Abstract

Early detection of CKD using point of care creatinine and eGFR testing improves patient management outcomes. We undertook a field study to evaluate the use of a whole blood creatinine/eGFR device to screen a rural Nicaraguan population to determine the variability between creatinine methods and specimen types. All specimens including capillary and venous dried blood spots (DBS) were tested with an isotope dilution liquid chromatography mass spectrometry (ID-LCMS) gold standard method. This is to our knowledge the first time a capillary whole blood (POC) method has been directly compared to the gold standard IDMS method, through the novel approach of using dried blood spots. Capillary and venous whole blood specimens were obtained and tested directly with the BCMS method, and then, DBS samples were prepared. Venous plasma specimens were tested using three laboratory analyzer creatinine methods. DBS were sent to the site performing ID-LCMS. Control samples were also prepared to assess the stability of shipment and storage of DBS. The ID-LCMS method was aligned using primary and secondary standards. Sixty-six (66) patients participated in the study, and the CKD prevalence rate was 7.8%. While all creatinine methods showed a good correlation to ID-LCMS, there was a positive bias (mean absolute bias range: 0.21–0.63 mg/dL). All methods used were 100% sensitive, but specificity varied from 62.7 to 94.9% with PPV ranging from 25 to 62.5%. A correction factor was used to align the values from each method to ID-LCMS which improved the specificity of each method. This study used a unique DBS approach to align capillary whole blood creatinine to ID-LCMS. To ensure reliability of BCMS for identifying screened patients with CKD, it is important to establish IDMS traceability and alignment prior to undertaking CKD studies.

Highlights

  • Chronic kidney disease (CKD) is recognized as a major global public health problem [1, 2]

  • Myers et al [20] suggest that the use of National Institute of Standards and Technology (NIST) serum reference material (SRM) 957 standards should reduce or eliminate method variability but use of this standard set cannot be applied to whole blood creatinine methods [31, 32]. This is to our knowledge the first time a capillary whole blood (POC) method has been directly compared to the gold standard isotope dilution mass spectrometry (IDMS) method, through the novel approach of using dried blood spots

  • A total of 66 patients participated in the study ranging in age from 24 to 88 years, of which 42 were adult females, 20 were adult males, and four patients’ genders were not recorded

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Summary

Introduction

Chronic kidney disease (CKD) is recognized as a major global public health problem [1, 2]. In. Europe, the prevalence of diabetic stage 5 CKD is predicted to increase annually by 3.2% in the 10 years [5]. Has impacted the incidence of CKD, in the US, with estimates suggesting close to 40% of patients with. This has led to an increasing incidence of end-stage renal disease (ESRD) as the prevalence of T2DM increases [8]. The number of patients requiring renal replacement therapy (RRT) will exceed five million by 2030 [9], adversely impacting public and private healthcare costs [8, 10]

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