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A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care

NCT05107258 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 195

Last updated 2021-11-04

No results posted yet for this study

Summary

The scope of this study is to validate the Pine Trees Health COVID-19 Molecular Test with unique clinical specimens from across two (2) geographically diverse point-of-care testing sites in the United States. The results will be analyzed and compared against results from the CDC 2019- Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The primary objective is to generate clinical performance data for the Pine Trees Health COVID19 molecular diagnostic test in the point-of-care setting.

Conditions

  • SARS (Severe Acute Respiratory Syndrome)
  • Covid19

Interventions

DIAGNOSTIC_TEST

The Pine Trees Health Test System

Consists of the Pine Trees Health Reader and the Pine Trees Health COVID-19 Test Kit, which contains the Pine Trees Health Cartridge, Pine Trees Health Sample Vial containing Sample Lysis Buffer and the Pine Trees Health Nasal Swab (anterior nares) for collection. The Test System is a point-of-care test used for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in nasal swabs taken from individuals who are suspected by a healthcare professional of having COVID-19. The COVID-19 test is a rapid molecular, in vitro diagnostic test using isothermal nucleic acid amplification technology and detection of the resulting amplicon using CRISPR-mediated collateral reporter unlocking.

Sponsors & Collaborators

  • Eastside Research Associates

    collaborator UNKNOWN

  • ICON plc

    collaborator INDUSTRY

  • ASCLEPES Research Center

    collaborator UNKNOWN

  • DuPage Medical Group

    collaborator OTHER

  • MRI Global

    collaborator INDUSTRY

  • Piedmont Healthcare

    collaborator OTHER

  • Pine Trees, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrice Milos, PhD · Pine Trees Health

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2021-09-16
Completion
2021-09-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107258 on ClinicalTrials.gov