Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05771714 |
| Other study ID # |
CT-22255-PR |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 9, 2023 |
| Est. completion date |
May 11, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
AccessBio, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 subject's 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 subject's test cartridge, labeled with
their corresponding subject ID number. Additionally, the study staff member will record
whether or not they agree with the test result's 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 -70°C 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, i.e., positive or
negative for COVID-19, and the cycle threshold (Ct) value for all positive samples.
