NCT04904510

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 297 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	INDICAID™ COVID-19 Rapid Antigen Test	The diagnostic assay will be compared to a EUA SARS-CoV-2 assay

Timeline

• Start date: 2020-11-20
• Primary completion: 2021-03-09
• Completion: 2021-03-09
• First posted: 2021-05-27
• Last updated: 2023-02-15
• Results posted: 2023-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study