The Anigen Rapid B.Brucella Ab Test Kit is a chromatographic immunoassay for the qualitative detection of antibodies against Brucella abortus in bovine whole blood, plasma, serum or milk.
The Anigen Rapid B.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 which indicates the Genprice Gentaur test is performing properly. The control line has to appear every time when the test has performed. If the antibodies against Brucella abortus are present in sample, a purple test line would appear in the result window.

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)
• The black line on the capillary tube is the indicator line for 10 μl.
• Materials required, but not provided – Timer

Precautions

1. The test kit is for canine use only. Do not use for other animals.
2. The test device is sensitive to humidity as well as heat. Perform the test immediately after removing the test device from the foil pouch. Do not re-use the test components.
3. Apply the sample and assay diluent vertically.
4. Do not touch the membrane in the result window of test device.
5. Do not use the test kit beyond the stated expiration date marked on the
6. package label.
7. Do not use the test kit if the pouch is damaged or the seal is broken.
8. Do not mix components from different lot numbers because the components in this kit have been quality control tested as standard batch unit.
9. All samples should be handled as being potentially infectious. Wear protective gloves while handling samples. Wash hands thoroughly afterwards.
10. Decontaminate and dispose of all samples, reaction kits and potentially contaminatedmaterials safely in accordance with national and local regulations.

Limitations of the Test

1. Although the Anigen Rapid C.Brucella Ab Test kit is very accurate for detecting antibodies to Brucella canis, but a low incidence of false results can occur. Other clinical tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the veterinarian after all clinical and laboratory findings have been evaluated.
2. The reading window may show a light pink background coloration; this will not affect the accuracy of the results.
3. The manufacturer and its distributors cannot be held responsible for the consequences of misuse or misinterpretation of the results given by the test.

Expected Values

The 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

Brucellosis, also known as undulant fever, Mediterranean fever is a zoonosis and the infection is almost invariably transmitted by direct or indirect contact with infected animals or their products. Expansion of animal industries and urbanization, and the lack of hygienic measures in animal husbandry and in food handling partly account for brucellosis remaining a public health hazard. Expansion of international travel which stimulates the taste for exotic dairy goods such as fresh cheeses which may be contaminated, and the importation of such foods into Brucella-free regions, also contribute to the ever-increasing concern over human brucellosis.

Introduction

The kit is based on sandwich immunochromatographic assay, to detect bovine brucellosis antibody in serum / plasma / blood, which is rapid, accurate and easy-to-operate.

Brucella canis is sexually transmitted by the mating of infected males and females. Brucella canis in the
female dog will live in the vaginal and uterine tissue and secretions for years, usually for life. In males, the Brucella bacteria live in the testicles and seminal fluids.
An infected male is just as contagious as the female since he can spread the Brucella bacteria via urine or semen. Transmission between dogs occurs via mucous membranes, so the bacteria may enter the body through the nose, mouth, conjunctiva of the eye and vagina.
The majority of bacteria in infected dogs are secreted in semen and vaginal secretions. Bacteria may also be present in milk, urine and saliva, thus any body fluids can
infect another dog.
When an infected bitch aborts, spread throughout a kennel can be very rapid. Infected bitches may deliver both living and dead puppies. These surviving puppies
are infected and will shed bacteria in their secretions.

WHAT IS THE IMMUNOCOMB ASSAY?

The ImmunoComb test is a modified ELISA, which can be described as an enzyme labeled “dot assay”, that detects antibody levels in serum, plasma or whole blood. The kit contains all the necessary reagents for developing the test. Results for the Brucella canis tests are obtained within 23 minutes.

 HOW DOES THE IMMUNOCOMB WORK?

■ The ImmunoComb Kit contains 2 main components: a comb shaped plastic card, hereafter
referred to as the Comb and a multi compartment developing plate.
■ The Comb has 12 teeth – sufficient for 12 tests. Each tooth will be developed in a corresponding column of wells in the developing plate. Individual or multiple tests are processed by breaking off the
desired number of teeth from the Comb.
■ A test spot of Brucella antigen is attached to the lowest spot of each tooth on the Comb. The upper
most spot is a Positive Reference.
■ The first step of the test is to deposit a serum, plasma or whole blood specimen into a well in row
A of the multi-compartment developing plate.
■ Next, the Comb is inserted into the well(s) with the sample(s) and transferred to the remaining wells
(B-F) at timed intervals, according to the step by step instructions (see section VII). Specific IgG antibodies from the specimen, if present, bind to the antigen
at the test spots and will be labeled in row C, which contains an enzyme labeled anti-dog IgG antibody.
■ At the end of the developing process, a purplegrey color results are developed in all Positive Reference spots and in any positive sample tested spot.
■ The intensity of the color result corresponds directly to the antibody level in the test specimen. Results are scored using the Positive Reference spot and CombScale.

Kit Components

• Test Cassette, 50 pcs
• Sample buffer, 2 pcs
• Disposable pipette, 50 pcs
• Kit instruction, 1 pc

Special features

– Earlier detection of C. Brucella Ab than blood culture and 2-ME RSAT
– World’s first & sole C.brucella Ab Rapid Test Kit
– One step testing procedure: Easy to use, Saving time and labor
– No additional equipment is required.

Specifications
– Principle: lmmunochromatographic assay
– (LPS capture)-(blood)-(Monoclonal anti-canine lgG detector) = LPS (Lipopolysaccharide) antigen originated from Brucella canis
– Purpose: Detection of Brucella canins antibody
– Specimen: Canine whole blood, plasma, or serum.

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– Reading time: 20 minutes
– Sensitivity: 93% vs. blood culture
– Specificity: 100% vs. blood culture
– Shelf life: 24 months
– Storage temperature: 2-30ºC.