Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Chemiluminescent
Reexamination Certificate
1999-06-15
2002-06-18
Snay, Jeffrey (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Chemiluminescent
C422S067000, C436S534000, C436S172000
Reexamination Certificate
active
06406667
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to methods, compositions and kits for detecting a number of different components in a single test medium.
The clinical diagnostic field has seen a broad expansion in recent years, both as to the variety of materials of interest that may be readily and accurately determined, as well as the methods for the determination. Convenient, reliable and non-hazardous means for detecting the presence of low concentrations of materials in liquids is desired. In clinical chemistry these materials may be present in body fluids in concentrations below 10
−12
molar. The difficulty of detecting low concentrations of these materials is enhanced by the relatively small sample sizes that can be utilized.
The need to determine many analytes in blood and other biological fluids has become increasingly apparent in many branches of medicine. In endocrinology the knowledge of plasma concentration of a number of different hormones is often required to resolve a diagnostic problem or a panel of markers for a given diagnosis where the ratios could assist in determining disease progression. An even more pressing need is evident in other areas such as allergy testing, the screening of transfused blood for viral contamination or genetic diagnosis.
In other assays such as nucleic acid hybridization assays, there is need to detect and quantify specific target and positive control sequence in a single tube without time consuming separations and transfer steps. In principle internal controls will eliminate the need for a standard curve. Amplification and detection in a single tube without opening the tube also overcomes contamination problems. In mutation analysis, the ability to measure two or more variants in a single tube would allow one to monitor quantitatively the appearance of mutant populations.
Most multi-analyte assays are heterogeneous, have poor sensitivity and poor dynamic range (2 to 100 fold difference in concentration of the analytes is determined) and some require the use of sophisticated instrumentation. A homogeneous assay that has higher sensitivity, large dynamic range (10
3
to 10
4
-fold difference in analyte concentration), and fewer and more stable reagents would increase the simplicity and reliability or multianalyte assays.
Luminescent compounds, such as fluorescent compounds and chemiluminescent compounds, find wide application in the assay field because of their ability to emit light. For this reason, luminescers have been utilized as labels in assays such as nucleic acid assays and immunoassays. For example, a member of a specific binding pair is conjugated to a luminescer and various protocols are employed. The luminescer conjugate can be partitioned between a solid phase and a liquid phase in relation to the amount of analyte in a sample suspected of containing the analyte. By measuring the luminescence of either of the phases, one can relate the level of luminescence observed to a concentration of the analyte in the sample.
Particles, such as liposomes and erythrocyte ghosts, have been utilized as carriers of encapsulated water-soluble materials. For example, liposomes have been employed to encapsulate biologically active material for a variety of uses, such as drug delivery systems wherein a medicament is entrapped during liposome preparation and then administered to the patient to be treated.
Particles, such as latex beads and liposomes, have also been utilized in assays. For example, in homogeneous assays an enzyme may be entrapped in the aqueous phase of a liposome labeled with an antibody or antigen. The liposomes are caused to release the enzyme in the presence of a sample and complement. Antibody or antigen-labeled liposomes, having water soluble fluorescent or non-fluorescent dyes encapsulated within an aqueous phase vesicle or lipid soluble dyes dissolved in the lipid bilayer of a lipid, have also been utilized to assay for analytes capable of entering into an immunochemical reaction with the surface bound antibody or antigen. Detergents have been used to release the dyes from the aqueous phase of the liposomes.
Various labels have been used to produce distinguishable signals in multianalyte assays: (a) two different radioisotope labels, (b) two or more different fluorescent labels, (c) a fluorescent and a chemiluminescent label, (c) different lanthanide chelates where both lifetime and wavelength are measured, (e) an enzyme and an acridinium ester, (f) spatial resolution of different analytes, (g) different enzymes with sequential substrate additions, and (h) different acridinium esters that produce dioxetanones having different lifetimes.
2. Brief Description of the Related Art
U.S. Pat. No. 5,656,207 (Woodhead, et al.) discloses a method for detecting or quantifying multiple analytes using labelling techniques.
U.S. Pat. No. 5,340,716 (Ullman, et al.) describes an assay method utilizing photoactivated chemiluminescent labels.
Photoactivatable chemiluminescent matrices are described in patent application WO 94/03812 (Pease, et at.).
European Patent Application No. 0 515 194 A2 (Ullman, et at.) discloses assay methods utilizing induced luminescence. The references cited therein are incorporated herein by reference including without limitation U.S. Pat. No. 5,017,473 (Wagner), which discloses a homogeneous chemiluminescence immunoassay using a light absorbing material, European Patent Application No. 0,345,776 (McCapra), which discloses specific binding assays that utilize a sensitizer as a label, U.S. Pat. No. 4,193,983 (Ullman, et al.), which discloses labeled liposome particle compositions and immunoassays therewith, U.S. Pat. No. 4,891,324 (Pease, et al.), which describes a particle with luminescer for assays.
SUMMARY OF THE INVENTION
One aspect of the present invention is a method for determining the presence or relative amounts of two or more components in a medium. A combination is provided comprising a medium suspected of containing the components and a label reagent for each of the components. The label reagent comprises a chemiluminescent composition. Luminescence emitted by each of the chemiluminescent compositions is activated by electromagnetic radiation and is differentially detectable. At least one of the chemiluminescent compositions comprises a fluorescent energy acceptor. The chemiluminescent compositions are activated and the amount of luminescence generated by each of the chemiluminescent compositions is detected. The amount of luminescence is related to the amount of each of the components in the medium.
Another aspect of the present invention is a method for determining the presence or relative amounts of two or more components in a medium. A combination is provided comprising a medium suspected of containing the components and a label reagent for each of the components. The label reagent comprises a first specific binding pair (sbp) member associated with a chemiluminescent composition. Luminescence emitted by each of the chemiluminescent compositions activated by electromagnetic radiation and is differentially detectable. The first sbp member is capable of binding to the component or to a second sbp member to form a complex related to the amount of the component. At least one of the chemiluminescent compositions comprises a fluorescent energy acceptor. After the above are combined, the chemiluminescent compositions are activated. The amount of luminescence generated by each of the chemiluminescent compositions is detected and related to the amount of each of the components in the medium.
Another aspect of the present invention is a homogeneous method for determining the presence or relative amounts of two or more components in a medium. A combination is provided comprising a medium suspected of containing the components and a label reagent for each of the components. The label reagent comprises a first specific binding pair (sbp) member associated with a chemiluminescent composition. Each of the chemiluminescent compositions comprises an olefinic compound activat
Singh Sharat
Ullman Edwin F.
Dade Behring Marburg GmbH
Leitereg Theodore J.
Snay Jeffrey
LandOfFree
Chemiluminescent compositions for use in detection of... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Chemiluminescent compositions for use in detection of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Chemiluminescent compositions for use in detection of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2922700