OraQuick Ebola RapidAg Test Kit Controls

General description:
OraQuick Ebola Rapid Antigen Test Kit Controls must be used with OraQuick Ebola Rapid Antigen Test. Main objectives of this Kit Controls are: To ensure performance of the Test and to verify ability to properly perform the test and interpret the results.

Technical specifications:
Use of kit control reagents manufactured by any other source may not produce the required results, and therefore, will not meet the requirements for an adequate quality assurance program for the OraQuick Ebola Rapid Antigen Test. Contact manufacturer, if the Kit Control reagents do not produce the expected results.

Run the Controls under the following circumstances:
·Each new operator prior to performing testing on patient specimens
·When opening a new test kit lot
·Whenever a new shipment of test kits is received
·If the temperature of the test kit storage area falls outside of 2°-30°C
·If the temperature of the testing area falls outside of 15°-40°C
·At periodic intervals as dictated by local, state and country laws and by the user facility

Manufacturer product reference: OraSure Technologies, Inc., 1001-0425

Items supplied with:
·1 x Ebola Positive Control Vial (Orange cap, 0.25ml)
·1 x Ebola Negative Control Vial (White cap, 0.25ml)
·Package Insert

Shelf life:
12 months if stored at 2-8°C from date of manufacturing.

Weight & volume:
Estimated weight: 0.05kg
Estimated volume: 0.007m3

Storage & transportation condition:
At 2-8°C

Useful links:
Ebola EUAL Status after PHEIC Termination

WHO Emergency Use Assessment and Listing for Ebola Virus Disease IVDs