Capillary Blood Draw for Blood Tests

Recruiting at 2 trial locations

Overseen By Miranda Gonzalez Aguirre, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Point of Care

Disqualifiers: Previous enrollment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

425 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the accuracy of blood tests for potassium and ionized calcium using a small blood sample from a fingertip. Researchers will use the i-STAT 1 analyzer to evaluate the effectiveness of these tests with capillary blood. The trial seeks adults who have not previously participated in this study. As an unphased trial, it offers participants the chance to contribute to the advancement of medical testing techniques.

What prior data suggests that this capillary blood draw is safe for blood tests?

Research shows that capillary blood draws, like those used in this trial, are generally safe and easy to handle. Capillary blood sampling involves taking a small blood sample from a fingerstick. This method is less invasive than drawing blood from a vein and usually causes only minor discomfort.

Studies have found that potassium and ionized calcium levels in capillary blood can slightly differ from those in venous blood. However, these differences do not affect the procedure's safety. This method is commonly used for various tests and is considered safe by medical guidelines.

Since the trial focuses on the accuracy of blood tests using capillary samples, not on testing a new drug or treatment, the procedure poses no significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the precision of using a capillary blood draw for key blood tests like potassium and ionized calcium, which are typically done with venous blood draws. Unlike traditional methods, this technique uses a small, quick finger prick to collect blood, which is less invasive and more convenient, especially for patients who dislike needles or have difficult veins. The trial is evaluating how well the i-STAT K and i-STAT iCa tests work with these capillary samples, potentially offering a faster and easier option for routine blood testing. If successful, this method could simplify blood testing and make it more comfortable for many patients.

What evidence suggests that the capillary blood draw is effective for assessing potassium and ionized calcium levels?

Research has shown that blood gas analyzers, such as the i-STAT 1, match the accuracy of automated machines for checking potassium levels. They deliver results quickly, often in about five minutes. This trial will evaluate the precision of potassium (K) and ionized calcium (iCa) tests in capillary blood using the i-STAT CG8+ cartridge on the i-STAT 1 analyzer. Studies have found that capillary blood, collected with a simple fingerstick, reliably tests for potassium and ionized calcium levels. This method is accurate and convenient, offering a promising option for quick and effective testing. The i-STAT CG8+ cartridge used with the i-STAT 1 analyzer has been tested and shown to provide precise results for these blood tests. ^{1 4 6 7 8}

Who Is on the Research Team?

Manish Gupta, MS, MBA

Principal Investigator

Abbott Point of Care

Are You a Good Fit for This Trial?

This clinical trial is open to individuals who require blood tests for potassium and ionized calcium levels. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)

I am 18 years old or older.

Exclusion Criteria

Previous enrollment in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Precision Assessment

Assess the precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using capillary specimens

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-test reactions or data collection

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Capillary blood draw

Trial Overview

The trial is evaluating the accuracy of i-STAT potassium (K) and ionized calcium (iCa) tests using a CG8+ cartridge on an i-STAT 1 analyzer. It involves taking capillary blood samples from participants.

How Is the Trial Designed?

Group I: Precision of potassium (K) and ionized calcium (iCa) tests in capillary blood Experimental Treatment 1 Intervention

Precision evaluation of the i-STAT K test and the i-STAT iCa test using i-STAT CG8+ cartridge on i-STAT 1 analyzer with capillary specimens from each subject enrolled in the study.

Who Is Running the Clinical Trial?

Abbott Point of Care

Lead Sponsor

Trials

13

Recruited

10,200+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07287618

Evaluation of Potassium (K) and Ionized Calcium (iCa) ...

Diagnostic Test : Blood draw. Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.

2.

ctv.veeva.com

ctv.veeva.com/study/clinical-evaluation-of-precision-for-the-potassium-and-ionized-calcium-tests-in-capillary-specimens

Clinical Evaluation of Precision for the Potassium and Ionized ...

The objective of this study is to assess the precision of the i-STAT K and iCa tests using the IUO i-STAT CG8+ cartridge on the i-STAT 1 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06295835

Method Comparison Study for Measuring Potassium (K) ...

The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8971128/

Accuracy of Potassium Measurement Using Blood Gas Analyzer

When measuring potassium, blood gas analyzers are as accurate as automated analyzers. They produce results in five minutes or so and can be ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352551723000197

Capillary blood stability and analytical accuracy of 12 ...

The aim of this study was to determine feasibility of collecting capillary blood by traditional fingerstick and next day analysis after transport in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4622200/

Capillary blood sampling: national recommendations on ...

Potassium levels in capillary blood samples can be lower (47), higher (48) or even similar (46) to those in venous blood samples. Levels of total proteins, ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/K092849.pdf

Decision Summary - REVIEW MEMORANDUM - FDA

The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit -.

8.

labcorp.com

labcorp.com/tests/004804/calcium-ionized

004804: Calcium, Ionized

Measurement of serum ionized calcium provides insight into the effect of total protein and albumin on serum calcium levels.