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ARIES® System Provides Excellent Sensitivity and Specificity for HSV 1&2 Testing

May 11th, 2017 / Anjana Bhattacharya, Ph. D.

Mayo Clinic study compares ARIES® HSV 1&2 Assay with Roche and Hologic assays/platforms

A new publication from scientists at the Mayo Clinic reports results of the first comparison of three automated molecular diagnostic platforms for detecting and differentiating herpes simplex virus types 1 and 2. We were pleased to see that the ARIES® System was included and delivered the best combination of sensitivity and specificity.

ARIES® System Provides Excellent Sensitivity and Specificity for HSV1&2 Testing

Automated processing, extraction, and detection of herpes simplex virus types 1 and 2: A comparative evaluation of three commercial platforms using clinical specimens” was published in the Journal of Clinical Virology by lead author, Dr. Matthew Binnicker (Director of Clinical Virology at Mayo Clinic) and collaborators. The study was inspired by Mayo’s high-capacity reference lab, which received more than 30,000 samples for HSV 1&2 testing in 2015 alone. The authors note that molecular testing has shown many advantages compared to conventional tests, such as viral cell culture and serology, but until recently, it involved different processes for sample extraction and detection. “The necessity for manual intervention during the testing process increases the risk of errors, especially in high volume diagnostic laboratories,” Binnicker et al. write.

“This high testing volume prompted us to evaluate the performance of three new, commercial assays/platforms … designed for automated processing and qualitative detection of HSV-1/2 nucleic acid,” they add. “To our knowledge, this is the first study to evaluate the recently FDA-cleared cobas and ARIES® HSV-1/2 assays, and the first report to directly compare the Aptima, ARIES®, and cobas assays to a consensus reference standard.”

For the evaluation, the group analyzed 277 clinical specimens on all three automated platforms, comparing the results to routine HSV 1&2 testing with real-time PCR through a laboratory-developed test. The results of all four assays were combined to create a rigorous consensus standard to which each platform was compared. That was important, according to the scientists, because comparisons to viral culture tend to underestimate the specificity achieved in molecular tests.

The authors determined that the ARIES® HSV 1&2 Assay “showed 100% sensitivity and 99.5% specificity.” They also noted that the ARIES® System “requires minimal hands-on time per test (~ 20 min/24 samples).” Binnicker et al. conclude that automated testing platforms streamline the workflow and help reduce errors from manual sample processing.

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