4.6 Article

Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus

Journal

PLOS ONE
Volume 10, Issue 11, Pages -

Publisher

PUBLIC LIBRARY SCIENCE
DOI: 10.1371/journal.pone.0142216

Keywords

-

Funding

  1. Bill and Melinda Gates Foundation
  2. Paul Allen Family Foundation
  3. U.S. Department of Energy by Lawrence Livermore National Laboratory [DE-AC52-07NA27344]

Ask authors/readers for more resources

Background The recently developed Xpert (R) Ebola Assay is a novel nucleic acid amplification test for simplified detection of Ebola virus (EBOV) in whole blood and buccal swab samples. The assay targets sequences in two EBOV genes, lowering the risk for new variants to escape detection in the test. The objective of this report is to present analytical characteristics of the Xpert (R) Ebola Assay on whole blood samples. Methods and Findings This study evaluated the assay's analytical sensitivity, analytical specificity, inclusivity and exclusivity performance in whole blood specimens. EBOV RNA, inactivated EBOV, and infectious EBOV were used as targets. The dynamic range of the assay, the inactivation of virus, and specimen stability were also evaluated. The lower limit of detection (LoD) for the assay using inactivated virus was estimated to be 73 copies/mL (95% CI: 51-97 copies/mL). The LoD for infectious virus was estimated to be 1 plaque-forming unit/mL, and for RNA to be 232 copies/mL (95% CI 163-302 copies/mL). The assay correctly identified five different Ebola viruses, Yambuku-Mayinga, Makona-C07, Yambuku-Ecran, Gabon-Ilembe, and Kikwit-956210, and correctly excluded all non-EBOV isolates tested. The conditions used by Xpert (R) Ebola for inactivation of infectious virus reduced EBOV titer by >= 6 logs. Conclusion In summary, we found the Xpert (R) Ebola Assay to have high analytical sensitivity and specificity for the detection of EBOV in whole blood. It offers ease of use, fast turnaround time, and remote monitoring. The test has an efficient viral inactivation protocol, fulfills inclusivity and exclusivity criteria, and has specimen stability characteristics consistent with the need for decentralized testing. The simplicity of the assay should enable testing in a wide variety of laboratory settings, including remote laboratories that are not capable of performing highly complex nucleic acid amplification tests, and during outbreaks where time to detection is critical.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.6
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

Article Emergency Medicine

SARS-CoV-2 IgG Seropositivity and Acute Asymptomatic Infection Rate among Firefighter First Responders in an Early Outbreak County in California

Jennifer A. Newberry, Marc Gautreau, Katherine Staats, Eli Carrillo, William Mulkerin, Samuel Yang, Michael A. Kohn, Loretta Matheson, Scott D. Boyd, Benjamin A. Pinsky, Andra L. Blomkalns, Matthew C. Strehlow, Peter A. D'Souza

Summary: The study investigated the seropositivity rate and acute infection rate of SARS-CoV-2 among firefighter first responders in Santa Clara County, California. The results showed a lower seroprevalence rate but a higher cumulative incidence compared to the surrounding community.

PREHOSPITAL EMERGENCY CARE (2022)

Article Medical Laboratory Technology

SARS-CoV-2 Nucleocapsid Plasma Antigen for Diagnosis and Monitoring of COVID-19

Hannah Wang, Catherine A. Hogan, Michelle Verghese, Daniel Solis, Mamdouh Sibai, ChunHong Huang, Katharina Roltgen, Bryan A. Stevens, Fumiko Yamamoto, Malaya K. Sahoo, James Zehnder, Scott D. Boyd, Benjamin A. Pinsky

Summary: This study found that the concentration of nucleocapsid antigen in plasma is associated with the severity of COVID-19, particularly with ICU admission. Antigenemia showed comparable diagnostic performance to upper respiratory NAAT, aiding in triaging patients for optimized intensive care utilization.

CLINICAL CHEMISTRY (2022)

Article Microbiology

Evaluation of a Rapid and Accessible Reverse Transcription-Quantitative PCR Approach for SARS-CoV-2 Variant of Concern Identification

Priscilla S-W Yeung, Hannah Wang, Mamdouh Sibai, Daniel Solis, Fumiko Yamamoto, Naomi Iwai, Becky Jiang, Nathan Hammond, Bernadette Truong, Selamawit Bihon, Suzette Santos, Marilyn Mar, Claire Mai, Kenji O. Mfuh, Jacob A. Miller, ChunHong Huang, Malaya K. Sahoo, James L. Zehnder, Benjamin A. Pinsky

Summary: This study developed and validated an RT-qPCR-based detection method that can accurately distinguish different SARS-CoV-2 variants. The method showed high accuracy in identifying various variants and can be used in clinical laboratories for epidemiological surveillance and clinical decision-making.

JOURNAL OF CLINICAL MICROBIOLOGY (2022)

Letter Virology

Development and evaluation of an RT-qPCR for the identification of the SARS-CoV-2 Omicron variant

Mamdouh Sibai, Hannah Wang, Priscilla S-W Yeung, Malaya K. Sahoo, Daniel Solis, Kenji O. Mfuh, ChunHong Huang, Fumiko Yamamoto, Benjamin A. Pinsky

JOURNAL OF CLINICAL VIROLOGY (2022)

Article Genetics & Heredity

An 8-gene machine learning model improves clinical prediction of severe dengue progression

Yiran E. Liu, Sirle Saul, Aditya Manohar Rao, Makeda Lucretia Robinson, Olga Lucia Agudelo Rojas, Ana Maria Sanz, Michelle Verghese, Daniel Solis, Mamdouh Sibai, Chun Hong Huang, Malaya Kumar Sahoo, Rosa Margarita Gelvez, Nathalia Bueno, Maria Isabel Estupinan Cardenas, Luis Angel Villar Centeno, Elsa Marina Rojas Garrido, Fernando Rosso, Michele Donato, Benjamin A. Pinsky, Shirit Einav, Purvesh Khatri

Summary: The study integrated multiple datasets and developed an XGBoost model based on 8 genes, which accurately predicted the progression of severe dengue. The model performed well in predicting during the early febrile stage.

GENOME MEDICINE (2022)

Article Immunology

A single intranasal dose of human parainfluenza virus type 3-vectored vaccine induces effective antibody and memory T cell response in the lungs and protects hamsters against SARS-CoV-2

Philipp A. Ilinykh, Sivakumar Periasamy, Kai Huang, Natalia A. Kuzmina, Palaniappan Ramanathan, Michelle N. Meyer, Chad E. Mire, Ivan V. Kuzmin, Preeti Bharaj, Jessica R. Endsley, Maria Chikina, Stuart C. Sealfon, Steven G. Widen, Mark A. Endsley, Alexander Bukreyev

Summary: Respiratory tract vaccination induces immune responses at the portal of SARS-CoV-2 entry, including neutralizing antibodies and memory T cell responses, providing advantages against COVID-19.

NPJ VACCINES (2022)

Letter Microbiology

Interepidemic Respiratory Syncytial Virus during the COVID-19 Pandemic

ChunHong Huang, Malaya K. Sahoo, Michelle Verghese, Mamdouh Sibai, Daniel Solis, Kenji O. Mfuh, Jason Kurzer, Catherine A. Hogan, Thuy A. Doan, Benjamin A. Pinsky

MICROBIOLOGY SPECTRUM (2022)

Article Medicine, General & Internal

Characterizing the Severity of SARS-CoV-2 Variants at a Single Pediatric Center

Aslam Khan, Caroline Ichura, Hannah Wang, Izabela Rezende, Malaya K. Sahoo, ChunHong Huang, Daniel Solis, Mamdouh Sibai, Fumiko Yamamoto, Sindiso Nyathi, Bethel Bayrau, Benjamin A. Pinsky, A. Desiree LaBeaud

Summary: This study aimed to characterize the clinical severity and host factors associated with disease by different SARS-CoV-2 variants and evaluate if there are differences in disease severity caused by circulating variants. The results indicated that the delta variant was associated with severe/critical disease compared to other studied variants. The model also revealed that underlying respiratory disease and diabetes were risk factors for progression to severe disease.

FRONTIERS IN MEDICINE (2022)

Article Pharmacology & Pharmacy

Numb-associated kinases are required for SARS-CoV-2 infection and are cellular targets for antiviral strategies

Marwah Karim, Sirle Saul, Luca Ghita, Malaya Kumar Sahoo, Chengjin Ye, Nishank Bhalla, Chieh-Wen Lo, Jing Jin, Jun-Gyu Park, Belen Martinez-Gualda, Michael Patrick East, Gary L. Johnson, Benjamin A. Pinsky, Luis Martinez-Sobrido, Christopher R. M. Asquith, Aarthi Narayanan, Steven De Jonghe, Shirit Einav

Summary: This study investigates the functional relevance of NAKs in SARS-CoV-2 infection and demonstrates that pharmacological inhibition of NAKs can be a potential approach to treat COVID-19.

ANTIVIRAL RESEARCH (2022)

Article Multidisciplinary Sciences

Magnitude and kinetics of the human immune cell response associated with severe dengue progression by single-cell proteomics

Makeda L. Robinson, David R. Glass, Veronica Duran, Olga Lucia Agudelo Rojas, Ana Maria Sanz, Monika Consuegra, Malaya Kumar Sahoo, Felix J. Hartmann, Marc Bosse, Rosa Margarita Gelvez, Nathalia Bueno, Benjamin A. Pinsky, Jose G. Montoya, Holden Maecker, Maria Isabel Estupinan Cardenas, Luis Angel Villar Centeno, Elsa Marina Rojas Garrido, Fernando Rosso, Sean C. Bendall, Shirit Einav

Summary: Approximately 5 million dengue virus-infected patients progress to severe dengue (SD) infection annually. This study reveals uncoordinated immune responses in SD patients and provides insights into SD pathogenesis in humans with potential implications for prediction and treatment.

SCIENCE ADVANCES (2023)

Article Microbiology

Evaluation of a Semiautomated System for the Quantitation of Human Adenovirus DNA from Clinical Samples

Jordan Mah, Chun Hong Huang, Malaya K. Sahoo, Benjamin A. Pinsky

Summary: Human adenoviruses (HAdVs) cause severe disease in immunocompromised patients. Quantitation of HAdV DNA in peripheral blood is used to assess the risk of disseminated disease and to monitor response to therapy. The semiautomated AltoStar adenovirus quantitative PCR provides accurate quantitation of HAdV DNA and is well suited for virological testing following transplantation.

MICROBIOLOGY SPECTRUM (2023)

Article Entomology

The increasing threat of Rift Valley fever virus globalization: strategic guidance for protection and preparation

Seth Gibson, Leela E. Noronha, Heidi Tubbs, Lee W. Cohnstaedt, William C. Wilson, Chad Mire, Dana Mitzel, Assaf Anyamba, Melinda Rostal, Kenneth J. Linthicum, Ary Faraji

Summary: Rift Valley fever virus (RVFV) is a vector-borne zoonotic disease that poses a threat to global agriculture and public health. It can be transmitted by mosquitoes and direct contact with infected tissues. With changing climate and environmental factors, the virus may be introduced to new areas. However, understanding the virus's transmission patterns and evolutionary factors can help reduce the risk of outbreaks.

JOURNAL OF MEDICAL ENTOMOLOGY (2023)

Article Multidisciplinary Sciences

A Lassa virus mRNA vaccine confers protection but does not require neutralizing antibody in a guinea pig model of infection

Adam J. Ronk, Nicole M. Lloyd, Min Zhang, Caroline Atyeo, Hailee R. Perrett, Chad E. Mire, Kathryn M. Hastie, Rogier W. Sanders, Philip J. M. Brouwer, Erica Olmann Saphire, Andrew B. Ward, Thomas G. Ksiazek, Juan Carlos Alvarez Moreno, Harshwardhan M. Thaker, Galit Alter, Sunny Himansu, Andrea Carfi, Alexander Bukreyev

Summary: The study presents an mRNA-based Lassa virus vaccine that provides protection against lethal infection in a guinea pig model without the need for neutralizing antibodies. Vaccination induced strong binding antibody responses and demonstrated the potential of mRNA vaccines as a platform against Lassa virus.

NATURE COMMUNICATIONS (2023)

Article Environmental Sciences

SARS-CoV-2 RNA and N Antigen Quantification via Wastewater at the Campus Level, Building Cluster Level, and Individual-Building Level

Winnie Zambrana, David Catoe, Mhara M. Coffman, Sooyeol Kim, Archana Anand, Daniel Solis, Malaya K. Sahoo, Benjamin A. Pinsky, Ami S. Bhatt, Alexandria B. Boehm, Marlene K. Wolfe

Summary: Monitoring wastewater for SARS-CoV-2 RNA can help identify small spatial areas with COVID-19 infections outside the scope of wastewater treatment plants. This study demonstrates that wastewater monitoring can aid the public health response at the subsewershed level.

ACS ES&T WATER (2022)

Letter Immunology

Vaccine-Associated Measles Encephalitis in Immunocompromised Child, California, USA

Cristina Costales, Malaya K. Sahoo, ChunHong Huang, Carolina V. Guimaraes, Donald Born, Lauren Kushner, Hayley A. Gans, Thuy A. Doan, Benjamin A. Pinsky

Summary: This article reports a fatal case of vaccine-associated measles encephalitis in an immunocompromised child in California, USA. The infection was confirmed by whole-genome RNA sequencing of measles virus from brain tissue. Biased matrix-gene hypermutation consistent with persistent measles virus central nervous system infection was observed.

EMERGING INFECTIOUS DISEASES (2022)

No Data Available