US-12625065-B2 - Systems and methods for multianalyte detection

Abstract

Provided herein are systems, devices and methods for performing multianalyte detection in a biological sample, such as a human blood sample. Multiwell plates useful for performing multianalyte detection are also provided. The systems, devices and methods provided herein relate to the field of direct-to-consumer diagnostics (DTC diagnostics) and are useful, e.g., for facilitating consumer access to consumer healthcare and consumer wellness information. Other uses of the systems, devices and methods provided herein relate to the fields of medical research and drug discovery.

Inventors

• Dena C. Marrinucci
• Randal L. Erman
• Bala S. Manian

Assignees

• TRUVIAN SCIENCES, INC.

Dates

Publication Date

20260512

Application Date

20221018

Claims (1)

1. 1 . A method of performing point-of-care assays for a plurality of analytes in a liquid sample, the method being performed within a single diagnostic system, the method comprising: A. providing a multiwell plate comprising a plurality of wells, each well containing a portion of the liquid sample, the multiwell plate having a translucent bottom and opaque well walls wherein: i) a first well contains a first reagent comprising a fluorogenic substrate or a fluorescently labeled binding protein configured to emit a fluorescent signal upon interaction with a first analyte in the sample; and ii) a second well contains a second reagent comprising a chromogenic substrate configured to produce a detectable absorbance change upon interaction with a second analyte in the sample; a single light source; a single CMOS; a motor; a platform configured to receive the multiwell plate, the platform comprises platform magnets, platform vertical keys and an opaque film wherein the opaque film is disposed on an upper surface of the platform; wherein a peripheral portion of the multiwell plate comprising a plurality of overhang wells including the first well and the second well, overhangs the platform and a selected overhang well from the plurality of overhang wells is within an optical path of the light source and CMOS and is aligned to permit transmission of light through the translucent bottom of the first overhang well without obstruction from the platform or the motor; the platform vertical keys engaged with a seat by a seat vertical key and platform magnets engaged with the seat by seat magnets in the seat, the seat coupled to the motor; and a processor operatively connected to the CMOS; B. moving, under control of the motor, the multiwell plate relative to the single CMOS and single light source, such that the first well of the plurality of overhang wells is aligned with the CMOS and the light source; C. directing light from the single light source to the translucent bottom of the first well of the plurality of overhang wells and detecting by the CMOS a fluorescence emission generated upon interaction between a first analyte in the sample and the first reagent; D. moving, under control of the motor, the multiwell plate relative to the single CMOS and single light source, such that the second well of the plurality of overhang wells is aligned with the CMOS and the light source; E. directing light from the single light source to the translucent bottom of the second well of the plurality of overhang wells and detecting by the CMOS transmitted or absorbed light generated upon interaction between a second analyte in the sample and the second reagent; F. processing, by the processor, (i) the detected fluorescence emission from the CMOS to generate analyte measurements for the first analyte in the liquid sample and (ii) the transmitted or absorbed light detected from the CMOS to generate analyte measurements for the second analyte in the liquid sample.

Description

This application is a Continuation Application of U.S. patent application Ser. No. 16/082,878 filed Sep. 6, 2018, which is a US National Stage of International Application No. PCT/US2017/023784 having an international filing date of Mar. 23, 2017, which claims the benefit of priority to U.S. Provisional Application No. 62/312,191 filed Mar. 23, 2016, the entire contents of each of which are incorporated herein by reference. 1. INTRODUCTION Provided herein are systems, devices and methods for performing multianalyte detection in a biological sample, such as a human blood sample. Multiwell plates useful for performing multianalyte detection are also provided. The systems, devices and methods provided herein relate to the field of direct-to-consumer diagnostics (DTC diagnostics) and are useful, e.g., for facilitating consumer access to consumer healthcare and consumer wellness information. Other uses of the systems, devices and methods provided herein relate to the fields of medical research and drug discovery. 2. BACKGROUND DTC diagnostics involves consumers (e.g., patients) directly accessing healthcare or wellness-related diagnostic tests and test results, without the need for a doctor's prescription. Recently, U.S. and international DTC diagnostics markets have expanded rapidly as a result of growing consumer interest in the tracking of personalized fitness, wellness, and healthcare-related information. A key to the success of DTC diagnostics is the availability of robust technologies for testing a broad range of diagnostically meaningful analytes with accuracy, fast turnaround times, and at low-cost. While certain handheld or portable devices, such as blood glucose meters, or test strips, e.g., for urine analysis, have been developed to facilitate personalized medical testing (“bedside testing” or point-of-care testing (POCT)”) by healthcare providers, there remains a need for technologies facilitating the reliable, rapid, and cost-effective analysis of multiple analytes, e.g., at a “point-of-customer-contact (POCC)” site, such as in a pharmacy or a general store. See, e.g., Bond M. M. et al. (2015) Drop-to-Drop Variations in the Cellular Components of Fingerprick Blood. Am. J. Clin. Pathol. 144, 885-894. 3. SUMMARY In one aspect, provided herein is a circular multiwell plate comprising a plurality of 100-500 wells, wherein the plurality of wells is organized in concentric circles around the center of the circular multiwell plate, wherein the plurality of wells is arranged in a spokes-like arrangement, and wherein the circular multiwell plate further comprises one or more troughs. In some embodiments, the circular multiwell plate of claim 1, wherein the plurality of 100-500 wells comprises 120 or 400 wells. In another aspect, provided herein is a multiwell plate comprising a carrier component and one or more chip components that are removable attached to the carrier component, wherein each of the one or more chip components comprises one or more pluralities of wells. In some embodiments, wherein one or more chip component comprises two or more pluralities of different wells. In some embodiments, all wells in one or more chip component share the same shape or the same dimensions. In some embodiments, the multiwell plate has a circular shape. In some embodiments, the carrier component comprises one or more troughs. In another aspect, provided herein is a multiwell plate comprising two or more different pluralities of wells, wherein the two or more different pluralities of wells differ with respect to the wells' shape, dimension, optical properties, or surface properties. In some embodiments, two or more different pluralities of wells are located on two or more chip components of the multiwell plate that are each independently removable from a carrier component of the multiwell plate. In some embodiments, the shape of one or more pluralities of the two or more different pluralities of wells comprises a cylinder, a cone, a cube, or a rectangular cuboid. In some embodiments, the multiwell plate comprises a plurality of cylindrical wells and a different plurality of rectangular cuboid wells. In some embodiments, the dimension comprises the height, width, length, radius, diameter, or volume of a well. In some embodiments, the multiwell plate comprises a plurality of wells comprising a diameter of between about 5.0 mm and about 7.0 mm and a different plurality of wells comprising a diameter of between about 2.0 mm and about 7.0 mm. In some embodiments, the optical properties comprise a light transmission characteristic of a well bottom or a well wall. In some embodiments, the multiwell plate comprises a plurality of wells comprising a well bottom that is translucent for light of a wavelength between 200 nm and 850 nm and a different plurality of wells comprising a well bottom that is opaque for light of a wavelength between 200 nm and 850 nm. In some embodiments, the surface properties comprise a characteristic o