Processes, reagents and means for early diagnosis of pregnancy
AssigneeLaboratoire Theranol
InventorRobert Louis Prugnaud
Life of this patent
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Abstract
A reagent for the early diagnosis of pregnancy comprising a substrate of suitable erythrocytes or polymer having adsorbed thereon a predetermined ratio of chorionic gonadotropin antigen and antisera therefor. The ratio is selected so as to be insensitive to the presence of less than 1,500 I.U. per liter of chorionic gonadotropin in the urine being tested. The reagent is used by combining with a predetermined quantity of the urine to be tested and after 1/2-2 hours inspecting for agglutination, the presence of which indicates a negative result. An apparatus is also disclosed for carrying out the process.
Claims9
In a process for early diagnosis of pregnancy in mammals for whom pregnancy causes elimination of chorionic gonadotropin of placental origin in the urine comprising:
- combining a predetermined quantity and dilution of urine from a subject being tested for pregnancy with a reagent comprising a storable, dry composition mixable with diluting liquid immediately prior to usage, said composition comprising a substrate of erythrocytes or synthetic polymer suitable for use as such a substrate on which are adsorbed chorionic gonadotropin endowed with antigen properties and said composition including a substance acting as an anti-serum with respect to this antigen;
- allowing the mixture to stand from one-half to 2 hours;
- and
- inspecting the mixture for the occurrence of agglutination reaction or the inhibition thereof, the improvement wherein
- the ratio of said adsorbed chorionic gonadotropin endowed with antigen properties to said substance acting as an anti-serum with respect to this hormone is such that said reagent is sensitive to chorionic gonadotropin in the urine only when the latter is eliminated in the urine at a rate exceeding 1,500 I.U. of chorionic gonadotropin per liter of urine, and the agglutination reaction is prevented when the urine contains more than 1,500 I.U. of chorionic gonadotropin per liter of urine.
- and wherein said composition comprises three superimposed dried layers, the lower layer comprising said substrate having adsorbed thereon said HCG antigen, the top layer comprising said antiserum, and a middle layer interposed between said bottom and top layers, said middle layer comprising a phosphate buffer containing a calcium ion chelating agent.
In a reagent for early pregnancy diagnosis, said reagent consisting essentially of a diluting liquid and a storable, dry composition of a substrate consisting essentially of erythrocytes or of synthetic polymer suitable for use as such a substrate, said substrate having adsorbed thereon chorionic gonadotropin (HCG) antigen and said composition including a substance acting as an antiserum with respect to said antigen, the improvement comprising:
- means to positively show pregnancy only when the rate of HCG exceeds 1,500 I.U. per liter of urine, said means comprising said reagent wherein the ratio of antigen to antiserum is selected so as to endow said reagent with a selective sensitivity threshold as regards to amount of chorionic gonadotropin eliminated in the urine so that said reagent will provide agglutination which is a negative pregnancy reaction when mixed with urine only when such urine contains less than 1,500 I.U. of HCG per liter of urine, said reagent being wholly insensitive of chorionic gonadotropin when the latter is eliminated in the urine until the rate exceeds 1,500 I.U. of HCG per liter of urine and wherein said reagent comprises three superimposed dried layers, the lower layer comprising said substrate having adsorbed thereon said HCG antigen, the top layer comprising said antiserum, and a middle layer interposed between said bottom and top layers, said middle layer comprising a phosphate buffer containing a calcium ion chelating agent.
Dependencies are inferred from the claim text.