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NIH Assessing Home Covid-19 Diagnostic with App

QuickVue test package

QuickVue At-Home COVID-19 Test (Quidel Corp., NIH)

1 Mar. 2021. A home Covid-19 test is being evaluated with a smartphone app, as part of an NIH program to quickly develop Covid-19 diagnostics for widespread use. The QuickVue At-Home Covid-19 Test, made by medical diagnostics company Quidel Corp. in San Diego is being assessed with the MyDataHelps app made by CareEvolution LLC in Ann Arbor, Michigan.

The QuickVue At-Home Covid-19 Test takes a mid-nose nasal swab sample, which individuals can do at home. The nasal swab sample is placed in a tube with a reagent and a paper test strip, treated to react to the presence of characteristic antigen proteins from SARS-CoV-2 viruses responsible for Covid-19 infections. In 10 minutes, printed lines on the paper strip change color to indicate positive or negative results. Quidel Corp. says its data show the QuickVue test returns true positive results 85 percent of the time, and true negative results 99 percent of the time, when compared to the so-called gold standard RT-PCR molecular tests.

Food and Drug Administration today granted Quidel Corp. an emergency use authorization for the QuickVue home test. The action authorizes the QuickVue home test when prescribed by a clinician for teens and adults age 14 and up, and children age 8 and up, when performed by an adult. In addition, the test is authorized for detecting infections within six days of noticing Covid-19 symptoms.

App to boost compliance and test performance

While the QuickVue At-Home Covid-19 Test comes with step-by-step instructions, the National Institute for Biomedical Imaging and Bioengineering, or NIBIB, part of National Institutes of Health, wants to learn if a companion smartphone app can improve compliance with directions, as well as help verify the results. The app in this case is MyDataHelps, written for both Apple iOS and Android phones, that will also provide step-by-step instructions for the QuickVue test, a timer for performing the steps, and a module for verifying test strip results with a photo taken by the phone’s camera.

NIBIB wants to evaluate the app’s potential for collecting and interpreting home test results, as well as tracking symptoms. The institute reports so far more than 200 participants enrolled in the study, collecting daily test results for two weeks. The MyDataHelps app is already in use for a study with the Scripps Research Translational Institute, collecting data on Covid-19 symptoms from phones and wearable devices, as reported in November 2020 by Science & Enterprise. The results could help Quidel Corp. with its next objective, clearance from FDA for marketing the QuickVue test as an over-the-counter device without the need for a prescription.

Quidel Corp. is taking part in NIH’s Rapid Acceleration of Diagnostics or RADx initiative, also administered by NIBIB. RADx operates as a crowd-sourced challenge competition seeking the best candidates for point-of-care and home Covid-19 diagnostics that can translate into large numbers of inexpensive and easy-to-use tests in a relatively short period of time. The RADx organizers hope to generate innovative solutions for fast, accurate, and easy-to-use diagnostics to detect SARS-CoV-2 viruses and antigens indicating the presence of antibodies protecting against infections.

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