Plasma Specimen Blood Infection Test Detect Brucella Abortus Antigen 98% Accuracy

One Step Brucella Abortus Antigen Rapid Diagnostic Test, serum/plasma specimen,gold colloidal method, easily and quick

Product Name:

One Step Brucella Abortus Antigen Rapid Diagnostic Test Cassette

Intended Use:

The Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Brucella abortus antigen in human whole blood, serum or plasma specimen.

Summary:

Brucella abortus is a gram-negative bacterium that is found in cattle populations1. This intracellular parasite is a blood borne pathogen that causes premature abortion of a cattle fetus. What makes this bacterium so dangerous is that it is zoonotic, meaning it can be transferred from an animal to a human host and still remain pathogenic2. In humans this disease cause both acute and chronic symptoms, but can be treated with antibiotics. Because of this economic effect on the cattle business and the disease potential in humans, the US has spent close to $3.5 billion trying to vaccinate the cattle herds in the US3. It is possible for B. abortus to be spread from wild populations of elk and bison into domestic cattle herds and this is why the US government continues to be vigilant in tracking potential cases within herds4.

TEST PRINCIPLE

The Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of Brucella abortus antigen in human whole blood, serum or plasma specimen. The membrane is pre-coated with mouse anti-Brucella abortus. During testing, the Brucella abortus antigen in whole blood, serum or plasma specimen reacts with the dye conjugate, which has been pre-coated anti-Brucella abortus on the conjugate pad. The mixture then migrates upward on the membrane by capillary action, reacts with mouse anti-Brucella abortus antibodies on the membrane on Test Line region. If the specimen contains Brucella abortus antigen, a colored line will appear in test line region. The absence of the colored lines in test line region indicates that the specimen does not contain Brucella abortus antigen. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERS:

The performance of the Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with 240 clinical specimens collected from the patient symptomatic and asymptomatic in comparison with latex agglutination method. The results show that the relative sensitivity of the Brucella Abortus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is 97.5% and the relative specificity is 99.0%.

Brucella Abortus Antigen Rapid Test Cassette vs. Latex Agglutination

Relative Sensitivity: 97.5% (95%CI*: 86.8%~99.9%);

Relative Specificity: 99.0% (95%CI*: 96.4%~99.9%);

Overall Accuracy: 98.8% (95%CI*: 96.4%~99.7%). *Confidence Intervals