Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test

Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing

The INDICAID™ Rapid Antigen Test was used in real-world outbreak testing. The antigen test was used together with PCR testing. This study was designed to evaluate whether the addition of a rapid antigen test decreased time to results in a real-world setting.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: INDICAID™ COVID-19 Rapid Antigen Test

Detailed Description

Description of the INDICAID™ COVID-19 Rapid Antigen Test The INDICAID™ Rapid Test by PHASE Scientific is a LFA designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein in nasal swab samples.

Sample collection and procedure To collect a sample, a nasal swab sample is collected by inserting the provided swab 1 inch into the nasal cavity. The swab is rubbed against the inside walls of both nostrils 5 times in a large circular path. The swab is then dipped into a buffer solution to elute the sample. Finally, three drops of the buffer solution-specimen mix are applied to the LFA test device. After 20 minutes, the user observes the test device for the presence or absence of a test line that indicates detection of the SARS-CoV-2 antigen. An Internal Quality Control line is included to indicate whether the test has been performed correctly.

COVID-19 outbreak screening with the LFA In this Dual-Track testing approach, the LFA is used to identify preliminary positives to trigger prioritization of sample processing for subsequent RT-PCR confirmatory testing.

In Approach A, a preliminary positive result from the LFA would expedite the corresponding patient VTM sample for laboratory-based RT-PCR. Expedited testing would obtain results. In Approach B, a preliminary positive result from the LFA result would trigger the testing of the corresponding patient VTM sample with an onsite rapid nucleic acid amplification test (cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test on the cobas® Liat system, Roche Molecular Diagnostics). In addition to the onsite rapid RT-PCR test, the corresponding patient VTM sample was also sent for expedited laboratory-based RT-PCR testing. All samples testing negative with the LFA were sent for RT-PCR testing.

• Study Type: Observational
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • CityHealth Urgent Care Oakland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People testing for COVID at multiple sites in California

Description

Inclusion Criteria:

• at least 5 years of age and report onset
• at least two of the following COVID-19 symptoms within 5 days or less: fever or chills, fatigue, sore throat, congestion or runny nose, cough, headache, diarrhea, shortness of breath or difficulty breathing, muscle or body aches, new loss of taste or smell, nausea, or vomiting.

Exclusion Criteria:

• That do not fit inclusion criteria or vulnerable populations

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sample Collection; People routinely testing for COVID-19 would have an extra sample collected to assess the diagnostic device.	Diagnostic test: INDICAID™ COVID-19 Rapid Antigen Test; The diagnostic assay will be compared to a EUA SARS-CoV-2 assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Concordance	The concordance with the INDICAID COVID-19 Rapid Antigen Test with an EUA PCR test	Day 1

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00047510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No