[Main Ingredients and Content]
The antigen consists primarily of Brucella strain S2 (CVCC 70502) or a combination of strains S2 and A99 (CVCC 70502 and CVCC 70203), at a concentration sufficient to produce a ++ tube agglutination reaction when compared with the national standard positive serum diluted 1:1000.
【Characteristics】
The antigen is a uniformly suspended liquid that, after standing for an extended period, becomes a clear and transparent solution with a small amount of bacterial sediment at the bottom. Both the positive and negative sera appear as loose aggregates that easily detach from the bottle walls and dissolve rapidly upon addition of diluent.
[Function and Use] Used for the diagnosis of brucellosis by tube agglutination test.
[Usage and Judgment]
(1) The antigen should be diluted 1:20 before use. The serum samples to be tested should be diluted 1:12.5, 1:25, 1:50, 1:100, and 1:200, respectively. A negative control serum and a positive control serum should also be included.
(2) Add 0.5 ml of antigen and 0.5 ml of serum respectively into a test tube, incubate at 37℃ for 24 hours, and observe the results of the agglutination test.
(3) Result Interpretation: For cattle, horses, deer, and camels, a serum dilution of 1:100 (++ ) is considered positive, while a dilution of 1:50 (++ ) is considered suspect. For pigs, sheep, and dogs, a serum dilution of 1:50 (++ ) is considered positive, while a dilution of 1:25 (++ ) is considered suspect.
For animals whose test results are “suspect,” blood samples should be collected again for retesting after 3 to 4 weeks. If the result remains suspect, the animal should be classified as positive. Criteria for interpreting agglutination reactions:
++++ The bacterial cells have completely aggregated and precipitated, and the liquid is 100% clear.
+++ The bacterial cells have almost completely aggregated and precipitated, and the liquid is 75% clear.
++ There is significant agglutination and precipitation; the liquid is 50% clear.
+ There is visible agglutination and precipitation; the liquid is 25% clear.
- No agglutination or precipitation; the liquid is uniformly turbid.
[Precautions]
(1) Not suitable for the diagnosis of rough-type Brucella infections.
(2) Do not use if contamination occurs or if insoluble clots remain.
(3) Dilute with 0.5% phenol saline solution and use up on the same day only.
(4) Shake well before use.
【Specifications】
Antigen (1) 10 ml/bottle (2) 20 ml/bottle
Negative and Positive Serums (1) 1 ml/bottle (2) 2 ml/bottle (3) 5 ml/bottle [Storage and Shelf Life]
The antigen should be stored at 2–8°C and has a shelf life of 18 months. After the expiration date, its potency should be retested; if it meets the specified requirements, it can continue to be used for an additional 6 months.
Positive and negative sera should be stored at temperatures below 8°C, with a shelf life of 18 months.
[Packaging]
Antigen 10 vials/box
Negative and positive serum, 1 bottle/box