Letter to the Editor
A novel point-of-care device for blood potassium detection of patients on dialysis: Comparison with a reference method
Un nuevo dispositivo de punto de atención para la detección de potasio en sangre de pacientes en diálisis: comparación con un método de referencia
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"autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Marta Novell, Nayra Rico, Pascal Blondeau, Miquel Blasco, Adrià Maceira, José Luis Bedini, Francisco Javier Andrade, Francesc Maduell" "autores" => array:8 [ 0 => array:3 [ "nombre" => "Marta" "apellidos" => "Novell" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 1 => array:3 [ "nombre" => "Nayra" "apellidos" => "Rico" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Pascal" "apellidos" => "Blondeau" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "Miquel" "apellidos" => "Blasco" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 4 => array:3 [ "nombre" => "Adrià" "apellidos" => "Maceira" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] 5 => array:3 [ "nombre" => "José Luis" "apellidos" => "Bedini" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 6 => array:4 [ "nombre" => "Francisco Javier" "apellidos" => "Andrade" "email" => array:1 [ 0 => "franciscojavier.andrade@urv.cat" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 7 => array:3 [ "nombre" => "Francesc" "apellidos" => "Maduell" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Univ Rovira & Virgili, Dept Analyt & Organ Chem, Tarragona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Hosp Clin Barcelona, Dept Biochem, Barcelona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Hosp Clin Barcelona, Dept Nephrol, Barcelona, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Creatsens Health, SL, Tarragona, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "<span class="elsevierStyleItalic">Corresponding author</span>." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Un nuevo dispositivo de punto de atención para la detección de potasio en sangre de pacientes en diálisis: comparación con un método de referencia" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1025 "Ancho" => 2313 "Tamanyo" => 203996 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">(A) Passing–Bablock regression analysis. Dashed lines represent the 95% CIs. POC<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>1.0769 (95% CI 1.1053/1.0455) ADVIA Chemistry XPT – 0.3231 (95% CI −0.4158/−0.2205), <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>694. (B) Comparison of potassium values between the reference technique and the developed potassium sensor by Bland–Altman plots displayed in difference in mM. The solid black line is the average difference, the dashed lines the limits of agreement, and the gray lines the 95% CIs.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Determination of potassium levels in serum is routinely performed in clinical labs, as it is a critical parameter and abnormal potassium concentrations may lead to fatal cardiac consequences.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a> An immediate test for determination of blood potassium may contribute to prevent such critical issues, for example, arrhythmias. Therefore we have developed and tested a novel point-of-care (POC) device that provides a simple and highly affordable way of measuring potassium levels in a single drop of blood outside the clinical laboratory.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">We have measured the concentration of potassium in blood of 36 patients suffering from chronic kidney disease (CKD) before and after each dialysis session during three weeks with the POC presented and a reference method following the routine workflow in a clinical laboratory. A total of 705 measurements of potassium have been analyzed and compared using statistical tools. ADVIA Chemistry XPT from Siemens Healthineers was used as the reference system for the potassium measurement, this system measures potassium in plasma with a predilution of 1:33, while the POC device performs a direct measurement of potassium in whole blood with ion-selective electrodes technology.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Passing-Bablock regression and Blant-Altman analysis (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>) confirmed that there is a strong correlation (Pearson correlation coefficient is <span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.953) between the results obtained by both methodologies with a small bias (0.03) and limits of agreement in -0.62 and 0.68<span class="elsevierStyleHsp" style=""></span>mM. Whether the bias and limits of agreement are adequate or not, it is a clinical rather than a statistical question. As normal potassium levels in blood can vary from 3.5 to 5.5<span class="elsevierStyleHsp" style=""></span>mM a bias of 0.03<span class="elsevierStyleHsp" style=""></span>mM can be considered insignificant from a clinical standpoint. Moreover, the confidence intervals obtained by the POC device (−0.62/0.68<span class="elsevierStyleHsp" style=""></span>mM) are in good agreement with previous validation studies of POC devices<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">3–5</span></a> and suitable for the type of situations where a POC device will be used – such as screening for general conditions in the global population or control and monitoring of chronic patients-. The higher contribution to the variability of the technique comes from the precision of the sensor (0.25<span class="elsevierStyleHsp" style=""></span>mM). Other parameters such as the manual calibration or some interferences from blood may contribute to the remaining variability. Another parameter that has to be considered is that the ADVIA Chemistry XPT system measures with indirect ion selective electrodes in a pre-diluted sample, while the POC device measures with direct ISEs in whole blood. Lipemia in serum causes a reduction in the aqueous fraction leading to abnormally lower values, which does not happen in the whole blood measurements. This may be an additional source of variation between the two methodologies.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">This POC device is not conceived to compete with the reference technique in the healthcare facility, but rather to complement the conventional approaches by giving an immediate response when required. Conventional parameters such as sensitivity, limits of detection and linear range are comparable in both techniques. And although the value is less precise, it may have a great impact when triaging life-threatening conditions. Hence, the relative importance of the analytical parameters must be evaluated under different contexts. Thus, the POC device may have a significant impact on the early detection of several medical conditions that will avoid future problems and complications for the patient health and wellbeing, eventually reducing the costs of the treatment.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The POC device meets the requirement for direct analysis since it uses a small amount of blood and no pretreatment is performed although precision is inferior to clinical lab analysis. However, this lower precision is common in POC devices, for example, FDA accepts glucometers with an accuracy of +/−15% for 95% of the results within all the range, and +/−20% for 99%.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">7</span></a> The POC device presents the benefits that this implies, especially the reduction of the time between the sample withdraw from the patient and the given result. This POC device has the particular advantage to work with paper-based sensors, which are suitable for mass-scale production and, due to the materials used, present very low manufacturing cost.</p><p id="par0030" class="elsevierStylePara elsevierViewall">In conclusion, the POC device has demonstrated a good correlation with the reference method, proving that it can be an alternative for specific situations where an immediate response is required. What remains for the future is to validate its utility as an alternative method for specific situations, which depends on whether the reduction of the analysis time can have benefits in the decision making process of the doctors and the quality of life of the patients.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0035" class="elsevierStylePara elsevierViewall">The co-authors (Andrade FJ, Blondeau P, Maceira A and Novell M) disclose a potential conflict of interest as they are co-founders of CreatSens Health, SL which intends to commercialize blood bio-sensing technologies. No potential conflicts of interest exists for the rest of the authors.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of interest" ] 1 => array:2 [ "identificador" => "xack473744" "titulo" => "Acknowledgements" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1025 "Ancho" => 2313 "Tamanyo" => 203996 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">(A) Passing–Bablock regression analysis. Dashed lines represent the 95% CIs. POC<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>1.0769 (95% CI 1.1053/1.0455) ADVIA Chemistry XPT – 0.3231 (95% CI −0.4158/−0.2205), <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>694. (B) Comparison of potassium values between the reference technique and the developed potassium sensor by Bland–Altman plots displayed in difference in mM. The solid black line is the average difference, the dashed lines the limits of agreement, and the gray lines the 95% CIs.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Potassium disorders: hypokalemia and hyperkalemia" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "A.J. Viera" 1 => "N. 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Signouret" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1371/journal.pone.0169593" "Revista" => array:5 [ "tituloSerie" => "PLOS ONE" "fecha" => "2017" "volumen" => "12" "paginaInicial" => "1" "paginaFinal" => "16" ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0060" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Potassium values in cardiac arrest patients measured with a point-of-care blood gas analyzer" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "S. Ahn" 1 => "W.Y. Kim" 2 => "C.H. Sohn" 3 => "D.W. Seo" 4 => "W. Kim" 5 => "K.S. Lim" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.resuscitation.2011.08.010" "Revista" => array:6 [ "tituloSerie" => "Resuscitation" "fecha" => "2011" "volumen" => "82" "paginaInicial" => "e25" "paginaFinal" => "e26" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21871855" "web" => "Medline" ] ] ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib0065" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Lipemia: causes, interference mechanisms, detection and management" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "N. Nikolac" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.11613/BM. 2014.008" "Revista" => array:6 [ "tituloSerie" => "Biochem Med" "fecha" => "2014" "volumen" => "24" "paginaInicial" => "57" "paginaFinal" => "67" "itemHostRev" => array:3 [ "pii" => "S0091674917302269" "estado" => "S300" "issn" => "00916749" ] ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib0070" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Division of Chemistry and Toxicology Devices, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; 2016." ] ] ] ] ] ] ] "agradecimientos" => array:1 [ 0 => array:4 [ "identificador" => "xack473744" "titulo" => "Acknowledgements" "texto" => "<p id="par0040" class="elsevierStylePara elsevierViewall">The authors would like to acknowledge the financial support from the Spanish ministry of Economy and Competitiveness and European Regional Development Fund (ERDF) (Project CTQ2016-77128-R) as well as the Fundación Renal Iñigo Alvarez de Toledo (FRIAT) and the Fundació Miarnau. The patients involved in the study and the staff from the Dialysis section from Hospital Clínic de Barcelona are also acknowledged for their collaboration and enthusiasm in this study.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/20132514/0000004000000003/v1_202007190656/S2013251420300602/v1_202007190656/en/main.assets" "Apartado" => array:4 [ "identificador" => "35436" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/20132514/0000004000000003/v1_202007190656/S2013251420300602/v1_202007190656/en/main.pdf?idApp=UINPBA000064&text.app=https://revistanefrologia.com/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2013251420300602?idApp=UINPBA000064" ]
| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 5 | 10 | 15 |
| 2024 October | 46 | 48 | 94 |
| 2024 September | 39 | 33 | 72 |
| 2024 August | 58 | 73 | 131 |
| 2024 July | 37 | 24 | 61 |
| 2024 June | 43 | 36 | 79 |
| 2024 May | 53 | 29 | 82 |
| 2024 April | 40 | 23 | 63 |
| 2024 March | 43 | 25 | 68 |
| 2024 February | 42 | 30 | 72 |
| 2024 January | 32 | 28 | 60 |
| 2023 December | 37 | 29 | 66 |
| 2023 November | 41 | 37 | 78 |
| 2023 October | 113 | 28 | 141 |
| 2023 September | 291 | 36 | 327 |
| 2023 August | 271 | 29 | 300 |
| 2023 July | 62 | 24 | 86 |
| 2023 June | 122 | 19 | 141 |
| 2023 May | 65 | 30 | 95 |
| 2023 April | 51 | 19 | 70 |
| 2023 March | 60 | 28 | 88 |
| 2023 February | 45 | 15 | 60 |
| 2023 January | 34 | 26 | 60 |
| 2022 December | 62 | 36 | 98 |
| 2022 November | 71 | 54 | 125 |
| 2022 October | 59 | 47 | 106 |
| 2022 September | 44 | 45 | 89 |
| 2022 August | 50 | 37 | 87 |
| 2022 July | 51 | 46 | 97 |
| 2022 June | 43 | 40 | 83 |
| 2022 May | 60 | 30 | 90 |
| 2022 April | 41 | 47 | 88 |
| 2022 March | 40 | 50 | 90 |
| 2022 February | 42 | 50 | 92 |
| 2022 January | 60 | 34 | 94 |
| 2021 December | 46 | 50 | 96 |
| 2021 November | 50 | 49 | 99 |
| 2021 October | 105 | 61 | 166 |
| 2021 September | 48 | 47 | 95 |
| 2021 August | 69 | 45 | 114 |
| 2021 July | 89 | 39 | 128 |
| 2021 June | 35 | 19 | 54 |
| 2021 May | 69 | 40 | 109 |
| 2021 April | 95 | 67 | 162 |
| 2021 March | 68 | 38 | 106 |
| 2021 February | 61 | 44 | 105 |
| 2021 January | 34 | 18 | 52 |
| 2020 December | 36 | 20 | 56 |
| 2020 November | 17 | 9 | 26 |
| 2020 October | 19 | 14 | 33 |
| 2020 September | 35 | 26 | 61 |
| 2020 August | 26 | 19 | 45 |
| 2020 July | 20 | 12 | 32 |
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