Abstract: An automated method for assuring sample adequacy. The method includes providing a sample in a testing container, activating an illumination source to pass an illumination beam through the testing container and into the sample, and detecting an intensity of an emitted beam. The emitted beam includes at least a portion of the illumination beam that has been scattered by the sample. The method also includes generating a sample turbidity measurement based on the intensity of the emitted beam, and determining, based on the sample turbidity measurement, an adequacy of the sample to provide accurate results in a primary test.

Abstract: A sample adequacy measurement system having sample tubes and a housing having a receptacle to receive the sample tubes. The housing has sample adequacy measurement stations that each have a light source and a sample detector. The light source generates an illumination beam directed into one of the sample tubes. The sample detector is positioned along the tube, and receives at least a portion of the illumination beam scattered by turbidity in the sample tube. The detector is positioned at the end of an emitted beam path that extends in a plane that is perpendicular to the vertical direction and is oriented at a non-perpendicular angle with respect to the longitudinal axis of the sample tube unit. This reduce the likelihood that the emitted beam will pass through a damaged portion of the respective one of the sample tubes by passing the light through a protected portion of the tube.

Abstract: Cervical cancer screening using HPV testing can yields a high negative predictive value of approximately 99.5% for prediction of cervical lesions of CIN3 or greater. However, sample adequacy can affect the number of at-risk women that may go undetected due to the inadequacy of the tested sample. We have approached this challenge of increasing sample assurance of the negative results by estimating the cell count in known fluid volumes using light scattering techniques, in particular turbidity. These methods may be used as a fast, convenient, and economical method for measuring sample adequacy for other uses as well. Particular examples using these methods in conjunction with the HC2 HPV test are provided herein.

Abstract: This disclosure generally relates to methods of measuring the adequacy of a clinical sample by estimating the cell count in known fluid volumes using light scattering techniques, in particular turbidity. In another aspect, this disclosure provides machines for measuring the adequacy of a clinical sample by estimating the cell count. These machines can be used for high-throuhput processing of clinical samples. In another aspect this disclosure provides methods of determining whether testing of a clinical sample would be informative. Particular examples using these methods in conjunction with the HC2 HPV test are provided herein.

Abstract: The present invention is directed to compositions and methods for enhancing synthesis of nucleic acid molecules, particularly GC-rich nucleic acid molecules. Specifically, the invention provides compositions comprising one or more nitrogen-containing organic compounds having a formula selected from the group consisting of formula I and formula II (or salts or derivatives thereof), preferably 4-methylmorpholine N-oxide or betaine (carboxymethyltrimethylammonium), and further comprising one or more compounds selected from the group consisting of proline and an N-alkylimidazole compound, and more preferably proline, 1-methylimidazole or 4-methylimidazole. The invention further relates to methods for enhanced, high-fidelity synthesis of nucleic acid molecules, including via amplification (particularly PCR), reverse transcription, and sequencing methods.

Abstract: The present invention is directed to compositions and methods for enhancing synthesis of nucleic acid molecules, particularly GC-rich nucleic acid molecules. Specifically, the invention provides compositions comprising one or more nitrogen-containing organic compounds having a formula selected from the group consisting of formula I and formula II (or salts or derivatives thereof), preferably 4-methylmorpholine N-oxide or betaine (carboxymethyltrimethylammonium), and further comprising one or more compounds selected from the group consisting of proline and an N-alkylimidazole compound, and more preferably proline, 1-methylimidazole or 4-methylimidazole. The invention further relates to methods for enhanced, high-fidelity synthesis of nucleic acid molecules, including via amplification (particularly PCR), reverse transcription, and sequencing methods.

Abstract: The present invention is directed to compositions and methods for enhancing synthesis of nucleic acid molecules, particularly GC-rich nucleic acid molecules. Specifically, the invention provides compositions comprising one or more nitrogen-containing organic compounds having a formula selected from the group consisting of formula I and formula II (or salts or derivatives thereof), preferably 4-methylmorpholine N-oxide or betaine (carboxymethyltrimethylammonium), and further comprising one or more compounds selected from the group consisting of proline and an N-alkylimidazole compound, and more preferably proline, 1-methyliimidazole or 4-methylimidazole. The invention further relates to methods for enhanced, high-fidelity synthesis of nucleic acid molecules, including via amplification (particularly PCR), reverse transcription, and sequencing methods.

Abstract: Described are unique preferred enzyme coacervate compositions and their use in catalyzing the reaction of substrates to which the enzyme is specific. Preferred coacervates of the invention are complex coacervates formed by complexing enzymes with polyelectrolytes.