Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection
| Autor: | Robert W. Cross, Brima Kargbo, Krystle N. Agans, Megan L. Heinrich, Erica Ollmann Saphire, Ha Pham, Momoh Gbetuwa, Bethany L. Brown, Matthew L. Boisen, Mambu Momoh, Robert F. Garry, Mohamed Fullah, Sahr M. Gevao, Diana K. S. Nelson, Thomas W. Geisbert, Russell B. Wilson, John S. Schieffelin, Kelly R. Pitts, Shun-ichiro Oda, Jeffrey G. Shaffer, Zachary A. Bornholdt, Donald S. Grant, Jessica N. Hartnett, Molly M. Millett, Peter C. Kulakosky, Augustine Goba, Luis M. Branco, Joan B. Geisbert, Megan M. Rowland, Marnie L. Fusco, Darin Oottamasathien, Abigal B. Jones, Dafna M. Abelson, Sheik Humarr Khan |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Emergency Use Authorization medicine.medical_specialty Point-of-care testing viruses Point-of-Care Systems 030231 tropical medicine Enzyme-Linked Immunosorbent Assay medicine.disease_cause Sensitivity and Specificity Sierra leone Disease Outbreaks Viral Matrix Proteins 03 medical and health sciences 0302 clinical medicine Limit of Detection Internal medicine medicine Immunology and Allergy Animals Humans Lassa fever Antigens Viral Point of care Immunoassay Ebola Outbreak in West Africa Ebola virus business.industry Hemorrhagic Fever Ebola medicine.disease Ebolavirus Triage Confidence interval Africa Western 030104 developmental biology Infectious Diseases Immunology Reagent Kits Diagnostic business |
| Zdroj: | The Journal of infectious diseases. 214(suppl 3) |
| ISSN: | 1537-6613 |
| Popis: | BACKGROUND The 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOV Antigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD. METHODS Samples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR. RESULTS Preliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates. CONCLUSIONS The ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency. |
| Databáze: | OpenAIRE |
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