Universal testing system for quantitative analysis
Inventors
Piasio, Roger • Wheeler, Andrew • Cowperthwaite, Wesley
Assignees
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Publication Number
US-10823729-B2
Publication Date
2020-11-03
Expiration Date
Abstract
A cassette is disclosed that permits, with an instrument, quantitative analysis to be performed at the moment of sample testing without additional steps to the end user. The cassette includes a calibration strip and a sample strip. The calibration strip contains known quantities of analyte, from which a calibration curve can be created and applied to the analysis of the sample strip. The disclosed cassette can utilize light transmission or light reflectance techniques. The cassette may include a separate wash port for rapid washing of a high background sample. The disclosed cassette may perform diagnostic tests for humans, animals, environmental sample, and/or food samples. In some cases, the disclosed devices and techniques may be used to monitor efficacy of drug therapy and patient compliance with respect to physician-prescribed medication in a point of care setting.
Core Innovation
The invention relates to a cassette-based on-board quantitative lateral-flow testing system that performs calibration concurrently with sample testing. A cassette includes a calibration strip and a sample strip, where the sample is introduced to the sample strip and not to the calibration strip. The calibration strip includes known concentrations of the analyte and the sample strip includes a binding partner for the analyte.
A chase fluid is introduced to the calibration strip and the sample strip, releasing a conjugate substance that is a binding partner to the analyte and a marker. The conjugate substance travels up both the calibration strip and the sample strip, so that marker signals are generated on both strips. At least two signals from markers bound to the analyte on the calibration strip are optically detected and used to generate a calibration curve.
A signal from markers bound to the analyte on the sample strip is optically detected. A quantitative measurement of the concentration of the analyte in the sample is determined based on the signal from the sample strip and the signals from the calibration curve. The system is configured so that optical detection reads marker signals from the calibration strip to enable calibration directly within the cassette during the same assay.
Claims Coverage
The partial content provides one independent claim (clm-00001). It specifies a cassette-based quantitative method in which a calibration curve is generated from an on-board calibration strip and is then used to compute the analyte concentration from a sample strip signal, using a shared chase fluid and optically detected marker signals.
Separate sample introduction to sample strip and calibration strip
introducing the sample into a cassette having a calibration strip and a sample strip, wherein the sample is introduced to the sample strip and not to the calibration strip; the calibration strip includes known concentrations of the analyte; and the sample strip includes a binding partner for the analyte
Shared chase fluid releases labeled conjugate to both strips
introducing a chase fluid to the calibration strip and the sample strip, wherein introducing the chase fluid releases a conjugate substance, which is a binding partner to the analyte and a marker, and the conjugate substance travels up both the calibration strip and the sample strip
Optical detection of at least two calibration-strip marker signals and calibration curve generation
optically detecting at least two signals from markers bound to the analyte on the calibration strip; generating a calibration curve from the at least two signals
Optical detection of sample-strip marker signal and quantitative determination using the calibration curve
detecting a signal from markers bound to the analyte on the sample strip; and determining a quantitative measurement of the concentration of the analyte in the sample based on the signal from the sample strip and the signals from the calibration curve
The independent claim centers on generating an on-board calibration curve from at least two optically detected marker signals on a calibration strip with known analyte concentrations, while simultaneously producing an analyte-dependent marker signal on a sample strip using a shared chase-fluid-released conjugate, and then using the calibration curve to determine a quantitative analyte concentration.
Stated Advantages
Quantitative measurement of the concentration of an analyte in a sample using an on-board calibration curve generated from calibration-strip marker signals.
Calibration is performed concurrently with sample testing by using a cassette that includes both a calibration strip and a sample strip exposed to a shared chase fluid.
Documented Applications
Experimental examples include measuring analytes such as Respiratory Syncytial Virus (RSV) and thyroid stimulating hormone (TSH), and detecting Histoplasma in urine.
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