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Posters
C. difficile: Comparison of Simplexa™ C. difficile Direct Assay and BD MAX® Cdiff Assay For Identification of Clostridium difficile (ASM 2017)
“…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.”
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Posters
C. difficile: Evaluation of Two Molecular Assays for the Detection of Clostridium difficile (ASM 2017)
Overall, Simplexa™ was more sensitive than illumigene™. Simplexa™ is a sensitive and simple method to detect the presence of C. difficile in stool.
Posters
C. difficile: Performance comparison and evaluation of the Simplexa™ C. difficile Direct test for the laboratory diagnosis of C. difficile in liquid stool specimens (CVS 2017)
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.
Posters
Bordetella: Comparison of a novel PCR assay for Bordetella pertussis detection with a Helicase Based Assay (ASM 2018)
“Simplexa™ is able to detect B. pertussis and B. parapertussis.”
“Simplexa™ PCR Assay demonstrated equal or greater sensitivity compared to AmpliVue® Helicase assay.”
Posters
Bordetella: Evaluation of DiaSorin Molecular Simplexa™ Bordetella Real-Time Sample-to-Result PCR Test on the LIAISON® MDX System (AMP 2018)
“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.”
Posters
Bordetella: Performance and Workflow Comparison of Simplexa Bordetella Direct with illumigene Pertussis (AMP 2018)
“Both testing platforms provided results in approximately 1hr 15 min.”
“Simplexa™ was superior to illumigene in the following aspects:
- Overall Test Performance
- Fewer Procedural Steps
- Hands-on-Time per Sample
- Walk-away-Time per Sample
- Multiplexing Capability – Simultaneous Reporting (B. pertussis and B. parapertussis)”
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Posters
Flu A/B & RSV: Comparison of Xpert Flu®, FilmArray RVP®, Simplexa™ Flu A/B & RSV and Luminex RVP® for Diagnosis of Viral Lower Respiratory Tract Infection (ECCMID 2013)
“The SM assay detected 4 additional Influenza A positive NS specimens than the other three POC tests, and the non-POC LX test.”
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Posters
Flu A/B & RSV: Evaluation of Simplexa™ Flu A/B & RSV Direct assay for detection of influenza and respiratory syncytial virus (CVS 2013)
“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.”
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Posters
Group A Strep: Detection of Streptococcus Pyogenes Using the Simplexa™ Group A Strep Direct Assay (AMP 2014)
“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.”
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Posters
Group A Strep: Rapid Detection of Streptococcus pyogenes Using the Simplexa™ Group A Strep Direct Assay (AMP 2015)
“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.”
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Posters
HSV 1 & 2: Availability of 24/7 Rapid HSV PCR Test Directly Impacts Acyclovir Exposure in Pediatric Patients (ECCMID 2016)
“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.”
Posters
HSV 1 & 2: Comparative Study of Simplexa™ HSV 1&2 Direct with AmpliVue® HSV 1+2 Assay (CVS 2016)
“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.”
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Posters
HSV 1 & 2: Comparison of 3 Molecular Assays for the Detection of HSV 1 and 2 from Genital and Non-genital Lesion Specimens (CVS 2016)
“Excellent sensitivity and precision”
“Comparable clinical performance allows space, cost and specimen volume to factor into platform decision”
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Posters
HSV 1 & 2: Comparison of ARIES® HSV 1&2 Assay, Simplexa™ HSV 1 & 2 Direct and a Real-Time PCR Lab Developed Test for the Detection of HSV from Lesions (CVS 2017)
“…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.”
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Posters
HSV 1 & 2: Comparison of the Simplexa™ HSV 1 & 2 Direct Kit and Laboratory-Developed Real-time PCR Assays for Herpes Simplex Virus Detection (CVS 2014)
“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.”
Posters
HSV 1 & 2: Comparison of Three Laboratory Protocols for the Detection of Herpes Simplex Virus in Low Volume Cerebrospinal Fluid Specimens (CVS 2015)
“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.”
Posters
HSV 1 & 2: CSF Sample-to Answer Validation Studies Using Focus Diagnostics’ Simplexa™ HSV 1 & 2 Direct Assay (ECCMID 2014)
“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.”
Posters
HSV 1 & 2: Detection of HSV in CSF using the Focus Diagnostics Simplexa™ HSV 1 & 2 Direct Sample-to-Answer Real-time PCR Assay (CVS 2014)
“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.”
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Posters
HSV 1 & 2: Evaluation of the Focus Diagnostics Simplexa™ HSV 1 & 2 Direct for Detection and Differentiation of Herpes Simplex Virus 1 and 2 in Neonatal Swab Specimens (AMP 2017)
“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.”
Posters
HSV 1 & 2: Multicenter Evaluation of the Simplexa™ HSV 1 & 2 Direct Assay for Detection of Herpes Simplex Virus Types 1 and 2 from Unprocessed Cutaneous and Mucosal Specimens (CVS 2016)
“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.”
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HSV 1 & 2: Performance Comparison and Workflow Evaluation of Simplexa™ HSV 1 & 2 Direct and Aries HSV 1 & 2 Assay for the Detection of HSV 1 & 2 in Genital and Non-genital Specimens (CVS 2016)
“95% agreement with viral cultue/ DFA for both ARIES and Simplexa™.”
“98% Agreement with viral culture/ DFA for non-genital specimens.”
Posters
VZV: Evaluation of a VZV Molecular Assay and Its Comparison to a VZV Analyte Specific Reagent (CVS 2019)
“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.”
