IP Library Granted Patent US 11,131,666
Granted Patent B2
US 11,131,666 · App. 16/297,503 · Granted Sep 28, 2021

System and apparatus for point-of-care diagnostics

Inventors: Richard L. Egan (Oceanside, CA); Michael Jon Hale (San Diego, CA); Jhobe Steadman (San Diego, CA)
Assignee: Quidel Corporation
G01N33/54366B01L9/52G01N21/6428G01N21/6486G01N21/8483G01N33/53G01N33/558G01N33/56944G01N33/56983B01L2300/0816B01L2300/0825G01N2021/6439G01N2201/12707G01N2201/12792G01N2333/11G01N2469/10
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Quick Facts
Patent No.
US 11,131,666
App. No.
16/297,503
Granted
Sep 28, 2021
Kind
B2
Abstract

A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Claims (22)

1. An apparatus, comprising:

a housing configured to receive a test device, wherein the test device comprises a reference line and an analyte-specific test line;

an illumination source;

a detector; and

a processor comprising a software program for control of the illumination source and the detector and for processing data obtained from the detector;

wherein the processor is configured to direct the apparatus to:

(a) generate a one-dimensional data array of values corresponding to signal associated with the reference line and the analyte-specific test line in response to illumination by the illumination source,

(b) use data in the data array corresponding to data from the reference line to identify a location of data in the data array that corresponds to the analyte-specific test line, and

(c) analyze data in the data array that corresponds to the analyte-specific test line to report a result regarding presence or absence of an analyte at the analyte-specific test line.

2. The apparatus of claim 1 , wherein the detector is a single-element photodetector.

3. The apparatus of claim 1 , wherein the illumination source is a light emitting diode.

4. The apparatus of claim 3 , wherein the light emitting diode emits light at about 365 nm.

5. The apparatus of claim 3 , further comprising a power output that provides the light emitting diode with at least about 4 mW.

6. The apparatus of claim 1 , further comprising a cellular component that provides wireless transmission of data.

7. The apparatus of claim 6 , wherein the cellular component transmits the result obtained from analysis of the data in the data array.

8. The apparatus of claim 1 , wherein the apparatus further comprises a port for connection with an external instrument.

9. The apparatus of claim 1 , wherein the processor is configured to direct the apparatus to analyze data in the data array by calculating a first derivative of the data array to identify a minimum peak and a maximum peak corresponding to the reference line.

10. The apparatus of claim 1 , wherein the processor is configured to direct the apparatus to analyze data in the data array by taking the first derivative of the data array to form a derivative data set, wherein a first maximal value in the derivative data set corresponds to a maximum signal from a reference line or a control line on the test device, and the position in the derivate data array of the first maximal value determines the position of data from the analyte-specific test line.

11. The apparatus of claim 1 , wherein the detector detects signal emitted from the test device during illumination by the illumination source.

12. The apparatus of claim 11 , wherein the emitted signal is emitted from a fluorescing lanthanide compound.

13. The apparatus of claim 12 , wherein the fluorescing lanthanide compound is chelated europium.

14. The apparatus of claim 13 , wherein the chelated europium is embedded in microparticles.

Assignments (5)
SECURITY AGREEMENT Recorded Aug 22, 2025
From: CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072526/0643 →
RELEASE (REEL 060220 / FRAME 0711) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
Reel/Frame 072577/0536 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2024
From: QUIDEL CORPORATION
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 068657/0827 →
SECURITY AGREEMENT Recorded May 31, 2022
From: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 060220/0711 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 8, 2019
From: EGAN, RICHARD L.; HALE, MICHAEL JON; STEADMAN, JHOBE
To: QUIDEL CORPORATION
Reel/Frame 048552/0938 →
Continuity (6)
Continuation 14932769 · Nov 4, 2015
Continuation 13783019 · Mar 1, 2013
Provisional Application 61666689 · Jun 29, 2012
Provisional Application 61636105 · Apr 20, 2012
Provisional Application 61605694 · Mar 1, 2012
Related Publication 20190271695A1 · Sep 5, 2019
Cited By (1)
US 12,474,333