Covid19
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTINDICAID™ COVID-19 Rapid Antigen Test
The diagnostic assay will be compared to a EUA SARS-CoV-2 assay
Sponsors
University of California, Los Angeles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Concordance | Day 1 | The concordance with the INDICAID COVID-19 Rapid Antigen Test with an EUA PCR test |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test Sample specimens were collected from participants testing for SARS-CoV-2. Results from the diagnostic test were compared to the EUA SARS-CoV-2 assay. | 297 |
| Total | 297 |
Baseline characteristics
| Characteristic | Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test |
|---|---|
| Age, Continuous | 32 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 231 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 259 Participants |
| Region of Enrollment United States | 297 participants |
| Sex: Female, Male Female | 158 Participants |
| Sex: Female, Male Male | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 297 |
| other Total, other adverse events | 0 / 297 |
| serious Total, serious adverse events | 0 / 297 |
Outcome results
Primary
Test Concordance
The concordance with the INDICAID COVID-19 Rapid Antigen Test with an EUA PCR test
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sample Collection | Test Concordance | 85.3 positive percent agreement |