PRINCIPLE

The TB One Step Rapid Test is a lateral flow chromatographic immunoassay. The test consists of: 1) a burgundy coloredconjugate pad containing recombinant TB antigens conjugated with colloid gold (TB conjugates) and rabbit IgG-goldconjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band(C band).

The T1 band is pre-coated with monoclonal anti-human IgM for detection of IgM anti-TB,T2 band is pre-coated withreagents for detection of IgG anti-TB,and the C band is pre-coated with goat anti rabbit IgG.When an adequatevolume of test specimen is applied into the sample pad of the test, the specimen migrates by capillary action across thestrip. IgM anti-TB if present in the specimen will bind to the TB conjugates.

The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundycolored T1 band, indicating a TB IgM positive test result.

IgG anti-TB if present in the specimen will bind to the TB conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored T2 band, indicating a TB IgG positive test result.

Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) whichshould exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugateregardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must beretested with another device.

MATERIALS SUPPLIED

Each test contains :

1. One cassette device

2. One pipette dropper

3. One desiccant

Each kit contains:

1. 40 test devices

2. One instruction