METHOD CORRELATION OF SERUM, SODIUM CITRATE PLASMA, LITHIUM HEPARIN PLASMA AND K2-EDTA WHOLE BLOOD COLLECTED WITH VARIOUS COLLECTION TUBES AND COMPARED VIA SELECTED ICON CENTRAL LAB ASSAYS

Completed

Conditions: lab-tube validation
N/A

Registration Number: NL-OMON53190

Lead Sponsor: ICON Clinical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Comparison of the results of 3 different parties<br /><br>• Comparison of results between tubes of the same batch<br /><br>• Comparison of repeated analyzes of the same tube<br /><br>• Comparison of dipotassium ethylenediaminetetraacetic acid (K2EDTA) collection<br /><br>tube results with repeat analysis on Day 0, Day 1, Day 2, Day 3 and Day 4<br /><br>• Comparison of results from 3 different lots for SST and K2EDTA tubes<br /><br>• Comparison of the results of 2 different lots for sodium citrate tubes<br /><br>• Comparison of the results of 3 types of Li heparin tubes (3 ml, 4 ml and 7 ml)<br /><br>• Comparison of results between tubes of the same batch<br /><br>• Comparison of repeated analyzes of the same tube<br /><br>• Comparison of the results of the K2EDTA collection of tubes with repeat<br /><br>analysis on Day 0, Day 1, Day 2, Day 3 and Day 4</p><br>

Secondary Outcome Measures