Liquid Diagnostics is the exclusive worldwide licensee of certain intellectual property rights related to the Amperial platform
Liquid Diagnostics announced today the development and successful CLIA validation of a home-collection assay for the quantitative testing of COVID-19 antibodies using saliva. It is now possible for individuals to monitor the level of their COVID-19 antibodies over time without leaving home. This test utilizes the proprietary Amperial™ technology and measures IgG to the S1 domain of the SARS-CoV-2 Spike Protein. The test is classified as a Laboratory Developed Test. An emergency use authorization (EUA) application has been filed and is awaiting FDA clearance.
This quantitative COVID-19 antibody test is the first home-collection, ultra-specific, non-invasive saliva test. The CLIA evaluation was performed at the UCLA Microbiology Laboratory in the Department of Pathology and Laboratory Medicine. The test has a specificity (absence of false negatives) of at least 99.994% and a positive predictive value of > 96% (the percentage of positive tests that are true positives). The full description of the assay development, precision determination and CLIA validation is posted on the MedRxiv preprint archives.
This test is perfect for monitoring both epidemiologic and vaccine response studies because of its unparalleled specificity of this assay and because individuals can collect samples with an easy-to-use mouth swab at home and mail the sample to a centralized laboratory. Results can be returned the day following the receipt of the sample. Individuals can be tested multiple times to assess the persistence of COVID-19 antibody production following exposure or vaccination. “With increasing evidence that the presence of SARS-CoV-2 antibodies correlates with immunity to infection, our Amperial™ assay with its exquisite specificity and high positive predictive value could be useful for essential workers to determine if they have already had a COVID-19 infection and developed immunity. Because it quantifies the amount of antibodies, the test could be used to track the persistence of antibodies following infection or vaccination to assess the potential need for booster shots,” said Dr. Charles Strom, CEO of Liquid Diagnostics, LLC.
Formerly known as Electric Field Induced Release and Measurement (EFIRMTM), the Amperial™ process was invented in the laboratory of Dr. David Wong at the UCLA School of Dentistry. The AmperialTM chemistry is based on immobilizing biomolecules in a conducting gel matrix and measuring current following electrochemical detection. “I am gratified this unique technology can be used as a tool in the fight to contain the COVID-19 pandemic. Saliva is a perfect biofluid to be analyzed for this purpose,” said Dr. David Wong, the co-inventor of the Amperial™ technology and the Director of the Head and Neck Oncology Center at the UCLA School of Dentistry.
Source: Company Press Release