Abstract: SA-PO710
Performance of StatSensor Point-of-Care Device for Measuring Creatinine in Patients with CKD or Post-Kidney Transplantation
Session Information
- Pathology and Lab Medicine: Clinical
November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Pathology and Lab Medicine
- 1602 Pathology and Lab Medicine: Clinical
Authors
- Nataatmadja, Melissa S., Sunshine Coast University Hospital, Birtinya, Queensland, Australia
- Fung, Angela, St. Paul''s Hospital, Vancouver, British Columbia, Canada
- Jacobson, Beryl E., CEQAL Inc, Vancouver, British Columbia, Canada
- Bernstein, Eva, Providence Health Care Research Institute, Vancouver, British Columbia, Canada
- Komenda, Paul, University of Manitoba, Winnipeg, Manitoba, Canada
- Mattman, Andre, St. Paul''s Hospital, Vancouver, British Columbia, Canada
- Seccombe, David, CEQAL Inc, Vancouver, British Columbia, Canada
- Levin, Adeera, St. Paul's Hospital, Vancouver, British Columbia, Canada
Background
The StatSensor measures creatinine in “fingerstick” capillary blood samples. Previous studies reported a negative bias at higher creatinine concentrations. The current accuracy-based study evaluates the use of this device in kidney transplanted patients and those with CKD.
Methods
Duplicate StatSensor creatinine measurements were performed on direct fingerstick samples from 60 participants (mean age 61.9 years, 55% male, 33% transplant, mean plasma creatinine 137 µmol/L) and compared to plasma creatinine values obtained from simultaneous venous blood sampling using a Roche Integra 400 mainframe analyser.
Results
Bland-Altman analysis indicated a positive mean difference (bias) of 25.4 µmol/L between StatSensor fingerstick creatinine measurement and plasma creatinine. Comparison of eGFR (CKD-EPI) calculated from the StatSensor fingerstick creatinine versus plasma creatinine revealed misclassification across all KDIGO CKD stages (Figure 1). Post-analytical correction of the bias did not improve misclassification. Use of mean of duplicate StatSensor creatinine results did not improve performance compared to use of singlet results.
Conclusion
Our results suggest that the limiting characteristics of the StatSensor are not only bias, but also imprecision. The level of imprecision observed would likely influence clinical decision making and limits the StatSensor’s usefulness as a CKD screening tool. If choosing to utilise it for either screening for or monitoring CKD, it is essential that clinicians understand the limitations of point-of-care devices and apply this knowledge to test interpretation.
Figure 1. eGFR with StatSensor creatinine vs plasma (● Uncorrected creatinine; ○ Bias corrected creatinine)