Analytical test devices for competition assay for drugs of non-protein antigens using immunochromatographic techniques

An analytical test assembly for producing a visually-perceptible indication of whether particular non-protein antigens are present via simultaneous multiple competition assays for said particular non-protein antigens representing drugs of abuse, consisting essentially of:

• a plurality of test kit housings each having means for introduction of a body fluid sample at a first end of said housings and means defining a flow path for the body fluid sample to a second end within said housings;
• a supply of microscopic colored latex particles disposed adjacent to each of the means for introduction of the body fluid sample along the flow path, the colored latex particles becoming suspended in the body fluid sample and moving with flow of the body fluid sample along the flow path from said first end toward said second end, the colored latex particles being sensitized with a supply of antibodies for the non-protein antigen at least on a surface thereof, said antibodies being responsive to said non-protein antigens and being operable to complex therewith;
• a chromatographic membrane support disposed within each of the test kit housings and being impregnated at a first predetermined site along the flow path downstream of the colored latex particles towards said second end with an immobilized drug conjugate probe sensitive to said antibodies on the latex particles, and operable to complex therewith;
• means for exposing the colored latex particles at said first end to the body fluid sample for substantially complete reaction of the non-protein antigens in the body fluid sample with the antibodies for the non-protein antigen on the colored latex particles, prior to the body fluid sample reaching the predetermined site along the flow path whereby when said non-protein antigens are not present in the body fluid sample the colored latex particles accumulate at the predetermined site downstream of said first end by complexing of the antibodies on the colored latex particles with the drug conjugate probe on the membrane support to leave a visually perceptible colored mark of a same color as the colored latex particles, and when said non-protein antigens are present in the body fluid sample, complexing of the non-protein antigens to the supply of antibodies on the colored latex particles substantially exhausts the antibody supply on the colored latex particles such that the colored latex particles cannot complex to the immobilized drug conjugate probe, leaving no visually perceptible mark at the predetermined site;
• and,
• a holder for maintaining a plurality of analytical test devices, each said analytical test device including one of said test kit housings, said supply of microscopic colored latex particles and chromatographic membranes in fixed relationship, comprising:
• a holder body adapted to removably receive the plurality of analytical test devices, and means for securing the plurality of analytical test devices in the holder.

An analytical test device for competition assay for particular non-protein antigens representing drugs of abuse, consisting essentially of:

• a test kit housing having means for introduction of a body fluid sample at a first end of said housing and means defining a flow path for the body fluid sample to a second end within said housing;
• a supply of microscopic colored latex particles disposed adjacent to the means for introduction of the body fluid sample along the flow path, the colored latex particles becoming suspended in the body fluid sample and moving with flow of the body fluid sample along the flow path from said first end toward said second end, the colored latex particles being sensitized at least on a surface thereof with at least one of said antigens representing drugs of abuse and a functionally identical antigen conjugate;
• a chromatographic membrane support disposed within the test kit housing and being impregnated at a first predetermined site along the flow path with an immobilized antibody responsive to said antigen and said antigen conjugate, and operable to complex therewith;
• and
• means in proximity with said means for introduction of the body fluid, for allowing the colored latex particles and the body fluid sample to mix and for allowing the mixed colored latex particles and the body fluid sample to flow along the flow path from said first end toward said second end to the predetermined site such that the body fluid sample reaches the predetermined site prior to the colored latex particles, whereby presence of the antigen in the body fluid is indicated by lack of a colored mark at the predetermined site, due to exhaustion of said antibodies by binding with the antigen in the body fluid sample, and absence of the antigen in the body fluid sample is indicated by presence of the colored mark at the predetermined site due to binding of the latex particles to the antibodies the colored mark being of a same color as the colored latex particles.