Table 1.

Characteristics of diagnostic tests that have been approved by the World Health Organization.

Test name	Detected	Sensitivity	Specificity	95% limit of detection	Time to result	Principal logistic challenge	Cost
RealStar Filovirus3,13*	Ebola-specific RNA	NR	NR	1,390 RNA cps ml−1 (95% CI = 690–5,320)	Hours	Kit is shipped on dry ice and should arrive frozen and be kept at −20 °C; needs equipment, including an appropriate PCR machine; needs special training; and needs high safety level in the laboratory	NR
ReEBOV Antigen Rapid Test14–16*	Ebola virus (EBOV) VP40 antigen	91.8% (95% CI = 84.5–96.8) compared with RealStar15	84.6% (95% CI = 78.8–89.4) compared to RealStar15	6.25E+02 ng ml−1 Ebola rVP40 antigen	15 minutes	Requires refrigeration at 2–8 °C, requires visual interpretation, should be used in biosafety level 4 facility or with full PPE and can use whole blood from finger prick or venipuncture	NR
Xpert26,27*	Ebola-specific RNA	For Ebola Mayinga RNA: 100%, (95% CI = 92.9–100.0) (PPA)	For Ebola Mayinga RNA: 100.0%, (95% CI = 92.9–100.0) (NPA)	232.4 RNA cps ml−1 (95% CI = 163.1– 301.6)	90 minutes	Requires refrigeration at 2–8 °C, optimally should be used in a class II safety cabinet or similar, needs special training, automated process and requires a minimum of 100 μl whole blood by venipuncture	US$19.80 per cartridge
LifeRiver4,28	Ebola-specific RNA	1 log10 lower limit of detection than RealStar	NR	23.9 RNA cps per reaction (95% CI = 13.4–405.9)	Results in 2 hours, total processing 4–6 hours	Reagents must be kept at −20 °C; needs equipment, including an appropriate PCR machine; needs special training; needs high safety level in the laboratory	NR

^*Test is also US Food and Drug Administration (FDA) authorized. All sensitivity, specificity and limits of detection are reported for Zaire EBOV unless otherwise stated.

Cps, copies; NPA, negative per cent agreement; NR, not reported; PCR, polymerase chain reaction; PPA, positive per cent agreement; PPE, personal protective equipment.