StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.

Detailed Description
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The study will be conducted at three (3) different healthcare settings (hereafter referred to as testing sites) in POC sites/departments, by at least nine (9) CLIAW operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. Examples of hospital departments include (but are not limited to) Emergency Department (ED), Intensive Care Unit (ICU), Pediatric Intensive Care Unit (PICU), Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Cardiac Intensive Care Unit (CICU), Operating Room (OR), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized. Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females. Each Study Subject will provide: Two (2) capillary whole blood fingerstick specimens One Lactate capillary test using the Fingerstick Blood Contamination Barrier One Hb/Hct capillary test following traditional fingerstick protocol One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe: One lactate venous test One Hb/Hct venous test

Official Title
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CLIA Waived Study: StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

Conditions
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Sepsis, Anemia, Bleeding, Erythrocytosis

Intervention / Treatment
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* Diagnostic Test: Lactate, Hemoglobin, Hematocrit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects (over or equal to 18 years old) with ordered hemoglobin and hematocrit Exclusion Criteria: Pediatric

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lactate, Hemoglobin, Hematocrit|Compare diagnostic tests to reference methods|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison | StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Lactate blood results in mmol/L | 20 days | 
| Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison | StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hemoglobin blood results in g/dL | 20 days | 
| Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison | StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hematocrit blood results in % | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactate, Hemoglobin, Hematocrict