Capillary potassium and ionized calcium testing with the i-STAT 1 versus a lab analyzer
Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
This will test whether potassium and ionized calcium results from two fingerstick (capillary) samples run on the i-STAT 1 match results from a standard laboratory analyzer in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 425 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Point of Care Industry-sponsored |
| Locations | 3 sites (Albuquerque, New Mexico and 2 other locations) |
| Trial ID | NCT07287618 on ClinicalTrials.gov |
What this trial studies
Adult participants (≥18) will provide two separate capillary blood specimens that are run on the i-STAT 1 using the CG8+ cartridge and compared to results from a comparator laboratory blood analysis system. The study collects paired measurements of potassium (K) and ionized calcium (iCa) to determine agreement between the point-of-care device and the lab analyzer. Enrollment occurs at three US academic medical centers with trained staff performing the capillary draws and tests. Data will be analyzed for concordance and any systematic differences between methods.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent and provide two capillary blood samples are suitable candidates for participation.
Not a fit: People under 18, those unable to provide capillary fingerstick samples, or those previously enrolled in this study are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could allow accurate potassium and ionized calcium testing from fingerstick samples, enabling faster and more convenient point-of-care results.
How similar studies have performed: Previous evaluations of i-STAT and other point-of-care devices have shown good agreement for many electrolytes, though direct capillary-specific comparisons for potassium and iCa are less extensively published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB) 2. ≥ 18 years of age Exclusion Criteria: 1\. Previous enrollment in this study
Where this trial is running
Albuquerque, New Mexico and 2 other locations
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Penn State Health Milton S. Hershey Medical Center (Hershey) — Hershey, Pennsylvania, United States (Not_yet_recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Miranda Gonzalez Aguirre, PhD
- Email: miranda.gonzalezaguirre@abbott.com
- Phone: 613-604-8539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.