Performance Evaluation of the Truvian System with Clinical Specimens
Evaluation of a System Under Investigation Using Clinical Blood Samples
Thomas E. Davis
Primary Investigator
Brief description of study
The objective of this study is to evaluate the performance of the Truvian System with clinical specimens. Blood samples from enrolled patients will be tested in one or more of three study arms to generate data demonstrating the clinical performance of the Truvian System:
- Study Arm 1: Method Comparison Assesses the degree of agreement between Truvian System s results and an FDA-cleared comparator method for each analyte.
- Study Arm 2: Whole Blood Precision Assesses the precision performance of the Truvian System, incorporating sources of variation including sites, operators, samples (normal and abnormal), and instruments.
- Study Arm 3: WBC Flagging Assesses the degree of agreement between Truvian System s WBC Flagging compared to the reference method (manual WBC differential).
Detailed description of study
The study will include three study arms:
Study Arm 1: Method Comparison
Study Arm 2: Whole Blood Precision
Study Arm 3: WBC Flagging
Subjects will be assigned to one or more of these study arms, based on their health status and the requirements of each study arm.
In general, each subject will participate in a single study visit lasting approximately 30-60 min. Blood samples will be collected. Enrollment is expected to be completed within 3-4 months of initiation and study closeout is expected to be completed approximately 2-3 months thereafter.
Subjects & Sites
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all, Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria:
1) Subject must be 18 years or older
2) Subject must be willing and able to provide written informed consent
3) Subject must be willing and able to comply with study requirements
Exclusion criteria:
1) Subject received blood product transfusion or has provided ≥ 500mL of blood products within 60 days
(2 months) of enrollment
2) Subject has already participated in this study (unless if part of Familiarization)
3) Subject has a significant disease or disorder that, in the opinion of the site investigator, may increase
the risk to the subject’s health by participating in the study
Inclusion Criteria for Sample Collection Group 1: Apparently Healthy (“normal”)
1) Subjects must meet inclusion criteria that are applicable to all study subjects, AND
2) Subjects must:
a. Be apparently healthy (not acutely ill, no significant infections within the last month), AND
b. Have no known history of a medical disorder known to affect WBC differential
Inclusion Criteria for Sample Collection Group 2: Co-morbidities
1) Subjects must meet inclusion criteria that are applicable to all study subjects, AND
2) Subjects must:
a. Have two or more abnormal test results within CMP, Lipid, CBC, HbA1c, and TSH from lab tests
performed within the last 7 days, OR
b. Be currently in an acute care setting AND have one or more of the following conditions:
Heart disease
Dyslipidemia
Liver disease (including symptomatic gallbladder disease)
Kidney disease (including those requiring dialysis)
Thyroid disorder
Blood disorder and/or blood malignancy
Diabetes
Bone disease with history of hypercalcemia (excludes osteoporosis)
Parathyroid disease
GI disorder
Two or more of these clinical features: active smoker, morbidly obese (BMI > 35), high
blood pressure (> 180 systolic)
Inclusion Criteria for Sample Collection Group 3: Abnormal CBC
1) Subjects must meet inclusion criteria that are applicable to all study subjects, AND
2) Subjects must:
a. Have abnormal CBC results within the last 7 days, OR
b. Be currently in an acute care setting AND have one or more of the following conditions:
Acute Infection (includes viral, bacterial or parasitic)
Anemia (includes B12 or folate deficiency, iron deficiency, Hemoglobinopathies /
hereditary RBC diseases like thalassemia, microcytic or macrocytic anemia, or other causes)
Leukemia
Autoimmune/rheumatological disease
Multiple myeloma
Platelet disorder
Lymphoma
Conditions causing eosinophilia (e.g. allergic reaction, parasitic infection)
Severe trauma or bleeding due to surgery or childbirth
History of monocytosis (e.g. chronic inflammation)
History of low white count (e.g. HIV Infection, chemo, etc.)
Any active cancer patient on treatment
Inclusion Criteria for Sample Collection Group 4: Specific conditions for samples at extreme ends
of AMRs for specific tests
1) Subjects must meet inclusion criteria that are applicable to all study subjects, AND
2) Subjects must:
a. Have had within the last 7 days abnormal results in the extreme range for specific tests as
required by the study design days, OR
b. Have one or more conditions that may cause abnormality in specific tests (example conditions
provided in Attachment A)
The purpose of this study is to evaluate an investigational system using clinical blood samples. This study investigates its performance by comparing results from the investigational system to established methods. The study involves three arms: Method Comparison, Whole Blood Precision, and WBC Flagging. Method Comparison assesses how closely the investigational system's results match those of an FDA-cleared method. Whole Blood Precision evaluates the consistency of results across different variables like sites and operators. WBC Flagging compares the system's ability to identify white blood cell variations against a manual reference.
Participants in this study will have a single visit lasting about 30 to 60 minutes. During this visit, blood samples will be collected for analysis. The samples will be tested in one or more of the three study arms based on the participant's health status. The study will take place at multiple clinical sites, including primary and urgent care centers. The samples collected will help establish reference ranges for various tests conducted by the investigational system.
- Who can participate: Participants must be 18 years or older and able to provide informed consent. They should be willing to comply with study requirements. Individuals who have received a blood transfusion or donated a significant amount of blood recently, or have certain health risks, are excluded.
- Study details: Participants will provide blood samples during a single visit. The samples will be used to evaluate the investigational system's performance. The study does not involve any changes to participants' usual care.
- Study timelines and visits: The study will last 3-4 months. The study requires 1 visit.
