Elsevier

Clinical Biochemistry

Volume 48, Issue 6, April 2015, Pages 456-458
Clinical Biochemistry

Short Communication
Chronic kidney disease prevalence in Rivas, Nicaragua: Use of a field device for creatinine measurement

https://doi.org/10.1016/j.clinbiochem.2015.01.005Get rights and content

Highlights

  • General prevalence data regarding kidney disease in many low income countries are lacking.

  • Reliable data collection in these large, geographically isolated settings is fraught with logistical challenges.

  • A screening strategy would use a rapid, inexpensive, and portable device to test subjects for elevated creatinine.

  • The screening device must have acceptable repeatability, sensitivity, and specificity.

  • The StatSensor Xpress offers high sensitivity and acceptable repeatability as a screening device for kidney disease.

Abstract

Objective

An epidemic of chronic kidney disease (CKD) has been identified in Pacific coastal regions of Central America, and screening in the field in these low income countries remains logistically problematic. We tested the performance characteristics of a point of care creatinine analyzer compared to standardized serum creatinine measurements.

Methods

Measurements were conducted in 100 persons from a local health center (n = 34) and hospital (n = 66) in Rivas, Nicaragua using both a point-of-care analyzer (StatSensor Xpress, Nova Biomedical) and serum creatinine by Jaffe kinetic method with a Roche Cobas Integra 400 analyzer. Percent coefficient of variation, sensitivity and specificity of the StatSensor Xpress were determined.

Results

The average coefficient of variation (CV) was 1.28% for the serum creatinine and CV for the StatSensor Xpress analyzer was 6.8%. The median intra-individual creatinine results obtained with the StatSensor Xpress device were 0.32 mg/dL higher than those by serum creatinine by Jaffe kinetic method. The sensitivity and specificity of the StatSensor Xpress device for identifying subjects with abnormal creatinine (defined as > 1.2 mg/dL) was 100% and 79%, respectively.

Conclusions

Point of care testing for creatinine demonstrated acceptable repeatability, excellent sensitivity (100%) and modest specificity (79%). Using the point of care testing will allow for generalized screening in the field in low income countries; however, confirmation for elevated levels > 1.2 mg/dL will require a second laboratory test confirmation.

Introduction

Rates of chronic kidney disease (CKD) are rising at an alarming rate in developing countries, presumably due to a global increase in conventional risk factors including hypertension, diabetes, aging, and the use of nephrotoxic drugs [1], [2]. Over the past decade, evidence emerged for an epidemic of CKD of unknown etiology (CKDu) affecting young, male agricultural workers along the Pacific rim of Mesoamerica [3]. The pathophysiology of CKDu has not been elucidated.

A number of studies conducted in northwestern Nicaragua and El Salvador between 2008 and 2012 have shown the prevalence of stage III or IV CKD (defined by estimated glomerular filtration rate or eGFR < 60 mL/min/1.73 m2) to be between 10 and 15% in men with lower rates in women. In these reports, higher rates of CKD were seen in male agriculture workers [4], [5], [6], [7], miners [5], older individuals, and participants living at altitudes less than 500 m above sea level [8], [9]. There are no data regarding the prevalence of CKD in other regions of Nicaragua.

The present pilot study determines the sensitivity and specificity of a point of care, hand held device (StatSensor Xpress, Nova Biomedical, Waltham, MA, USA) when used as a screening test for CKD. With appropriate performance characteristics the device could be used in the future to screen subjects in their homes.

Section snippets

Material and methods

This study was performed in the Department of Rivas in southern Nicaragua over a one week period in March of 2013. Study subjects were recruited from the waiting rooms of the health center in San Juan del Sur (34 subjects) and the hospital in the municipality of Rivas (66 subjects). The study was approved by the Institutional Review Board of the Direccion General de Docencia e Investigaciones of the Ministry of Health of Nicaragua (MINSA). All study staff were trained on the protocol and in the

Results

Thirty percent of the total subjects were male. A total of 99 blood samples were run in duplicate on the CNDR machine by Jaffe kinetic method. The average CV across these samples (creatinine range of 0.5–3.6 mg/dL) was 1.28%. Duplicate StatSensor Xpress results were available for 64 subjects (creatinine range of 0.4–3.5 mg/dL) with a CV of 6.67%. One subject was dropped from the analysis due to laboratory error.

The median creatinine for the StatSensor Xpress was 1.04 mg/dL with an interquartile

Discussion

We demonstrate the utility of the StatSensor Xpress as a screening device for chronic kidney disease, as defined by a creatinine greater than 1.2 mg/dL, for use in point-of-care testing in low income countries. Results from the StatSensor Xpress show considerable variability compared to the standard laboratory measurement; however, the test characteristics are sufficient to provide adequate screening for use in the field. A confirmatory test to establish the precise value of creatinine is still

Acknowledgments

This project was funded entirely by private donations to the ‘Lowering Poverty and Disease in Southern Nicaragua Group’ (www.LPD.com) and the work was done in collaboration with the ‘Newton-San Juan Del Sur Sister City Project’ (http://sanjuandelsursistercityproject.wordpress.com/).

References (10)

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