Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771714
Status:
TERMINATED
Last Update Posted:
2023-07-13
First Post:
2023-03-14
Brief Title:
Clinical Performance Evaluation of the CareSuperb COVID-19 Antigen Home Test
Sponsor:
AccessBio Inc
Organization:
AccessBio Inc
Study Overview
Official Title:
Clinical Performance Evaluation of the CareSuperb COVID-19 Antigen Home Test
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Cancel study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the accuracy of the CareSuperb COVID-19 Antigen Home Test sensitivity and specificity in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 EUA200009 Hologic Panther Fusion SARS-CoV-2 EUA200014 and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System EUA210388 high sensitivity Emergency Use Authorization EUA SARS-CoV-2 RT-PCR assays
Detailed Description:
This is an open label prospective randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb COVID-19 Antigen Home Test when a lay person conducts the test on themselves or another study participant as compared to EUA authorized high sensitivity RT-PCR comparator tests
Patients presenting to the study site for COVID-19 testing who have signed the informed consent and assent if applicable and who meet the eligibility criteria will be enrolled in the study Upon enrollment the subject will be assigned a unique subject identification ID number After obtaining relevant demographic and medical information testing will ensue
The first sample collected by the clinical research staff will be for the standard of care SOC Results of the SOC test will be used for subject treatment and management To mitigate any potential bias which may affect the subjects visual interpretation of the CareSuperb test result the study staff will not provide the SOC test results to the subject until after the results of the CareSuperb test are read by the subject
There will be a 15-minute minimum wait period prior to the collection of the second anterior nares swab sample and an additional 15-minute minimum wait period between the second and third sample collection
For Even numbered subjects the second sample collected by a study staff member will be used for the RT-PCR comparator tests The third sample will be collected and tested by the lay user using the CareSuperb COVID-19 Antigen Home Test
For Odd numbered subjects the second sample will be collected and tested by the lay user using the CareSuperb COVID-19 Antigen Home Test The third sample will be collected by a study staff member and will be used for the RT-PCR comparator tests
The clinical study staff member will photograph each subjects test cartridge labeled with their corresponding subject ID number Additionally the study staff member will record whether or not they agree with the test results interpretation by the subject and if not why
The RT-PCR sample will be placed in the provided viral transport medium VTM vial and stored in a -70C freezer until ready for shipment to the central lab
The comparator samples for RT-PCR testing will be shipped to the central lab weekly unless directed otherwise by either the sponsor or the Clinical Research Organization CRO Specimens should be shipped on dry ice for next day delivery avoiding weekend delivery RT-PCR testing will be performed by the central lab and residual samples will be stored The central lab will report both the qualitative results for each sample ie positive or negative for COVID-19 and the cycle threshold Ct value for all positive samples
Patients presenting to the study site for COVID-19 testing who have signed the informed consent and assent if applicable and who meet the eligibility criteria will be enrolled in the study Upon enrollment the subject will be assigned a unique subject identification ID number After obtaining relevant demographic and medical information testing will ensue
The first sample collected by the clinical research staff will be for the standard of care SOC Results of the SOC test will be used for subject treatment and management To mitigate any potential bias which may affect the subjects visual interpretation of the CareSuperb test result the study staff will not provide the SOC test results to the subject until after the results of the CareSuperb test are read by the subject
There will be a 15-minute minimum wait period prior to the collection of the second anterior nares swab sample and an additional 15-minute minimum wait period between the second and third sample collection
For Even numbered subjects the second sample collected by a study staff member will be used for the RT-PCR comparator tests The third sample will be collected and tested by the lay user using the CareSuperb COVID-19 Antigen Home Test
For Odd numbered subjects the second sample will be collected and tested by the lay user using the CareSuperb COVID-19 Antigen Home Test The third sample will be collected by a study staff member and will be used for the RT-PCR comparator tests
The clinical study staff member will photograph each subjects test cartridge labeled with their corresponding subject ID number Additionally the study staff member will record whether or not they agree with the test results interpretation by the subject and if not why
The RT-PCR sample will be placed in the provided viral transport medium VTM vial and stored in a -70C freezer until ready for shipment to the central lab
The comparator samples for RT-PCR testing will be shipped to the central lab weekly unless directed otherwise by either the sponsor or the Clinical Research Organization CRO Specimens should be shipped on dry ice for next day delivery avoiding weekend delivery RT-PCR testing will be performed by the central lab and residual samples will be stored The central lab will report both the qualitative results for each sample ie positive or negative for COVID-19 and the cycle threshold Ct value for all positive samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None