Interactive test device and apparatus with timing mechanism

Patent metadata

Field	Value
Publication number	US-11061020-B2
Application number	US-201313783065-A
Country	US
Kind code	B2
Filing date	Mar 1, 2013
Priority date	Mar 1, 2012
Publication date	Jul 13, 2021
Grant date	Jul 13, 2021

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. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

First claim

It is claimed:

1. A system, comprising:
a test device comprising:
(a) a label zone comprising
(i) a first population of mobilizable, detectable particles for specific binding to a test analyte in a sample; and
(ii) a second population of mobilizable, detectable particles for specific binding to a non-test analyte but not to the test analyte;

(b) a first detection site at a first position comprising a first binding member having specific binding affinity for detectable particles in the first population bound to the test analyte; and
(c) a second detection site at a second position that is separate from the first position, the second detection site comprising a second binding member having specific binding affinity for detectable particles in the second population bound to the non-test analyte; and
an analyzer comprising:
(1) a drawer dimensioned to receive the test device,
(2) an optical system for detection of a signal generated from the first population of mobilizable, detectable particles at the first position and the second population of mobilizable, detectable particles at the second position when each population reaches a specific and separate position on the test device,
(3) a motor to move a detector in the optical system from the first detection site to the second detection site,
(4) a processor communicatively coupled with the optical system to receive the signal from the detector and to evaluate a ratio of a signal detected from all or a portion of the first population of mobilizable, detectable particles to a cut-off value to determine a presence or an absence of analyte in the sample based on the ratio, and
(5) a memory storing the cut-off value, wherein the cut-off value is an exponentially transformed signal from all or a portion of the second population of mobilizable, detectable particles, adjusted by a constant value empirically determined for a manufacturing lot comprising the test device.

2. The system of claim 1 , wherein the signal from all or a portion of the first population of mobilizable, detectable particles is used by the processor to provide a quantitative or semi-quantitative amount of analyte present in the sample.

3. The system of claim 1 , wherein signal from the second population of mobilizable, detectable particles is mathematically transformed by the processor in the analyzer to provide a transformed signal.

4. The system of claim 3 , wherein the signal from the second population of mobilizable, detectable particles is mathematically transformed by the processor using an exponential transformation.

5. The system of claim 4 , wherein the exponential transformation is selected from an exponential value of between 1.3-1.8.

6. The system of claim 1 , wherein the test device is a lateral flow immunoassay.

7. The system of claim 6 , wherein one or both of the first population of mobilizable, detectable particles and the second population of mobilizable, detectable particles is comprised of particles comprised of a fluorescing lanthanide compound.

8. The system of claim 7 , wherein the fluorescing lanthanide compound is europium.

Assignees

• Quidel Corp

Inventors

• De Callier Rhys
• Egan Richard L
• Ferenczy William J
• Hale Michael Jon

Classifications

• G01N33/54388 Primary

  based on lateral flow · CPC title

• G01N33/5302 Primary

  Apparatus specially adapted for immunological test procedures · CPC title

• G01N33/585

  with a particulate label, e.g. coloured latex · CPC title

• Y02A90/10

  Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation · CPC title

• G01N33/558

  using diffusion or migration of antigen or antibody {(immunochromatographic test strips G01N33/54387)} · CPC title