Beijing Kinghawk CO.,LTD

Intended use

The test is a rapid, in vitro qualitative test that detects the presence of Brucella antibody in human or animal serum specimen.

There appears Brucella antibody in serum 2 weeks after human or mammal infected with Brucella. Brucellosis is characterized by acute undulating fever, headache, muscle pain, arthritis pain, night sweats, fatigue and anorexia. Brucellosis is also considered an occupational disease because of a higher incidence in people working with animals (slaughterhouse, pasture, etc.). People become infected by contact with fluids from infected animals (sheep, cattle or pigs) or derived food products like unpasteurized milk and cheese. The kit is assistant to diagnose the suspicious human or animal specimen.

Principle

The membrane is coated with Brucella antigen on the test line region and the goat anti-rabbit IgG on the control line region of the device. When Sample is applied at the sample well of the device, if the sample contains Brucella antibody, it will react with staphylococcus aureus protein A (SPA)labeled with colloidal gold particle that has already been applied to the specimen pad. The mixture then migrates chromatographically towards the other end of the device and reacts with Brucella antigen on the membrane in the test line region, showing a positive result. Absence of the colored line indicates that the sample does not contain Brucella antibody, showing a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

Product Description

Components

l Cassette, Specification.

Materials required, but not provided

l test tube, dropper, physiological saline, masks, gloves, timer

Storage and Stability

Store the test kit at room temperature（4-25℃）,avoid bright.

The test kit is stable until the assigned expiration date indicated on the outer package label and on each individual component. Do not use past the assigned expiration date.

Precautions

1. The detection should be done according to the management standard for the Brucella experiment and the biology safety guideline. Wear disposal latex gloves and work clothes while handling specimens and reagents.

2. All the specimens and prepared or used reagents have to be treated as extremely poisonous.

3. Store the test cassette in the sealed pouch until ready to use. Do not use the test cassette if the pouch is not intact.

4. Use it at once when the cassette is picked out. Exposure to humidity can affect assay performance.

Sample Requirement

Human serum or animal serum

Test Procedure

1. Take 10µl specimen (human serum or animal serum) into test tube, add 400µl physiological saline, as detection liquid.

2. Remove the cassette out from its foil pouch and place it on a flat, dry surface.

3. Add 3-4 drops (approx.150µl) of detection liquid from the test tube into the sample port of the cassette.

4. Interpret the test results 2 minutes later, but do not after 15 minutes.

5. When the test is finished, recap the test tube and return all the materials to the original resealable biohazard bag for proper processing.

6. Fill in the monitor label and seal the biohazard bag.

Interpretation of result

POSITIVE:Two distinct red lines appear. One line should be in the control region(C) and another line should be in the test region (T).

NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

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 with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Package: 1 test / kit, 10 tests / kit

Shelf Life:  24 months