Table 2.
Point-of-care tests implemented for Ebola secured settings.
| 2A. Emory university hospital
specialized isolation area | ||
|---|---|---|
| Manufacturer website | Instrument | Tests/status |
| Abaxis www.abaxis.com |
Piccolo Express | Chemistry profiles, Magnesium, Phosphate, liver enzyme assays, others available† |
| Instrumentation Laboratory www.instrumentationlaboratory.com |
GEM Premier 4000 | pH, pC02, p02, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, THb, CO-Oximetry, TBil |
| Siemens www.healthcare.siemens.com |
CLINITEK Status automated urinalysis |
Albumin, Bilirubin, Cr, Glu, Ketone, Leukocytes, Nitrite, pH, Protein, Specific Gravity, Urobilinogen, others available‡ |
| Hoffman-La Roche www.coaguchek.com |
CoaguChek | PT/INR§ |
| Sysmex www.sysmex.com |
pocH-100i | CBC: WBC (3-part differential), RBC, Hb, Hct, MCV, MCH, MCHC, Platelets¶ |
| Alere www.alere.com/us/en/product-details/binaxnowmalaria.html |
BinaxNOW | Malaria |
| BioFire Diagnostics www.biofiredx.com |
FilmArray | Infectious diseases including Ebola FDA Ebola EUA 10/25/14, reissue 3/2/15 |
| 2B. University of nebraska
medical center biocontainment BSL-3 laboratory | ||
|---|---|---|
| Manufacturer website | Instrument/method | Tests |
| Abbott www.Abbott.com |
i-Stat | G3+ cartridge (pH, pCO2, pO2) & Chem8+ cartridge (Na+, K+, Cl-, TCO2, Ca++, Glu, UN, Cr, Hct) |
| International Technidyne Corp. www.itcmed.com |
Hemochron signature elite | Citrate prothrombin time (PT), citrate-activated partial thromboplastin time (aPTT) |
| Slide agglutination | Manual | Blood & serum antibody typing (for transfusion) |
| Slide preparation | Manual | Malaria—modified for the slide to be fixed in methanol 15 min before delivering to Core Lab for staining & interpretation |
| NS | Rapid manual assay | HIV Ab/Ag |
| Urine dipstick | Manual dipstick | For tests not on strip, specimen transferred with precautions to Core Lab for non-decapped DxI800 & DXC800i# analysis |
| NS | RPR | Syphilis (card assay) |
| 2C. Ebola holding units (4)
in Sierra Leone, West Africa†† | ||
| Developer website | Method | Performance |
| United Kingdom’s Defense Science & Technology Laboratory https://www.gov.uk/government/organisations/defence-scienceand-technology-laboratory | Rapid diagnostic antigen test |
Sensitivity 100, 95% CI: 78.2–100. Specificity: 96.6, 95%
CI: 91.3–99.1. Positive and negative predictive values: 79.0% (95% CI: 54.4–93.8)/100% (95% CI: 96.7–100) |
| 2D. Suite environment, ARUP
Institute for clinical & experimental pathology | ||
| Manufacturer website | Instrument/method | Tests, Evaluation study objectives |
| Abaxis www.abaxis.com |
Piccolo Express | Liver Panel Plus‡‡ using disposable exact volume transfer pipettes and BSL-2 cabinet in BSL-3 suite environment for Ebola patient workup. Checked device air flow characteristics are suitable. |
†See [72] for test clusters.
‡See [73].
§FDA-cleared for warfarin monitoring only.
¶See [74] for list of variables and parameters.
#Beckman-Coulter, La Brea, California, manufactures the DxI800 and DXC800i.
††See [21].
‡‡See [22] and [75], for evaluation study details and panel details, respectively. See [73] for test cluster lists.
ARUP: Associated regional and university pathologists; BSL: Biosafety level; Ca++: Ionized calcium; CBC: Complete blood count; Cr: Creatinine; EUA: Emergency use authorization; Glu: Glucose; Hb: Hemoglobin; Hct: Hematocrit; Lac: Lactate; MCV: Mean corpuscular volume; MCH: Mean corpuscular hemoglobin; MCHC: Mean corpuscular hemoglobin concentration; NS: Not specified in reference no. 15; pCO2: Partial pressure of carbon dioxide; pO2: Partial pressure of oxygen; PT/INR: Prothrombin time/international normalized ratio; RBC: Red blood cell; TBil: Total bilirubin; TCO2: Total carbon dioxide content; THb: Total hemoglobin; TP: Total protein; UN: Urea nitrogen; WBC: White blood cell.