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The effect of rheumatoid factor on three commercial immunoassays for serum cystatin C
Qun Zhang1, Zhigang Feng1, Jun Zhou2
1Department of Laboratory Medicine, Taihe Hospital of Traditional Chinese Medicine, Anhui, P. R. China.
Insights
Rheumatoid factor (RF) can falsely elevate cystatin C (CysC) levels, impacting early renal insufficiency diagnosis. This interference is reagent-dependent, necessitating careful reagent selection and evaluation.
Area of Science:
- Clinical Chemistry
- Nephrology
- Immunology
Background:
- Cystatin C (CysC) is a biomarker for detecting early renal insufficiency.
- The potential interference of Rheumatoid Factor (RF) on CysC measurements is not well-established.
Purpose of the Study:
- To investigate the interference of RF on CysC levels.
- To determine if RF concentration affects CysC measurements and assess reagent-specific interference.
Main Methods:
- Randomly selected 30 patients with high RF and 33 healthy subjects with low RF.
- Measured CysC concentrations using different reagents and instruments.
- Conducted interference experiments to quantify the effect of RF on CysC.
Main Results:
- Measured CysC concentration increased in a dose-dependent manner with increasing RF concentration.
- RF interference led to falsely elevated CysC levels, with variability depending on the specific CysC reagent used (Whitman, Nanjing, China).
Conclusions:
- RF can interfere with CysC measurements, potentially leading to misdiagnosis of renal function.
- Reagent manufacturers must address RF interference during CysC assay development and validation.
- Clinical laboratories should evaluate RF interference when selecting CysC reagents to ensure accurate patient results.
Abstract:
Cystatin C (CysC) can be used to diagnose early changes in renal insufficiency. However, there are little researches to study whether there is an interference between the level of CysC and RF. Thus, we conducted this study to investigate it. We randomly selected 30 patients with high RF (RF concentration: 552.05 ± 476.23 IU/mL) and 33 healthy subjects with RF concentration <11.1 IU/mL and CysC were measured with different reagents and instruments; Interference experiment was also be included. The results showed that the measured CysC concentration increases with increasing RF concentration in a dose-dependent manner and CysC levels are falsely increased by RF interference depends on the reagents used (CysC reagent: Whitman, Nanjing, China). Reagent manufacturers should fully consider RF interference when developing CysC reagents, and evaluate them before they are sold. When selecting CysC reagents, we should evaluate RF interference to the measurement to avoid misleading results.
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