Related Experiment Videos
Evaluation of CoaguChek Pro ACT in cardiac catheterization laboratory
M Müller-Bardorff1, R H Strasser, S Schön
1Department of Medicine II, University of Lübeck, 23562, Lübeck, Germany.
Insights
The CoaguChek Pro ACT assay effectively monitors heparin in cardiac catheterization labs, showing excellent agreement and good correlation with established methods. Its analytical performance is reliable for activated clotting time (ACT) measurements.
Area of Science:
- Clinical Chemistry
- Hematology
- Medical Devices
Background:
- Accurate monitoring of anticoagulation, particularly heparin, is critical in cardiac catheterization laboratories (cathlabs).
- Existing methods for activated clotting time (ACT) measurement require validation for new point-of-care devices.
Purpose of the Study:
- To evaluate the analytical performance of the CoaguChek Pro ACT assay.
- To compare CoaguChek Pro ACT assay with the Hemochron Celite ACT assay for activated clotting time (ACT) determination.
- To assess the correlation of both assays with heparin levels.
Main Methods:
- Analytical performance assessment of CoaguChek Pro ACT assay versus Hemochron Celite ACT assay.
- Inclusion of 158 patients and 101 normal subjects across five cathlabs.
- Comparison of two CoaguChek Pro ACT lots against different Hemochron Celite ACT lots using arterial and venous blood.
- ACT measurements performed before, directly after, and 1-4 hours post-heparinization.
Main Results:
- Good correlations were observed between CoaguChek Pro ACT and Hemochron Celite assays for both arterial and venous blood (r=0.88 and 0.84).
- Excellent agreement was found between the two CoaguChek Pro ACT lots (r=0.99).
- Correlations with heparin levels were similar for both assays, with minimal influence from hematocrit and platelets; method imprecision was very good (CV<6%).
Conclusions:
- The CoaguChek Pro ACT assay demonstrates reliable analytical performance for ACT monitoring.
- The assay is suitable for monitoring heparin in cathlab settings.
- CoaguChek Pro ACT assay offers a viable alternative for point-of-care ACT testing.
Abstract:
The objective of this study was to assess the analytical performance of CoaguChek Pro ACT assay versus Hemochron Celite ACT assay concerning activated clotting time (ACT) values and the correlations versus heparin. Enrolled were 158 patients and 101 normal subjects from five cardiac catheterization laboratories (cathlabs). Two different CoaguChek Pro ACT lots were compared to different lots of Hemochron Celite ACT. All sites used arterial blood and one site also used venous blood. Determinations were carried out before and directly after heparinization, and 1-4 h later. Besides the ACT values, hematocrit, platelet counts and factor Xa levels were also determined. The correlations between the Hemochron Celite lots and the two different CoaguChek Pro lots for arterial and venous blood for all sites were good (r=0.88 and 0.84). The agreement between both CoaguChek Pro ACT lots was excellent (r=0.99). The correlations between heparin and CoaguChek Pro ACT were similar to those for the Hemochron Celite lots. There was no influence of the hematocrit and the platelets. The imprecision of the method was very good (CV<6%). This demonstrates that the CoaguChek Pro ACT assay is especially useful for monitoring heparin in cathlabs.