Abstract: The present invention relates to a system for performing assays on a solid phase to measure the level of analyte in a sample. Such a system may perform immunoassays using electrochemiluminescence (ECL) including a counterbalanced orbital shaking apparatus for assay consumables. The counter-balanced orbital shaking apparatus also incubates the assay consumables, and has a cooling system to maintain a preset temperature within the shaking apparatus.

Abstract: An automated sample processing system having a sample input adapted to simultaneously receive a number of sample containers, a reagent input adapted to receive one or more new reagent supplies, a consumable input adapted to receive one or more new consumable supplies, a solid waste output adapted to receive used consumable supplies, a liquid waste output adapted to receive one or more used reagent supplies, and a processing center. The processing center includes a decapper adapted to remove a lid from at least one sample container, an aspirator adapted to remove a specimen from the at least one sample container and transfer the specimen to an output vessel, and a capper adapted to replace the lid on the at least one sample container.

Abstract: An automated process for converting samples includes: receiving tube strips having a number of sample tubes and samples therein, transferring multiple tube strips to a tube strip holder, dispensing sample conversion buffer into each tube, shaking the tube strip holder a first time, centrifuging the tube strip holder, removing a liquid supernatant from each tube, simultaneously inspecting the contents of each tube, dispensing a specimen transport medium and a denaturation reagent into each tube, shaking the tube strip holder a second time, heating the tube strip holder for a first length of time, shaking the tube strip holder a third time, heating the tube strip holder for a second length of time, shaking the tube strip holder a fourth time, and transferring at least a portion of each sample to a respective well on an output plate.

Abstract: A method for removing supernatant from a sample tube. The method includes providing a sample tube having a pellet at a bottom of the sample tube and a supernatant liquid above the pellet, visually inspecting the sample tube to determine one or more geometric properties of the pellet, and determining an expected height of a top surface of the pellet based on the one or more geometric properties determined in the visual inspection step. The method also includes inserting an aspirator into the supernatant liquid, moving the aspirator downwards towards the expected height of the top surface of the pellet, and aspirating the supernatant liquid through the aspirator.

Abstract: A cover for covering an array of sample tubes during an incubation process. The cover has an upper panel and protrusions extending downward from the upper panel. Each protrusion has an upper seal and a lower seal. The upper seal includes a first conical section that tapers from a first diameter that is larger than the inside diameter of a corresponding sample tube to a second diameter that is smaller than the inside diameter of the corresponding sample tube. The lower seal includes a cylindrical section extending downward from the bottom of the first conical section. The cylindrical section has a diameter selected to create a capillary seal, in the presence of a liquid, between the cylindrical section and an adjacent portion of an inner wall of the corresponding sample tube.

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 method for removing supernatant from a sample tube. The method includes providing a sample tube having a pellet at a bottom of the sample tube and a supernatant liquid above the pellet, visually inspecting the sample tube to determine one or more geometric properties of the pellet, and determining an expected height of a top surface of the pellet based on the one or more geometric properties determined in the visual inspection step. The method also includes inserting an aspirator into the supernatant liquid, moving the aspirator downwards towards the expected height of the top surface of the pellet, and aspirating the supernatant liquid through the aspirator.

Abstract: An automated sample processing system having a sample input adapted to simultaneously receive a number of sample containers, a reagent input adapted to receive one or more new reagent supplies, a consumable input adapted to receive one or more new consumable supplies, a solid waste output adapted to receive used consumable supplies, a liquid waste output adapted to receive one or more used reagent supplies, and a processing center. The processing center includes a decapper adapted to remove a lid from at least one sample container, an aspirator adapted to remove a specimen from the at least one sample container and transfer the specimen to an output vessel, and a capper adapted to replace the lid on the at least one sample container.

Abstract: An automated process for converting samples includes: receiving tube strips having a number of sample tubes and samples therein, transferring multiple tube strips to a tube strip holder, dispensing sample conversion buffer into each tube, shaking the tube strip holder a first time, centrifuging the tube strip holder, removing a liquid supernatant from each tube, simultaneously inspecting the contents of each tube, dispensing a specimen transport medium and a denaturation reagent into each tube, shaking the tube strip holder a second time, heating the tube strip holder for a first length of time, shaking the tube strip holder a third time, heating the tube strip holder for a second length of time, shaking the tube strip holder a fourth time, and transferring at least a portion of each sample to a respective well on an output plate.

Abstract: A cover for covering an array of sample tubes during an incubation process. The cover has an upper panel and protrusions extending downward from the upper panel. Each protrusion has an upper seal and a lower seal. The upper seal includes a first conical section that tapers from a first diameter that is larger than the inside diameter of a corresponding sample tube to a second diameter that is smaller than the inside diameter of the corresponding sample tube. The lower seal includes a cylindrical section extending downward from the bottom of the first conical section. The cylindrical section has a diameter selected to create a capillary seal, in the presence of a liquid, between the cylindrical section and an adjacent portion of an inner wall of the corresponding sample tube.

Abstract: A tube strip handling and heating frame having a rectangular outer frame having two spaced longitudinal walls extending in a longitudinal direction, and two spaced lateral walls extending in a lateral direction and extending between respective ends of the longitudinal walls. The outer frame forms an enclosure having an open upper side and an open lower side. The frame also has a number of tube strip wells located inside the outer frame, each tube strip well has a slot elongated in the lateral direction, and each slot is configured to receive a respective tube strip through the open upper side and support the respective tube strip in a vertical direction. The tube strip wells are arranged in a series along the longitudinal direction.

Abstract: An automated sample processing system having a sample input adapted to simultaneously receive a number of sample containers, a reagent input adapted to receive one or more new reagent supplies, a consumable input adapted to receive one or more new consumable supplies, a solid waste output adapted to receive used consumable supplies, a liquid waste output adapted to receive one or more used reagent supplies, and a processing center. The processing center includes a decapper adapted to remove a lid from at least one sample container, an aspirator adapted to remove a specimen from the at least one sample container and transfer the specimen to an output vessel, and a capper adapted to replace the lid on the at least one sample container.

Abstract: An automated assay processing method including transferring a first number of samples from respective sample containers to a first intermediary vessel, determining the testing adequacy of a second number of samples in a second intermediary vessel, preparing a third number of samples in a third intermediary vessel for downstream testing; and transferring a fourth number of samples from a fourth intermediary vessel to an output sample tray. These steps are all performed essentially simultaneously within the duration of a single clock cycle and are repeated during one or more subsequent clock cycles. The clock cycle may be relative to each intermediary vessel. The clock cycle also may be universal to the first, second, third and fourth intermediary vessels.

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: An automated assay processing method including transferring a first number of samples from respective sample containers to a first intermediary vessel, determining the testing adequacy of a second number of samples in a second intermediary vessel, preparing a third number of samples in a third intermediary vessel for downstream testing; and transferring a fourth number of samples from a fourth intermediary vessel to an output sample tray. These steps are all performed essentially simultaneously within the duration of a single clock cycle and are repeated during one or more subsequent clock cycles. The clock cycle may be relative to each intermediary vessel. The clock cycle also may be universal to the first, second, third and fourth intermediary vessels.

Abstract: An automated sample processing system having a sample input adapted to simultaneously receive a number of sample containers, a reagent input adapted to receive one or more new reagent supplies, a consumable input adapted to receive one or more new consumable supplies, a solid waste output adapted to receive used consumable supplies, a liquid waste output adapted to receive one or more used reagent supplies, and a processing center. The processing center includes a decapper adapted to remove a lid from at least one sample container, an aspirator adapted to remove a specimen from the at least one sample container and transfer the specimen to an output vessel, and a capper adapted to replace the lid on the at least one sample container.

Abstract: Disclosed are an optical flow particle apparatus and method for conducting a particle light scatter-based immunoassay for simultaneously measuring the presence or amount of one or more analytes in a fluid sample, which involves the steps of:

Abstract: Disclosed are an optical flow particle apparatus and method for conducting a particle light scatter-based immunoassay for simultaneously measuring the presence or amount of one or more analytes in a fluid sample which involves the use of a reagent set for each analyte including first binding molecule-coated monodisperse microspheres and second binding molecule-coated colloidal particles in which at least one of the first or second binding molecules specifically binds a respective one of the analytes. In the case where more than one analytes are detected, each monodisperse microperse microsphere of a particular reagent set has a light scatter signal resolvable from that of microspheres of any other reagent set. Changes determined in the distributions of the measured light scatter signals for individual microspheres of each of the particular reagent sets are indicative of the presence or amount of the respective analyte(s) in the sample.