A Study Of Asserachrom® HPIA Kit On Dynex® DS2 System
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-000712
About this study
The purpose of this study is to validate the sample stability of citrated plasma and serum at 15- 25°C, 2-8°C, ≤ -20°C and ≤ -70°C for samples tested with Asserachrom® HPIA on Dynex® DS2 System.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Samples must belong to one of the categories described in Tables 3 and 4.
Samples can be from either gender.
Sample donors must be ≥ 21 years of age. Any patient ≥ 89 years of age will be included in the study, but their age will be entered into the DCF as ≥ 89 years old.
Samples must be collected and handled per CLSI guidelines H212 and WHO guidelines on drawing blood: best practices in phlebotomy9 (for serum samples)
Samples must be de-identified.
Samples must be from consented donors.
Samples must be collected in accordance with all local ethical regulations and IRB.
Exclusion Criteria:
Sample does not meet the inclusion criteria.
Sample is hemolyzed, icteric or lipemic.
Sample is not de-identified.
Sample contains an interfering substance listed in the package insert of the predicate device. Subjects on heparin or exposed to heparin within the past 6 months
Sample tested in different conditions that the ones recommended by Stago in the package inserts of the reagents.
Sample that does not have valid data
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 03/09/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Rajiv Pruthi, M.B.B.S. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available