One Step Ebola Virus Antigen Rapid Test Kit Whole Blood Serum Plasma Screening Test
INTENDED USE
The Ebola Antigen Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of antigens from Ebola viruses in human whole blood, serum or plasma specimens as an aid in the diagnosis of Ebola virus infection.
INTRODUCTION
The Ebola virus causes an acute, serious illness which is often fatal if untreated. Ebola virus disease (EVD) first appeared in 1976 in 2 simultaneous outbreaks, one in Nzara, Sudan, and the other in Yambuku, Democratic Republic of Congo. The latter occurred in a village near the Ebola River, from which the disease takes its name.
PRINCIPLE
The Ebola Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of antigens from Ebola viruses in human whole blood, serum or plasma specimens. After specimen is added to the specimen well (S) on the sample pad, it moves through the conjugate pad and mobilizes gold anti-Ebola conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-Ebola antibody that is coated on the test line region (T). If the specimen contains Ebola virus antigen, a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain Ebola virus antigen, a colored line will not appear in this region, indicating a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 2 drops of serum/Plasma to the specimen well (S) of the cassette with the provided disposable pipette, then start the timer.
OR
Transfer 1 drop of whole blood specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
OR
Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the cassette, then add 1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
Preliminary positive (+)Only one colored band appears, in the control region (C). No colored band appears in the test region (T).Negative (-)Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).InvalidControl band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
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