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Dx Focus Mar 24, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News

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Qiagen last week announced that its second-generation hepatitis C real-time PCR test, the careHCV RT-PCR kit v2, has received approval from the State Food and Drug Administration of China for HCV detection and viral load analysis.

The test is based on Qiagen's sample and molecular assay technologies and manufactured by the company's Shenzhen subsidiary.

Qiagen said that the careHCV RT-PCR Kit v2 offers several advantages over existing testing and monitoring technologies, including an internal control for result validation and detection of all key HCV subtypes.

In addition, Qiagen said that it is the first locally manufactured PCR test that can be used in conjunction with automated sample technology products, such as Qiagen's QIAcube.


Abbott this week announced that it has received the CE Mark for RealTime HIV-1, a new qualitative PCR-based HIV-1 test for dried blood spot and plasma specimens.

The new assay is performed on Abbott's automated, high-throughput m2000 system, and detects both DNA and RNA from HIV-1. Abbott said that DBS samples are more convenient for testing infants because only a small volume of sample is needed and the sample remains stable under various environmental conditions.

The assay will be available for diagnostic laboratories and supplied to non-governmental organizations and health agencies collaborating with the Ministries of Health in countries most affected by the HIV-1 epidemic, Abbott said.


Asuragen this week said that it has received the CE Mark for its AmplideX FMR1 PCR kit for detecting CGG repeats in the fragile X mental retardation gene; and has commercially launched the test in Europe.

The AmplideX FMR1 PCR Kit is used as an aid in diagnosing fragile X syndrome and associated disorders, such as fragile X-associated primary ovarian insufficiency and fragile X-associated tremor/ataxia syndrome.

The kit provides a high-throughput PCR and capillary electrophoresis analysis workflow that can accurately resolve sample zygosity and reproducibly detect the full range of full mutation alleles in a single reaction. These assay capabilities reduce the need for Southern blot testing to 2 percent or less of all samples, the company said.

The Scan

Investigators Find Shared, Distinct Genetic Contributors to Childhood Hodgkin Lymphoma

An association study in JAMA Network Open uncovers risk variants within and beyond the human leukocyte antigen locus.

Transcriptomic, Epigenetic Study Appears to Explain Anti-Viral Effects of TB Vaccine

Researchers report in Science Advances on an interferon signature and long-term shifts in monocyte cell DNA methylation in Bacille Calmette-Guérin-vaccinated infant samples.

DNA Storage Method Taps Into Gene Editing Technology

With a dual-plasmid system informed by gene editing, researchers re-wrote DNA sequences in E. coli to store Charles Dickens prose over hundreds of generations, as they recount in Science Advances.

Researchers Model Microbiome Dynamics in Effort to Understand Chronic Human Conditions

Investigators demonstrate in PLOS Computational Biology a computational method for following microbiome dynamics in the absence of longitudinally collected samples.