OraQuick Ebola Rapid Antigen Test,kit/25

General description:
OraQuick Ebola Rapid Antigen Test Kit is a chromatographic immunoassay for the rapid, qualitative detection of Ebola virus (EBOV) VP40 antigen. It is intended for the two uses.

Whole blood: For presumptive detection of Ebola Zaire virus in whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographical location with high prevalence of Ebola infection).

Cadaveric oral fluid. For detection of Ebola Zaire virus in cadaveric oral fluid specimens to aid in diagnosing Ebola Zaire virus as the cause of death in order to make informed decisions on safe and dignified burial procedures to prevent transmission of the Ebola Zaire virus in 2 the community.

The results should be confirmed by further testing using an approved Ebola virus nucleic acid test (NAT). For professional use only.

Technical specifications:
Technology: Rapid immunochromatographic assay
Sample type: Whole blood, cadaveric oral fluid
Sensitivity on cadaveric oral fluid: 94.12%
Specificity on cadaveric oral fluid: 100.00%
Sensitivity on whole blood: 84.00%
Specificity on whole blood: 98.00%
Time to result: Interpret the test result at 30 minutes.

Manufacturer product reference: OraSure Technologies, Inc., 1001-0426

Items supplied with:
·25 × Divided Pouch containing: 1 Test Device and 1 Absorbent Packet and 1 Developer Solution Vial (1.0ml)
·25 × Re-usable Test Stands
·30 × Plastic Micropipettes
·1 × Cadaveric Oral Fluid Package Insert
·1 × Whole Blood Package Insert
·1 × Cadaveric Oral Fluid Quick Reference Guide
·1 × Whole Blood Quick Reference Guide

Items required and available as an accessory to the kit:
OraQuick Ebola Rapid Antigen Oral Fluid Test Kit Controls (1001-0425)
·Ebola Positive Control (1 vial, orange cap, 0.25 mL)
·Ebola Negative Control (1 vial, white cap, 0.25 mL)
·Package Insert

OraQuick Ebola Visual Reference Panel (1001-0428)
·Ebola Limit of Detection (1 device)
·Ebola Low Positive (1 device)
·Ebola Negative (1 device)
·Package Insert

Foil Transfer Pouch (1001-0494)

Items required, but not supplied:
Timer, biohazard waste container, materials for venipuncture whole blood specimen collection, materials to obtain a fingerstick whole blood specimen

Optional items not provided with kit:
BD Universal Viral Transport for Viruses, Chlamydia, Mycoplasmasand Ureaplasmas, Σ-Virocult System (MW951S)

Shelf life:
·Test Devices: 12 months if stored at 2-30°C
·Kit Controls: 12 months if stored at 2-8°C
·Visual Reference Panel: 5 months if stored at 15-30°C

Weight & volume:
Estimated weight: 1.250kg
Estimated volume: 0.012m3

Storage & transportation condition:
At 2-30°C. If stored refrigerated, ensure that the Divided Pouch is brought to operating temperature before opening.

Useful links:
Ebola EUAL Status after PHEIC Termination

WHO Emergency Use Assessment and Listing for Ebola Virus Disease IVDs