Accuracy of two point-of-care devices in detecting elevated serum creatinine in individuals at risk for Mesoamerican nethropathy.

Details

• Personal Author:
  Amador JJ ; Brooks D ; Butler-Dawson J ; Dally M ; Friedman, Deborah B. ; Gero A ; Griffin B ; Kupferman J ; Lopez Pilarte D ; Newman L
• Description:
  Purpose: The purpose of this analysis was to assess the accuracy of two point-of-care creatinine devices, the i-STAT handheld (Abbott, Princeton, New Jersey, USA) and the StatSensor Xpress (Nova Biomedical, Waltham, Massachusetts, USA) in comparison to venipuncture creatinine measures. Additionally, we explored how accurate a previously calculated correction factor for the StatSensor Xpress performed in two independent studies. Methods: There were 213 paired i-STAT and venipuncture samples collected from a community study in Nicaragua in 2015-2016. An additional 267 paired StatSensor Xpress and venipuncture samples were collected, 158 from a community setting in Nicaragua and 109 from a Guatemala sugarcane worker cohort. Pearson correlation coefficients, Bland-Altman plots, and no intercept linear regression models were used to assess agreement between point-of-care devices and blood samples. The previously calculated correction factor of 0.78 was applied to the StatSensor Xpress data and was compared to the paired blood samples. Results: The i-STAT performed the most accurately, overestimating creatinine by 0.07 mg/dL (95% CI: 0.02, 0.12) with no evidence of proportional bias. The StatSensor Xpress performed well at low levels of creatinine (Mean (SD): 0.87 (0.19)). Due to proportional bias, the StatSensor Xpress performed worse in the Nicaragua community setting where creatinine values ranged from 0.31 to 7.04, suggesting a correction factor of 0.66 was needed. The previously calculated correction factor of 0.78 performed well with the Nicaragua data when the data was restricted to creatinine ≤ 2.59 mg/dL (Adjusted difference: 0.06 mg/dL; 95% CI: 0.03, 0.09). Conclusions: These data suggest that the StatSensor Xpress is less accurate as the values of measured creatinine increase, a consideration when using the point-of-care device for screening individuals at risk for Mesoamerican Nephropathy. The i-STAT handheld is an accurate field alternative to lab tested serum; however, in low-resource settings other considerations such as cost and ease of use must be considered when conducting field research. [Description provided by NIOSH]
• Subjects:
  Blood Health Care Facilities Workforce And Services Hematologic Tests Occupational Health Safety
• Keywords:
  Blood tests; Kidney function; Kidneys; Medical equipment; Kidney disorders; Mobile equipment
• Publisher:
  National Institute of Environmental Health Sciences (NIEHS)
• Document Type:
  Text
• Funding:
  Cooperative Agreement
• Genre:
  Abstract or Summary
• Place as Subject:
  Colorado ; Massachusetts ; OSHA Region 1 ; OSHA Region 8
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  24-25
• NIOSHTIC Number:
  nn:20065449
• Citation:
  Third International Workshop on Chronic Kidney Diseases of Uncertain/Non-traditional Etiology in Mesoamerica and Other Regions, March 20-22, 2019, San José, Costa Rica. Research Triangle Park, NC: National Institute of Environmental Health Sciences (NIEHS), 2019 Mar; :24-25
• Federal Fiscal Year:
  2019
• NORA Priority Area:
  Manufacturing ; Services
• Performing Organization:
  University of Colorado Denver, Aurora
• Peer Reviewed:
  False
• Start Date:
  20160901
• Source Full Name:
  Third International Workshop on Chronic Kidney Diseases of Uncertain/Non-traditional Etiology in Mesoamerica and Other Regions, March 20-22, 2019, San José, Costa Rica
• End Date:
  20260831
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:dde821fd2bb5f9e42912c8bac8c1f8b2598aafbdd185d12dcb380f3c4cf034d2cc2f3eac8e74585a02c6fbd6e6c37b7cf2d0b33a2678cfbb43e4b690b417bc42
• Download URL:
  https://stacks.cdc.gov/view/cdc/248571/cdc_248571_DS1.pdf
• File Type:
  [PDF - 2.88 MB ]