#lateral flow assay

[qawachbio]

InstaNGAL® Test kit

Rapid and Reliable Kidney Injury Assessment: Introducing the InstaNGAL® Test Kit

Rapid and Reliable Kidney Injury Assessment: Introducing the InstaNGAL® Test Kit InstaNGAL®, developed by QAWaCh Bio Pvt. Ltd., is an innovative early detection test for acute kidney injury (AKI), based on estimation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in human urine using a unique semi-quantitative and quantitative lateral flow assay platform. InstaNGAL® is a bed-side test that is intended for early diagnosis of AKI, based on levels of NGAL in human urine. This novel test kit is based on QAWaCh Bio’s novel patented technology ‘Q-Plat’, that uses combination of a lateral flow assay-based test card and smartphone

[qawach]

Urinary NGAL

Urinary NGAL (Neutrophil Gelatinase-Associated Lipocalin) refers to the measurement of NGAL levels in urine.

Healthcare professionals measure urinary NGAL levels using immunoassay techniques to detect and monitor kidney injury using NGAL. NGAL, a protein, is produced and released by various cells, including neutrophils (a type of white blood cell) and epithelial cells of the kidneys. NGAL serves as an early marking of kidney injury or insult, playing a role in the assessment and early detection diagnosis of acute kidney injury (AKI).When the kidneys are injured or under stress, NGAL levels increase rapidly in both blood and urine. Urinary NGAL Laboratory tests can measure levels to detecting and monitoring kidney injury. This will be especially valuable for early identification of. AKI, allowing for timely intervention and management.

[aarunresearcher]

United States point of care diagnostics market size is projected to exhibit a growth rate (CAGR) of 6.90% during 2024-2032. Numerous advancements in portable and handheld diagnostic devices have enhanced the convenience and user-friendliness of testing, which is primarily driving the market growth.

[marketsndata]

[healthcaremarketanalysis]

The global lateral flow assays market, valued at $10.8 billion in 2023, is expected to reach $16.8 billion by 2029, growing at a CAGR of 7.6%. This growth is driven by the rising adoption of kits & reagents and lateral flow assay readers for various applications, including infectious disease testing, veterinary diagnostics, and drug abuse testing. However, challenges such as qualitative detection limitations and variability in results may hinder market growth. The increase in eye disorders like diabetic retinopathy and cataracts is a significant driver, while the rising adoption of refurbished equipment presents a restraint. Opportunities exist in the low adoption of phacoemulsification devices and premium IOLs in emerging regions. North America holds the largest market share, with significant investments in ophthalmic technology, while the Asia Pacific is the fastest-growing region. Key players include Abbott, Roche, Danaher Corporation and Siemens Healthineers. Recent developments include new authorizations and product launches by QuidelOrtho, Abbott, and Roche.

[healthcarehubhh]

Lateral Flow Assay: A Simple Yet Powerful Diagnostic Tool

Introduction A lateral flow assay is a simple and versatile immunodiagnostic test strip that allows for rapid detection and identification of target analytes in complex biological and non-biological samples. History and Development The fundamental concept of flow assays originated from simple home pregnancy tests that were introduced in the late 1970s and early 1980s. Since then, the technology has been refined and expanded to detect a wide variety of biological and chemical analytes for point-of-care clinical diagnostics as well as non-clinical uses such as environmental testing, food safety analysis, and forensic investigation. The driving force behind the continuous development of flow assays has been the need for easy-to-use tests that provide reliable and rapid results outside of centralized laboratory settings. Basic Principle and Workflow At its core, a typical lateral flow assay uses capillary action to transport liquid samples through a porous membrane or pad. The membrane is pretreated with specific biological reagents (antibodies, antigens) arranged in distinct test and control lines. When a fluid sample containing the target analyte is applied, it migrates laterally across the membrane. Analytes in the sample will bind to the labeled (often colloidal gold) probe element that has been preloaded at the sample pad. This complex then flows until it encounters and binds to the capture reagent immobilized at the test line. A visible colored line appears to indicate a positive result. Unbound probe continues to flow and binds to the control reagent that validates proper functioning of the test. Results can usually be interpreted visually within 10-30 minutes without any specialized instrumentation. Key Components All flow assays share a basic design consisting of a sample pad, conjugate pad, membrane, and absorbent pad arranged in a linear sandwich format. The sample pad is where the liquid sample is first applied. The conjugate pad contains the labeled probes or antibodies. The porous membrane acts as the carrier for capillary flow and zone for binding reactions. The absorbent pad collects excess fluid at the other end. Additional functional components can include blood/fluid separators, quality control lines, and labeling areas for test information. Applications in Point-of-Care Testing The ease-of-use and quick speed of flow assays have made them very suitable for decentralized point-of-care applications. Common clinical uses include rapid tests for pregnancy, fertility, infections (HIV, malaria, influenza), cardiac markers, drugs-of-abuse, and therapeutic drug monitoring. Lateral flow formats have also gained popularity for home use self-tests beyond pregnancy like ovulation prediction and urinary tract infection screening. Critical settings like emergency rooms, ambulance services, physicians’ offices, pharmacies, and even space missions have embraced lateral flow technology to expedite

[rahulp3]

Lateral Flow Assay Component Market Outlook from 2024 to 2034

The global lateral flow assay component market is anticipated to reach a valuation of US$ 373.1 million in 2024, driven by integration with renewable energy systems. The trend is expected to create new opportunities for the market, leading to a projected CAGR of 4.1% between 2024 and 2034, and reaching a total valuation of approximately US$ 558.0 million by 2034.

The rising demand for rapid and cost-effective diagnostic solutions in veterinary healthcare, including for the detection of infectious diseases and monitoring animal health, presents opportunities for the expansion of lateral flow assay components into the veterinary diagnostics market.

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[futuretonext]

The Global Lateral Flow Assay Market was valued at USD9.3 billion in 2022 and is projected to grow at a CAGR of around 3.4% during the forecast period, i.e., 2023-28. The market is witnessing significant growth due to the increasing demand for point-of-care testing, expansion of home-based testing applications, and favorable market trends in various regions stemming from the growing prevalence of infectious diseases. 

[qawachbio]

Colloidal Gold

Colloidal gold refers to a suspension of gold nanoparticles in a liquid medium.

CD solutions contain gold nanoparticles that are exceptionally tiny, typically falling within the size range of 1 to 100 nanometers. These nanoparticles showcase distinctive optical characteristics, such as a distinct red, pink, or purple hue, attributed to the interaction between light and particles at the nanoscale. As a result, colloidal gold or gold nanoparticles find application in binding with detection molecules to provide visual cues in numerous diagnostic tests, thereby boasting extensive utility in diagnostic healthcare. CD finds diverse applications across various fields.

[qawach]

Lateral Flow Assay Uncut Sheets

Lateral Flow Assay Uncut Sheets uncut sheets are specialized materials.

They consist of a large sheet or roll of the various components that make up a lateral flow , including the nitrocellulose membrane, sample pad, conjugate pad, absorbent pad, and backing card. The uncut sheets serve as a precursor to the individual lateral flows test strips that are commonly seen in in vitro diagnostic kits.Firstly Manufacturers typically purchase these uncut sheets and then customize them according to their specific test requirements, including the target analyte, detection method, and desired performance characteristics. Secondly The uncut sheets allow for flexibility in the manufacturing process, as they can be customized to produce lateral flow test strips with different configurations and specifications. Thirdly Manufacturers can cut the sheets into smaller strips of specific dimensions, apply additional coatings or reagents, and assemble them into the final test format.

[healthcaremarketanalysis]

Lateral Flow Assay Market worth $16.8 billion by 2029

Lateral Flow Assays Market in terms of revenue was estimated to be worth $10.8 billion in 2023 and is poised to reach $16.8 billion by 2029, growing at a CAGR of 7.6% from 2023 to 2029 according to a new report by MarketsandMarkets™. The rising demand of lateral flow assays due to increasing number of geriatric populations, growing prevalence of infectious diseases as well as increasing of point of care tests are some of the key factors that are driving the growth of this market. However, the hesitance in the patients as well as in health professionals to change in the conventional diagnostic method and the lack of accuracy of lateral flow assays are some of the key restraints for lateral flow assays market.

Lateral Flow Assays Market Size, Dynamics & Ecosystem

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"Kits and Reagents segment is expected to witness the highest growth during the forecast period"

Based on product type, the lateral flow assays market is segmented into kits & reagents and lateral flow readers. During the forecast period, the the lateral flow readers segment is expected to witness the second highest growth during the forecast period. The growth of this segment can be attributed as these are economical, quantitative as well as capability of assaying multiple analytes simultaneously.

"Veterinary Diagnostic segment accounted for the second largest share of lateral flow assays market in 2022"

Based on applications, the lateral flow assays market is segmented into clinical testing, veterinary diagnostics, food safety & environmental testing, and drug development & quality testing. The veterinary diagnostic segment accounted for the second largest share of the lateral flow assays market in 2022.In the veterinary diagnostic segment, lateral flow tests are used to test commercial livestock and household pets for various medical conditions, including bacterial and viral infections, allergies, fertility issues, and diabetes. The possibility of infectious disease outbreaks (particularly in large livestock animals) drives the demand for lateral flow tests due to their simplicity and rapidity compared to conventional detection methods.

"The multiplex detection assays technique is expected to witness the fastest growth during the forecast period"

Based on technique, the lateral flow assay kits & reagents market is segmented into competitive assays, sandwich assays, and multiplex detection assays. The multiplex detection assays technique anticipated to undergo the most substantial growth in the given forecast period. The multiplex assays are useful in clinical diagnosis as it allows to help and decide the stage of a disease where multiple interdependent analytes are involved in the test process. It is highly desirable to analyze multiple analytes simultaneously under the same set of conditions.

North America is expected to account for the largest share of the lateral flow assays industry.

North America has some of the highest worldwide healthcare spending rates, which translates into large investments in state-of-the-art ophthalmic technology. This encourages the creation and uptake of cutting-edge technology, expanding the realm of what is practical for preventive and vision restoration. World-class research facilities and medical centers that are at the forefront of ocular research and development can be found in the area. This creates a vibrant ecosystem that encourages innovation, which results in a steady supply of new and enhanced equipment coming to market. Naturally, as North America's population ages, age-related eye conditions like cataracts and macular degeneration become more common. Growth is further accelerated as a result of the expanded market for diagnostic and therapeutic equipment.

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Lateral Flow Assays Market Dynamics:

Drivers:

High prevalence of infectious diseases

Rising geriatric population

Growing use of home-based lateral flow assay devices

Growing demand for POC testing

Restraints:

Inconsistent results of lateral flow assay tests

Opportunities:

Evolving applications of lateral flow assays

Rising demand for lateral flow assays in food & beverage industry

Emergence of Omicron COVID variant

Challenge:

Limited reimbursements for lateral flow assay products

Difficulties in procuring quality raw materials to develop tests

Key Market Players of Lateral Flow Assays Industry:

The key players in the global lateral flow assays market include Abbott Laboratories (US), Quidel Corporation (US), F. Hoffman-La Roche AG (Switzerland), Danaher Corporation (US), Siemens AG (Germany), BD (US), bioMérieux SA (France), Thermo Fisher Scientific, Inc. (US), and PerkinElmer Inc. (US).

A breakdown of the primary participants (supply-side) for the lateral flow assays market referred to for this report is provided below:

By Company Type: Tier 1–35%, Tier 2–20%, and Tier 3–45%

By Designation: C-level–45%, Director Level–25%, and Others–30%

By Region: North America–36%, Europe–26%, Asia Pacific–21%, Latin America- 10%, and Middle East and Africa– 7%

Recent Developments of Lateral Flow Assays Industry:

In August 2023, Quidelortho received authorization from the US Food and Drug Administration (FDA), allowing the company to market its new Sofia 2 SARS Antigen+ FIA.

In February 2022, Abbott Laboratories received FDA Emergency Use Authorization (EUA) for its Alinity M assay to detect antibodies to SARS-CoV-2.

In October 2022, Roche launched the next-generation portfolio of SARS-CoV-2 rapid antigen tests ("2.0").

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