PRINCIPLE

The Brucella IgG/IgM Antibody Rapid Test is a qualitative membrane - based immunoassay for the detection of Brucella antibodies in whole blood, serum, or plasma. 

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 - 30°C) prior to testing.

1. Take out the test device

For Serum or Plasma Specimens:

• Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

• To use a dropper: Hold the dropper vertically, draw the specimen 0.5 - 1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 uL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.
• To use a micropipette: Pipette and dispense 20 uL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer.

2. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

IgG POSITIVE: The colored line in the control line region (C) appears, and a colored line appears in test line region G The result is positive for Brucella specific-IgG and is probably indicative of secondary Brucella infection.

IgM POSITIVE: The colored line in the control line region (C) appears, and a colored line appears in test line region M. The result is positive for Brucella specific-IgM antibodies and is indicative of primary Brucella infection.

IgG AND IgM POSITIVE: The colored line in the control line region (C) appears, and two colored lines should appear in test line regions G and M. The color intensities of the lines do not have to match. The result is positive for IgG and IgM antibodies and is indicative of secondary Brucella infection.

NEGATIVE: Only one colored band appears, in the control region (C). No line appears in test line regions G or M.

INVALID: No Control line (C) appears.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The Brucella IgG/IgM Antibody Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Brucella PCR kit

Brucella IgG/IgM Antibody Rapid Test vs.PCRkit

For the primary and secondary infection,The overall sensitivity is IgM 75.6%, IgG 59.3%. The overall specificity is IgM >99.0%, IgG IgM >99.0%. The overall accuracy is IgM 94.1%, IgG 90.2%.