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Dx Focus Aug 5, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Life Technologies this week launched the MicroSEQ E. coli O157:H7 assay, and said that the test has secured Performance Tested Methods certification from the AOAC Research Institute for detecting bacteria in the food supply.

Based on Life Tech's real-time PCR technology, the MicroSEQ E. coli test is highly specific and sensitive and can be run in as little as eight hours, the company said.

The assay joins Life Tech's portfolio of MicroSEQ kits designed to detect pathogens that contaminate the food supply, including kits for Salmonella, Listeria monocytogenes, and Listeria spp.

BD Diagnostics, a segment of Becton Dickinson, said this week that its BD MAX GBS assay for Group B Streptococcus on the BD MAX system has received "moderate complexity" designation from the US Food and Drug Administration under the Clinical Laboratory Improvement Amendments act.

BD said that the new designation will increase access to cost-effective molecular testing for a wide range of laboratories performing GBS screening.

The BD MAX GBS assay is the only fully automated PCR method using Lim broth, which provide a high level of sensitivity and rapid results for detecting GBS, BD said. The test is also the first offering in a "broad menu of infectious disease tests under development" for BD MAX, the company said.

The Scan

Call to Look Again

More than a dozen researchers penned a letter in Science saying a previous investigation into the origin of SARS-CoV-2 did not give theories equal consideration.

Not Always Trusted

In a new poll, slightly more than half of US adults have a great deal or quite a lot of trust in the Centers for Disease Control and Prevention, the Hill reports.

Identified Decades Later

A genetic genealogy approach has identified "Christy Crystal Creek," the New York Times reports.

Science Papers Report on Splicing Enhancer, Point of Care Test for Sexual Transmitted Disease

In Science this week: a novel RNA structural element that acts as a splicing enhancer, and more.