Adults, Covid19, Emergency Department, Sepsis
Conditions
Brief summary
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.
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.
Interventions
DEVICECBC-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.
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 diseased patients | Within 12 hours from presentation to the emergency department | MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 diseased patients diagnosed clinically | Within 12 hours from presentation to the emergency department | MDW's ability to identify COVID-19 diseased patients versus site's COVID-19 diagnosis, including those that were RT-PCR negative |
Other
| Measure | Time frame | Description |
|---|---|---|
| Initial Disposition: Hospitalization | Within 12 hours from presentation to the emergency department | MDW's ability to identify COVID-19 patients who require hospitalization |
| Initial Disposition: ICU Admission | Within 12 hours from presentation to the emergency department | MDW's ability to identify COVID-19 patients who require treatment in the intensive care unit |
| Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions | Within 72 hours from presentation to the emergency department | MDW's ability to identify COVID-19 patients upon emergency department that may require increased respiratory requirements in 72 hours from presentation |
| COVID-19 Severity | Within 12 hours from presentation to the emergency department | MDW's ability to identify COVID-19 patient severity \[mild, moderate, severe and critical\] |
Countries
United States
Outcome results
None listed