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
What is InstaNGAL® Test kit ?
InstaNGAL® Test kit works on the principle of ‘time-based analyte concentration estimation’ in the patient’s urine sample using a lateral flow assay platform. Researchers have conducted clinical studies on the Indian population to assess this test’s performance. A successful completion of a phase I-Pilot clinical study for InstaNGAL® has been achieved at several hospital sites in India.
Currently, the phase II of the clinical study for this test kit is in progress. The test kit has demonstrated high sensitivity in detecting uNGAL for early detection of AKI. Once, however the clinical study for this test kit is completed, InstaNGAL® will be launched for Indian market with all regulatory guidelines followed as per MDR 2017.
We exemplify the application of the ‘need-driven’ product design principle in developing a rapid test kit for detecting SARS-COV-2 (COVID-19). Our intention is to use these tests in the field and eventually for home usage. The tests ascertain whether a subject is presently infected with the virus and is capable of transmitting it.
The necessity for a large volume of tests in field settings introduces limitations. These include a short testing duration and the absence of access to specialized equipment, laboratories, and skilled technicians for conducting and interpreting the test.
The InstaNGAL® Test Kit, a groundbreaking creation by QAWaCh Bio Pvt. Ltd., represents a rapid and dependable diagnostic tool for the early assessment of acute kidney injury (AKI). Moreover, this innovative test relies on the measurement of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) levels in human urine, employing a unique semi-quantitative and quantitative lateral flow assay platform. Additionally, InstaNGAL® serves as a bedside test designed to enable the early diagnosis of AKI, leveraging NGAL levels in human urine.
QAWaCh Bio’s patented technology, ‘Q-Plat,’ forms the foundation of InstaNGAL®. This innovative system seamlessly merges a lateral flow assay-based test card with smartphone technology, resulting in an efficient and user-friendly method for assessing kidney injury. This integration allows for precise ‘time-based analyte concentration estimation’ on the patient’s urine sample, utilizing the lateral flow assay platform. Furthermore, extensive clinical studies on the Indian population have rigorously evaluated the test’s performance, unequivocally demonstrating its remarkable sensitivity in uNGAL detection for early AKI identification.
Strength:
The strength of the InstaNGAL® Test Kit lies in its rapidity, reliability, and potential to transform AKI diagnosis. By providing early detection capabilities for AKI, it facilitates timely intervention and improved patient outcomes. This test empowers healthcare professionals to swiftly identify kidney injury, enabling them to implement appropriate treatment strategies promptly.
Advantages:
InstaNGAL® offers several advantages. These include its user-friendliness and high sensitivity in detecting uNGAL. Additionally, its semi-quantitative and quantitative capabilities enhance its accuracy and versatility. Moreover, the integration of smartphone technology simplifies the testing process, making it accessible even in settings with limited resources. Furthermore, the ongoing clinical studies and adherence to regulatory guidelines ensure the test's reliability and compliance with safety standards.
Recognitions:
The InstaNGAL® Test Kit is a testament to need-driven product design, showcasing innovation in the field of medical diagnostics. Furthermore, its potential applications extend beyond kidney injury assessment. This is exemplified by its use in detecting SARS-COV-2 (COVID-19). This adaptability makes it a valuable tool for various healthcare scenarios. This is particularly crucial in field settings where rapid testing is essential. Moreover, the commitment to regulatory guidelines, such as MDR 2017, underscores its dedication to quality and patient safety.
Innovation:
The InstaNGAL® Test Kit embodies innovation by seamlessly merging lateral flow assay technology with smartphone functionality. This integration creates a user-friendly, rapid diagnostic tool. Furthermore, its successful clinical studies and ongoing research highlight its potential to revolutionize AKI diagnosis. This approach also broadens its scope to address emerging healthcare challenges, such as infectious disease detection. This innovative approach aligns with the evolving landscape of healthcare. It emphasizes the importance of accessible and accurate diagnostics in meeting the demands of modern healthcare.