One- Step Brucella IgM Rapid Test

One- Step Brucella IgM Rapid Test

INTENDED USE

The Brucella IgM Rapid Test Device is a lateral flow immunoassay for the simultaneous detection and differentiation of IgM antibody to Brucella in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Brucella. Any reactive specimen with the Brucella IgM Rapid Test-sheet must be confirmed with alternative testing method(s).

SUMMARY AND  EXPLANATION OF THE TEST

Brucellosis (Brucella) is a gram-negative bacteria of not exercise, no capsule, catalase, oxidase positive,and absolutely aerobic bacteria.^1,2 It can be reduced nitrate.It can be survival in a variety of domestic animals because of  its intracellular parasite.³

Pathogen was to be spread by their excrements and contaminated food which infected animals (zoonosis).⁴ The serum IgM antibodies of untreated patients are elevated at first. Later the IgG are elevated. Followed the IgA are elevated by a low level in the subsequent rise and fall lasted about a year later. Thereafter whenever the condition repeated exacerbations, IgG can be quickly recovered.⁵

The Brucella IgM is a simple serological test that utilizes antigens from Brucella and detects IgM antibodies to these microorganisms simultaneously. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment and the result is available within 15 minutes. 

TEST PRINCIPLE

The Brucella IgM Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the IgM capture assay. The test cassette consists of: 1) a burgundy colored conjugate pad containing Brucella antigens conjugated with colloid gold (Brucella conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with anti-human M antibody, and the C band is pre-coated with goat anti-rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette.  IgM anti- Brucella if present in the specimen will bind to the Brucella conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored M band, indicating a Brucella IgM positive test result.

Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

KIT COMPONENTS