lab-tube validation N/A
Conditions
Interventions
None listed
Sponsors
ICON Clinical Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Sex : male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal. 2. Age : 18 years or older, at screening. 3. Body mass index (BMI) : 18.0 kg/m2 or higher, at screening 4. Status : healthy subjects. 5. Willing and able to sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Previous participation in this study 2. Employee of ICON. 3. Donation or loss of more than 450 mL of blood within 60 days prior to the day of consent in the current study. 4. Significant and/or acute illness within 5 days prior to the day of consent in the current study that may impact safety, in the opinion of the Investigator. 5. Unsuitable veins for blood sampling. 6. Subjects who are, in the opinion of the Investigator, not suitable for enrolment for another reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Comparison of the results of 3 different parties • Comparison of results between tubes of the same batch • Comparison of repeated analyzes of the same tube • Comparison of dipotassium ethylenediaminetetraacetic acid (K2EDTA) collection tube results with repeat analysis on Day 0, Day 1, Day 2, Day 3 and Day 4 • Comparison of results from 3 different lots for SST and K2EDTA tubes • Comparison of the results of 2 different lots for sodium citrate tubes • Comparison of the results of 3 types of Li heparin tubes (3 ml, 4 ml and 7 ml) • Comparison of results between tubes of the same batch • Comparison of repeated analyzes of the same tube • Comparison of the results of the K2EDTA collection of tubes with repeat analysis on Day 0, Day 1, Day 2, Day 3 and Day 4 | — |
Countries
Netherlands
Outcome results
None listed