CONICET scientists demonstrated the effectiveness of a digital test in a clinical trial

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The digital diagnostic device for hepatitis E, developed by a CONICET research team and unveiled last March, has a precedent that, while already very promising from the outset, is now an achievement with even greater potential. It uses the same technology, but in this case, applied to chronic kidney disease (CKD)—the progressive deterioration and loss of kidney function caused primarily by diabetes and high blood pressure—as an alternative to the conventional monitoring method in healthcare facilities: a procedure performed using expensive and large equipment called a modular laboratory analyzer, which processes biological samples to verify the values of various indicators.

The portable digital device uses capillary blood and provides results in seven minutes. PHOTOS: CONICET Photography/Rayelen Baridon.

Thus, through a comparative study carried out in the Nephrology Service of the Interzonal General Hospital of Acute Care (HIGA) “General San Martín” of La Plata, it was demonstrated that the new test, developed by scientists from the Institute of Theoretical and Applied Physicochemical Research (INIFTA, CONICET-UNLP) and the technology company Gisens Biotech, offers multiple advantages and opens the doors to position the region at the forefront of treatments for this pathology

The results of the study were published in a joint report written by the scientific team and the doctor.

With a sustained increase globally and, even worse, an accompanying underdiagnosis, chronic kidney disease (CKD) is an irreversible condition that frequently leads to the need for a kidney transplant, with a high mortality rate for patients and significant suffering throughout their lives. According to the Second National Nutrition and Health Survey (ENNyS 2, conducted between 2018 and 2019), almost 3.8 million adults in Argentina suffer from some degree of CKD, and most alarmingly, the vast majority are unaware of it, as symptoms only appear in advanced stages.

Esteban Piccinini and Omar Azzaroni, researchers at INIFTA and scientific leaders of the study.

“Interested in the research and development of rapid and portable biosensors, we saw in this disease a significant public health problem toward which we could direct our work,” said Esteban Piccinini and Omar Azzaroni, CONICET researchers at INIFTA and the project’s scientific leaders. It was along this path that, as they progressed in the development of the device together with the aforementioned company, they contacted the hospital and began to outline the clinical study that they would eventually carry out with the nearly 70 patients who undergo dialysis at that health center.

Renal replacement therapy
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Renal replacement therapy is of two types: hemodialysis, which uses a machine to filter the blood for several hours and is typically performed three times a week; and peritoneal dialysis, which uses a catheter to introduce a solution into the abdominal cavity and remove waste products into an external bag that must be changed several times a day. Unlike hemodialysis, which is performed in a healthcare facility, peritoneal dialysis can be done on an outpatient basis. In both cases, but with varying frequency, patients have their urea, sodium, and potassium levels analyzed to monitor their overall health. This monitoring takes place in hospitals and clinics using a laboratory analyzer. This is where the innovative digital test comes in. At a minimum, it offers the benefit of being minimally invasive, as it uses capillary blood—a drop taken from a finger prick—instead of venous blood, which requires a traditional blood draw. It is also portable and easy to use, allowing for measurements in patients who live far from urban centers. and is designed so that patients can self-test at home, obtaining results in just seven minutes.

Just a little puncture
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“These characteristics greatly interested the medical team at San Martín Hospital, a leading center that receives dozens of patients from across the province for dialysis and other treatments,” explained Piccinini, adding, “These professionals are truly attentive to global nephrology research and the practices of leading countries in the field.”

From left to right: Silvina Maltas, Agustín Ferrigno, and Martín Mamberti, three doctors from the Nephrology Service of the hospital.

As head of the medical service, Silvina Maltas highlighted the technological innovation and the opportunity to bridge the gap between research and clinical practice as “the main aspects of this project that caught our attention and led us to participate, considering that in institutions like a public hospital, the capacity for research is always overwhelmed by the need to treat incoming cases, and this work is a way to bridge that gap.” Thus, all patients undergoing both types of dialysis agreed to provide samples for six months to be monitored periodically by both the hospital laboratory and the portable diagnostic kit, allowing for a comparison of the methods.

Very successful
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The results were more than successful for the new device, which not only proved to be as effective and safe as the traditional technique, but also achieved 97.5 percent accuracy in the data obtained. It also demonstrated a lower coefficient of variation, or in other words, greater precision compared to the 15 to 20 percent accuracy of other widely used commercial measuring instruments in the healthcare field. Alongside these figures, the study included a survey that also provided valuable qualitative information.

The hemodialysis unit at San Martín Hospital. The new test could help change the lives of many people.

Regarding the level of pain caused by each type of blood draw, respondents rated the rapid test at 1.7 on a scale of 1 to 5, while the traditional test scored 4.2, very close to the maximum. Furthermore, almost 80 percent agreed that having a device for home use would give them the opportunity to monitor their health whenever they felt unwell or noticed changes in their condition. “This gives them more peace of mind but also indirectly influences their life expectancy, since it would allow any anomaly to be detected in time, before the person arrives at a health center in a decompensated state,” Piccinini explained.

“Global statistics indicate that smart patient monitoring tools contribute to reducing adverse metabolic and cardiovascular events by 50 to 60 percent and hospitalizations by 64 percent. This, in turn, results in a 44 percent decrease in mortality. These aren’t figures we obtained; this is what nephrology indicates globally,” Azzaroni pointed out.

Moreover, according to project estimates, manufacturing the device would cost less than 2 percent of the price of a laboratory analyzer, and only the disposable sample collection kits would need to be purchased, which could have a similar cost to the test strips used by diabetic patients to measure glucose. Of all the reported advantages, the scientific team doesn’t hesitate to highlight the least tangible of all: the impact on quality of life. “There are those who travel three or four hours a day for dialysis or blood tests, and their survival depends on this,” Piccinini explained, adding: “these are people who can’t travel long distances to visit family, for example, if it means missing a treatment session, and if they do, they suffer a lot of fear and anxiety at the possibility of feeling unwell far from a health center. There are truly heartbreaking stories behind this problem.”

Citation
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Member os the clinical study: Dr. Martín Mamberti (Medical Director of the study), Dr. Silvina Maltas (Head of Nephrology Service), Dr. Agustín Ferrigno (Head of Nephrology), Dr. María Elena Bruzzone (Head of Nephrology), Dr. Carolina Barabani (coordinator of the peritoneal dialysis program), Dr. Lucía Dall Aglio, Dr. Maximiliano Malinar, Dr. Mayte Fuentes, Dr. Cecilia Benítez, Dr. Cintia Mora, Dr. Denis Norma, Dr. Javier Reyes, Dr. Noelia Lafuente, Dr. Roger Quintanilla Mamani, Bibiana Pizarro (Head of Central Laboratory), Susana Cattáneo, Vanina Dolcini, Dr. Waldemar Marmisolle, Dr. Ezequiel Giménez, Lic. Joaquín Diforti, Nicolás Martiarena, Sofía Sánchez Caro, Dr. Omar Azzaroni, Dr. Esteban Piccinini (Scientific Director of the study).

Funding
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The project has received financial contributions from Gisens Biotech, FITBA 2025-124B, ANPCYT (PICT 2018-04684), CONICET-UNLP-GISENS BIOTECH (700-2845/20-000).

The article Cruzando la línea del laboratorio: científicos del CONICET mostraron la eficacia de un test digital en un ensayo clínico, signed by Mercedes Beanialgo was published in CONICET’s website.

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