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PRINCIPLES OF THE TEST
The FebriDx
test is a 10-minute lateral flow immunoassay within a plastic housing that incorporates a built-in retractable
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lancet, blood collection and transfer tube, and buffer release mechanism. FebriDx
anti-CRP antibodies to simultaneously detect MxA at the medical decision point of approximately 40 ng/mL and CRP of
approximately 20 mg/L serum equivalent.
If the fingerstick blood samples contain elevated levels of MxA or CRP at or above their respective cut-off levels, the
appropriate test line will appear in the Result Window. FebriDx
and valid results.
Materials Provided
• 25 single use tests
• 1 package insert
Materials Not Provided
• Timer
• Gauze
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use only.
2. Keep the FebriDx
test in the sealed foil pouch until just before use. If the foil pouch is damaged do not use the test.
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3. Do not use the FebriDx
4. Use standard precautions for collecting and handling a fingerstick blood sample.
5. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
6. Wash hands before and after performing the test and wear disposable gloves while handling specimens.
7. The lancet is sterile until the protective tab is removed. Do not use the lancet if the protective tab is not secured in place.
8. The FebriDx
test is designed to proceed in sequential order and locking mechanisms exist to prevent skipping
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the prior step.
9. The FebriDx
test is a single-use item with no reusable components. Proper handling and disposal methods should be
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established according to local, state, and federal regulations.
10. The FebriDx
test requires a visual readout. Do not interpret the test result if you have color-impaired vision.
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11. A brightly lit environment is recommended for interpreting the test results.
STORAGE AND STABILITY
Store the FebriDx
test between 4-25°C (39-77°F). Unopened, the FebriDx
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on their packaging.
ALTITUDE AND RELATIVE HUMIDITY (RH)
The FebriDx
test performed acceptably when tested at altitudes between 0-2000 meters and 5-85% RH.
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• Alcohol
• Sterile dressing
test past the expiration date.
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also contains a control line to indicate correct sample flow
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tests are stable until the expiration dates printed
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4
utilizes monoclonal anti-MxA and
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