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Systems, devices, and methods for amplifying signals of a lateral flow assay

A lateral flow, fluid flow technology, applied in measurement devices, material analysis, instruments, etc. by observing the effect on chemical indicators, can solve the problem of inability to provide reliable or accurate indications of target analytes, and reduce false positives. Effects of negative readings

Pending Publication Date: 2021-03-16
BECTON DICKINSON & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the analyte is present in the sample in low amounts or concentrations, the signal generated by the labeled analyte captured in the test region of a lateral flow assay may not exceed the detection threshold at which the measurement system reads and processes this signal
Therefore, lateral flow assays may not provide a reliable or accurate indication of the presence of the target analyte in the sample

Method used

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  • Systems, devices, and methods for amplifying signals of a lateral flow assay
  • Systems, devices, and methods for amplifying signals of a lateral flow assay
  • Systems, devices, and methods for amplifying signals of a lateral flow assay

Examples

Experimental program
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Effect test

Embodiment 1

[0084] Preparation of Lateral Flow Assays According to the Disclosure

[0085] The following examples describe the preparation of a lateral flow assay according to the present disclosure to measure analytes present in a sample at low concentrations. In this non-limiting example, the analyte of interest is influenza A virus ("Flu A").

[0086] A test strip is prepared having a conjugate pad with a sample receiving area and a buffer receiving area. The analyte-specific conjugate was prepared in solution and the solution was sprayed onto the sample receiving area by air jet deposition. Briefly, anti-Flu A antibody and biotin were incubated with gold nanoparticles to form analyte-specific conjugates. The analyte-specific conjugate was deposited on the conjugate pad at the sample receiving area in an amount of 7 μL / test strip by spraying the solution including the analyte-specific conjugate with an air jet. The conjugate pad is heated to dry the analyte-specific conjugate to t...

Embodiment 2

[0092] Amplification of signal from low concentration analytes

[0093] The following example illustrates the detection of low concentrations of FluA in samples using the lateral flow assay described in Example 1.

[0094] The lateral flow assay prepared in Example 1 was contacted with a sample containing a low concentration of Flu A. In this non-limiting example, Flu A antigen was a dilution of recombinant Flu A nucleoprotein expressed in E. coli and used for crude cell lysates. As a control, a lateral flow assay prepared as in Example 1 but lacking the signal-amplifying conjugate was used. Samples with Flu A were added to the sample wells of the lateral flow device and the control lateral flow device. Measure the resulting signal at various time points such as Figure 4 and shown in Table 1.

[0095] Table 1: Signal Variation Over Time

[0096]

[0097]

[0098] Samples without the analyte of interest were also applied to lateral flow assays prepared with vari...

Embodiment

[0126] Features of Example Lateral Flow Devices

[0127] The lateral flow devices described herein include a device housing. The housing of any of the lateral flow devices described herein, including the top housing or the bottom housing, can be made from any suitable material, including, for example, vinyl, nylon, polyvinyl chloride, polypropylene, polystyrene , polyethylene, polycarbonate, polysulfone, polyester, urethane or epoxy. The housing can be prepared by any suitable method, including, for example, by injection molding, compression molding, transfer molding, blow molding, extrusion molding, foam molding, thermoforming, casting, layer deposition, or printing.

[0128]The lateral flow devices described herein may include sample wells in which a fluid sample is introduced to a test strip, such as, but not limited to, immunochromatographic test strips found in lateral flow devices. In one example, the sample can be introduced into the sample well by external applicat...

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Abstract

Lateral flow assay devices, systems, and methods described herein detect analyte present in a sample in low quantity or at low concentration by amplifying a signal generated at a detection zone. The generated signal can exceed a detection threshold of a measurement system and increase the sensitivity of the lateral flow assay devices, systems, and methods. In one aspect, the lateral flow device includes a signal-amplification conjugate that binds to a complex bound to immobilized capture agent in the detection zone, causing a chain reaction of binding events in the detection zone that result in an amplification of the signal generated in the detection zone.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application No. 62 / 686,606, filed June 18, 2018, which is hereby incorporated by reference in its entirety. technical field [0003] The present disclosure generally relates to lateral flow devices, testing systems and methods. More specifically, the present disclosure relates to lateral flow assay devices capable of measuring analytes present in low amounts or concentrations in a sample by amplifying the detection signal. Background technique [0004] Immunoassay systems including lateral flow assays provide reliable, inexpensive, portable, rapid, and simple diagnostic tests. Lateral flow assays can quickly and accurately detect the presence, and in some cases quantify, of target analytes in samples. Advantageously, lateral flow assays can be minimally invasive and used as point-of-care testing systems. [0005] Lateral flow assays produce a signal that can be m...

Claims

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Application Information

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IPC IPC(8): G01N21/01G01N33/531G01N33/538G01N33/569
CPCG01N21/8483G01N21/77G01N2021/7759G01N33/558G01N33/54388
Inventor 任汇淼
Owner BECTON DICKINSON & CO