Feasibility Study of Hematology Parameters in COVID-19 Disease
Feasibility Study of Hematology Parameters in COVID-19 Disease
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.
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