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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Feb 10, 2011


Roche said last week that the Cobas TaqScreen DPX test for use on the Cobas S 201 system is now available in the US.

Cobas TaqScreen DPX is the first commercial test to quantify parvovirus B19 and detect hepatitis A virus simultaneously in one assay in human plasma, Roche said.

Both parvovirus B19 and HAV are difficult to inactivate by traditional methods used by the plasma industry, and there have been reports on the transmission of the viruses through blood and plasma products, Roche said.

The newly available test uses multi-dye, real-time PCR-based technology that offers complete coverage of all human genotypes of parvovirus B19 (genotypes 1, 2, and 3 DNA) and HAV (genotypes I, II, and III DNA) in human plasma.

Roche said that the test allows for simultaneous detection and identification of individual viral targets without the use of additional discriminatory tests. The company also noted that the test facilitates quantification of parvovirus B19 while detecting extremely low levels of HAV.

BlackBio said this week that its BlackLight Fungal ID kit has received the CE IVD Mark.

BlackLight Fungal ID allows the detection and identification of the most clinically relevant fungi and yeast species, Candida and Aspergillus, by microsequencing. These species are responsible for about 95 percent of all invasive fungal diseases characterized by a high mortality rate of 30 to 40 percent, BlackBio said.

The kit uses a gelified PCR format designed specifically for high performance in pyrosequencing or any other PCR method for large-scale fungal and yeast identification, as well as for other procedures that require high PCR performance without using a hot-start effect, the company said.

In addition, the kit increases the quality of pyrosequencing, PCR, or other DNA synthesis procedures, BlackBio said.

The company said that the kit minimizes handling and can be performed in less than four hours.

The Scan

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University of Utah researchers report in Nature Communications on their development of brain cell organoids to study SHANK3-related autism.

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.