Bionote Anigen Rapid Canine Brucella Ab Test

The Rapid C. Brucella Ab Test Kit is a chromatographic immunoassay for the qualitative detection of Brucella canis antibodies in canine whole blood, plasma or serum.
The Rapid C. Brucella Ab Test Kit has two letters which are test (T) line and control (C) line on the surface of device. The test line and control line in the result window are not visible before applying any samples. The control line is a reference line that indicates the ABBOTT test is performing properly.

The control line has to appear every time when the test has performed. If the antibodies against Brucella canis in the sample, a purple test line would appear in the result window.
The highly selective Brucella canis antigens are used as a capture and detector in the assay. These antigens are capable of detecting antibodies against Brucella canis directly, with a high accuracy.

Materials provided (10 Tests/Kit)

  • Anigen Rapid C.Brucella Ab Test Device (10)
  • Assay diluent bottle (01)
  • Anticoagulant tube (10)
  • Disposable capillary tube (10)
  • Instructions for use (01)

Explanation of the Test

  1. Canine Brucellosis is an infectious disease caused by the bacteria of the genus
    Brucella canis. The Anigen Rapid C. Brucella Ab Test Kit is a chromatographic
    immunoassay for the qualitative detection of Brucella canins antibody in whole
    blood, plasma, or serum.
  2. The Anigen Rapid C. Brucella Ab Test Kit has a letter of T and C as “Test
    Line” and “Control Line” on the surface of the kit. Both the “Test Line” and
    “Control Line” in result window are not visible before applying any samples. The
    “Control Lines” is used for procedural control. Control line should always appear
    if this procedure is performed properly and the test reagents of control line works.
    A purple “Test Line” will be visible in the result window if there are enough
    Brucella canis antibodies in the specimen.
  3. The specially selected Brucella canis antigen is used in test and as both capture
    and detector materials. These enable the Anigen Rapid C. Brucella Ab Test Kit to
    identify to Brucella canis antibodies in specimens, with a high degree of
    accuracy.

Materials Provided

Anigen Rapid C. Brucella Ab Test Kit contains following items to perform
the assay.
1) Ten (10) Anigen Rapid C. Brucella Ab Test Kits
2) One (1) Assay Diluent bottles
3) Ten (10) Capillary tubes for 10ul
4) One (1) Instructions for use

Precautions

1) For in-vitro diagnostic use only.
2) Do not eat or smoke while handling specimens.
3)Wear protective gloves while handling specimens. Wash hands thoroughly
afterwards.
4) Avoid splashing or aerosol formation.
5) Clean up spills thoroughly using an appropriate disinfectant.
6) Decontaminate and dispose all specimens, reaction kits and potentially
contaminated materials, in a biohazard container.
7) Do not use the test kit if the pouch is damaged or the seal is broken.

Storage and Stability

The Anigen Rapid C. Brucella Ab Test Kit should be stored at room
temperature. The test kit is sensitive to humidity, and as well as to heat.
Perform the test immediately after removing the test device from the foil
pouch. Do not use it beyond the expiration.

Specimen Collection and Storage

1) [Whole blood] Collect the whole blood by using the suitable anticoagulant. Use the whole blood within 1 day after collection. Do not
use the hemolysis blood.
2) [Serum or Plasma] Centrifuge whole blood to get plasma or serum
specimen.
3) If specimens are not immediately tested they should be refrigerated at 2
~ 8℃. For keeping specimens more than three days with fresh, them at
– 20℃ or below(serum, plasma). They should be brought to room
temperature before use.
4) Specimens containing precipitate may yield inconsistent test results
Such specimens must be clarified before assaying.

Test Procedures
1) Remove the test kit from the foil pouch, and place it on the flat, dry
surface.
2) Take 10ul of serum, plasma, or whole blood to the dark score line of a
capillary tube.
3) Slowly add 10 ul of serum, plasma, or whole blood to the sample well
with capillary tube with a score line for volume of 10ul and then add 2
drops (approximately 60ul) with bottle containing diluent buffer. If the
migration is not appeared whitin 1 minute, add one more buffer to sample
well. 4) As the test result, you can see the purple band in the result window of the
kit.
5) Interpret test results at 20 minutes.
6) Please do not read after 20 minutes.

Interpretation of the Test

1) A color band which would be appeared in the left section of the result
window shows that the test is works properly, and it called is the Control
line (C).
2) The right section of the result window called test band indicates the test
results. If another color band appears on the test band. (T).
Negative : The presence of only one purple color band within the result
window indicates a negative result.

Positive : The presence of two color bands (“T” band and “C” band) within
the result window, no matter which band appears first, means
positive.

Invalid : If the purple color band is not visible within the result window
after performing the test, the result is considered invalid. The
directions may not have been followed correctly or the test may
have deteriorated. It is recommended to take the test again with
same specimen.

Limitations of the Test

1) The Anigen Rapid C. Brucella Ab Test Kit will only indicate the antibody
presence against Brucella canis in the specimen.
2) As with all diagnostic tests, all results must be interpreted together with
other clinical information available to the veterinarian.
3) If the test result is negative and clinical symptom is persist, additional
testing using other clinical methods is recommended. A negative result
does not preclude the possibility of canine brucellosis.
9. Expected Values
The Anigen Rapid C. Brucella Ab Test Kit has been compared with 2-
mercapto-ethanol Rapid Slide Agglutination Test. The overall accuracy is
greater or equal to 90.0%.

Background

Bovine brucellosis is commonly caused by Brucella abortus and less frequently by B. melitensis, and rarely by B. suis. Infection is widespread globally. Humans may be infected by contact with animals or animal products contaminated with these bacteria. Available serological tests include the Rose Bengal, ELISA, complement fixation test and tube agglutination test. However, these tests do not provide rapid diagnosis and each requires specialised laboratories and equipment. The new Anigen immunochromatographic rapid assay was developed to provide accurate, rapid and easy testing of B. brucellosis.

Specifications

■Principle: Immunochromatographic assay
•(LPS capture)-(Antibody in blood, milk)-(Protein G detector)
•LPS (Lipopolysaccharide) antigen originated from B. abortus
■Purpose: Detection of Brucella abortus, melintensis or suis antibodies
■Specimen: Bovine whole blood, serum, plasma and raw milk
■Reading time: 20 minutes
■Sensitivity: 97.9% vs. a commercial ELISA, 96.2% vs. Milk Ring Test.
■Specificity: 96.8% vs. a commercial ELISA, 89.7% vs. Milk Ring Test
■No cross reaction against Brucella canis, Yersinia Enterocolitica
■Shelf life: 24 months
■Storage temperature: 2~30℃
■Packing size: 30 multi-devices/Kit, 10 tests/Kit

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