SeraCare Announces Industry's First Comprehensive NGS Reference Material for Hematologic Malignancies

Comprehensive suite of Zika IgM and recombinant Zika virus reference materials for method validation and evaluation of serological and molecular infectious disease assays.

MILFORD, Mass., August 1, 2017 -- SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories is announcing the launch of a set of unique Zika virus products as critical components of a robust QC program for validating and monitoring Zika virus test methods. These new innovative products provide highly characterized Zika IgM materials as well as safe to handle recombinant virus that can be used as positive reference materials for Zika diagnostic assays.

A major challenge in developing and validating a Zika assay is high cross-reactivity to other flaviviruses such as dengue and chikungunya, which are present in the same geographic regions as on-going Zika infections. To overcome this challenge, SeraCare has developed the AccuSetTM Zika Performance Panel, which is acomprehensive 10-member panel consisting of patient samples demonstrating a range of reactivity for Zika IgM antibodies, and assessed for cross-reactivity to dengue and chikungunya. This panel is intended for use by researchers, diagnostic manufacturers, and clinical laboratories to develop, evaluate, and validate Zika serological test methods. The panel members have been comprehensively tested following the recommended CDC algorithm and using several commercially available methods. This unprecedented panel of Zika IgM materials will ensure test method validation specific to Zika IgM reactivity and rule out cross-reactivity to related flaviviruses.

Molecular assays for Zika virus detection are based on PCR methodologies. However, the options available for use as positive reference materials are limited to bacteriophage, RT-DNA (plasmids), and chemically treated, cultured virus.  These alternatives either do not represent the full viral genome or are potentially infectious to handle. This is a concern when working within fertility laboratories where samples are of utmost value for use in fertilization techniques.

To address these challenges, SeraCare has developed two new products: the AccuSpan™ Zika RNA Linearity Panel and the AccuPlex™ Zika RNA Reference Material, both formulated using our innovative AccuPlex recombinant virus technology.  This technology offers a safe, non-replicative, non-infectious, and fully extractable positive reference material to support the development and evaluation of molecular diagnostics detecting the Zika virus. This fully packaged RNA virus closely resembles natural Zika virus genetically, containing the entire RNA genome of the ZIKV 2007 strain. The AccuSpan Zika Linearity Panel allows for assessment of the dynamic ranges of Zika PCR-based assays and the AccuPlex Zika RNA Reference Material, targeted to 1,000 copies/mL, serves as a positive reference material. These two products combined provide essential tools to validate and monitor Zika assays used for screening plasma, urine, and semen.

Dr. Hisham Greiss, Director of the Fertility and Cryogenics Lab, located in Illinois, utilized the AccuPlex Zika materials to validate the Hologic Aptima® Zika Virus Assay for screening of semen samples. “I have very valuable samples in my fertility lab, therefore I chose the AccuPlex recombinant virus technology as a safer and suitable material to be used within my lab. I would not want the potential risk of exposure using a high titer Zika virus in a heat or chemically treated format. The AccuPlex recombinant virus was easy to use, performed as a patient sample, and supported the validation for my method.”

“The AccuPlex recombinant technology provides a valuable option to fast-track the development, validation, and implementation of molecular tests against pathogenic DNA or RNA viruses in multiple matrices,” said Dr. Russell Garlick, CSO, SeraCare. “SeraCare is honored to collaborate with Dr. Greiss on this new application and delighted the AccuPlex Zika reference material performed to specification for screening semen samples.”

High specificity and sensitivity Zika diagnostic tests will enable clinicians to quickly and accurately diagnose Zika infection. Transmission of Zika Virus is primarily mosquito-borne, but sexual transmission has also been reported. Zika virus has been detected in semen up to 188 days post-infection and an infected mother has an increased risk of delivering babies with fetal microcephaly and other congenital brain abnormalities.