| CPC G01N 33/689 (2013.01) [G01N 33/54389 (2021.08)] | 7 Claims |
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1. A diagnostic system for monitoring ovulation cycles, comprising:
a lateral flow assay test cassette configured to simultaneously measure at least two hormones and/or analytes present within a single sample, wherein the lateral flow assay test cassette comprises:
a sample well configured to collect and receive the single sample; and
a test strip configured to receive the single sample from the sample well and to detect the presence of pregnanediol glucuronide (PdG) and at least one other hormone and/or analyte in the single sample, wherein the test strip comprises:
labeled monoclonal anti-PdG antibodies of IgG isotype impregnated onto an upstream portion of the test strip, wherein the labeled monoclonal anti-PdG antibodies of IgG isotype bind to PdG present in the single sample and move with fluid flowing downstream through the test strip, wherein the monoclonal anti-PdG antibodies of IgG isotype are deposited under ATCC accession number PTA-127054;
one or more of the following further impregnated onto the upstream portion of the test strip:
i. labeled anti-luteinizing hormone (LH) antibodies that bind to LH present in the single sample and move with fluid flowing downstream through the test strip;
ii. labeled anti-human chorionic gonadotropin (hCG) antibodies that bind to hCG present in the single sample and move with fluid flowing downstream through the test strip;
iii. labeled anti-follicle stimulating hormone (FSH) antibodies that bind to FSH present in the single sample and move with fluid flowing downstream through the test strip;
iv. labeled anti-estradiol (E2) antibodies that bind to E2 present in the single sample and move with fluid flowing downstream through the test strip;
V. labeled anti-estrogen metabolite antibodies that bind to estrogen metabolites present in the single sample and move with fluid flowing downstream through the test strip; and/or
vi. labeled anti-progesterone (P4) antibodies that bind to P4 that is present in the single sample and move with fluid flowing downstream through the test strip; and
a reagent-impregnated membrane, positioned in a downstream portion of the test strip, wherein the reagent-impregnated membrane comprises a plurality of detection zones, wherein:
PdG is immobilized by impregnation onto a first detection zone of the reagent-impregnated membrane for binding labeled monoclonal anti-PdG antibodies of IgG isotype in a competitive assay format, to indicate the presence of PdG in the single sample at a minimum concentration of 1-20 ug/mL, and
one or more of the following are further immobilized by impregnation onto one or more additional detection zones of the reagent-impregnated membrane:
i. anti-LH antibodies for binding LH complexed to the labeled anti-LH antibodies from the upstream portion of the test strip in a sandwich assay format, to indicate the presence of LH at a minimum concentration of 1-50 mIU/mL,
ii. anti-hCG antibodies for binding hCG complexed to the labeled anti-hCG antibodies from the upstream portion of the test strip in a sandwich assay format, to indicate the presence of hCG at a minimum concentration of 1-10,000 mlU/ml,
iii. anti-FSH antibodies for binding FSH complexed to the labeled anti-FSH antibodies from the upstream portion of the test strip in a sandwich assay format, to indicate the presence of FSH at a minimum concentration of 3-20 mlU/mL,
iv. E2 for binding labeled anti-E2 antibodies in a competitive assay format, or anti-E2 antibodies for binding E2 complexed to the labeled anti-E2 antibodies from the upstream portion of the test strip in a sandwich assay format, to indicate the presence of E2 in the single sample at a minimum concentration of 25-250 pg/mL,
v. estrogen metabolite for binding labeled anti-estrogen metabolite antibodies in a competitive assay format, or anti-estrogen metabolites for binding estrogen metabolites complexed to the labeled anti-estrogen metabolites from the upstream portion of the test strip in a sandwich assay format, to indicate the presence of estrogen metabolites in the single sample at a minimum concentration of 1-1000 ng/ml; and/or
vi. P4 for binding labeled anti-P4 antibodies in a competitive assay format, to indicate the presence of progesterone in the single sample at a minimum concentration of 1-60 ng/ml.
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