Abstract: A improved method for preparing a concentrated meconium extract containing basic and acid-neutral target analytes present in a meconium sample suspected of containing the target analytes is provided. The meconium sample is extracted with a mixed solvent of acetonitrile and a volatile organic acid and the resulting organic phase is separated. The organic phase is diluted with water to provide an organic solution which is passed through a mixed mode solid phase extraction column having strong cation exchange and hydrophobic functionality. Acid-neutral and basic target analytes are sequentially eluted from the column and the eluates are combined to form a combined extract. The combined extract is evaporated to dryness and reconstituted in buffer to provide a clean concentrated neonatal meconium extract for use in qualitative and quantitative analyses.

Abstract: A method for reducing or eliminating tyramine interference from amphetamine and methamphetamine immunoassays, comprising treating the sample with aqueous tyramine oxidase for a time and at a temperature and pH sufficient to deaminate any tyramine present in the sample, is provided.

Abstract: Device for the determination of analytes having a sample application point, several separate sample withdrawal zones that are each connected with the sample application point by one capillary transport path and that have several test elements for the individual determination of analytes wherein a retardation zone is provided on at least one of the transport paths. Material for the capillary transport of a liquid sample defines a sample application zone and a plurality of sample withdrawal zones connected to said application zone by a like plurality of transport paths. At least one of said paths has a retardation zone which assures that liquid applied to said application zone arrives simultaneously at said withdrawal zones, regardless of the lengths of the paths.

Abstract: This invention relates to a method and apparatus for detecting and identifying a non-volatile chemical substance, in which the chemical substance (when in a sample) is pyrolyzed into its gaseous components and then the gaseous components are monitored to determine whether or not specific gaseous components are present.

Abstract: A method of monitoring compliance of a patient that has been placed on a medication maintenance program with a prescribed medication dosage by determining a normalized urine methadone concentration. An unadulterated urine sample is obtained from the patient. The urine methadone concentration and urine specific gravity are measured. The normalized urine medication concentration is calculated as a function of the measured medication concentration in the urine and the urine specific gravity. The calculated normalized urine medication concentration is compared with an expected medication concentration value for the patient for the maintenance program prescribed to determine any significant differences therebetween as an indication of noncompliance.Alternatively, a urinary-parameter normalized urine medication concentration is calculated as a function of the measured medication concentration in the urine, the urine specific gravity and at least one selected pharmacokinetic parameter of the medication.

Abstract: Fresh urine to be tested eventually for detection of abuse-type drugs is preserved at room temperature for as long as six months by adding to the urine a small amount of a methanol solution of methyl and propyl parahydroxybenzoic acids.

Abstract: The present invention relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of generic anti-hapten antibodies. Also disclosed are multi-analyte immunoassay methods. Reagents, devices, and kits using the anti-hapten antibodies are also disclosed. The present invention also relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of a dual antibody format.The present invention also relates to dyed erythrocytes, preferably fixed, which are coated with antibodies. Also disclosed is the use of these dyed erythrocytes in agglutination assays to detect and measure the presence of an analyte in a sample. The analyte can be a hapten, an antigen, or an antibody. Also included are agglutination assays, compositions and kits using these dyed and coated erythrocytes.

Abstract: A system and method of determining absence or presence of an illicit substance in a flowing mixture of requisite reagents by agglutination or lack thereof. A plurality of photodetectors are positioned over an illuminated read area oblique to a path of the flowing mixture. Signal samples of each of the detectors are processed individually. Successive samples are processed over a period time to detect differences or edges between relatively clear liquid and relatively opaque clusters in the flowing mixture. The illicit substance is determined in accordance with the number of variations in signal samples for a predetermined number of detectors.

Abstract: Disclosed is a method of rapidly checking surfaces for the presence of traces of specific compounds such as certain explosives and drugs. A hand-covering such as a cotton glove is used to wipe surfaces to pick up particles of the specific compound which may indicate the presence of larger amounts or previous contact of a surface by a person who has handled the compound. The particles are transferred--unheated--to collection surfaces of a hand-held sample probe by vacuuming of the gloved hand by the battery-operated probe. Heat is then supplied by a source external to the probe to vaporize the particles, and the vapors are analyzed by a suitable technique such as high speed gas chromatography. The method permits checking of surfaces for explosives at processing rates of up to several samples per minute.

Abstract: A method for the direct analysis of analyte indicative of marijuana exposure found in keratinized structures, e.g., hair, fingernails and toenails, which comprises preparing a mixture containing dithiothreitol or dithioerythritol, a protease suitable for the digestion of the keratin structure and a sample of the keratin structure; permitting the enzyme to at least substantially digest the sample of keratin structure to form a digest solution, followed by mixing the digest solution with a suspension of an ion exchange resin to remove an interfering, cross reacting substance naturally found in hair and finally subjecting the digest solution to analysis to determine the identity and amount of marijuana analyte in the keratin structure sample. To accelerate the method, cupric sulfate may be added to the mixture after degradation of the keratin sample in order to deactivate the activator. The enzyme may be a protease with papain, chymopapain, and proteinase K being preferred for use in the invention.

Abstract: A method of detecting gluteraldehyde adulterant in a urine sample. An aliquot of urine is inserted into an automatic chemical analyzer and a spectrophotometric absorbance reading is taken. Thereafter, the aliquot is mixed with a reagent mixture containing a carbonyl indicator and a second spectrophotometric absorbance reading is taken and compared to the first reading.

Abstract: A self-contained unit test for qualitative identification of suspect substances including cocaine, heroin and cannabis, includes a visualization reagent having a compound which undergoes a visible color change when contacted by a suspect substance. The unit test further includes a pad formed from a bibulous material impregnated with the reagent and a unit package for containing the pad and maintaining the reagent in an as-filled, ready-to-use state during storage. A method for visualization of a suspect substance with a unit test of the present invention includes providing a unit test for a suspect substance which includes a visualization reagent for qualitative identification of a suspect substance impregnated on a pad formed from a bibulous material, and scaled in a unit package. The method further includes opening the package, and wiping the pad on as sample containing the suspect substance.

Abstract: The present invention relates to an apparatus for conducting a variety of assays that are responsive to a change in the viscosity of a sample fluid and relates to methods of conducting such assays. In particular, the present invention is related to the use of a cartridge for conducting one or more coagulation assays or, conversely, fibrinolysis assays. The disclosed device enjoys simplicity and is adaptable to the point-of-care clinical diagnostic area, including use in accident sites, emergency rooms, surgery or intensive care units.

Abstract: A surface ionization detector for detecting organic molecules such as illicit drugs and non-organo-nitrate explosives includes a heated surface and a collector electrode. A sample containing trace amounts of the organic molecules in ambient air is directed over the heated surface maintained at a temperature in the range of 500.degree. C. to 800.degree. C., thereby causing the molecules to decompose into fragments. A polarization voltage between 18 V and 24 V is applied to ionize the fragments which are then collected by the collector electrode. An electrometer connected to the collector electrode measures the current and a change in the current indicates the presence of ionized fragments, and thereby indicates the presence of the organic molecules. The temperature of the heated surface and the polarization voltage are optimized for detection of particular organic molecules.

Abstract: Biological samples are analyzed for benzodiazepines in a single isocratic analysis using a chromatographic column system containing an immobilized enzyme reactor which cleaves glucuronic acid-conjugated benzodiazepines, an anion exchange column, a hydrophobic cation exchange column and a reverse-phase analytical column. Preferred methods of performing the analysis further involve the use of a hydrophobic cation exchange precolumn prior to the anion exchange column. The system readily lends itself to automation, automatic periodic sampling and benzodiazepine identification and quantification. The system is particularly well adapted to the determination and identification of benzodiazepines in urine samples.

Abstract: A method of tagging and detecting illicit drugs or paper currency is disclosed which comprises the steps of:(a) applying a Perfluorocarbon Tracer (PFT) to the drugs or currency such that said PFT is released over a period of time as a vapor taggant; and(b) subsequently detecting the presence of said vapor taggant, and therefore the drugs or currency.

Abstract: A labelling color which includes a pentamethine of the following formula (1): ##STR1## wherein R.sup.1, R.sup.2, R.sup.3 and R.sup.4 each are a C.sub.1-6 alkyl group, and X is an anion.

Abstract: The present invention is an in-vitro blood assay method for determining the past and/or present use of exogenous erythropoietin by a living subject. The blood assay method detects, identifies, and determines the consequences of using an exogenous erythropoietin to generate an increase in red blood cell production in the living subject and provides a methodology by which to detect and determine both surreptitious as well as authorized therapeutic uses and applications of erythropoietin.

Abstract: The precision of identification of analyte composition in a sample, where the possible analytes cross-react with specific binding reagents, is enhanced by applying pattern recognition techniques. Samples to be tested are reacted with a panel of specific binding reagents reactive with the set of analytes to be tested to obtain a pattern of reactivity with respect to each analyte at a given concentration. This results in a databank of "CRIM profiles" for known concentrations of each analyte. This databank is stored in a computationally accessible form, which then can be matched against CRIM patterns obtained by testing unknown samples. In one embodiment, each CRIM pattern obtained is plotted as a single point in n-dimensional space, wherein n represents the number of specific binding reagents in the panel.

Abstract: Methods for collecting neonatal meconium samples, preparing meconium specimens for testing and for chemically analyzing neonatal meconium samples to determine their chemical composition are provided. A novel extraction method is employed in accordance with the invention to provide a non-aqueous, concentrated "cocktail" meconium extract containing substantially all of many possible target analytes in a single extraction step. Preliminary screening by fluorescence polarization immunoassay methods may be performed on the cocktail extract to qualitatively determine the presence of the target analytes in the meconium sample. If a positive preliminary result is obtained, new and improved quantitative GC/MS confirmatory procedures are provided by this invention to unequivocally identify and quantitate the amount of target analyte present in the sample in terms of nanograms of analyte per gram of meconium tested.

Abstract: Novel derivatives of phencyclidine are provided as precursors for conjugating to antigenic proteins for the preparation of antibodies which bind to phencyclidine or conjugation to enzymes for use as reagents in immunoassays. The combination of the antibodies and enzyme conjugates provide a sensitive and rapid assay for phencyclidine.

Abstract: The present invention relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of generic anti-hapten antibodies. Also disclosed are multi-analyte immunoassay methods. Reagents, devices, and kits using the anti-hapten antibodies are also disclosed. The present invention also relates to dyed erythrocytes, preferably fixed, which are coated with antibodies. Also disclosed is the use of these dyed erythrocytes in agglutination assays to detect and measure the presence of an analyte in a sample. The analyte can be a hapten, an antigen, or an antibody. Also included are agglutination assays, compositions and kits using these dyed and coated erythrocytes.

Abstract: A method and apparatus for selective, high speed detection of vapors of specific gas-chromatographically-separable compounds. In the disclosed method separate analyses are performed on two portions of a gas sample formed by flash-heating trapped vapors to successively higher temperatures while flowing hydrogen carrier gas over coatings in/on which the vapors are held. Within a total time interval of about twenty seconds 1) two sample portions are formed, 2) each portion is rapidly separated in two series-connected, high speed, temperature-programmed gas chromatographs, and 3) specific compounds are identified by detection of NO gas formed during an oxidative pyrolysis of each separated portion. One application of the described method and apparatus is the rapid, selective, and sensitive detection of nitrogen-containing compounds such as the drugs methamphetamine, cocaine, and heroin.

Abstract: The method of identification of the country of origin of CANNABIS (Marijuana). The method comprises gas chromatographic/mass spectrometric analysis of extracts of multiple samples of marijuana plant material from a country or geographical location, preparing a location profile from the chemical profiles made from analysis of the multiple samples from a specific country or location. The analyzed profile of a sample of unknown origin is compared with the location profiles of the various countries growing marijuana.

Abstract: A method and device for testing for the presence of substances such as drugs in body fluids while simultaneously positively identifying the test subject. The device comprises an absorbent pad and a membrane mounted to the absorbent pad containing a plurality of separated areas provided with different immobilized ligand having a specific receptor site for capture or rejection of specific antigens produced by different predetermined drugs.

Abstract: An immunofluorescent assay method, characterized in using an immunodetective reagent, which is an antigen-like substance comprising a fluorescent substance and an antigen chemically bonded thereto with or without intervention of an additional chemical bond, said fluorescent substance being changed in the wavelength or intensity of the fluorescence when an antibody comes close thereto, and said antigen being specific to said antibody.

Abstract: An analytical test device for competition assay for particular non-protein antigens, such as antigens representing drugs of abuse, is disclosed. The analytical test device is a test kit housing having an opening for introduction of a body fluid sample and a flow path for the body fluid sample. A supply of microscopic colored latex particles is adjacent to the opening along the flow path. A chromatographic membrane support is within the test kit housing for exposing the colored latex particles to the body fluid sample. When non-protein antigens are not present in the body fluid specimen, the colored latex particles accumulate at a predetermined site on the chromatographic membrane by complexing of antibodies on the colored latex particles to a drug conjugate probe on the membrane support to leave a visually perceptible colored mark of the same color as the colored latex particles.

Abstract: An improved method for detecting the presence of durg metabolites in the meconium of newborn infants is described. The method involves a single step extraction of the drug metabolites from meconium using a buffered aqueous solution containing methanol in an amount between about 10 and 30% by volume and buffered to a pH between 6 and 7 and then assaying the extract individually for the presence of the drug metabolites. The method is particularly useful for detection of cocaine, morphine, cannabinoid and amphetamine metabolites; however, any drug metabolite in the infant meconium can be tested if it is extracted by the solution from the meconium. Various assay methods are used for the drug metabolites in the solutions derived from the meconium, including immunoassays, fluorescent assays and mass spectroscopy. The method provides for early detection of drug presence in newborn infants which contribute to infant illness.

Abstract: The present invention relates to a method and a kit for verifying the source and completeness of urine samples when collected for testing for the presence of drugs of abuse. The method involves observing an individual consume (1) a quantity of a first chemical marker reagent capable of confirming upon chemical analysis the completeness of the urine sample and (2) a quantity of a second chemical marker reagent capable of confirming upon analysis the accuracy of the source of the urine sample. The urine subsequently collected is analyzed by known analytical techniques.

Abstract: A capillary flow device useful in double capture assays, such as double capture immunoassays, and a double capture assay. The capillary flow device comprises a capillary track, a sample receptacle, a particle collecting means and, optionally, a magnet and a particle concentrator. The assay method is useful for determining any analyte of interest for which there is a specific binding partner.

Abstract: The bonded phases generated from the reaction of aliphatic and aromatic azidosilanes with silica gel are suitable for use as packings in solid phase extraction columns for cleanup of urine samples for analysis of acid metabolites of cannabinoids. Such bonded phases are unique in their ability to selectively retain the acid metabolites of cannabinoids from a urine sample matrix.

Abstract: The invention provides a method and a test area to prevent tampering in the collection of specimens for substance abuse testing from a subject utilizing a specimen collection container. More particularly, the present invention prevents the substitution of the subject by another person and prevents the subject from introducing a previously obtained and concealed false specimen while minimizing intrusion on the subject's privacy.

Abstract: An electrically conducting self-doped carbazole polymer of the formula: ##STR1## wherein A is a bifunctional molecule capable of bonding to a positively charged molecule at one end and is capable of bonding to a flexible spacer group Z at another end, Z is a flexible spacer group capable of bonding to an anionic group A at one end and is capable of bonding either to a nitrogen or aromatic electron withdrawing or electron donating group at another end, E is a bifunctional molecule capable of bonding to nitrogen at one end and is capable of bonding to a flexible spacer group Z at anther end, X is a positively charged counterion, and n is at least 2.

Abstract: A fluorescence polarization immunoassay (FPIA) for detecting the presence of one or more amphetamine-class analytes in a test sample is provided. The immunoassay uses competition between the analyte and a fluorescently labeled tracer for the binding site on an antibody specific for phenethylamine derivatives. The concentration of amphetamine-class analyte in the sample determines the amount of tracer that binds to the antibody. The amount of tracer/antibody complex formed can be quantitatively measured and is inversely proportional to the quantity of analyte in the test sample. The invention relates to tracers, to immunogens used to elicit antibodies for use as assay reagents, and to assay kits incorporating these tracers and assay reagents.

Abstract: A method and test kit for detecting and treating inherited substance abuse dependency by counting viable T-cell suppressor cells (CD8) is described. In the preferred form the T-cell suppressor cells are isolated and then counted. The method and test kit are important for distinguishing a genetic deficiency with a tendency towards alcoholism as opposed to a psychological dependency on drugs.

Abstract: A method for distinguishing an alcoholic person from non-alocholic persons which comprises measuring the potential of lymphocytes from that person to produce phosphatidylenthanol and comparing the results obtained with a standard obtained from the lymphocytes of persons which are known not to be at substantial risk of becoming alcohol dependent which lymphocytes were incubated under identical conditions.

Abstract: Biological fluid test samples are analyzed for a broad spectrum of drugs, including benzodiazepines, amphetamines, tricyclic antidepressants and opiates, in a single isocratic analysis using a chromatographic column system containing three analytical columns--an anion exchange column, a reversed phase column and a cation exchange column. A pre-column is also included to purge the sample of salts, proteins, peptides and hydrophilic anions. Carrier liquids containing acetonitrile at various strengths are used for distribution of the various drugs among the columns, elution of the drugs from the columns, and column purging and conditioning. The system readily lends itself to automation, automatic periodic sampling, and component identification and quantification.

Abstract: This invention provides a method and a test area to prevent tampering in the collection of specimens for substance abuse testing from a subject utilizing a specimen collection container. More particularly, the present invention prevents the substitution of the subject by another person and prevents the subject from introducing a previously obtained and concealed false specimen while minimizing intrusion on the subject's privacy.

Abstract: New internal standards for use in gas chromatography/mass spectrometry test methods, comprising deuterated cannabinoids, have been developed for the analysis of tetrahydrocannabinol and its metabolites in biological fluids.

Abstract: A method for detecting the presence of drug metabolites in the meconium of newborn infants is described. The method involves separation of the drug metabolites from meconium in solution and then assaying the solution for the presence of the drug metabolites. The method is particularly useful for detection of cocaine, morphine and cannabinoids; however, any drug metabolite in the infant meconium can be tested. Conventional assay methods are used for the drug metabolites in the solutions derived from the meconium. The method provides for early detection of drug presence in infants which contribute to infant illness.

Abstract: A method for assaying compounds belonging to the group biogenic amines and including catecholamines, indoleamines, their metabolites and derivatives, and other small molecular weight compounds using a boric acid extraction method followed by high pressure liquid chromatographic separation in conjunction with electrochemical detection. The method utilizes high purity chemical and liquid components, a microparticulate-silica bonded phenyl stationary phase in the chromatography column and special cleaning and maintenance measures for the various components of the assaying apparatus which result in reduced baseline noise and allow the electrochemical cell to be operated at a sensitivity of one nanoamp or less full scale deflection on a continuous basis.

Abstract: The invention describes a method for determining the BZ-1 receptor activity of a test sample or a potential anxiolytic drug.

Abstract: A method of making drug abuse test papers wherein bibulous paper carriers are impregnated with specific test chemicals, (bismuth subnitrate, potassium iodide, acetic acid, and platinum salt), in two coatings and dried after each coating under specific temperature conditions. The test chemicals are provided for the detection of the drug abuse compounds of amphetamine, cocaine, marijuana, and narcotics contained in low concentrations in animal or human urine. Additionally described is a means of preserving urine samples using esters of parahydroxybenzoic acid.

Abstract: Disclosed are methods of rapidly and accurately detecting a compound-of interest, such as a toxic drug, in a body fluid. A liquid sample containing various native constituents and an anticipated exogenous chemical compound is obtained from the body. The sample is then subjected to analysis by ion mobility spectrometry to determine the presence of the exogenous chemical compound or related metabolite therein. The method may further include the step of separating the compound-of-interest from said native constituents in said fluid sample prior to analysis.

Abstract: Primary and secondary amines in biological fluids are selectively derivitized by reaction with esters of N-hydroxysuccinimide or N-hydroxysulfosuccinimide to form an N-acylated derivative. Those N-acylated derivatives may then be extracted into a polar organic phase and extracted. Non-electroactive amines may be made suitable for coulometric analysis by selecting the ester used so as to attach an electroactive group to the amine. For example, histamine may be reacted with the Bolton-Hunter reagent to form a suitable derivative in high yield.

Abstract: This disclosure relates to a method and reagents for determining amphetamine and methamphetamine in a biological fluid such as urine. In particular, this disclosure relates to a fluorescence polarization immunoassay procedure for determining the presence of amphetamine and methamphetamine in a single assay and to a novel class of tracer compounds employed as reagents in such procedures. The procedure described includes pretreatment of the biological sample to eliminate cross-reactants such as .beta.-hydroxyphenethylamine by preincubating the sample solely with an aqueous periodate solution having a pH from about 4.0 to about 7.5 without adjustment to an alkaline pH.

Abstract: An improved method for the detection of tetrahydrocannabinol in human urine wherein the pigment melanin is precipitated out of the urine prior to analysis with a solution of nitroferricyanide so that the melanin does not interfere with the analysis. The value attributable to melanin can also be subtracted from the value obtained during the analysis of the urine. The precipitation of melanin prior to analysis or subtraction of the melanin value during analysis greatly reduces the occurrence of false positive test results for persons with dark skin.

Abstract: The invention provides a process for the presumptive identification of cocaine or heroin street drug comprising applying to a sample of the suspected drug a reagent which gives a characteristic color reaction in the presence of trace amounts of organic bases or acetic acid. The invention also provides a prepacked screening kit for illicit cocaine and heroin street drug if present, comprising a reagent which gives a characteristic color reaction in the presence of the trace amounts of organic bases or acetic acid in said illicit substances.

Abstract: A method for the determination of the drug or other analyte content and concentration in bodily fluids that are directly injected in a micellar chromatographic column. Various embodiments of kits are also disclosed.

Abstract: A method for detecting cannabinoids in body fluids which comprises filtering body fluids through a cellulosic filtering means treated with a binding agent for cannabinoids and the filtering means. The binding agent is an arylcarboxylic acid. The cannabinoids are then treated with a subsequent reagent to produce a color reaction. A device for detecting cannabinoids is also disclosed which contains the filtering means treated with the binding agent so as to concentrate the cannabinoid prior to reaction with a suitable indicator.