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Chronic kidney disease is a main confounding factor for 25-vitamin D measurement
Hanna Karla Andrade Guapyassú Machado1, Carolina Steller Wagner Martins1, Vanda Jorgetti1
1Divisão de Nefrologia, Universidade de São Paulo, São Paulo, SP, Brazil.
Insights
Vitamin D testing in chronic kidney disease (CKD) patients shows significant assay variability. This impacts hypovitaminosis D diagnosis and can lead to incorrect vitamin D supplementation for CKD patients.
Area of Science:
- Nephrology
- Clinical Chemistry
- Endocrinology
Background:
- Current guidelines recommend 25-vitamin D assessment for chronic kidney disease (CKD) patients.
- Assay variability in 25-vitamin D measurement is known, but its impact in CKD is unstudied.
Purpose of the Study:
- To evaluate the variability between two different 25-vitamin D assays in patients with CKD.
- To determine if CKD affects the performance and agreement of these assays.
Main Methods:
- Consecutive 25-vitamin D measurements from 791 adult patients (122 normal renal function, 669 CKD stages 3-5/dialysis) were analyzed.
- Measurements were taken in 2015 using Assay 1 (Diasorin LIASON) and in 2016 using Assay 2 (Beckman Coulter Unicel).
Main Results:
- 25-vitamin D levels were lower and hypovitaminosis D prevalence higher with Assay 1 compared to Assay 2 in CKD patients.
- Assay disagreement increased as kidney function declined.
- These differences persisted despite similar calcium, phosphate, and parathyroid hormone levels.
Conclusions:
- Significant variability exists between 25-vitamin D assays in CKD patients, altering hypovitaminosis D diagnosis.
- The underlying mechanism remains unclear but may involve analytical interference.
- This variability has clinical significance, potentially leading to erroneous vitamin D supplementation prescriptions.
Background:
Current guidelines recommend assessment of 25-vitamin D status in patients with chronic kidney disease (CKD). Although significant differences among assays have been described, the impact of CKD on this variability has never been tested.
Methods:
We tested the variability between two 25-vitamin D assays in patients with CKD (eGFR < 60 mL/min/1.73m2) who had consecutive 25-vitamin D measurements in 2015 (Assay 1 - Diasorin LIASON 25 TOTAL - D assay®) and 2016 (Assay 2 - Beckman Coulter Unicel Xl 800®). The cohort consisted of 791 adult patients (122 with normal renal function and 669 with CKD - 33, 30, and 37% in stages 3, 4, and 5 on dialysis, respectively).
Results:
Levels of 25-vitamin D were lower and the prevalence of hypovitaminosis D using assay 1 was higher than using assay 2 in patients with CKD, regardless of similar levels of calcium, phosphate, and parathyroid hormone. As kidney function decreased, the percentage of disagreement between the assays increased.
Conclusion:
There is a noteworthy variability between assays in patients with CKD such that the diagnosis of hypovitaminosis D is modified. The mechanism behind this result is still unclear and might be due to a possible interference in the analytical process. However, the clinical significance is unquestionable, as the supplementation of vitamin D can be erroneously prescribed to these patients.
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