Posted July 26, 2023

Johann deSa, Ph.D., Instadiagnostics, Inc.

According to the World Health Organization, an estimated 296 million people globally live with a chronic Hepatitis B virus (HBV) infection.¹ Chronic HBV infection can lead to potentially lethal complications such as liver cirrhosis and liver cancer. Treatments for HBV are most effective before cirrhosis occurs; however, many patients are asymptomatic until the onset of cirrhosis or late-stage liver disease. High-risk populations are advised to undergo routine screening for HBV, but, for many patients, there is a barrier to accessing labs that test for HBV and point-of-care tests that can be taken at their physician's office. With support from a fiscal year 2019 (FY19) Peer Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development Award, Dr. Johann deSa and his team sought to address this gap by developing a novel point-of-care test that can rapidly detect HBV in a few drops of blood. His proposal addressed the topic area of Hepatitis B, which has been a PRMRP Topic Area since FY15.

The team aimed to develop the InstaReader System and disposable InstaCartridges specific to HBV, which utilize the following components: piezoelectric sensors; nanoparticles that detect the presence of three blood-based biomarkers for HBV recommended by the Centers for Disease Control and Prevention (HBV surface antigen, antibodies to HBV surface antigen, and antibodies to HBV core antigen); and a unique blend of microfluidics and automated sample handling to make for a test that requires minimal user interaction.

The team then developed immunoassays capable of detecting a combination of antibodies and antigens for the three biomarkers. In order to test these assays in a clinic, Dr. deSa and his team designed prototypes of the InstaReader System and the plug-and-test InstaCartridges. The InstaCartridge is a single-use cartridge that has all the features needed to accept a whole-blood patient sample, extract plasma from the blood, meter the plasma to ensure test accuracy, and detect each of the three biomarkers in triplicate with controls. The InstaReader System contains all active components, such as motors, valves, pumps, and biochip-electronics, as well as a microcontroller to operate these components. Whole blood is placed in the sample reservoir of the InstaCartridges, which are plugged into the InstaReader to perform all necessary steps for the assays; the results are available within 15 minutes.

With a completed prototype design, the research team is currently preparing to test the device's performance with all three assays on the same chip and validate their data in a pilot clinical study. The device will be tested on a cohort of 150 patient samples, of which 75 are HBV-positive and 75 are HBV-negative. While further studies are needed before this device can be used in clinics, this point-of-care test has the potential to make access to HBV diagnostic tests easier, thus allowing for earlier diagnosis and treatment, and reducing the risk for liver cirrhosis and cancer for patients with HBV. Furthermore, if successful, the InstaReader system and InstaCartridge could be developed to test for other infectious diseases.

References:

¹Global HIV Programme. 2021. Web Annex 1. Key Data at a Glance. In: Global Progress Report on HIV, Viral Hepatitis and Sexually Transmitted Infections, 2021. Accountability for the Global Health Sector Strategies 2016-2021: Actions for Impact. WHO (Eds.) Geneva: World Health Organization.

Links:
Public and Technical Abstracts: A Portable Point-of-Care Diagnostic Device for the Rapid Screening of Hepatitis B

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