CC16 Lateral Flow Strip for Early Silicosis Screening

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Solution Overview

Problem

Current methods for diagnosing silicosis are costly, require specialized skills, and often detect the condition only in its irreversible advanced stages, making early detection difficult and costly, especially in unorganized sectors with poor health care delivery.

Innovation Solution

A lateral flow immunoassay-based point-of-care device using gold nanoparticles and anti-CC16 antibodies for semi-quantitative detection of Club cell protein 16 (CC16) in serum samples, allowing for early detection of silicosis through a simple, affordable, and user-friendly test strip.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional diagnostic methods (chest radiology, ELISA) are used for silicosis detection, then diagnostic accuracy is improved, but device complexity and cost increase significantly

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs disposable lateral flow test strips with pre-coated antibodies and gold nanoparticle conjugates. These single-use strips eliminate the need for expensive, complex equipment like ELISA readers or X-ray machines. The strips are discarded after one use, ensuring accuracy while keeping the device simple and affordable for point-of-care settings.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The invention utilizes gold nanoparticles that exhibit color changes based on their interaction with CC16 biomarkers in the sample. The lateral flow strip produces visible color bands at different positions, allowing qualitative and semi-quantitative detection of silicosis without requiring complex instrumentation. This colorimetric detection method simplifies the device while maintaining diagnostic accuracy.

Inventive Principle:
Principle #32Color changes

2Measurement precision

If conventional diagnostic methods are used, then measurement precision is improved, but ease of operation deteriorates due to specialized skill requirements

Engineering Contradiction:
Improvedetection accuracyVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The lateral flow test strip is designed as a self-service diagnostic tool that requires minimal training. The strip automatically performs sample application, reagent mixing, and result visualization through color band formation. Users simply apply the sample and read the results within 10-15 minutes, eliminating the need for specialized laboratory skills required by conventional methods.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention replaces complex mechanical and instrumentation-based diagnostic systems with a simple lateral flow capillary action system. The test strip uses capillary forces to move the sample through reagent zones, eliminating the need for pumps, motors, or electronic controls. This mechanical simplification maintains detection accuracy while dramatically improving ease of operation.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If advanced stage detection methods are used, then reliability of diagnosis is improved, but loss of time increases due to irreversible disease progression

Engineering Contradiction:
Improvediagnosis reliabilityVSAvoiddetection time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The lateral flow test detects CC16 biomarkers that appear in the blood during early stages of silicosis, before significant lung damage occurs or before chest X-ray changes become apparent. This preliminary detection capability allows intervention at an reversible stage, preventing disease progression while maintaining reliable diagnosis through specific biomarker detection.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention skips the lengthy and complex conventional diagnostic process by using a rapid lateral flow assay that delivers results in 10-15 minutes. The test bypasses the need for prolonged observation periods, multiple imaging studies, or complex laboratory procedures, enabling quick detection and timely intervention while maintaining diagnostic reliability through specific biomarker detection.

Inventive Principle:
Principle #21Skipping (Rushing through)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables early detection of silicosis with minimal sample volume and operational expertise, reducing the risk of premature disability and death by providing rapid, semi-quantitative results within 10 minutes, at a fraction of the cost of conventional methods.

Implementation Method 1

The present invention provides a point of care device, in the form of a lateral flow immunoassay-based strip for semi-quantitative detection of CC16 in a test sample, comprising: a) a conjugate pad comprising a membrane-based coated with an anti-CC16 antibody; b) a sample pad to which a test sample is applied

Methodology Applied
Scientific EffectAntigen-antibody interaction:

Implementation Method 2

The present invention provides a point of care device, in the form of a lateral flow immunoassay-based strip for semi-quantitative detection of CC16 in a test sample

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS12566182B2Point of care device, method and kit involving club cell protein 16 as a marker for silicosis
Publication Date: 2026.03.03 INDIAN COUNCIL OF MEDICAL RES
  • US12566182B2 patent drawing
  • US12566182B2 patent drawing

AI summary

The present invention provides a device and method based on lateral flow immunoassay for CC16 semi-quantification in serum sample. A novel membrane based semi quantitative detection of physiological/pathological levels of CC16 in the serum has been provided. The device of the present invention provides affordable and easy to use strip-based screening approach for early detection of silicosis using CC16 as a biomarker.