Brucella IgG/IgM Antibody Rapid Test

Brucellosis is an infectious disease caused by small ellipsoid, gram-negative bacteria. There are four different germs: Br. abortus, Br. melitensis, Br. suis and Br. canis. People are infected by contact with infected animals or by eating meat or drinking unpasteurized milk from infected animals. Breathing in the bacteria that causes brucellosis may also lead to infection. This risk is generally greater for people in laboratories that work with the bacteria. In addition, slaughterhouse and meat-packing employees have also been known to be exposed to the bacteria and ultimately become infected. Bacteria can also enter wounds in the skin/mucous membranes through contact with infected animals. Brucellosis can cause of range of signs and symptoms, some of which may present for prolonged periods of time. Initial symptoms can include: fever, sweats, malaise, anorexia, headache, pain in muscles, joint, and/or back, fatigue. Some signs and symptoms may persist for longer periods of time. Others may never go away or reoccur.The Brucella IgG/IgM Antibody Rapid Test is a rapid test that utilizes a combination of Brucella LPS antigen coated colored particles for the detection of IgG and IgM antibodies to Brucella spp in human whole blood, serum, or plasma.

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
   
   
   

   LIMITATIONS OF THE TEST

   1. 1. The Brucella IgG/IgM Antibody Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of Brucella antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Brucella antibody concentration can be determined by this qualitative test.
   2. 2. The Brucella IgG/IgM Antibody Rapid Testwill only indicate the presence of Brucella antibodies in the specimen and should not be used as the sole criteria for the diagnosis of Brucellosis.
   3. 3. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
   4. 4. Results from immunosuppressed patients should be interpreted with caution.
   5. 5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
   6. 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 Brucella
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