Controls Developed for Molecular Diagnosis of RNA Viruses

RNA controls were developed for sample preparation and assay performance in viral RNA testing. The coat protein of Escherichia coli bacteriophage MS2 was used to package RNA fragments, encoding target-specific viral sequences such as Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV).

Dubbed armored RNA controls, the packaged RNA fragments are stable and ribonuclease-resistant in plasma and other matrices. The armored RNA is compatible with any RNA-based clinical assay after sample extraction. If the target RNA is degraded, or if enzymatic inhibitors are co-purified with the target RNA, then a lower than expected result will be obtained for the control RNA, alerting laboratory personnel to a potential problem.

Asuragen, Inc., (Austin, TX, USA), a RNA-based therapeutics and diagnostics company, developed armored RNA technology together with Cenetron Diagnostics (Austin, TX, USA), a clinical reference laboratory.

Asuragen recently released armored RNA Quant, the next generation of quantitative standards. Armored RNA Quant contains a precisely quantified copy number of a specific target, and it is referenced to a [U.S.] National Institute of Standards & Technology (NIST; Gaithersburg, MD, USA) traceable phosphate standard. Armored RNA Quant can be used to construct standard curves for quantitation and as an internal quantitative sample calibrator for infectious disease and oncology testing.

Asuragen has granted Focus Diagnostics (Cypress, CA, USA) nonexclusive worldwide rights to incorporate armored RNA technology into its in vitro molecular diagnostics products. Under the terms of the agreement, Asragen will develop and supply reagents for Focus Diagnostics in Asuragen's manufacturing facility.

Related Links:
Asuragen
Cenetron Diagnostics
National Institute of Standards & Technology
Focus Diagnostics