Borrelia burgdorferi Antibody Rapid Test

INTENDED USE

The Borrelia Burgdorferi Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Borrelia spp. in human whole blood, serum or plasma specimen.

MATERIALS

Materials Provided

Materials Required but Not provided

PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.

To use a micropipette: Pipette and dispense 20 µL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 µL) and start the timer.

3. 3. Wait for the colored line(s) to appear. Read results at 10 minutes.Do not interpret the result after 20 minutes.

4. INTERPRETATION OF RESULTS
   
   

   POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

   NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

   INVALID: Control 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.

   LIMITATIONS OF THE TEST

   1. The Borrelia Burgdorferi Antibody Rapid Testis for in vitro diagnostic use only. The test should be used for the detection of Lyme Borrelia antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Borreliaantibody concentration can be determined by this qualitative test.

   1. 2. The Borrelia Burgdorferi Antibody Rapid Testwill only indicate the presence of Borreliaantibodies in the specimen and should not be used as the sole criteria for the diagnosis of Borrelia.
   2. 3. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
   3. 4. Results from immunosuppressed patients should be interpreted with caution.
   4. 5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
   5. 6. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Borrelia
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