SLE Latex Test (Serology Test Kit) description:

INTENDED USE
The SLE Test is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) through the detection and quantitation of serum antinucleoprotein factors associated with SLE.

SUMMARY AND PRINCIPLES
The detection of antinuclear antibodies by laboratory methods includes immunofluorescence, LE cell test, and agglutination of coated particles1-5. The antibodies that are believed to be most characteristic of SLE are those that are directed against deoxyribonucleoprotein (DNP). These antibodies are believed to cause the formation of the LE cell in vitro, with this unusual event occurring in 75-80% of those patients diagnosed as having SLE4, 6. It is not necessary to have a positive LE cell test for the diagnosis of SLE as this test had been found negative in certain individual having symptoms suggestive for SLE7. In these individuals, antinuclear antibodies may be demonstrated by methods other than the LE cell test.

The principle of the SLE Test is based on the agglutination reaction between latex particles coated with DNP being brought into contact with a serum, which contains antinuclear antibodies. A visible agglutination indicates a positive reaction. The reaction time for this occurrence is within one minute.