Micro-hematology Analyzer for Viral/Bacterial Description
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, theCytoTracker, to measure complete blood count (CBC) parameters and discriminate between viral and bacterial infections.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, the CytoTracker, to measure complete blood count (CBC) parameters. The CytoTracker results will be compared to those from a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros ES 60). If successful, the data from this study would be used to support a pre-submission meeting to the FDA for the CytoTracker. In addition to validating the CytoTracker, the project will study the use of CBC parameters to distinguish between observed bacterial or viral infections in adults. Hospitalized adult subjects with suspected or confirmed viral or bacterial infections will be enrolled in the study. After enrollment a venous blood sample (baseline sample) will be collected and the CytoTracker will be used to measure CBC parameters (cell counts and population distribution). Clinical data will be abstracted from the medical record and used with the CBC parameters to develop an algorithm to distinguish between bacterial and viral infections.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Viral Group known viral infection |
Diagnostic Test: complete blood count
Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.
|
| Bacterial group known bacterial infection |
Diagnostic Test: complete blood count
Complete blood count will be performed on the patient. Accuracy of micro-hematology analyzer will be assessed.
|
Outcome Measures
Primary Outcome Measures
- Accuracy [1 year]
Accuracy of Device in quantifying WBC, Neutrophils, and Lymphocytes; Accuracy of Viral/Bacterial Descrimination
Eligibility Criteria
Criteria
Inclusion Criteria:
-COVID positive or suspected/confirmed bacterial infection (lower UTI, pneumonia, septecemia, etc). -Adults 18 years of age and older. -Meet SIRS criteria anytime during the ED presentation.
Exclusion Criteria:
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Subjects who are unable to give informed consent will be excluded
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Subjects with the following conditions will also be excluded: Known white blood cell, neutrophil, and lymphocyte disorders Active cancer patients; For solid tumors, subject will be excluded if he/she has received chemotherapy in the last 3 months.
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Subjects who are pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ben Taub Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- RizLab Health, Inc.
- Baylor College of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Ahuja K, Rather GM, Lin Z, Sui J, Xie P, Le T, Bertino JR, Javanmard M. Toward point-of-care assessment of patient response: a portable tool for rapidly assessing cancer drug efficacy using multifrequency impedance cytometry and supervised machine learning. Microsyst Nanoeng. 2019 Jul 15;5:34. doi: 10.1038/s41378-019-0073-2. eCollection 2019.
- Chaves F, Tierno B, Xu D. Quantitative determination of neutrophil VCS parameters by the Coulter automated hematology analyzer: new and reliable indicators for acute bacterial infection. Am J Clin Pathol. 2005 Sep;124(3):440-4.
- Furniturewalla A, Chan M, Sui J, Ahuja K, Javanmard M. Fully integrated wearable impedance cytometry platform on flexible circuit board with online smartphone readout. Microsyst Nanoeng. 2018 Jul 30;4:20. doi: 10.1038/s41378-018-0019-0. eCollection 2018.
- Jung YJ, Kim JH, Park YJ, Kahng J, Lee H, Lee KY, Kim MY, Han K, Lee W. Evaluation of cell population data on the UniCel DxH 800 Coulter Cellular Analysis system as a screening for viral infection in children. Int J Lab Hematol. 2012 Jun;34(3):283-9. doi: 10.1111/j.1751-553X.2011.01392.x. Epub 2012 Jan 9.
- Juul S, Pliskin JS, Fineberg HV. Variation and information in white blood cell differential counts. Med Decis Making. 1984;4(1):69-80.
- Korppi M, Kröger L, Laitinen M. White blood cell and differential counts in acute respiratory viral and bacterial infections in children. Scand J Infect Dis. 1993;25(4):435-40.
- Kramer MS, Tange SM, Mills EL, Ciampi A, Bernstein ML, Drummond KN. Role of the complete blood count in detecting occult focal bacterial infection in the young febrile child. J Clin Epidemiol. 1993 Apr;46(4):349-57.
- Miller J, Starks B. Deciphering clues in the CBC count. Nursing. 2010 Jul;40(7):52-5. doi: 10.1097/01.NURSE.0000383454.33035.4b.
- Naess A, Nilssen SS, Mo R, Eide GE, Sjursen H. Role of neutrophil to lymphocyte and monocyte to lymphocyte ratios in the diagnosis of bacterial infection in patients with fever. Infection. 2017 Jun;45(3):299-307. doi: 10.1007/s15010-016-0972-1. Epub 2016 Dec 19.
- Power M, Fell G, Wright M. Principles for high-quality, high-value testing. Evid Based Med. 2013 Feb;18(1):5-10. doi: 10.1136/eb-2012-100645. Epub 2012 Jun 27.
- H-49795