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Purpose

The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care includes CBC-DIFF and microbial testing.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients [18-89 years of age] - Present to the Emergency Department - With symptoms suggestive of COVID-19 or respiratory infection - Whose assessment includes CBC-Diff and RT-PCR testing

Exclusion Criteria

  • Pregnancy - Prisoners - <18 years of age - >89 years of age - Previously evaluated in this study - No RT-PCR testing - Sample age >2 hours from time of draw - Instrument flags, including vote outs and review flags for the MDW parameter - Samples stored in refrigerated temperatures

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
CBC-Diff Monocyte Volume Width Distribution Monocyte Distribution Width [MDW] is part of the CBC with Differential. No intervention
  • Device: CBC-Diff Monocyte Volume Width Distribution
    MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care.

Recruiting Locations

More Details

NCT ID
NCT04816630
Status
Completed
Sponsor
Beckman Coulter, Inc.

Detailed Description

The objective of this study is to evaluate MDW and/or combination(s) of hematology parameters that best identify patients with COVID-19 disease who tested SAR-CoV-2 positive by standard of care (SOC) COVID-19 testing. A feasibility study of consecutive adult patients who presented to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care testing involves a CBC-DIFF and microbial testing including RT-PCR testing for SARS-CoV-2 will be enrolled. This study will evaluate MDW and other CPD parameters performance in COVID-19 patients and the ability of MDW to identify RT-PCR positive COVID-19 patients as well as potential added value to RT-PCR tests of MDW. A minimum of 50 COVID-19 positive and 150 COVID-19 negative patients meeting inclusion criteria will be evaluated. Patients with symptoms suggestive of COVID-19 and who have RT-PCR test samples drawn will be retested on the DxH900 hematology analyzer to capture baseline MDW results. In addition, a retrospective data extraction will be performed for those patient samples tested during the Post Market study during the COVID-19 pandemic that meet the revised study population.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.