Note: This package insert is also used for individually packed  Store serum at 2-8C until testing can

testing can be performed.

reagent.
PRUCEDURE
BRUCELLA (ROSE BENGAL) TEST MATERIALS REQUIRED BUT NOT PROVIDED Qualitative method
 Mechanical rotator with adjustable speed at 80- 1. Allow the reagents and samples to reach room
A rapid agglutination slide test for the detection of
100 r.p.m. temperature. The sensitivity of the test may be reduced
Brucella specific agglutinins
 Vortex mixer. at low temperatures.
 Pippetes 50 µL. 2. Place 50 µL of the sample and one drop of each Positive
For In-Vitro Diagnostic and professional use only. and Negative controls into separate circles on the slide
PRECAUTION test.
Store at 2 to 8C. 1. This reagent is for in vitro diagnostic and professional 3. Mix the R. Bengal reagent vigorously or on a vortex mixer
use. before using and add one drop next to the sample to be
INTENDED USE
2. Protective clothing should be worn when handling tested.
The Rose Bengal is a slide agglutination test for the qualitative
the reagents. 4. Mix the drops with a stirrer, spreading them over the
and semi-quantitative detection of antibodies anti-Brucella in
human and animal serum. 3. The reagents should be used as supplied and in entire surface of the circle. Use different stirrers for each
accordance to the procedure mentioned below. sample.
PRINCIPLE Don’t use beyond expiration date. 5. Place the slide on a mechanical rotator at 80-100 r.p.m.
In the course of human infection with any pathogenic 4. Don’t use these reagents if the label is not available for 4 minutes. False positive results could appear if the
microbiological agent, a variety of antibodies are formed. or damaged. test is read later than two minutes.
Among these antibodies are the agglutinins. An agglutinin 5. Don’t use the kit if damaged or the glass vials are Semi-quantitative method
when combined with homologous antigen (agglutinate) under broken or leaking and discard the contents 1. Make serial two fold dilutions of the sample in 9 g/L
the properly controlled conditions is capable of causing immediately. saline solution.
agglutination. A suspension of Brucella possessing active 6. Test materials and samples should be discarded 2. Proceed for each dilution as in the qualitative method.
antigen will agglutinate when exposed to homologous Brucella properly in a biohazard container.
antibody. This agglutination forms clumps of bacteria which 7. Wash hands and the test table top with water and READING AND INTERPRETATION
become macroscopically visible. soap once the testing is done. 1. Examine macroscopically the presence or absence of
The Rose Bengal stained Brucella antigen is used for the early 8. Don’t use these reagents if the label is not available visible agglutination immediately after removing the slide
detection of Brucella agglutinins (Brucella Abortus, Melitensis or damaged. from the rotator. The presence of agglutination indicates
and Suis). 9. The test should be performed at room temperature an antibody anti-Brucella concentration equal or greater
in a well let area with very good visibility. than 25 IU/mL.
MATERIALS 10. If spillage of reagent occurs clean with disinfectant 2. The titer, in the semi-quantitative method, is defined as
MATERIALS PROVIDED (disinfectant used could be irritable so handle with the highest dilution showing a positive result.
 Rose Bengal Brucella Antigen: Brucella abortus care).
suspension, strain S99, in lactate buffer 1 mol/L, CALCULATIONS
phenol 5 g/L, Rose Bengal, pH 3.6 . STORAGE The approximate antibody concentration in the patient sample
 Positive Control: Animal serum, with an Brucella antigen and control anti-sera must be stored at 2-8C. is calculated as follows:
antibody anti- Br.abortus concentration 50 25 x anti-Brucella Titer = IU/mL
IU/mL. Preservative . SPECIMEN COLLECTION & PREPARATION
 Negative Control: Animal serum. Preservative.  Collect 5ml whole blood samples aseptically from the QUALITY CONTROL
 White Glass slide. patient. Positive and Negative controls are recommended to monitor
 Stirring Sticks.  Allow blood to clot and remove serum as soon as the performance of the procedure, as well as a comparative
possible to prevent excess haemolysis. pattern for a better result interpretation.
All result different from the negative control result, will be
ATLAS MEDICAL
considered as a positive.
Ludwig-Erhard Ring 3
15827 Blankenfelde-Mahlow
REFERENCE VALUES
Germany
Up to 25 IU/mL.
Tel: +49 - 33708 – 3550 30
Each laboratory should establish its own reference range.
Email: [email protected]
PPI1503A01
PERFORMANCE CHARACTERISTICS
1. Analytical sensitivity: 25 (±5) IU/mL, under the described Rev A (02.09.2019)
assay conditions Temperature
Catalogue Number
2. Prozone effect: No prozone effect was detected up to limit
1000 IU/mL. In Vitro diagnostic
Caution
3. Diagnostic sensitivity: 100 %. medical device
4. Diagnostic specificity: 98 %. Contains sufficient Consult
for <n> tests and instructions for
INTERFERENCES Relative size use (IFU)
Hemoglobin (10 g/L), lipemia (10 g/L) and rheumatoid factors
Batch code Manufacturer
(300 IU/mL) do not interfere. Bilirrubin interferes at 2.5 mg/dL.
Other substances may interfere. Fragile,
Use-by date
handle with care
REFERENCES Do not use if
Manufacturer fax
1. Young E J. Clinical Infectious Diseases 1995; 21: 283-290. package is
number
2. Alton GC. Techniques for Brucellosis Laboratory INRA damaged
Paris, 1988. Manufacturer Date of
3. Ariza J. Current Opinion in Infectious Diseases 1996; 9: telephone number Manufacture
126-131.
Keep away from
4. Comité mixto FAO/OMS de expertos en Brucelosis. WLD Keep dry
sunlight
Health Org Tech Rep Ser 1958; 148: 1-60.
5. Young DS. Effects of drugs on clinical laboratory test, 4th
ed. AACC Press, 1995