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B. pertussis / parapertussis
C. difficile
COVID-19
Flu A/B & RSV
Group A Streptococcus
Group B Streptococcus
HSV 1&2
VZV
“…Simplexa™ C. difficile Direct can reduce TAT For diagnosis.”
“Sensitivity 97.1% | Specificity 100%”
“The New Simplexa™ C. difficile Direct assay is comparable to commercial PCR assays available for diagnosing C. difficile infection.”
Overall, Simplexa™ was more sensitive than illumigene™. Simplexa™ is a sensitive and simple method to detect the presence of C. difficile in stool.
We demonstrated that the Simplexa™ C. difficile Direct assay is a rapid and reliable method for confirmatory testing in laboratories that follow a two-step testing algorithm.
“Simplexa™ is able to detect B. pertussis and B. parapertussis.”
“Simplexa™ PCR Assay demonstrated equal or greater sensitivity compared to AmpliVue® Helicase assay.”
“A major advantage of the LIAISON® MDX method is the elimination of all upfront sample processing steps, significantly decreasing hands-on time, and greatly enhancing workflow, resulting in decreased turnaround time to a final result.”
“Both testing platforms provided results in approximately 1hr 15 min.”
“Simplexa™ was superior to illumigene in the following aspects:
“The SM assay detected 4 additional Influenza A positive NS specimens than the other three POC tests, and the non-POC LX test.”
“The SIRD Assay demonstrated a high level of reproducibility of Influenza A, Influenza B, and RSV at low and mid level viral concentrations…”
“The SIRD Assay performed well compared against the reference PCR method for Influenza A/B and RSV detection showing a sensitivity rate above 94.3% and NPV above 90.0% for each viral target.”
“The Simplexa™ Direct assay had >95% positive and negative agreement with conventional culture assay.”
“LoDs of the Simplexa™ Direct assay were 10 CFU per reaction for M1 strain and 50 CFU per reaction for M3 strain.”
“All analytical reactivity strains were detected by the Simplexa Direct Assay.”
“Limit of detection of the Simplexa™ Direct assay was 20 CFU per reaction.”
“Reproducibility of the Simplexa™ Direct assay was good (CV <2.3%).”
“No interference with other substances was observed.”
“The more rapid TAT of dHSV impacted patient care and management with the exclusion of HSV infection resulting in a reduction in the duration of potentially unnecessary acyclovir therapy.”
“The Simplexa™ assay had greater sensitivity, however it requires the use of a thermocycler, can test up to 8 samples at a time, and is FDA cleared for genital lesions and CSF.”
“Excellent sensitivity and precision”
“Comparable clinical performance allows space, cost and specimen volume to factor into platform decision”
“…the sensitivity and specificity were 100% and 100% for any HSV detected for Simplexa™ and Aries.”
“Commercial Real-time PCR systems offer enhanced workflow and significantly reduced time to results as compared with the TOR and other commercial methods.”
“Compared to our LDTs, which require several hours for nucleic acid extraction and PCR amplification, Simplexa™ HSV 1 & 2 Direct, which provides results in ~ 1 hour, will allow for more rapid antiviral treatment and patient management.”
“The [DiaSorin Molecular] HSV-1/2 Direct assay offers a sensitive and specific means of detecting HSV-1/2 directly from 50 μL CSF and provides a rapid (~65 min) turnaround time of results.”
“Simplexa™ HSV 1 & 2 Direct is a simple and rapid molecular test. Simplexa™ HSV 1 & 2 Direct provides answers in ~60 minutes, without requiring a separate extraction step.”
“Due to its ease of use, time to result and comparable performance to our well defined LDA, the Simplexa™ HSV-1&2 Direct test would be a reasonable addition to the molecular test menu especially for laboratories that currently send samples to a reference lab for HSV testing.”
“The Simplexa™ HSV 1 & 2 Direct assay demonstrated high specificity, sensitivity, and reproducibility in detection of the four HSV strains.”
“The results may be reported within a few hours of collection and therefore facilitate prompt decision making regarding patient treatment and discharge from the hospital.”
“The Simplexa™ HSV 1 & 2 Direct kit showed excellent sensitivity and specificity for the direct detection and differentiation of HSV-1 and HSV-2 from unprocessed skin and oral and genital mucosal specimens when compared to reference molecular tests on extracted specimen materials.”
“This platform offers complete specimen-to-result automation and has the distinct advantages of being rapid and extremely user-friendly.”
“Sample and reagent volumes are standardized to 50 μl each.”
“Any number of one to eight samples can be run in batch without was/ng reagents or consumables, and the instrument footprint is <1 square foot.”
“95% agreement with viral cultue/ DFA for both ARIES and Simplexa™.”
“98% Agreement with viral culture/ DFA for non-genital specimens.”
“The Simplexa™ VZV Direct kit demonstrated excellent assay performance in all analytical studies performed based on ~2X LoD of the VZV Ellen (LoD = 1,505 copies/mL) and VZV 9939 (LoD = 1,614 copies/mL) strains.”