We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics- Hematology Division

Download Mobile App

World's First Low Cost, Disposable COVID-19 Diagnostic Test to Identify T-Cell Immune Response to SARS-CoV-2

By LabMedica International staff writers
Posted on 21 Oct 2021
Print article
Image: BD Soluvia Microinjection System (Photo courtesy of BD)
Image: BD Soluvia Microinjection System (Photo courtesy of BD)

A new test is being developed to screen for a T-cell-mediated immune response to SARS-CoV-2 instead of just testing for the virus itself.

The test called CoviDTH based on Delayed-Type Hypersensitivity (DTH) technology is being jointly developed by BioVaxys Technology Corp. (Vancouver, Canada) and WuXi Biologics (Jiangsu, China). The test is the world's first low cost, disposable, diagnostic to identify a T-cell immune response to the presence of SARS-CoV-2. Data for this form of testing suggests it may even be more accurate than current methods, by measuring the immune system's active infection response.

Current tests for immunity to COVID-19 only measure antibodies, while the other form of the immune response, T-cell immunity, is often ignored. Recent study results in humans showed that the DTH response is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration. Measuring T-cell immunity requires the drawing of two ounces of blood from the test subject and a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment.

CoviDTH comes as a single-use, disposable, syringe containing the proper amount of recombinant, non-infectious, S1 subunit of the SARS-CoV-2 spike protein in liquid suspension. CoviDTH is based on DTH technology which is known to be a measure of T cell immunity and has been used for many years for immune response screening for other infectious diseases such as tuberculosis, fungal diseases, and mumps. The test is performed by injecting a small amount of test material, e.g. the SARS-CoV-2 spike protein, intradermally and inspecting the site for erythema and induration 24-48 hours later. The test results can be measured visually by a health care provider or optically using a cell phone app that the company plans to develop.

By adding the spike proteins from SARS-CoV-2 variants, CoviDTH has the potential for detecting T cell responses to new mutated variants strains of SARS-CoV-2 that are spreading worldwide. By detecting T-cell activation, it is believed that this can potentially identify safe and/or at-risk populations, while also providing an ability to evaluate the effectiveness of any SARS-CoV-2 vaccine in stimulating T-cell immunity. BioVaxys recently announced that WuXi successfully completed synthesis of a recombinant SARS-CoV-2 s-protein, which the company can then use as part of its work towards potential a US Food and Drug Administration (FDA) approval for CoviDTH, as well as BVX-0320, the company's COVID-19 vaccine candidate. Both products are headed for clinical trials, with BioVaxys having begun preparing an IND submission to the FDA for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

"The production of the recombinant s-protein using WuXi Biologics' proprietary cell expression system is a significant milestone for Biovaxys," said Kenneth Kovan, President and COO of BioVaxys. "We not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields."

Related Links:
BioVaxys Technology Corp. 
WuXi Biologics 

Gold Supplier
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Prepacked)
Lateral Flow Test Cassette Reader
Quantum Blue III
Laboratory Automation System
Pancreatic Elastase ELISA Kit
Pancreatic Elastase ELISA

Print article


Molecular Diagnostics

view channel
Image: Absence of nuclear immunohistochemical staining of MSH2 protein (A) and presence of MLH1 protein (B) in urothelial cell carcinoma of the urinary bladder of a patient carrying a germline MSH2 mutation. Observe the nuclear staining in stromal cells as an internal control (Photo courtesy of Radboud University Nijmegen Medical Centre)

Simple Urine Test Detects Urothelial Cancers in Lynch Syndrome Patients

Lynch Syndrome (LS) is an inherited genetic disorder that carries a high risk of cancer. LS is caused by mutations affecting MLH1, MSH2, MSH6 or PMS2 genes. More than one in 300 people have LS but most... Read more


view channel
Image: The Gazelle Hb Variant Test for screening, diagnosis and management of sickle cell disease and related hemoglobinopathies at the point of care (Photo courtesy of Hemex Health)

Point-of-Care Device Accurately Rapidly Diagnoses Sickle Cell Disease

Hemoglobinopathies are the most common autosomal hereditary disorders. Approximately 7% of the global population carries hemoglobin gene mutation including structural hemoglobin variants like sickle hemoglobin... Read more


view channel
Image: The IMMULITE 2000 XPi Immunoassay System provides multiple tests on a single, easy-to-use analyzer, including the thyroid-stimulating immunoglobulin assay (Photo courtesy of Siemens Healthcare)

Immunoassays Evaluated for Thyroid-Stimulating Receptor Antibody in Graves’ Disease

Graves' disease (GD), also known as toxic diffuse goiter, is an autoimmune disease that affects the thyroid. It frequently results in and is the most common cause of hyperthyroidism and it also often results... Read more


view channel
Image: The sciREADER CL2 enables high quality digital colorimetric imaging of various support formats (Photo courtesy of SCIENION)

Multiplex Immunoassay Developed for Confirmation and Typing of HTLV Infections

Human T-Cell Lymphotropic Viruses (HTLV) type 1 and type 2 account for an estimated five to 10 million infections worldwide and are transmitted through breast feeding, sexual contacts and contaminated... Read more


view channel

AI Accurately Detects and Diagnoses Colorectal Cancer from Tissue Scans As Well or Better Than Pathologists

Artificial intelligence (A) can accurately detect and diagnose colorectal cancer from tissue scans as well or better than pathologists, according to a new study. The study, which was conducted by researchers... Read more


view channel
Image: PKeye Workflow Monitor System (Photo courtesy of PerkinElmer, Inc.)

PerkinElmer’s New Cloud-Based Platform Enables Laboratory Personnel to Remotely Manage Its Instruments in Real-Time

PerkinElmer, Inc. (Waltham, MA; USA) has launched its PKeye Workflow Monitor, a cloud-based platform enabling laboratory personnel to remotely manage and monitor their PerkinElmer instruments and workflows... Read more


view channel

Global Point of Care Diagnostics Market to Top USD 35 Billion by 2027 Due to Rising Diabetic Cases

The global point of care diagnostics market is projected to grow at a CAGR of close to 6% from more than USD 23 billion in 2020 to over USD 35 billion by 2027, driven by an increase in the number of diabetic... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.