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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBC-Diff Monocyte Volume Width Distribution | Monocyte Distribution Width [MDW] is part of the CBC with Differential. No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBC-Diff Monocyte Volume Width Distribution | Device | MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 diseased patients | MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR | Within 12 hours from presentation to the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 diseased patients diagnosed clinically | MDW's ability to identify COVID-19 diseased patients versus site's COVID-19 diagnosis, including those that were RT-PCR negative | Within 12 hours from presentation to the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Disposition: Hospitalization | MDW's ability to identify COVID-19 patients who require hospitalization | Within 12 hours from presentation to the emergency department |
| Initial Disposition: ICU Admission |
Inclusion Criteria:
Exclusion Criteria:
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Adult (18 to 89 years) of all race and ethnicities presenting to the emergency department with symptoms suggestive of COVID-19 or respiratory infection and whose assessment includes a CBC-DIFF and microbial testing to include RT-PCR for SARS-CoV-2
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Osborn, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018805 | Sepsis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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MDW's ability to identify COVID-19 patients who require treatment in the intensive care unit
| Within 12 hours from presentation to the emergency department |
| Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions | MDW's ability to identify COVID-19 patients upon emergency department that may require increased respiratory requirements in 72 hours from presentation | Within 72 hours from presentation to the emergency department |
| COVID-19 Severity | MDW's ability to identify COVID-19 patient severity [mild, moderate, severe and critical] | Within 12 hours from presentation to the emergency department |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |