Table 2.
Test (manufacturer) | Test type | Target | Samples | Sensitivity | Specificity | Viruses detected |
---|---|---|---|---|---|---|
Rapid viral antigen detection tests | ||||||
Dual Path Platform (DPP) Ebola antigen system (Chembio)a | Immunochromatographic lateral flow assay | VP40 | Venous whole blood (EDTA), venous plasma (EDTA) and capillary fingerstick whole blood | Qualitative; less sensitive than PCR; requires confirmatory testing | From limited data, does not cross-react with other ebolaviruses | EBOV |
OraQuick Ebola rapid antigen test (OraSure Technologies)b,c | Immunochromatographic lateral flow assay | VP40 | Oral fluid and whole blood | 97.1% (from oral fluid from deceased individuals); LLOD: 53 ng per ml for whole blood samples and 106 ng per ml for oral fluid | 98–100% from venous whole blood samples; 99.1–100% from oral fluid from deceased individuals | BDBV, EBOV and SUDV; does not differentiate between ebolaviruses |
SD Q Line Ebola Zaire Ag test (SD Biosensor)b | Immunoprecipitation lateral flow assay | GP1,2, NP and VP40 | Plasma, serum and whole blood | 84.9% for whole blood and plasma | 99.7% for whole blood and plasma | EBOV |
PCR-based tests | ||||||
Ebola real-time RT-PCR kit (Liferiver Bio-tech)b | Fluorescent real-time RT-PCR | Nucleic acids from ebolaviruses | Serum, body fluid and urine | LLOD: 23.9 copies of viral genome per reaction | Not available | Ebolaviruses |
EZ1 test (DOD)a | Real-time TaqMan RT-PCR with fluorescent reporter dye detected at each PCR cycle | EBOV nucleic acids | Whole blood and plasma | Qualitative; LLOD: 100–1,000 pfu per ml depending on live or inactivated EBOV isolate and cycler used | 100%; no cross-reactivity with other ebolaviruses or marburgviruses | EBOV |
FilmArray NGDS BT-E (BioFire)a | Fluorescent nested multiplex RT-PCR | EBOV nucleic acids | Whole blood, plasma and serum | LLOD: 1,000 pfu per ml or 4.36 × 103 genome equivalentsd per ml for live virus | EBOV; no cross-reactivity with other ebolaviruses or marburgviruses | EBOV |
FilmArray Biothreat-E (BioFire)a | Fluorescent nested multiplex RT-PCR | EBOV nucleic acids | Whole blood and urine | 95% detection rate confirms LOD; LOD: 6 × 105 pfu per ml using γ-irradiated EBOV | 89–100% using whole blood samples, depending on the study population (Sierra Leone and UK) | EBOV |
Idylla Ebola virus triage test (Biocartis)a | Qualitative real-time RT-PCR with fluorescent reporter dyes generated upon amplification of cDNA | EBOV and SUDV nucleic acids | Whole blood and urine | 97% positive agreement compared with a non-reference standard; LLOD: 465 pfu per ml or 178 copies per ml | 100% for EBOV | EBOV and SUDV |
LightMix Ebola Zaire TIB MolBio with Lightcycler (Roche)a | Qualitative real-time RT-PCR with fluorescent reporter dye detected at each PCR cycle | EBOV nucleic acids | Whole blood | 95% positive agreement compared with a non-reference standard; LLOD: 4,781 pfu per ml | 100% for EBOV | EBOV |
Ebola virus NP real-time RT-PCR (ThermoFisher (CDC))a | Qualitative real-time RT-PCR with fluorescent reporter dye detected at each PCR cycle | EBOV NP RNA | Whole blood, serum, plasma and urinee | 99.80%; LLOD: 600–700 TCID50 copies per ml | 100% for EBOV | EBOV |
RealStar Ebolavirus RT-PCR kit (Altona Diagnostics)a,b | Real-time RT-PCR with fluorescent dye-labelled probes to detect PCR amplicons | Nucleic acids from ebolaviruses | Plasma | 82%; LLOD: 1 pfu per ml | 100% for EBOV | Ebolaviruses |
EBOV VP40 real-time RT-PCR (CDC)a | Real-time RT-PCR with fluorescent dye-labelled probes to detect PCR amplicons | EBOV VP40 RNA | Whole blood, serum, plasma and urinee | LLOD: 400–600 TCID50 per ml from whole blood; 250–600 TCID50 per ml, depending on body fluid sample and extraction method used | 100% for EBOV | EBOV |
Gene Xpert Ebola (Cepheid)a,b | Real-time RT-PCR with fluorescent signal from probes for quality control | EBOV NP and GP nucleic acids | Whole blood and oral fluids | 100%; LLOD: 232.4 genomic copies per ml | 99.5% from whole blood; 100% from oral fluid | EBOV |
BDBV, Bundibugyo virus; CDC, US Centers for Disease Control and Prevention; DOD, US Department of Defense; EBOV, Ebola virus; GP, glycoprotein; LLOD, lower limit of detection; LOD, limit of detection; NP, nucleoprotein; pfu: plaque-forming units; RT-PCR, PCR with reverse transcription; SUDV, Sudan virus; TCID50, 50% tissue culture infective dose (concentration at which 50% of cultured cells are infected with a diluted solution of viral fluid); VP40, viral protein 40. aEmergency use authorization approved by the US Food and Drug Administration (FDA). bEmergency use authorization approved by the WHO. cApproved by the FDA.; dGenome equivalents are calculated by converting the length of a genome in base pairs to micrograms of RNA. eShould not be the only specimen tested. Adapted from ref.288.