Kailey Minnings1, Eric Kerns2, Melissa Fiore3, Madeline Fiore4, Rulan S Parekh5, Jeff DuBois6, T Scott Isbell7, Ryan Ferguson8, Louis Fiore9. 1. University of Toronto Faculty of Medicine, 1 King's College Circle, Toronto, ON M52 1A8, Canada. Electronic address: Kailey.minnings@mail.utoronto.ca. 2. Warren Alpert Medical School of Brown University, 222 Richmond Street, Providence, RI 02903, USA. Electronic address: ekerns@lifespan.org. 3. Boston VA Healthcare System, 150 S. Huntington Avenue, Boston, MA 02458, USA. Electronic address: maf333@cornell.edu. 4. University of Massachusetts School of Medicine, 55 N. Lake Avenue, Worcester, MA 01655, USA. Electronic address: lynnefiore@gmail.com. 5. Hospital for Sick Children, University Health Network, University of Toronto, 555 University Ave., Toronto, ON M5G 1X8, Canada. Electronic address: rulan.parekh@sickkids.ca. 6. Nova Biomedical, 200 Prospect Street, Waltham, MA 02453, USA. Electronic address: jadubois@novabio.com. 7. Saint Louis University School of Medicine, 1402 South Grand Boulevard, St. Louis, MO 63104, USA. Electronic address: tscott.isbell@gmail.com. 8. Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, USA. Electronic address: rferg@bu.edu. 9. Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, USA. Electronic address: lfiore@bu.edu.
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.
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.
Authors: Ryan Ferguson; Sarah Leatherman; Madeline Fiore; Kailey Minnings; Martha Mosco; James Kaufman; Eric Kerns; Juan Jose Amador; Daniel R Brooks; Melissa Fiore; Rulan S Parekh; Louis Fiore Journal: J Am Soc Nephrol Date: 2020-05-29 Impact factor: 10.121
Authors: Lauren E Galbraith; Paul E Ronksley; Lianne J Barnieh; Joanne Kappel; Braden J Manns; Susan M Samuel; Min Jun; Rob Weaver; Nadine Valk; Brenda R Hemmelgarn Journal: Clin J Am Soc Nephrol Date: 2016-05-19 Impact factor: 8.237
Authors: Mark Corbett; Ana Duarte; Alexis Llewellyn; James Altunkaya; Melissa Harden; Martine Harris; Simon Walker; Stephen Palmer; Sofia Dias; Marta Soares Journal: Health Technol Assess Date: 2020-08 Impact factor: 4.014
Authors: Benjamin R Griffin; Jaime Butler-Dawson; Miranda Dally; Lyndsay Krisher; Alex Cruz; David Weitzenkamp; Cecilia Sorensen; Liliana Tenney; Richard J Johnson; Lee S Newman Journal: PLoS One Date: 2018-09-27 Impact factor: 3.240
Authors: Anthony J Carden; Edgardo S Salcedo; Nam K Tran; Eric Gross; Jennifer Mattice; Jan Shepard; Joseph M Galante Journal: Trauma Surg Acute Care Open Date: 2016-07-12