This technology relates to a method of generating artificial compositions that can be used as positive controls in a genetic testing assay, such as a diagnostic assay for a particular genetic disease. Such controls can be used to confirm the presence or absence of a particular genetic mutation. The lack of easily accessible, validated mutant controls has proven to be a major obstacle to the advancement of clinical molecular genetic testing, validation, quality control (QC), quality assurance (QA), and required proficiency testing.

CDC researchers have developed algorithmic methods for determining sigmoid curve optimums and calculating component concentrations. Sigmoid curves are commonly generated in bioassays and used to calculate results. Various techniques have been used to define the curve, analyze the observations, and calculate a concentration. This technology is an algorithmic approach to identifying the usable portion of a sigmoid curve.

This CDC developed optimization technology allows one to characterize the behavior of the coefficient of variation (CV) for a range of mass spectrometer machine settings. Surface-enhanced laser desorption/ionization (SELDI) and matrix-assisted laser desorption/ionization (MALDI) are used for the early detection of numerous diseases, for example cervical cancer . A critical step in the analytical process is the optimization of experiment and machine settings to ensure the best possible reproducibility of results, as measured by the CV.

CDC research scientists have developed a method to identify and quantify the activity of pathogenic bacterial adenylate cyclase toxins by liquid chromatography tandem mass spectrometry (LC-MS/MS). Bacterial protein toxins are among the most potent natural poisons known, causing paralysis, immune system collapse, hemorrhaging and death in some cases.

CDC researchers have developed technology that consists of a simple and inexpensive technique for creating fluorescent labeled primers for nucleic acid amplification. Fluorescent chemical-labeled probes and primers are extensively used in clinical and research laboratories for rapid, real-time detection and identification of microbes and genetic sequences. During nucleic acid amplification, the "UniFluor" primer is incorporated into newly synthesized double stranded DNA.

This CDC generated invention entails improved methods of analyzing microneutralization assays, especially for the purposes of determining specific antibody concentrations and optimizing vaccine formulation. More specifically, the invention is a set of SAS based programs using 4-parameter logistic curve fitting algorithms to interpolate between individual data points, allowing for enhanced accuracy and precision when establishing neutralization titers.

CDC scientists have developed a rapid and cost-efficient method for generating fluorescently labeled primers for PCR and real-time PCR. At present, fluorescent primers are useful for detecting and identifying microbes and specific nucleic acid sequences, amplifying nucleic acids for pyro-sequencing, determining the levels of gene expression, and many other uses. However, problems exist with current techniques used to create fluorescent primers. For one, labeling is not one hundred percent efficient, leading to inaccurate results.

This novel assay features real-time PCR reagents and methods for detecting drug-resistance related mutations in HIV, for newly diagnosed patients and those individuals currently receiving antiretroviral therapies. As the use of antiretroviral compounds to treat HIV infection proliferates, viruses adapt and evolve mutations limiting the efficacy of these drugs and disrupting the success of treatment.

Micro-Screen is a CDC developed software program designed to capture images and archive and display a compiled image(s) from a portion of a microscope slide in real time. This program allows for the re-creation of larger images that are constructed from individual microscopic fields captured in up to five focal planes and two magnifications. This program may be especially useful for the creation of data archives for diagnostic and teaching purposes and for tracking histological changes during disease progression.

CDC researchers have developed a novel method that generates globally amplified DNA copies retaining parental methylation information; making accurate DNA-archiving for methylation studies much more feasible and cost-effective than undertaking such an endeavor with alternate technologies. This unique approach eliminates a significant bottleneck in the collection of methylation information in the genome(s) of an individual organism, hosts and pathogens.