Abbott Neonate i-STAT
T
Thomas E. Davis
Primary Investigator
Enrolling By Invitation
28 years and younger
All
Phase
N/A
160 participants needed
1 Location
Brief description of study
Compare the performance of the tests on the i-STAT CG4+ and CG8+ cartridges on the iSTAT 1 analyzer to the performance of the tests on the comparator device, the
RAPIDPoint® 500e System or epoc® Blood Analysis System using neonatal capillary
whole blood specimens
Detailed description of study
Method comparison testing will be performed using prospectively collected capillary blood
specimens. Protocol directed testing will be performed with a minimum of one (1) IUO i-STAT
CG4+ and one (1) IUO i-STAT CG8+ cartridge lot and each specimen will be tested in singlicate
at a minimum of two (2) clinical sites.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: i-STAT
-
Age: - 28 Days
-
Gender: All
Inclusion Criteria: Birth to 28 days of age (neonates)
Exclusion Criteria:
- More than 5% of neonate total blood volume (TBV) has been collected from neonate in the past 24 hours or per institutional protocol.
Updated on
01 Aug 2024.
Study ID: 15977; PATH-ABBOTT-NEONATE-I-STAT
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