SeraCare Life Sciences, Milford, Mass, has launched the AccuPlex Zika reference material to fast-track the development and validation of polymerase chain reaction (PCR)-based Zika virus assays. Based on SeraCare’s patent-pending AccuPlex recombinant virus technology, the new reference material provides a safe, non-replicative, and fully extractable positive material that covers the entire Zika virus genome.
Within infected areas, Zika has been linked to microcephaly, a neurological birth defect, and is also considered a possible cause for an increase in adult Guillain-Barré syndrome cases. In response to this outbreak, diagnostic laboratories and test developers have an accelerated need to develop and validate molecular diagnostic assays, which require stable and reproducible manufactured positive reference materials.
Utilizing AccuPlex recombinant virus technology, SeraCare’s Zika reference material contains the entire RNA genome of the ZIKV 2007 strain in four separate overlapping virus constructs. This product is formulated at ~1.0E+05 copies/ml in 0.25ml of defibrinated human plasma; the copy number is assigned based on results from a digital PCR assay developed in-house. As a recombinant virus product, the AccuPlex Zika reference material utilizes a mammalian RNA virus that closely mimics the Zika virus in both size and complexity. Ongoing accelerated and real-time stability studies indicate that AccuPlex recombinant viruses are stable at room temperature for at least 20 months and at 4°C for at least 2 years.
“We have developed and manufactured this plasma-based product in just a matter of weeks by leveraging our scalable, recombinant virus technology,” says Bharathi Anekella, PhD, vice president of research and development at SeraCare Life Sciences. “As a result, we have provided assay developers, such as Siemens Healthineers, a reliable source of safe, positive material to aid in the development of their Zika virus assays.” Siemens developed its research use only PCR assay to test for the presence of the Zika virus prior to the development of antibodies.
In addition to assay development, AccuPlex Zika reference material was developed for public health agencies around the globe to implement training, interlab studies, and proficiency programs.