n e f r o l o g i a 2 0 2 0;4 0(3):356–370 363
Carta al Director
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
Dear Editor: considered is that the ADVIA Chemistry XPT system measures
with indirect ion selective electrodes in a pre-diluted sample,
Determination of potassium levels in serum is routinely per- while the POC device measures with direct ISEs in whole blood.
formed in clinical labs, as it is a critical parameter and Lipemia in serum causes a reduction in the aqueous fraction
abnormal potassium concentrations may lead to fatal cardiac leading to abnormally lower values, which does not happen
consequences.1 An immediate test for determination of blood in the whole blood measurements. This may be an additional
potassium may contribute to prevent such critical issues, for source of variation between the two methodologies.6
example, arrhythmias. Therefore we have developed and tes- This POC device is not conceived to compete with the
ted a novel point-of-care (POC) device that provides a simple reference technique in the healthcare facility, but rather
and highly affordable way of measuring potassium levels in a to complement the conventional approaches by giving an
single drop of blood outside the clinical laboratory.2 immediate response when required. Conventional para-
We have measured the concentration of potassium in meters such as sensitivity, limits of detection and linear
blood of 36 patients suffering from chronic kidney disease range are comparable in both techniques. And although the
(CKD) before and after each dialysis session during three value is less precise, it may have a great impact when
weeks with the POC presented and a reference method follo- triaging life-threatening conditions. Hence, the relative impor-
wing the routine workflow in a clinical laboratory. A total tance of the analytical parameters must be evaluated under
of 705 measurements of potassium have been analyzed and different contexts. Thus, the POC device may have a significant
compared using statistical tools. ADVIA Chemistry XPT from impact on the early detection of several medical conditions
Siemens Healthineers was used as the reference system for that will avoid future problems and complications for the
the potassium measurement, this system measures potas- patient health and wellbeing, eventually reducing the costs
sium in plasma with a predilution of 1:33, while the POC device of the treatment.
performs a direct measurement of potassium in whole blood The POC device meets the requirement for direct analysis
with ion-selective electrodes technology. since it uses a small amount of blood and no pretreatment
Passing-Bablock regression and Blant-Altman analysis is performed although precision is inferior to clinical lab
(Fig. 1) confirmed that there is a strong correlation (Pear- analysis. However, this lower precision is common in POC
son correlation coefficient is R2 = 0.953) between the results devices, for example, FDA accepts glucometers with an accu-
obtained by both methodologies with a small bias (0.03) and racy of +/−15% for 95% of the results within all the range, and
limits of agreement in -0.62 and 0.68 mM. Whether the bias +/−20% for 99%.7 The POC device presents the benefits that
and limits of agreement are adequate or not, it is a clini- this implies, especially the reduction of the time between the
cal rather than a statistical question. As normal potassium sample withdraw from the patient and the given result. This
levels in blood can vary from 3.5 to 5.5 mM a bias of 0.03 mM POC device has the particular advantage to work with paper-
can be considered insignificant from a clinical standpoint. based sensors, which are suitable for mass-scale production
Moreover, the confidence intervals obtained by the POC device and, due to the materials used, present very low manufactu-
(−0.62/0.68 mM) are in good agreement with previous valida- ring cost.
tion studies of POC devices3–5 and suitable for the type of In conclusion, the POC device has demonstrated a good
situations where a POC device will be used – such as scree- correlation with the reference method, proving that it can be
ning for general conditions in the global population or control an alternative for specific situations where an immediate res-
and monitoring of chronic patients-. The higher contribution ponse is required. What remains for the future is to validate its
to the variability of the technique comes from the precision utility as an alternative method for specific situations, which
of the sensor (0.25 mM). Other parameters such as the manual depends on whether the reduction of the analysis time can
calibration or some interferences from blood may contribute have benefits in the decision making process of the doctors
to the remaining variability. Another parameter that has to be and the quality of life of the patients.
364 n e f r o l o g i a 2 0 2 0;4 0(3):356–370
A B
8 1.5
7 1.0
Difference in potassium
0.68
concentrattion (mM)
6 0.5
[k+] / POC
0.03
5 0.0
8
4 -0.5 -0.62
3 -1.0
2 -1.5
2 3 4 5 6 7 8 2 3 4 5 6 7
[k+] / ADVIA chemistry XPT Mean of potassium concentration between ADVIA
chemistry XPT and POC (mM)
Fig. 1 – (A) Passing–Bablock regression analysis. Dashed lines represent the 95% CIs. POC = 1.0769 (95% CI 1.1053/1.0455)
ADVIA Chemistry XPT – 0.3231 (95% CI −0.4158/−0.2205), n = 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.
4. Allardet-Servent J, Lebsir M, Dubroca C, Fabrigoule M, Jordana
Conflict of interest S, Signouret T, et al. Point-of-care versus central laboratory
measurements of hemoglobin, hematocrit, glucose,
The co-authors (Andrade FJ, Blondeau P, Maceira A and bicarbonate and electrolytes: a prospective observational study
Novell M) disclose a potential conflict of interest as they in critically ill patients. PLOS ONE. 2017;12:1–16,
are co-founders of CreatSens Health, SL which intends to http://dx.doi.org/10.1371/journal.pone.0169593
5. Ahn S, Kim WY, Sohn CH, Seo DW, Kim W, Lim KS. Potassium
commercialize blood bio-sensing technologies. No potential
values in cardiac arrest patients measured with a point-of-care
conflicts of interest exists for the rest of the authors.
blood gas analyzer. Resuscitation. 2011;82:e25–6,
http://dx.doi.org/10.1016/j.resuscitation.2011.08.010
Acknowledgements 6. Nikolac N. Lipemia: causes, interference mechanisms,
detection and management. Biochem Med. 2014;24:57–67,
http://dx.doi.org/10.11613/BM. 2014.008
The authors would like to acknowledge the financial support
7. U.S. Department of Health and Human Services, Food and
from the Spanish ministry of Economy and Competitiveness Drug Administration, Center for Devices and Radiological
and European Regional Development Fund (ERDF) (Project Health, Office of In Vitro Diagnostics and Radiological Health,
CTQ2016-77128-R) as well as the Fundación Renal Iñigo Alva- Division of Chemistry and Toxicology Devices, Blood Glucose
rez de Toledo (FRIAT) and the Fundació Miarnau. The patients Monitoring Test Systems for Prescription Point-of-Care Use;
involved in the study and the staff from the Dialysis section 2016.
from Hospital Clínic de Barcelona are also acknowledged for
Marta Novell a , Nayra Rico b , Pascal Blondeau a ,
their collaboration and enthusiasm in this study.
Miquel Blasco c , Adrià Maceira d , José Luis Bedini b ,
Francisco Javier Andrade a,∗ , Francesc Maduell c
bibliograf í a
a Univ Rovira & Virgili, Dept Analyt & Organ Chem, Tarragona,
Spain
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hyperkalemia. Am Fam Phys. 2015;92:487–95, c Hosp Clin Barcelona, Dept Nephrol, Barcelona, Spain
http://dx.doi.org/10.1016/j.ehmc.2014.09.008 d Creatsens Health, SL, Tarragona, Spain
2. Novell M, Guinovart T, Blondeau P, Rius FX, Andrade FJ. A
paper-based potentiometric cell for decentralized monitoring
∗ Corresponding
author.
of Li levels in whole blood. Lab Chip. 2014;14:1308–14,
http://dx.doi.org/10.1039/c3lc51098k E-mail address: franciscojavier.andrade@urv.cat (F.J. Andrade).
3. You JS, Park YS, Chung HS, Lee HS, Joo Y, Park JW, et al.
Evaluating the utility of rapid point-of-care potassium testing 0211-6995/© 2019 Published by Elsevier España, S.L.U. on
for the early identification of Hyperkalemia in Patients with
behalf of Sociedad Española de Nefrologı́a. This is an
Chronic Kidney disease in the emergency department. Yonsei
Med J. 2014;55:1348–53, open access article under the CC BY-NC-ND license (http://
http://dx.doi.org/10.3349/ymj.2014.55.5.1348 creativecommons.org/licenses/by-nc-nd/4.0/).
https://doi.org/10.1016/j.nefro.2019.06.002
