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

Covid19 Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Covid19

• NCT number: NCT04937595
• Study type: Interventional
• Source: Medical College of Wisconsin
• Contact: Matthew L Faron, PhD
• Phone: 414-805-6967
• Email: mfaron@mcw.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Completion date: December 31, 2021