Description

The Ebola Rapid Antigen Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of antigens from Ebola viruses (EBOV, including Zaire Ebola virus, Sudan Ebola virus, and Bundibugyo Ebola virus) in Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Ebola viruses.

Principle：Mouse monoclonal Antibodies (mAbs) recognizing the Ebola VP40 matrix protein have been developed to detect the presence of Ebola virus in the whole blood or plasma of  suspected  Ebola Virus Disease (EVD) patients. The Ebola Rapid Antigen Test is an immunoassay based on the principle of the double antibody-sandwich technique. During testing, anti-EBOV/VP40 mAb is immobilized in the test line region of the device.  After a Whole Blood /Serum / Plasma  specimen  is placed in the Sample Pad, it reacts with anti-EBOV/VP40 mAb coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length  of the  test strip and interacts with the immobilized anti-EBOV/VP40 mAb. If the specimen contains Ebola virus antigen, a colored line will appear in the test line region 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. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. Visual interpretation is made after 25 minutes signal development time.

Components：

20 ×Rapid Test cassettes in sealed foil pouches with desiccant.

20 ×1.0mL Sample Buffer Vials.

Materials required but not provided: Specimen collection container, Timer.

Storage and Stability：Store as packaged in the sealed pouch at room temperature (2-30℃).If stored refrigerated, ensure that the Divided Pouch is brought to operating temperature (15-40℃ ) before opening. The kit is stable within the expiration date printed on the labeling.  Once open  the pouch,   the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

Specimen：

The test can be used to test Serum/Plasma and whole blood.

To collect whole blood, serum or plasma specimens following regular clinical laboratory.

Separateserum  or plasma from blood as soon as possible to avoid  Use only clear non-hemolyzed  specimens.

Store specimens at 2-8℃ if not tested immediately. Store specimens at2-8℃ up to 7 day.  The  specimens  should be frozen at -20℃  for longer storage. Do not freeze whole blood specimens.

Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result.

Test Procedure:Allow the test device and specimens to equilibrate to room temperature  (15-40 ℃ ) prior to testing.

Removethe test device from the sealed pouch and use it as soon as  possible.

Place the test device on a clean and level surface.

Add 10μL of venous serum/plasma or fingerstick whole blood to a test tube containing 1 mL Sample buffer.

Transfer 100 μL of mixed liquor into the sample well of the test device using a pipettor.

Wait for the colored line to appear. Read results at 15-25 minutes. Do not interpret the result after 30 minute.

Interpretation of Results:

Positive: Two lines appear. One red line should be in the control region (C), and another apparent red or pink line adjacent should be in the test region (T). This positive result indicates the presence of antigens to Ebola.

Negative: One red line appears in the control region (C). No line appears in the test region (T). This negative result indicates the absence of antigens to Ebola.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your local distributor.

Limitations:

The Ebola Rapid Antigen Test is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antigen in the blood.

The results obtained from this test are intended to be an aid in diagnosis only. Eachphysician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic  procedures.

A negative test result indicates that antigens to Ebola are either not present or at levels undetectable by the test.