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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.
“A reverse two-step algorithm (PCR + EIA) would have lowered the CDI rate by 13.9%.”
“A single step algorithm (PCR+) correctly identified 11 patients who are at risk for developing severe/fulminant CDI.”
“Clinical presentation along with a single step molecular algorithm is most appropriate in diagnosing CDI in our pediatric population.”
“The Simplexa® C. difficile Direct kit and LIAISON® MDx from DiaSorin Molecular provide sample-to answer detection of Clostridium difficile from unextracted liquid or unformed stool in approximately one hour, with a simple workflow.”
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.
“Overall percent agreement of Simplexa® C. difficile Direct with Illumigene was 98%.”
“Illumigene assay showed higher False Negative Rate (6%) compared to Simplexa Direct (2%).”
“Workflow evaluation showed shorter total turnaround time ( ~10 min.) for the Simplexa® assay versus illumigene® assay when testing 8 samples.”
“Simplexa™ is able to detect B. pertussis and B. parapertussis.”
“Simplexa™ PCR Assay demonstrated equal or greater sensitivity compared to AmpliVue® Helicase assay.”
“…the Simplexa™ Bordetella Direct assay required less hands on time and provided detection of more specimens containing B. pertussis.”
“The Simplexa™ Bordetella Direct assay was also able to detect one B. parapertussis specimen which was not possible with the AmpliVue Bordetella 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:
“Nearly 100% of samples took less than a day to report after implementation of the FDA-approved assay.”
“This new FDA-approved assay is accurate, reproducible and exhibits a low limit of detection, is simple to run 7 days a week, and provides an easier format compared to the in-house LDT.”
“DiaSorin Molecular had the lowest LoD (39 ± 23 copies/mL).”
“the DiaSorin… assay had 100% PPA and detected all specimens deemed positive by the consensus standard (interpretation of three of four evaluated assays as “gold standard”)”.
“DiaSorin Molecular… showed 100% NPA”.
“Using Simplexa™ COVID-19 Direct on Oral Fluid (OF) matrix, 100% analytical detection down to 1 TCID50/mL (corresponding to 4 x 103 copies (cp)/mL) was observed.”
“Parallel testing of 337 OF and NPS samples showed highly concordant results (k = 0.831; 95 % CI = 0.771–0.891), and high correlation of Ct values (r = 0.921; p < 0.0001). High concordance and elevated correlation was observed also between OF and BAL.”
“Simplexa™ COVID-19 Direct assays on OF have high sensitivity and specificity to detect SARS-CoV-2 RNA and provide an alternative to NPS for diagnosis and monitoring SARS-CoV-2 shedding.”
“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.”
“There are fewer steps in the Simplexa assay as compared to the illumigene assay. This reduces the risks of cross-contamination and opportunities for technologists errors.”
“The Simplexa assay has significant reductions in both hands-on time and total-turn-around time compared to the illumigene assay. The reduction in hands-on time allows technologists more time to complete other tasks and a higher volume of samples to be tested.”
“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.”
“Our data shows that the DiaSorin Molecular Simplexa™ VZV Direct assay for direct detection of VZV DNA in CSF has excellent performance characteristics for clinical testing.”
“During this study period, the majority of patients only required HSV and VZV testing and this assay represents a good alternative for targeted detection of VZV in the CSF of both adult and pediatric population.”
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