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| Name | Class |
|---|---|
| Babson Diagnostics | INDUSTRY |
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This study designed to evaluate the safety and effectiveness of a newly developed sample collection device. Participants will be enrolled and samples will be collected by representative future users of the device. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be tested and average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations will be captured and device safety will be assessed.
The current method for collection of a large volume of capillary blood (up to 600 µL) involves optional warming of the hand or finger prior to procedure, lancing of the fingertip, squeezing the fingertip by hand, and dripping the blood into an open non-sterile tube. The capillary blood collection process is considered cumbersome and lacks standardization in how much pressure is applied in squeezing of the finger which may lead to poor sample quality or insufficient blood volume. Common sample quality issues for capillary blood collection include hemolysis and dilution of sample with interstitial fluid, potentially causing bias in test results. Open collection also carries a risk of blood exposure for healthcare workers and potential risk of infection at the finger puncture site. A new device, BD Microtainer® Easy Collect Capillary Blood Collection System for the collection of capillary blood was created to standardize the current collection process and improve sample quality.
This study designed to evaluate the safety and effectiveness of the BD Microtainer® Easy Collect Capillary Tube SST™ and BD Microtainer® Easy Collect Capillary Tube EDTA devices. This study will be conducted in two parts, one for the SST product and the other for the EDTA product. A minimum of 100 participants, and a maximum of 150 participants per part will be enrolled at a minimum of three various ancillary healthcare site settings representative of the intended use environment such as retail pharmacy site, patient service center, and/or urgent care clinic. Samples will be collected by representative future users of the BD Microtainer® Easy Collect Capillary Blood Collection System who may not have prior blood collection experience. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be collected, clotted (serum samples only) and centrifuged (serum samples only) before transportation to the laboratory where they will be tested.
Average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations for the SST products will be captured which include hemolysis as measured by Plasma Free Hemoglobin (PFH); collection volume; and duration of sample collection. Visual Observations for the EDTA products will be captured which include frequency of occurrence of instrument flags; frequency of occurrence of platelet clump instrument flags; frequency of instrument platelet clump flags with no platelet clump; evaluate whole blood collection volume; and duration of sample collection. Lastly, device safety will be assessed by device and procedure related adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | BD MiniDrawâ„¢ Capillary Blood Collection System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capillary Blood Collection System | Device | Test Blood Sample Collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of g/dL | within 4 hours of sample collection |
| White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators venous comparator and capillary comparator. This comparison was focused on the analytes with a unit of percentage | within 2 hours of sample collection |
| Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of µIU/mL | within 4 hours of sample collection |
| Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mg/dL | within 4 hours of sample collection |
| Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mmol/L |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | To evaluate sample hemolysis as measured by Plasma Free Hemoglobin (PFH) for BD Microtainer® Easy Collect Capillary Tube SST™ and all comparator tube types: capillary and venous | within 4 hours of sample collection |
| Serum Collection Volume of the Test Device SST Tube |
Inclusion Criteria:
Exclusion Criteria:
Evidence of skin issues such as infections, ulcerations, blisters, peripheral vascular disease, inflammation, extensive scarring or calluses, or healed burns at the fingerstick site. Subject to post-study exclusion period for this or other related studies:
Any condition which, in the opinion of the Investigator, would preclude participation in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Babson Diagnostics | Austin | Texas | 78753 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | BD MiniDrawâ„¢ Capillary Blood Collection System Capillary Blood Collection System: Test Blood Sample Collection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Serum |
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| ||||||||||||||||||
| Part B: EDTA |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | BD MiniDrawâ„¢ Capillary Blood Collection System Capillary Blood Collection System: Test Blood Sample Collection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chemistry Analytes [Albumin (ALB) and Total Protein (TP)] in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of g/dL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | g/dL | within 4 hours of sample collection | Blood Sample | Blood Sample |
|
7 days
Adverse events did not differ from the Clinicaltrials.gov definitions. A minimal number of adverse events, if any, would was expected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product | BD MiniDrawâ„¢ Capillary Blood Collection System Capillary Blood Collection System: Test Blood Sample Collection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Becton, Dickinson and Company | 9292850651 | Pierre.Asselin@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2022 | Oct 31, 2023 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D000208 | Acute Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| within 4 hours of sample collection |
| Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of ng/mL | within 4 hours of sample collection |
| Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of U/L | within 4 hours of sample collection |
| White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^3/µL | within 2 hours of sample collection |
| Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^6/µL | within 2 hours of sample collection |
| Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of fL | within 2 hours of sample collection |
| Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of g/dL | within 2 hours of sample collection |
| Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of pg | within 2 hours of sample collection |
To evaluate serum collection volume of the Test Device SST tube |
| within 4 hours of sample collection |
| Duration of Sample Collection for Test Device SST Tube and Comparator Tube | To evaluate duration of sample collection for Test Device SST tube tube and capillary comparator. | within 4 hours of sample collection |
| Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types | Evaluation of the frequency of occurrence of all instrument flags (both asterisks and IP messages) in the Test Device EDTA and all comparator tube types: venous and capillary tubes | within 4 hours of sample collection |
| Whole Blood Collection Volume for the Test Device EDTA | To evaluate whole blood collection volume for the Test Device EDTA | within 4 hours of sample collection |
| Duration of Sample Collection for the Test Device EDTA and Capillary Comparator | To evaluate duration of sample collection for the Test Device EDTA and capillary comparator | within 4 hours of sample collection |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Blood Sample |
|
|
|
| Primary | White Blood Cell Differential Counts, Hemoglobin A1c, Hematocrit, and Red Blood Cell Distribution Width in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators venous comparator and capillary comparator. This comparison was focused on the analytes with a unit of percentage | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | % of analyte in the sample | within 2 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Thyroid Stimulating Hormone (TSH) in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of µIU/mL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | µIU/mL | within 4 hours of sample collection |
|
|
|
|
| Primary | Lipid Analytes and Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mg/dL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | mg/dL | within 4 hours of sample collection |
|
|
|
|
| Primary | Metabolic Analytes, in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of mmol/L | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | mmol/L | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Vitamin D (Vit D), in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of ng/mL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | ng/mL | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), and Aspartate Aminotransferase (AST), in Serum Measured Using the Silica Clot Activator for Serum Samples | To demonstrate clinical equivalence of the SST test device as compared to Venous Comparator Serum and Capillary Comparator for chemistry analytes. This comparison was focused on the analytes with a unit of U/L | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | U/L | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | White Blood Cells (WBC) and Platelets (PLT) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^3/µL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | 10^3 cells per µL | within 2 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Red Blood Cells (RBC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of 10^6/µL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | 10^6 cells per µL | within 2 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Mean Corpuscular Volume (MCV) and Red Blood Cell Distribution Width (RDW) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of fL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | fL | within 2 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Hemoglobin (HgB) and Mean Corpuscular Hemoglobin Concentration (MCHC) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of g/dL | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | g/dL | within 2 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Primary | Mean Corpuscular Hemoglobin (MCH) in Plasma Measured With Ethylenediaminetetraacetic Acid (EDTA) | To demonstrate clinical equivalence of the EDTA test device as compared to their relevant comparators Venous Comparator and Capillary Comparator. This comparison was focused on the analytes with a unit of pg | This was a test for an analyte result. If there was no measurable value reported, it was not included in the analysis. | Posted | Mean | Full Range | pg | within 2 hours of sample collection | Blood samples | Blood samples |
|
|
|
|
| Other Pre-specified | Plasma Free Hemoglobin (PFH) in Serum Measured Using the Silica Clot Activator for Serum Samples | To evaluate sample hemolysis as measured by Plasma Free Hemoglobin (PFH) for BD Microtainer® Easy Collect Capillary Tube SST™ and all comparator tube types: capillary and venous | Posted | Mean | 95% Confidence Interval | mg/dL | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
| Other Pre-specified | Serum Collection Volume of the Test Device SST Tube | To evaluate serum collection volume of the Test Device SST tube | samples for collection volume | Posted | Mean | 95% Confidence Interval | uL | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
| Other Pre-specified | Duration of Sample Collection for Test Device SST Tube and Comparator Tube | To evaluate duration of sample collection for Test Device SST tube tube and capillary comparator. | time to fill tube | Posted | Mean | 95% Confidence Interval | seconds | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
| Other Pre-specified | Frequency of Occurrence of All Instrument Flags (Both Asterisks and IP Messages) in the Test Device EDTA and All Comparator Tube Types | Evaluation of the frequency of occurrence of all instrument flags (both asterisks and IP messages) in the Test Device EDTA and all comparator tube types: venous and capillary tubes | samples from tubes collected from participants. | Posted | Count of Units | Blood samples | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
| Other Pre-specified | Whole Blood Collection Volume for the Test Device EDTA | To evaluate whole blood collection volume for the Test Device EDTA | samples from tubes collected | Posted | Mean | 95% Confidence Interval | uL | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
| Other Pre-specified | Duration of Sample Collection for the Test Device EDTA and Capillary Comparator | To evaluate duration of sample collection for the Test Device EDTA and capillary comparator | samples from tubes filled | Posted | Mean | Full Range | s | within 4 hours of sample collection | Blood samples | Blood samples |
|
|
|
| 0 |
| 262 |
| 0 |
| 262 |
| 0 |
| 262 |
| EG001 | Comparator Product | respective comparator Comparator Blood Collection system: Comparator Blood Collection system | 0 | 262 | 0 | 262 | 0 | 262 |
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|
| Eosinophils (EO)% Capillary Comparator EDTA |
|
| EO% Venous comparator EDTA |
|
| EO% Test Device EDTA |
|
| hemoglobin A1c (HbA1c) Capillary Comparator EDTA |
|
| HbA1c Venous comparator EDTA |
|
| HbA1c Test Device EDTA |
|
| HCT Capillary Comparator EDTA |
|
| Hematocrit (HCT) Venous comparator EDTA |
|
| HCT Test Device EDTA |
|
| Lymphocytes (LY)% Capillary Comparator EDTA |
|
| LY% Venous comparator EDTA |
|
| LY% Test Device EDTA |
|
| Monocytes (MO)% Capillary Comparator EDTA |
|
| MO% Venous comparator EDTA |
|
| MO% Test Device EDTA |
|
| Neutrophils (NE)% Capillary Comparator EDTA |
|
| NE% Venous comparator EDTA |
|
| NE% Test Device EDTA |
|
| Red Blood Cell Distribution Width (RDW)-CV Capillary Comparator EDTA |
|
| RDW-CV Venous comparator EDTA |
|
| RDW-CV Test Device EDTA |
|
|
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| Ca Capillary Comparator SSTâ„¢ |
|
| cholesterol (Chol) Test Device SSTâ„¢ |
|
| Chol Capillary Comparator SSTâ„¢ |
|
| Creatinine (Creat) Test Device SSTâ„¢ |
|
| Creat Capillary Comparator SSTâ„¢ |
|
| Glucose (GLUC) Test Device SSTâ„¢ |
|
| GLUC Capillary Comparator SSTâ„¢ |
|
| high-density lipoprotein (HDL) Test Device SSTâ„¢ |
|
| HDL Capillary Comparator SSTâ„¢ |
|
| low-density lipoprotein (LDL) Test Device SSTâ„¢ |
|
| LDL Capillary Comparator SSTâ„¢ |
|
| Total Bilirubin (TBIL) Test Device SSTâ„¢ |
|
| TBIL Capillary Comparator SSTâ„¢ |
|
| Triglycerides (Trig) Test Device SSTâ„¢ |
|
| Trig Capillary Comparator SSTâ„¢ |
|
| BUN Venous comparator Serum |
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| Ca Venous comparator Serum |
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| Chol Venous comparator Serum |
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| Creat Venous comparator Serum |
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| GLUC Venous comparator Serum |
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| HDL Venous comparator Serum |
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| LDL Venous comparator Serum |
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| TBIL Venous comparator Serum |
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| Trig Venous comparator Serum |
|
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| CO2 Capillary Comparator SSTâ„¢ |
|
| potassium (K) Test Device SSTâ„¢ |
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| K Capillary Comparator SSTâ„¢ |
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| Sodium (Na) Test Device SSTâ„¢ |
|
| Na Capillary Comparator SSTâ„¢ |
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| CL Venous comparator Serum |
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| CO2 Venous comparator Serum |
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| K Venous comparator Serum |
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| Na Venous comparator Serum |
|
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| ALT Capillary Comparator SSTâ„¢ |
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| AST Test Device SSTâ„¢ |
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| AST Capillary Comparator SSTâ„¢ |
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| ALKP Venous comparator Serum |
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| ALT Venous comparator Serum |
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| AST Venous comparator Serum |
|
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| WBC Capillary Comparator EDTA |
|
| WBC Venous comparator EDTA |
|
| WBC Test Device EDTA |
|
|
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| RDW-SD Capillary Comparator EDTA |
|
| RDW-SD Venous comparator EDTA |
|
| RDW-SD Test Device EDTA |
|
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| MCHC Capillary Comparator EDTA |
|
| MCHC Venous comparator EDTA |
|
| MCHC Test Device EDTA |
|
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| Venous comparator Serum |
|
| Capillary Comparator EDTA |
|
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| BD Venous comparator EDTA |
|
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| Venous comparator EDTA |
|
|