcroMetrix, a leading manufacturer of quality control material for clinical diagnostic and blood testing laboratories, announced today the launch of its OptiQual HPV Genotype Panel. Designed to help clinical laboratories comply with CLIA guidelines for qualitative molecular assays that detect Human Papillomavirus (HPV), this addition to AcroMetrix’s line of women’s health products can assist laboratorians with the validation and verification of their molecular HPV tests. Panel members include HPV-16, 18, 68, and a negative, and are offered individually allowing users to customize their own HPV genotyping panel.

High-risk HPV testing is recommended in HPV testing guidelines composed by medical organizations such as the American College of Obstetricians and Gynecologists and the American Society for Colposcopy and Cervical Pathology. The goal of type-specific detection of individual HPV genotypes is to further assess the risk of cancer, and can be performed concurrent to the initial high-risk screen or as a reflex test. As clinicians realize the clinical utility of HPV genotyping and genotyping assays become more common, sufficient quality control materials will be needed for optimal patient care.

“AcroMetrix continues to show its dedication to women’s health with the launch of the OptiQual HPV Genotype Panel,” says Michael J. Eck, President and CEO of AcroMetrix. “AcroMetrix is committed to providing laboratories with the quality control products they need to assess the analytical performance of their molecular testing procedures.”

Each panel member contains whole cells with an integrated HPV genome, expressing the E6/E7 mRNA and thus mimicking a true oncogenic patient sample. This allows for full process control of molecular test procedures, from extraction through amplification and detection. Additionally, customers will observe excellent consistency and reproducibility in results from lot to lot because the panel members are manufactured in accordance with ISO 17511.