Posters & Publications

Discover our posters, publications, and articles

Available here is a selection of our recently published posters from our library of publications.

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B. pertussis / parapertussis

C. difficile


Flu A/B & RSV

Group A Streptococcus

Group B Streptococcus

HSV 1&2



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.”

Siu-Kei Chow, Mark G. M. Go, Jennifer A. Herres, Kirstie R. Hinson, Troy A. Pero, Gwyn A. Peterson, Susanna T. Reed, Craig L. Stevig, Melissa L. Thompson and Rhonda A. Warren Download PDF

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.

Matthew England, Patrick Erdman and Wallace Greene Download PDF

C. difficile: Clostridium difficile Toxin Testing in a Pediatric Population (ASM 2019)

“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.”

Chairut Vareechon, U. Pandey, V. Anand, S. Butler-Wu, J. Dien Bard Download PDF

C. difficile: Clinical and Analytical Performance of a New Molecular C. difficile Direct Assay (CVS 2017)

“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.”

L. Geller, C. Austria, B. Yu, S. Penilla, C. Timmerman, S. McCloud, Y. Parocua, A. Bologa and M. Tabb Download PDF

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.

J. Snyder and G. Thomson Download PDF

C. difficile: Performance Comparison of the DiaSorin Simplexa® C. difficile Direct Assay With the illumigene® C. difficile DNA Amplification Assay in Unformed Stool Samples (AMP 2017)

“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.”

E. Rowell, Q. Vu, K. Maggert , K. Gonzalez, M. Tabb, and B. Sutton Download PDF

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.”

Ian Harrold and Wallace Greene Download PDF

Bordetella: Comparison of Molecular Assays for the Diagnosis of Pertussis (IDWeek 2018)

“…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…”

JA Otiso, SA Vogel, GW Procop, SS Richter Download PDF

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.”

Tong Her and Ted Schutzbank Download PDF

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)”
Emily Dault, Anne Prada, and Bobby Boyanton Jr. Download PDF

Bordetella: Use of new FDA-approved Assay for improved detection of Bordetella pertussis and Bordetella parapertussis leading to improved turn around time in diagnosis. (ASM 2019)

“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.”

Jyotsna Bhattacharya, MD, David Goldman, MD, Stacia Semple, MD, Shaomin Hu, MD-PhD, Wendy A. Szymczak, PhD, Michael H. Levi, ScD Download PDF

COVID-19: Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens

“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”.

Wei Zhen, Ryhana Manji, Elizabeth Smith, Gregory J. Berry Download PDF

COVID-19: Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay

“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.”


Licia Bordi, Giuseppe Sberna, Eleonora Lalle, Pierluca Piselli, Francesca Colavita, Emanuele Nicastri, Andrea Antinori, Evangelo Boumis, Nicola Petrosillo, Luisa Marchioni, Giulia Minnucci, Elena D’Agostini, Concetta Castilletti, Franco Locatelli, Alimuddin Zumla, Giuseppe Ippolito, Maria Rosaria Capobianchi Download PDF

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.”

Laura Schindler, Karen Campbell, Sabrena Garr, Julio Ramirez & James T. Summersgill Download PDF

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.”

Patel A, Infield J, Patel C, Smith C, Greene K, and Davis J Download PDF

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.”

Cindy Cheng, Raymond Huang, Heather Gregson, Betsabe Torres, Michelle Tabb Download PDF

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.”

Heather Gregson, Cindy Cheng, Brian Yu, Ishfaq Maksud, Louis Geller and Michelle Tabb Download PDF

Group B Strep: Evaluation of the Simplexa and Illumigene Assays for Detection of Group B Streptococcus (ASM 2019)

“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.”

M.D. Lehman, S. E. Sefers, P. J. Foster, T. E. East, J. E. Schmitz, and C. W. Stratton Download PDF

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.”

Tam T. Van, Maryann Lustestica, Brian Bowland, Jennifer Dien Bard Download PDF

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.”

Wallace Greene, Grace Weyant Download PDF

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”

Scott McClellan Download PDF

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.”

Butt, S.A., Nattanmai, S.M., Nano, B. & Stellrecht, K.A Download PDF

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.”

Jane Kuypers, Gregory Boughton, Jina Chung, Lindsay Hussey, Meei-Li Huang, Linda Cook, Keith R. Jerome Download PDF

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.”

Mark Espy, Cole Irish, Matthew Binnicker Download PDF

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.”

Jules Chen, Yuan Xie, Yvette Parocua, Louis Geller, James Borgeson, Nellie Wilcox, Brian Yu, Dipesh Jaiswal and Michelle Tabb Download PDF

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.”

Mike Eltringham, Tim Peterson, Kathy Everhart, Doug Salamon, Amy Leber Download PDF

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.”

K. Gvozdjan, A. Harrington Download PDF

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.”

R.L. Hodinka Download PDF

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.”

Lisa Tingley, Monica Raposo, April M Bobenchik, Kimberle C. Chapin Download PDF

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.”

E. Eleazar, A. Bologa, J. Hugo, M. Garcia, S. Penilla, L. Geller, E. Alvarado, M. Xie, R. Huang, L. Plascencia, A.T. Tran Ha, M. Tabb & W. Lindsey Download PDF

VZV: Evaluation of the DiaSorin Molecular Simplexa VZV Direct Assay for Direct Detection of Varicella Zoster Virus in Cerebrospinal Fluid in Adult and Pediatric Populations (ASM 2019)

“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.”

Priyanka Uprety, Johnathan P. Belman, Kevin Alby, Laurel Glaser Download PDF

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DiaSorin Molecular Event Center provides high quality Continuing Education programs for laboratory professionals. Our Web-based educational seminars are designed to present current, relevant information on a number of infectious disease and other related topics. Speakers are selected for their expertise in laboratory diagnostics and excellent presentation skills.