An assay device, analytical instrument and assay method for determining the presence or amount of an analyte in a fluid is disclosed. The device is a one-step lateral flow dry reagent immunoassay with one, two or more zones along a transverse axis of the device, each zone can contain or be preceded by diffusively or non-diffusively bound reagents. The invention measures an indicator in one or two test zones for each analyte to determine its presence or concentration. The signal reagent (indicator) may be a particle such as a colored latex or colloidal gold. The assay quantitation may be read by an instrument.
Assay Device, Composition, And Method Of Optimizing Assay Sensitivity
Joel Blatt - Mountain View CA, US Wilma Mangan - Santa Clara CA, US
Assignee:
Metrika, Inc. - Sunnyvale CA
International Classification:
G01N033/563 G01N033/543
US Classification:
436518000
Abstract:
The present invention provides an assay composition for producing a physically detectable change upon contact with a sample which correlates with the amount of selected analyte in the sample. The composition includes a support matrix pervious to optical radiation and a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample. The support matrix has at least one detection zone for detecting the physical change with a cross-sectional area and depth profile. The composition includes an opacifier present in an amount sufficient to increase the resolution of the physically detectable change. The opacifier is distributed uniformly across the cross-sectional area of the detection zone and is distributed through at least a portion of the depth profile of the support matrix within the detection zone. The chemical reagent is substantially immobilized relative to the opacifier when detecting the physical change. The assay composition can be supported on a transport matrix and used in an assay device. The present invention determines the level of a selected analyte in a sample by optimizing a physically detectable change in an assay composition which correlates with the amount of selected analyte when contacted with the sample. The present invention optimizes the assay results of a selected analyte in a sample-exposed assay composition by increasing the reflection of optical radiation detecting a physical change of the sample-exposed assay composition to be within the range of optimal assay resolution.
Methods And Apparatus For Measuring Blood Coagulation
Emmanuel C. Mpock - Salida CA, US Wilma Mangan - Santa Clara CA, US
Assignee:
MEC DYNAMICS CORPORATION - Santa Clara CA
International Classification:
C12Q 1/56 B01J 19/00 C12M 1/40 G01N 33/86
US Classification:
435 13, 422 681, 422 73, 4352871, 436 69
Abstract:
The present invention provides apparatus and methods for performing assays for determining the time required for a sample of blood to coagulate. The apparatus comprises reaction chambers coated with one or more clotting agent. A drop of blood or equivalent is placed at the sample application port, diluted, and contacted with the clotting agents in the reaction chambers. The diluted blood sample can be moved back and forth through the reaction chambers until blood clots. The blood clotting process forms fibrin stands that prevent the flow of the blood sample in the reaction chambers. The clotting time is the total time from the sample entering the reaction chambers to the time at which the waveform in the reaction chambers change, or the motion or flow of the sample ceases, and can be measured by turbidity.
System And Method For Quantifying Analytes In Immuno Or Enzymatic Assays
Emmanuel Mpock - Salida CA, US Wilma Mangan - Santa Clara CA, US
Assignee:
MEC Dynamics Corporation - Salida CA
International Classification:
G01N 33/566
US Classification:
436501
Abstract:
The present invention provides apparatus and methods for performing assays for determining the presence of and/or quantifying an analyte in a sample. The analyte and a label preferably immobilized on a particle are mixed to provide a homogenous solution. The homogeneous solution can be optionally made to flow through a filter. The homogenous solution or the filtrate can be metered through the read zone at a controlled flow rate and the presence of the label or the presence of the particle can be detected. The methods and apparatus of the invention do not require the use of a capture zone.
Configurable Diagnostic Systems And Methods For Performing Assays
Emmanuel C. Mpock - Salida CA, US Wilma Mangan - Santa Clara CA, US
International Classification:
G01N 33/53
US Classification:
435 71, 4352872, 422400
Abstract:
A method and system for configuring an analyzer is disclosed. The analyzer receives a strip identifier from a strip or a vial identifier from a vial. The parameter module in the analyzer determines the parameters corresponding to the received strip identifier or the vial identifier. The parameter module then configures the analyzer to perform a test with the strip using the determined parameters. In one embodiment, the diagnostic test module determines the test corresponding to the received strip identifier or the vial identifier and the diagnostic test module configures the analyzer to perform the determined test with the strip. In another embodiment, the association determination module determines if the received strip identifier and vial identifier are associated with each other. If not, the analyzer renders an error requesting a correct strip.
Methods And Apparatus For Measuring Blood Coagulation
Emmanuel C. Mpock - Salida CA, US Wilma Mangan - Santa Clara CA, US
Assignee:
MEC DYNAMICS CORPORATION - San Jose CA
International Classification:
G01N 33/86 G01N 33/50
US Classification:
436 69, 422 73
Abstract:
The present invention provides apparatus and methods for performing assays for determining the time required for a sample of blood to coagulate. The apparatus comprises reaction chambers coated with one or more clotting agent. A drop of blood or equivalent is placed at the sample application port, diluted, and contacted with the clotting agents in the reaction chambers. The diluted blood sample can be moved back and forth through the reaction chambers until blood clots. The blood clotting process forms fibrin stands that prevent the flow of the blood sample in the reaction chambers. The clotting time is the total time from the sample entering the reaction chambers to the time at which the waveform in the reaction chambers change, or the motion or flow of the sample ceases, and can be measured by turbidity.
Device For Preventing Assay Interference Using Silver Or Lead To Remove The Interferant
Joel M. Blatt - Palo Alto CA Wilma M. Mangan - Santa Clara CA Paul J. Patel - Sunnyvale CA Victor A. Manneh - Sunnyvale CA
Assignee:
Metrika, Inc. - Sunnyvale CA
International Classification:
G01N 33543
US Classification:
436518
Abstract:
The present invention provides a filter for effectively removing substances from a sample of bodily fluid which can interfere with the results of an assay. The filter includes a solid phase support and an active chemical component for binding to the interfering substance. The active chemical component is insoluble in the sample and is immobilized on the solid phase support. The present invention also includes a filter device, transport matrix, assay device, and method for removing substances which interfere with determining the presence of one or more analytes in a sample.
Device For Blood Separation In A Diagnostic Device
Joel M. Blatt - Palo Alto CA Wilma M. Mangan - Santa Clara CA Paul J. Patel - Sunnyvale CA Michael P. Allen - Los Altos CA
Assignee:
Metrika, Inc. - Sunnyvale CA
International Classification:
G01N 118
US Classification:
436178
Abstract:
The invention provides a filter for separating red blood cells from a whole blood sample to form plasma. The filter includes a solid phase support and an agglutinin for red blood cells. The agglutinin is insoluble in the whole blood sample and is immobilized on the solid phase support. The present invention also includes a device and method for determining the presence of at least one of a plurality of analytes in a sample of whole blood.