Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

作者：Cross Robert W; Boisen Matthew L; Millett Molly M; Nelson Diana S; Oottamasathien Darin; Hartnett Jessica N; Jones Abigal B; Goba Augustine; Momoh Mambu; Fullah Mohamed; Bornholdt Zachary A; Fusco Marnie L; Abelson Dafna M; Oda Shunichiro; Brown Bethany L; Ha Pham; Rowland Megan M; Agans Krystle N; Gei**ert Joan B; Heinrich Megan L; Kulakosky Peter C; Shaffer Jeffrey G; Schieffelin John S; Kargbo Brima; Gbetuwa Momoh; Gevao Sahr M; Wilson Russell B

来源：Journal of Infectious Diseases, 2016, 214(suppl 3): S210-S217.

DOI：10.1093/infdis/jiw293

• Ebola
• point of care
• diagnostic
• lateral flow immunoassay

Background. Ebola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013-2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases.
Methods.aEuro integral Recombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance.
Results.aEuro integral The ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription-polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 x 10(5)-9.0 x 10(8) genomes/mL.
Conclusions.aEuro integral The analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015.

• 出版日期2016-10-15