Assay device for diagnosis of open-globe ocular injuries
Inventors
Silverman, Andrew • Shvartsman, Dmitry • Lasser, Jason
Assignees
Publication Number
US-12320816-B2
Publication Date
2025-06-03
Expiration Date
2044-09-11
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Abstract
Methods, kits, and devices for detecting open-globe eye injuries are described. A device including a target recognition element specific for intraocular fluid, appropriate for use in the field is described. A method for detecting an open-globe eye injury by detecting proteins found in intraocular fluid is also described. A device may include a soft absorbent swab for sample collection, a lateral flow assay device, and a blood filter to improve device performance.
Core Innovation
The invention presents methods, kits, and devices for detecting open-globe eye injuries, specifically focusing on a device that utilizes a target recognition element specific for intraocular fluid proteins, such as α-crystallin A. The device is designed for use in point-of-care and field settings, enabling timely and accurate diagnosis of open-globe injuries by non-specialized personnel. It employs a lateral flow assay system, which includes a soft absorbent swab for sampling, a blood filter to improve result clarity, and a mechanism to detect the presence of intraocular fluid biomarkers.
The problem being addressed is the urgent need for rapid, reliable, and user-friendly detection of open-globe injuries, which are ocular traumas where the integrity of the eye wall is compromised. Existing diagnostic methods such as the Seidel Test have significant disadvantages, including susceptibility to false negatives and requirements for specialized equipment and dark environments. Additionally, current techniques like slit-lamp inspection or imaging often need considerable expertise and can be unsuitable for immediate or field use, especially when access to the eye is restricted by swelling or patient guarding.
By targeting specific proteins highly abundant in intraocular fluids and largely absent from confounding extraocular fluids, the invention provides a robust and accurate diagnostic tool. The system is designed to operate effectively even when blood or other potential interferents are present in the sample. The inclusion of a blood filter, specific antibody pairs, and visual or colorimetric signal production ensures that the device delivers unambiguous results suitable for critical early intervention in cases of ocular trauma.
Claims Coverage
The patent claims primarily cover two inventive features relating to the composition and functionality of a lateral flow assay device and its method for detecting α-crystallin A in ocular fluid samples.
Lateral flow device substrate specific for α-crystallin A
A device comprising: - An assay strip substrate that includes a sample receiver pad to receive ocular fluid. - A conjugate pad downstream of the sample receiver, housing a first antibody conjugated to a signal-producing label (such as a gold nanoparticle), and a test pad with an immobilized test antibody forming a test line. - First and test antibodies specifically selected to bind human and rabbit α-crystallin A protein, with defined CDR sequences. - The signal produced at the test line indicates the presence of α-crystallin A, thus enabling detection of an open-globe injury.
Blood filter incorporated in the assay device
Integration of a blood filter within the lateral flow device, positioned either on top of or incorporated into the conjugate pad, wherein: - The blood filter retains red blood cells from the ocular fluid sample while allowing soluble proteins, including α-crystallin A, to flow into the conjugate pad. - This minimizes background coloration and improves assay readability and reliability in the presence of blood contamination commonly associated with eye injuries.
Control element on test pad for assay validation
Inclusion of a control element immobilized on the test pad to form a control line, which: - Is capable of binding the first antibody, providing an internal control to confirm the assay is functioning correctly.
Assay method for detecting α-crystallin A in ocular samples
A method comprising: 1. Obtaining an ocular fluid sample from a human or rabbit. 2. Placing the sample on the sample receiver pad of the described device. 3. Detecting binding events between α-crystallin A and the specific first and test antibodies via the produced signal at the test line, indicating the presence of α-crystallin A protein in the sample.
The inventive features claim a lateral flow assay system tailored for α-crystallin A detection in ocular fluids, incorporating sample collection, blood filtration, immunospecific recognition, and clear result interpretation to diagnose open-globe injuries.
Stated Advantages
Enables rapid and accurate diagnosis of open-globe eye injuries even by non-specialist personnel or in field settings.
Delivers unambiguous results at the point-of-care, facilitating timely medical intervention and treatment.
Utilizes a blood filter to enhance clarity and accuracy of assay results in samples containing blood.
Targets intraocular fluid-specific biomarkers (α-crystallin A) that are present at high concentrations in intraocular fluid but not in tear fluid or blood, reducing the risk of false positives.
Provides a device suitable for use when direct visual inspection of the eye is not possible due to patient guarding or swelling.
Documented Applications
Diagnosis of open-globe ocular injuries in humans and animals in field, emergency, clinical, or outpatient settings.
Postoperative monitoring to confirm globe closure after ophthalmic surgeries such as cataract or cornea replacement procedures.
Inclusion in first aid kits for military, hospitals, clinics, research laboratories, industrial, manufacturing, construction, and facilities maintenance environments.
Use with both animal and human subjects in research and pre-clinical validation settings.
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