Abstract: A digital computer system in a clinical testing laboratory assays free Beta in a biological sample obtained from a pregnant patient and uses the resulting data, along with other patient and reference data, to create a patient profile. Operations of the system include inputting patient data for a pregnant patient into an electronic memory and creating an individual profile for each patient. The processor assigns specific accession numbers for each specimen, creates an assay format for a biological sample, and interfaces with the assay equipment to control the assaying of the biological sample for free Beta. The assay results are communicated into memory in machine readable form and used along with patient data and reference data to calculate a patient specific risk that the patient is carrying a fetus having a designated defect. From all the input data, the processor creates comprehensive patient profiles in both machine readable form and human readable form.

Abstract: The present invention relates to a method for detecting fetal Down syndrome (Trisomy 21), trisomy 13, trisomy 18 and other chromosomal anomalies during prenatal screening by analyzing blood samples from a pregnant woman. More particularly the present invention relates to a method for improving detection efficiency in screening for the anomalies by measuring the amount of the free beta human chorionic gonadotropin (HCG) and nicked or fragmented or aberrant forms of free beta (HCG), all of which are referenced throughout this application as free beta (HCG) in blood samples from pregnant women.

Abstract: A method and apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome, The method comprises measuring the pregnant woman's maternal blood levels of the free beta subunit of human chorionic gonadotropin. The level of free beta subunit of human chorionic gonadotropin individually or with other markers may be compared to reference data. A computerized apparatus for making the determination preferably using a probability density function generated from a set of reference data by a linear discriminant analysis procedure is disclosed.

Abstract: A screening method for fetal Down syndrome using free beta (HCG) as a marker. The maternal blood level of free beta (HCG) is measured and compared to reference data, at a similar gestational age, of the level of free beta (HCG) in pregnant women carrying a fetus with Down syndrome and pregnant women carrying an unaffected fetus. The method may advantageously be utilized during the first and second trimesters of pregnancy. Fragments of free beta and "nicked" free beta may also be utilized as markers.

Abstract: A method and apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome. The method comprises measuring the pregnant woman's maternal blood levels of the free beta subunit of human chorionic gonadotropin. The level of free beta subunit of human chorionic gonadotropin individually or with other marker may be compared to reference data. A computerized apparatus for making the determination preferably using a probability density function generated from a set of reference data by a linear discriminant analysis procedure is disclosed.

Abstract: The present invention relates to a method for detecting fetal Down syndrome (Trisomy 21), trisomy 13, trisomy 18 and other chromosomal anomalies during prenatal screening by analyzing a dried blood sample from a pregnant woman. More particularly the present invention relates to a method for improving detection efficiency in screening for the anomalies by measuring the amount of the free beta human chorionic gonadotropin (HCG) and nicked or fragmented or aberrant forms of free beta (HCG), all of which are referenced throughout this application as free beta (HCG) in dried blood samples from pregnant women.

Abstract: An apparatus for the calibration and quality assurance of a multichannel spectrophotometer, particularly an ELISA spectrophotometer, comprises film selectively exposed in the presence of a color to produce a series of filters having a known first color and linearly increasing optical density. The response of the spectrophotometer is measured against the known color and linearly increasing optical density. Additional filters of at least one additional color permit checking the color response of the spectrophotometer. An algorithm determines whether the response conforms to predetermined conditions. An output is produced to provide a record of the calibration and quality assurance of the spectrophotometer. The invention has particular utility for conducting calibration and quality assurance of ELISA spectrophotometers used in clinical laboratory screening for infectious diseases, such as Hepatitis B. and the AIDS viruses.

Abstract: A method for determining if a pregnant woman is at significant risk of carrying a fetus with Edwards syndrome comprising measuring the pregnant woman's maternal blood levels of the free beta subunit of human chorionic gonadotropin.

Abstract: An apparatus for the calibration and quality assurance of a multichannel spectrophotometer, particularly an ELISA spectrophotometer, comprises a series of filters having a known first color and linearly increasing optical density. The response of the spectrophotometer is measured against the known color and linearly increasing optical density. Additional filters of at least one additional color permit checking the color response of the spectrophotmeter. An algorithm determines whether the response conforms to predetermined conditions. An output is produced to provide a record of the calibration and quality assurance of the spectrophotometer. The invention has particular utility for conducting calibration and quality assurance of ELISA spectrophotometers used in clinical laboratory screening for infectious diseases, such as Hepatitis B and the AIDS viruses.