PositiveID Corp., a developer of medical technologies for diabetes management, clinical diagnostics and bio-threat detection, announced today that the US Department of Homeland Security Science and Technologies Division has validated the performance of the recently launched Multiplex Bio Threat Assay (PSIDMBA) through an in-house blind study that took place over a year in a major east coast US City.
Intended for investigative and research use, the PSIDMBA offers rapid, accurate and efficient multiple organism identification in a cost-effective manner. Currently available methods require up to 16 times more sample, are more costly per signature and are not amenable to high-throughput analyses. The PSIDMBA assay is designed to provide test results for up to six organisms in the time of a single polymerase chain reaction (i.e. 30 to 90 minutes), versus the several hours or more required to test multiple samples with conventional methods. The PSIDMBA is also the first commercially available Multiple BioThreat Assay for the detection of up to six bio-threat organisms on the A and B lists of the CDC. The test is also fully customizable to meet specific customer needs and is the first in a series of environmental and food pathogen assays expected to be made available.
A blind assay validation study was successfully completed through DHS with more than 150 competing natural occurring strains, near-neighbors, and environmental samples. Samples were tested in triplicate with 100% agreement being achieved for all positives and negatives at a limit of detection which is equivalent or better than similar assays performed in a singleplex format.
“Having worked in the field of biodefense and assay development for the last 10 years, I believe the PSIDMBA achieves better performance and higher cost savings than any other assay currently on the market. In order to assess the assay’s ability to detect unknown samples, our team challenged it in triplicate against a series of blind samples provided by DHS. Our results indicate that the multiplex assay was strain specific and produced no false positives or negatives when challenged within house gDNA collections and DHS provided panels. Also, these results were achieved with a limit of detection that is state-of-the-art and equivalent or better than those achieved with in singleplex fashion,” Lyle Probst, Senior Director of Programs at MFS, and co-developer of the assay said in a press release on Thursday.
For more information the PSIDMBA, visit www.psidmba.com
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