Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05331976 |
| Other study ID # |
PDx-2233-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2022 |
| Est. completion date |
March 21, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Proof Diagnostics |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and
suspected/at-risk asymptomatic population and point-of-care use as compared to a standard
molecular comparator, Quidel Lyra SARS-CoV-2 Assay for diagnosing SARS-CoV-2 infection.
Description:
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in December
2019 in Wuhan, the capital of China's Hubei province, and has since spread globally,
resulting in the ongoing 2019-20 (and now 2021) coronavirus pandemic. The first confirmed
case of what was then an unknown coronavirus was traced back to November 2019 in Hubei.
Common symptoms include fever, dry cough, fatigue, sputum production, loss of smell, and
shortness of breath. While the majority of cases result in mild symptoms, some cases progress
to viral pneumonia and multi-organ failure. Emergency symptoms include difficulty breathing,
persistent chest pain or pressure, confusion, difficulty waking, and bluish face or lips. The
time from exposure to onset of symptoms is typically around five days but may range from two
to fourteen days. As of December 4th, 2020, more than 67.3 million cases have been reported
across 185 countries and territories, resulting in more than 1.54 million deaths.
On December 2nd, 2020 the Pfizer/BioNTech vaccine was approved in the United Kingdom,
followed by approval in the United States (under Emergency Use Authorization [EUA]) on
December 11th, 2020. Numerous antiviral and anti-inflammatory treatments have been proposed
for COVID-19. Today, management involves the treatment of symptoms, supportive care,
isolation, and experimental measures. The WHO has published several testing protocols for the
disease. The standard method of testing is real-time reverse transcription polymerase chain
reaction (rRT-PCR). The test is typically done on respiratory samples obtained by a
nasopharyngeal swab and more recently mid-turbinate and anterior nares nasal swab, and sputum
sample or saliva may also be used. Results are generally available within 12-18 hours but can
take upwards of two - four days depending on the testing needs of the community. Blood tests
can be used, but these require two blood samples taken two weeks apart, and the results have
little immediate value. Blood tests can be used to detect antibodies to the virus. The FDA in
the United States authorized under EUA the first antigen point-of-care test on 21 March 2020
for use at the end of that month and more recently Lucira has received EUA authorization for
at-home-testing.
The FDA has continued to request novel, molecular diagnostic tests which can be offered as
point-of-care tests with the potential for future at-home use with a prescription. Proof
Diagnostics believes our Proof Diagnostics Test System offers an important improvement to the
global testing challenge, providing a state-of-the-art CRISPR-based test for detecting
SARS-CoV-2 with sensitivity comparable to the gold standard RT-qPCR (Limit of Detection of
~300 copies/mL, sensitivity >95%, specificity >99%). The Proof Diagnostics Test System thus
offers a low-cost and scalable alternative which will be utilized in this clinical study
protocol and enable our EUA submission based on the data generated.
