The disclosure relates to methods of preparation of fetal nucleated red blood cells (NRBCs) from biological samples for diagnostic testing.

A highly accurate non-invasive prenatal testing methodology that allows accurate fetal rhesus determination and fetal DNA fraction measurement in a single assay is provided. The disclosed testing may be administered as early as at week 10 of pregnancy and can be conveniently combined with prenatal genetic disease testing and detection.

Methods, systems, and apparatus are provided for determining whether a nucleic acid sequence imbalance exists within a biological sample. One or more cutoff values for determining an imbalance of, for example, the ratio of the two sequences (or sets of sequences) are chosen. The cutoff value may be determined based at least in part on the percentage of fetal DNA in a sample, such as maternal plasma, containing a background of maternal nucleic acid sequences. The percentage of fetal DNA can be calculated from the same or different data used to determine the cutoff value, and can use a locus where the mother is homozygous and the fetus is heterozygous. The cutoff value may be determined using many different types of methods, such as sequential probability ratio testing (SPRT).

The disclosure pertains to methods of treating or preventing a disease or condition associated with and/or induced by soluble A-beta oligomer such as Alzheimer's disease by administering to a subject in need thereof conformation specific and/or selective antibodies or binding fragments thereof and related products.

The present invention includes methods and kits for the diagnosing a neurological disease within primary care settings comprising: obtaining a blood test sample from a subject, measuring IL-7 and TNFα biomarkers in the blood sample, comparing the level of the one or a combination of biomarkers and neurocognitive screening tests with the level of a corresponding one or combination of biomarkers in a normal blood sample and neurocognitive screening tests, and predicting that an increase in the level of the blood test sample in relation to that of the normal blood sample indicates that the subject is likely to have a neurological disease.

A method of making a noninvasive molecular control and analysis is described. The method of making the noninvasive molecular control includes, predetermining a positive control for a condition of interest, selecting a cell line with a control marker for the condition of interest, amplifying release of cfDNA from the selected cell line, isolating the released cfDNA from the selected cell line, quantifying the control marker from the isolated cfDNA, determining a volume of the control marker for addition to an isolated control plasma, isolating the control plasma from a control sample, treating the isolated control plasma with a control stabilizer, determining a volume of the control plasma to add to the volume of control marker, combining the volume of the control marker with the isolated control plasma, and analyzing a sample against the noninvasive molecular control to determine the presence or absence of a condition of interest.

The present invention includes methods and kits for measuring a level of four or more biomarkers selected measuring a level of four or more biomarkers selected from ILL IL7, TNFα, IL5, IL6, CRP, IL10, TNC, ICAM1, FVII, I309, TNFR1, A2M, TARC, adiponectin, MIP1, eotaxin3, sVCAM1, TPO, FABP, IL18, B2M, SAA, PPY, DJ1, and α-synuclein, Aβ40, Aβ42, tau, α-synuclein, and NfL in a sample separated from a human subject in the primary care setting with neurological disease with a nucleic acid, an immunoassay or an enzymatic activity assay.

A marker of fetal trophoblast cells, an identification method, a detection kit and the use thereof. The identification method comprises performing dyeing treatment on a sample containing fetal trophoblast cells with a fluorescence-labeled HK2 antibody substance, and then performing fluorescence detection, wherein HK2 positive cells are target cells. The kit comprises a fluorescence-labeled HK2 antibody substance and a cell nucleus dye. The above-mentioned technical solution can sensitively and reliably detect fetal trophoblast cells in the cervical mucus or blood samples of pregnant women in the first trimester, and especially can be used for prenatal diagnosis in early pregnancy.

Methods for detecting a Group of Biomarkers is provided herein. The translation profile of the Group of Biomarkers can be used for determining whether a subject, such as a fetus, has Down syndrome The methods include detecting one or more specific groups of biomarkers in a biological sample, and determining whether the expression of the biomarkers is altered when compared to expression of the biomarkers in one or more subjects that do not have trisomy 21 (e.g., a transcriptional standard). The biological sample can be a blood sample, and the biomarkers are cell free plasma RNAs.

The disclosure pertains to conformational epitopes in A-beta, antibodies thereto and methods of making and using immunogens and antibodies specific thereto.