United States FDA’s emergency use authorization of Ebola virus diagnostics: current impact and lessons for the future

Figures & data

Table 1. Available assays issued emergency use authorization by the US FDA.

Name of assay	Manufacturer	Sample types	Species detected	Gene target	LOD	Reagent storage	Reagents & disposables not included^†	Sample prep
EZ1 Real-time RT-PCR assay	US Department of Defense	Whole blood, plasma, Trizol-inactivated whole blood, or Trizol-inactivated plasma	Ebola Zaire	?	5000 PFU/ml with Trizol inactivated whole blood or plasma. 100 PFU/ml with live virus	−20°C	8	Exogenous
CDC Ebola virus NP real-time RT-PCR assay	US CDC	Whole blood, serum, plasma, and urine	Ebola Zaire	NP	30 TCID50/reaction with live virus in whole blood. 1–2 logs higher with inactivated	−20°C	14	Exogenous
CDC Ebola Virus VP40 real-time RT-PCR assay	US CDC	Whole blood, serum, plasma, and urine	Ebola Zaire	VP40	3 TCID50/reaction with live virus in whole blood. 1–2 logs higher with inactivated	−20°C	14	Exogenous
FilmArray Biothreat-E test	BioFire	Whole blood, urine	Ebola Zaire	?	6x10^5 PFU/ml with irradiated virus spiked into whole blood	15–25°C	1	Integrated
RealStar^® Ebolavirus RT-PCR Kit 1.0	altona	EDTA plasma	Ebola Zaire, Sudan, Tai Forest, Bundibugyo	L	1 PFU/ml with RNA spiked into plasma	−20°C	5	Exogenous
LightMix^® Ebola Zaire rRT-PCR Test	Roche	EDTA whole blood or TriPure-inactivated EDTA whole blood	Ebola Zaire	L	4781 PFU/ml with irradiated virus spiked into whole blood	4–24°C	13	Exogenous
ReEBOV™ Antigen Rapid Test	Corgenix	Capillary or venous whole blood, and plasma	Zaire Ebola, Sudan and Bundibugyo	VP40	1 × 10^6 PFU/ml with live virus spiked into whole blood	2–8°C	2	N/A
Xpert^® Ebola Assay	Cepheid	EDTA whole blood	Zaire Ebola	GP, NP	232 copies/ml RNA in whole blood, or 0.13–1 PFU/ml live virus in whole blood	2–28°C	0	Integrated, immediate inactivation

^†Number of items necessary to procure that are not included in the test kit (excluding bleach, gloves and blood drawing materials).

GP: Glycoprotein; LOD: Limit of detection; NP: Nucleoprotein; PFU: Plaque forming units; RT-PCR: Reverse transcriptase-PCR; TCID50: Median tissue culture infective dose; VP: Viral protein.