Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Outbreak testing population and locations Emergency outbreak testing centers were organized at select locations in Hong Kong. The sites were made available for asymptomatic individuals who perceived themselves as having a higher risk of exposure to SARS-CoV-2 or who were under compulsory testing requirements according to the guidelines from the Department of Health of the Government of the Hong Kong Special Administration Region.
Dual-Track Testing Algorithms Two Dual-Track testing algorithms were implemented. In both approaches, patient information is first collected at the registration station. Two nasal swab specimens and one oropharyngeal swab specimen are then collected by a clinician. One nasal swab specimen is used to perform the LFA immediately onsite. The additional nasal swab and oropharyngeal swab specimens are combined and stored in a single collection device containing viral transport medium (VTM) for subsequent RT-PCR 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dual-Track Testing Algorithms A In Approach A, a preliminary positive result from the INDICAID™ Rapid Test would expedite the corresponding patient VTM sample for laboratory-based RT-PCR. Expedited testing would obtain results typically within an additional 8 hours compared to the standard approach requiring 48-hour government mandated turnaround time. |
Device: Rapid antigen testing and offsite PCR testing
Positive INDICAID™ COVID-19 Rapid Antigen Test results would trigger expediting PCR testing at an offsite lab for outbreak testing.
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| Experimental: Dual-Track Testing Algorithms B In Approach B, a preliminary positive result from the INDICAID™ Rapid Test 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). Results from the onsite rapid nucleic acid amplification test would typically be obtained within an additional hour. 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 INDICAID™ Rapid Test were sent for RT-PCR testing with the standard approach by the ONCO Medical Laboratory in batches. |
Device: Rapid antigen testing and onsite PCR testing
Positive INDICAID™ COVID-19 Rapid Antigen Test results would trigger expediting PCR testing at an onsite rapid nucleic acid amplification test.
|
Outcome Measures
Primary Outcome Measures
- Time to delivery of PCR test result [8 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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at least 5 years of age and report onset
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CityHealth Urgent Care Oakland | Oakland | California | United States | 94612 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00047510