Single IntelligentMD PCR Reagent Test Demonstrates Clinical Equivalence to Standard Practice Across Several Methods of Detection
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IntelligentMD’s INF-A PCR reagent test demonstrated, in a simple, single-test format, 100 percent clinical equivalence to classification of a 95- patient reference set, based on standard clinical practice using DFA/culture after presumptive clinical diagnosis.
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Clinical Validation of IntelligentMD’s Influenza- PCR Reagent Test for the 2006-2007 Season
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A third-party evaluation of IntelligentMD PCR reagent tests designed by PriMD software demonstrated the ability to detect currently circulating INF-A strains and sensitivity equivalent to gold standard methods.
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Clinical Validation of IntelligentMD’s Herpes Simplex Virus PCR Reagent Test
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Brigham and Women’s Hospital compared the incidence rate of HSV in 100+ clinical samples using their standard culture methodology to a TaqMan assay designed by Intelligent Medical Devices’ cutting-edge bioinformatics system, PriMD. Only three samples showed discordant results. Additional testing of these samples by other methods reconfirmed the original TaqMan results.
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Clinical Validation of Intelligent Medical Devices’ PCR Reagent Test for Influenza A at University of Virginia Health System
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Both IMD’s and Cepheid’s nucleic-acid based tests delivered excellent results. The primers and probes designed by PriMD were equiva¬lent to those from Cepheid in clinical perfor¬mance and required less amplification. These findings are in line with previous clinical stud¬ies performed at the University of Alabama and at IMD
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Clinical Validation of IntelligentMD’s Herpes Simplex Virus PCR Reagents
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NYS Lab investigated the incidence rate and type of HSV in 115 archived clinical CSF samples using TaqMan typing and non-typing reagents designed by IMD’s cutting-edge bioinformatics system, PriMD. Test results from both IMD applica¬tions showed 100% concordance compared to results from the CLEP-validated TaqMan method currently used by NYS Lab.
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Clinical Validation of IntelligentMD’s Herpes Simplex Virus PCR Typing Reagents on Swab Samples at The Brigham and Women’s Hospital
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The Brigham and Women’s Hospital compared the incidence rate of HSV-1 and HSV-2 in 105 clinical samples using their standard culture methodology to a duplex TaqMan HSV typing assay designed by Intelligent Medical Devices’ cutting-edge bioinformatics system, PriMD. The sensitivity and specificity of the HSV-1 and HSV-2 reagents were found to be 96% or greater, with only four samples showing discordant results. This finding can be explained by TaqMan’s higher sensitivity, enabling it to detect more positive clinical samples. Three of the four discordant results were reconfirmed with additional testing at BWH and IMD and matched previous results at BWH and IMD using the HSV non-typing reagents that target a different gene region. Of interest, the remaining discordant sample was a new, as yet undescribed HSV-1 sequence variant.
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