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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    500
  • sponsor
    Medical College of Wisconsin
Updated on 30 June 2021

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.

Details
Condition COVID19
Treatment iCareDx PSS-1 RT-POC Testing System for SARS-CoV-2 using saliva
Clinical Study IdentifierNCT04937595
SponsorMedical College of Wisconsin
Last Modified on30 June 2021

Eligibility

Yes No Not Sure

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
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