iCareDx PSS-1 Point-of-Care (POC) Assay for Detection of COVID-19

Covid19 Clinical Trial

— iCare  

Official title:

Prospective Study for Clinical Validation of the iCareDx At-Home RT-PCR Testing System for SARS-CoV-2 Using Saliva, PSS-1 for Point of Care and At-home Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937595
• Other study ID #: PRO00039122
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Medical College of Wisconsin
• Contact: Matthew L Faron, PhD
• Phone: 414-805-6967
• Email: mfaron[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose of this clinical investigation is to establish the performance of the iCareDx PSS-1 RT PCR POC Testing Platform which is used to detect COVID-19 in symptomatic patients using the patients saliva. The study focuses on obtaining a minimum of 30 positive and 30 negative test for this study. Results will serve to establish the assay's performance. Symptomatic patients who are being tested for COVID-19 will be enrolled and consented into this study. If the patient consents, 2 saliva specimens will be collected for PSS-1 testing. One specimen will be used directly on the PSS-1 while the second one will be stored and used later if a repeat test is needed. This will be performed by comparing SARS-CoV-2 results from the clinical specimens on the PSS-1 platform and Roche Cobas 6800 COVID-19 real time-PCR molecular assay.

Description:

The iCareDx PSS-1 Real Time Polymerase Chain Reaction (RT-PCR) Point-of-Care (POC) testing platform is designed to detect RNAs from SARS-CoV-2 virus in saliva from patients who are suspected of having COVID-19. The intent of this study is to verify the performance of the platform used in the detection of COVID-19. Positive predictive and negative predictive agreement will be verified in comparison to the reference method. The reference method is to test nasopharyngeal (NP) swab specimen from the same patient that was collected for standard of care clinical testing using FDA-authorized Roche Cobas 6800 COVID-19 molecular assay. Symptomatic patients who are being tested for standard of care will be enrolled and consented into the study. If a patient consents and informed consent form will be obtained as well as two saliva sample specimens. One of the saliva specimen will be directly used on the PSS-1 and the second will be stored and used if needed to repeat the testing. The study staff will run the PSS-1 RT POC testing in which saliva specimen is heated to inactive and lyse the virus. After a 30 minute heat step EZ buffer is added and mixed. The cartridge is used to mix the heat-inactivated saliva sample with lyophilized, multiplex, one step RT-PCR reagents and load the reaction solution onto the disk without using pipetting instruments. The test will continue to run and the results will be automatically analyzed with gel electrophoresis and shown on the device screen. The benefits of the PSS-1 COVID-19 assay include a noninvasive and simple saliva collection resulting in a more efficient time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has symptoms indicative of an upper respiratory tract infection

• subject signed the approved consent form

• a NP specimen was collected for clinical care <24 hours from saliva collection

Exclusion Criteria:

• subject does not have a signed and approved consent form

• subject does not have signs or symptoms of a respiratory infection

• inability or unwillingness to provide sufficient saliva sample

• subject did not have a NP collected within 24 hours of saliva collection

• subject <18 years of age ->5 days from symptom onset

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• iCareDx PSS-1 RT-POC Testing System for SARS-CoV-2 using saliva
The PSS-1 COVID-19 assay is inteded for point of care use at patient care setting intended to detect RNA from the SARS-CoV-2-virus that causes COVID-19 from saliva specimens of symptomatic individuals.

Locations

Country	Name	City	State
United States	Froedtert Health WAC	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	iCareDx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance evaluation of PSS-1 saliva testing compared to NP Cobas 6800 COVID-19 assay (PPA, NPA, and 95% CI)	Results obtained from the PSS-1 will be compared to the reference method (NP Cobas) for the detection of SARS-CoV-2 from patient samples. Based on this comparison results (2x2 table) the following statistics will be performed to determine performance: Positive percent agreement, Negative percent agreement, and the 95% confidence intervals.	estimated 1-2 months
Primary	Evaluate invalid rate of PSS-1	Total invalid rate will be calculated based on the number of invalid results compared to total tests performed.	Estimated 1-2 months