US 10,094,783 B2Granted

Prevention of cross-contamination in systems for rapid analysis of biological samples

AssigneeFundamental Solutions Corporation

InventorsMarvin R. Williams, Charles McBrairty, Daniel W. Pfautz, Thomas J. Zupancic, Lingchun Zeng, Andrew Weiman, Richard S. Brody, Joseph D. Kittle, Anthony Truscott, Robert Baranowski

Life of this patent

Estimating the term…

patentgrep

Loading patent…

Abstract

A system for use in rapid sample analysis that includes a biosensor reagent, wherein the biosensor reagent includes living biological cells; a reservoir card, wherein the reservoir card stores the biosensor reagent; and a test cartridge base, wherein the test cartridge base is configured to accept the reservoir card, and wherein the test cartridge base further includes a reaction chamber having a central axis, wherein the reaction chamber has the shape of a revolved half ellipse; and an inlet channel connected to the reaction chamber, wherein the inlet channel is positioned above the reaction chamber at an angle of 15-60 degrees above the horizontal, and wherein the inlet channel is offset from the central axis of the reaction chamber.

Claims21

Dependent claims

A system for rapidly detecting the presence of an analyte in a biological sample, comprising:

(a) a biosensor reagent including at least one antibody specific for a predetermined analyte and a bioluminescent agent, wherein the at least one antibody is expressed on the surface of living, engineered lymphocytes and wherein the bioluminescent agent is expressed by the living, engineered lymphocytes, the biosensor reagent being operative to:
(i) detect the presence of a specific analyte in a sample to be tested, and
(ii) emit a detectable light signal when the biosensor reagent reacts with the sample and detects the presence of the specific analyte in the sample;
(b) a test cartridge, wherein the test cartridge further includes:
(i) a reservoir card, wherein the reservoir card further includes the biosensor reagent;
(ii) a test cartridge base, wherein the test cartridge base is configured to accept the reservoir card and wherein the test cartridge base further includes:
a) a reaction chamber having a central axis, wherein the reaction chamber has the shape of a revolved half ellipse;
b) an inlet channel connected to the reaction chamber, wherein the inlet channel is positioned above the reaction chamber at an angle of 15-60 degrees above the horizontal, and wherein the inlet channel is offset from the central axis of the reaction chamber;
and
c) wherein upon introducing the sample into the test cartridge base through the inlet channel, the sample is homogeneously mixed with the biosensor reagent while minimizing damage to the living, engineered lymphocytes and minimizing any bubbling of the mixed biosensor reagent and sample in the reaction chamber,
(iii) wherein the reservoir card and the cartridge base further include fluid ports formed therein, and wherein the fluid ports are sealed prior to use or otherwise adapted to prevent cross-contamination of any fluids contained in the reservoir card or the test cartridge base;
and
(c) a testing unit adapted to receive the test cartridge, the testing unit including a sensor for detecting the detectable light signal emitted by the biosensor reagent upon reacting with the sample, the detection of the emitted detectable light signal being indicative of the presence of the analyte in the sample and, wherein detection of the specific analyte in the sample occurs in real time.

10 more elements

A testing device for real time detection of an analyte in a biological sample, the testing device comprising:

(a) a housing comprising a lid and an input/output device;
(b) an analysis portion comprising:
(i) a recess in the housing for accepting a disposable test cartridge containing a biological sample to be tested, wherein the test cartridge includes:
a) a reservoir card, wherein the reservoir card further includes a biosensor reagent;
and
b) a test cartridge base, wherein the test cartridge base is configured to accept the reservoir card and wherein the test cartridge base further includes:
i) a reaction chamber having a central axis, wherein the reaction chamber has the shape of a revolved half ellipse;
and
ii) an inlet channel connected to the reaction chamber, wherein the inlet channel is positioned above the reaction chamber at an angle of 15-60 degrees above the horizontal, and wherein the inlet channel is offset from the central axis of the reaction chamber,
c) wherein the reservoir card and the cartridge base further include fluid ports formed therein, and wherein the fluid ports are sealed prior to use or otherwise adapted to prevent cross-contamination of any fluids contained in the reservoir card or the test cartridge base;
(ii) an actuator for interacting with the test cartridge when the lid is closed, the actuator causing the biosensor reagent in the test cartridge to be displaced to react with the biological sample during the performance of a test, the biosensor reagent including at least one antibody specific for a predetermined analyte and a bioluminescent agent;
wherein the at least one antibody is expressed on the surface of living, engineered lymphocytes and wherein the bioluminescent agent is expressed by the living, engineered lymphocytes, and wherein upon introducing the biological sample into the test cartridge base through the inlet channel, the biological sample is homogeneously mixed with the biosensor reagent while minimizing damage to the living, engineered lymphocytes and minimizing any bubbling of the mixed biosensor reagent and biological sample in the reaction chamber;
and
(iii) a sensor associated with the recess in the housing to detect a light signal emitted after the at least one biosensor reagent has been displaced by the actuator to react with the biological sample and to generate an output signal;
and
(c) a control unit configured to:
(i) receive an input from a user by way of the input/output device to initiate a test;
(ii) in response to receiving the user input and after the biological sample has been deposited in the recess of the analysis portion, actuate the actuator to displace the biosensor reagent in the test cartridge to react with the biological sample;
(iii) receive the output signal from the sensor;
and
(iv) output a test result to the user on the input/output device.

18 more elements

Dependencies are inferred from the claim text.

Facts

Application: 15/215,211Filed 20 Jul 2016 · continuation in part
Priority: 26 Mar 2015
Published: US 2016/0327488 A110 Nov 2016
Granted: 9 Oct 2018
Term ends: Not estimatedThe source records don’t support an estimate.

Classification11 codes

G01N 21/763
Chemiluminescence; Bioluminescence: bioluminescence
B01L 3/52
Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers: containers specially adapted for storing or dispensing a reagent
G01N 33/02
Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00: food
G01N 33/536
Immunoassay; Biospecific binding assay; Materials therefor: with immune complex formed in liquid phase

Family

Application14/669,970Parent of this continuation-in-part · filed 26 Mar 2015
Application62/195,090Us provisional application · filed 21 Jul 2015
US 2016/0327488 A1Pre-grant publication · published 10 Nov 2016
US 9,701,994 B2Parent of this continuation-in-part
US 2015/0197784 A1Published application
US 10,094,783 B2This patent

From the US filing history. Foreign family members aren’t listed.