Page 95 - Exploring the Potential of Self-Monitoring Kidney Function After Transplantation - Céline van Lint

Application of a creatinine device for trend monitoring 93
visits can be safely reduced. To investigate this approach, we have implemented a randomized controlled trial (RCT) with StatSensor®’s monitoring performance being tested in a clinical setting. One of the other outcomes of this study will show whether the results produced by patients at home, will yield the same clinically acceptable results for monitoring creatinine trends as observed when hospital professionals perform the measurements.
Besides offering the possibility of lowering the number of outpatient visits, self-monitoring kidney function after kidney transplantation is expected to have other benefits. Studies in other patient populations show that patients monitoring and/or managing their own disease results in more cost- effective healthcare systems by enabling the management of chronic diseases outside institutions [24– 29], improved health outcomes [4, 6, 7, 9, 30, 31] and higher patient satisfaction [7–15, 32–34]. Whether the possible benefits also apply to kidney transplant patients, has yet to be investigated.
In conclusion, the analytical validity assessment and comparison to an international JCTLM-listed IDMS reference method indicate that the StatSensor® is not suitable for detecting kidney (dys)function of kidney transplant patients in case of singlicate capillary blood measurements, i.e., more variation is observed with StatSensor® capillary blood results compared to StatSensor® venous blood results and plasma or serum central laboratory results. Further investigation is required to determine the nature of the variation in capillary blood. Nevertheless, our results show that the device has potential for trend monitoring in the context of daily follow-up for kidney function after kidney transplantation. In an ongoing RCT, the safety and clinical performance of the StatSensor® POC system for monitoring creatinine trends is further investigated.
The different conclusions concerning the suitability of the StatSensor® for detecting current kidney function with a single creatinine measurement versus monitoring creatinine trends with serial creatinine measurements in kidney transplant patients illustrate the importance of the interplay of the different components of the cyclical framework for the evaluation of medical tests and IVDs, which was described recently by a multidisciplinary group of the EFLM [21]. They state that the key components of test evaluation should be driven by the test purpose and test role in the clinical pathway, and that clinical effectiveness data should be fed back to refine analytical and clinical performances. This implies that the intended clinical applications and outcomes of the new test should determine its analytical performance requirements.
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