China's First Homegrown CF Screening Device Breaks Foreign Sensor Monopoly with Urine-Based Detection

Salt, known as the “King of Flavors,” is indispensable in our three daily meals. However, excessive salt intake can easily lead to edema, hypertension, and a range of cardiovascular diseases.

In China, the number of patients with cardiovascular diseases has already become very large. According to“Report on Cardiovascular Health and Diseases in China 2021”shows that the number of people with cardiovascular and cerebrovascular diseases in China is approximately330 million, and the prevalence continues to show a sustained upward trend.

Peng Yaguang, Beijing Children's Hospital, Capital Medical UniversityHe has long been deeply interested in the fields of dietary nutrition and health. He wondered: If people could independently monitor their salt intake in daily life, would it enhance their awareness of reducing and limiting salt consumption, thereby helping to prevent and control cardiovascular diseases?

With this in mind, he set out to develop a product capable ofUrineA device for detecting human salt intake.

By chance, Peng Yaguang discussed the urine ion excretion detector he was developing with the director of the hospital’s respiratory department. The director slapped his thigh and exclaimed, “Hey! This device could solve the challenge of screening for cystic fibrosis (CF) in China!”

Thus, the urinary ion excretion measuring instrument inadvertently bore the burden ofShouldering the critical mission of filling the domestic gap in CF screening, we embarked on this journey of translational medicine.

Cystic FibrosisAlso known as mucoviscidosis, it is an autosomal recessive genetic disorder characterized by dysfunction of the exocrine glands throughout the body. It affects multiple systems in the patient's body, such as the respiratory system, digestive system, and even the reproductive system, with a mortality rateUp to 90%。

Currently, there is no effective treatment available worldwide, and approximately half of affected children die before the age of 10 due to severe complications such as infections or cardiopulmonary failure. Existing clinical data indicate that early screening and intervention can significantly reduce childhood mortality, with some patients even surviving into adulthood.

Studies have shown that the chloride ion concentration in the sweat of patients with cystic fibrosis is higher than that of healthy individuals.3–5 timesTherefore, measuring the concentration of chloride ions in the human body has become a breakthrough for early screening—a principle that aligns perfectly with the urinary ion excretion detector developed by Peng Yaguang.

However, unlike foreign diagnostic devices that typically screen for cystic fibrosis by measuring sodium chloride concentration in sweat, Peng Yaguang chose urine as the analyte. Why is this the case?

Peng Yaguang explained, “The sodium chloride ingested by the human body,”92.8%All are metabolized by the kidneys to form urine, with the remainder excreted from the body through respiration, sweating, and other routes. Although the compositions of sweat and urine differ, both can be used to measure sodium chloride concentration. While sweat-based testing is currently prevalent in the market, we believe that using urine as a test sample offers distinct advantages based on clinical practice.

First, urine collection is simpler than sweat collection.Current sweat collection technologies primarily rely on microelectrodes in contact with the skin to stimulate and enrich sweat accumulation. This process requires patients to wear a microelectrode wristband during testing and remain as still as possible to ensure successful collection.

During this process, in addition to maintaining stillness for an extended period, patients must also tolerate the discomfort caused by microelectrode stimulation. However, the primary targets for cystic fibrosis (CF) screening are young children, including infants and toddlers, for whom sweat collection via microelectrodes is extremely challenging. In contrast, urine collection is far more convenient, allowing children of all ages to provide samples easily and naturally.

Furthermore, urine-based testing enables the simultaneous measurement of urine volume and concentration via an analyzer, allowing for direct assessment of sodium chloride mass and thereby avoiding test anomalies caused by sweat contamination due to concentration or dilution.Improved detection efficiency.

Although sweat collection and detection via sensors are available abroad, the collected volume remains limited. Furthermore, factors such as ambient temperature, humidity, body temperature, and mental state can all influence the sweat collection process, posing risks of sweat concentration or contamination that may lead to deviations in test results.

The most important point is that the sensors required for urine collection and testing have become relatively widespread, which canBreaking Through the “Chokehold” Challenges Facing China。

Currently, China has not yet developed independent, alternative technologies, and sweat measurement sensors have not yet received regulatory approval in the country. Consequently, there is no fixed domestic supply source for these sensors. At present, patients must rely on personal connections to import them from overseas, a process that consumes significant human and financial resources, places considerable pressure on patients and their families, and delays screening timelines.

and using urine for testing can be fully conducted in ChinaIndependently Developed, In-House ManufacturedCF Screening Instrument: Providing Alternative Technology for CF Screening in China and Offering Greater Survival Possibilities for Chinese CF Patients

For a diagnostic instrument, easy access to the test sample is merely the first step; ease of use and accurate results are what truly matter. So, how do urine ion analyzers meet these requirements?

First, the embedded urinary ion excretion detectorIntelligent Algorithms, effectively avoiding false positives or false negatives and improving the accuracy of test results.

Based on extensive clinical data, Peng Yaguang developed a smart algorithm and embedded it into detection instruments. This algorithm can directly estimate the total urinary sodium chloride excretion of an individual and, as needed, output numerical results such as chloride ion concentration, sodium ion concentration, mass, and urine volume. It eliminates the steps of sample extraction and processing, thereby avoiding false-positive or false-negative results caused by manual operational errors affecting concentration measurements.

Secondly, the detection of urinary ion excretion detectorLower cost, reducing the financial burden on patients.

The urine ion excretion analyzer relies on electrochemical methods for chloride ion concentration analysis. Electrochemical technology has been used in medical testing for nearly 60 years, and both testing procedures and equipment manufacturing are highly mature. Therefore, from the perspective of testing costs, patient acceptance is very high.

Additionally, although the urinary ion detector was developed for CF screening,However, its application scenarios are not limited to screening for cystic fibrosis (CF).Because this instrument can not only detect chloride ion concentration, but also measure data such as calcium and phosphorus ions, it is highly applicable in many testing fields.

Take child development, a major concern for parents, as an example. Currently, growth hormone testing in children primarily relies on stimulation tests involving intravenous drug administration, which require multiple injections over an extended period to yield accurate results. However, repeated injections are highly likely to cause psychological resistance in children, leading to non-compliance with the testing procedure.

Insulin-like growth factor 1 (IGF-1), which is associated with growth hormone, can also be detected in urine. When combined with bone metabolism markers such as calcium and phosphorus, it holds promise for enabling non-invasive, convenient, and rapid assessment of children’s growth and development. This functionality is currently under development.

Meanwhile, the urine ion detector is compact, portable, and easy to operate, making it highly suitable for home use. Patients with cardiovascular or renal diseases who need to control their salt intake can perform self-testing at home using this device, eliminating the hassle of frequent hospital visits and enabling more timely monitoring of their condition.

Beijing Children’s Hospital, Capital Medical University, where Peng Yaguang is based, attaches great importance to and supports clinicians in translating their research findings into practical applications. With the hospital’s assistance, Peng Yaguang’s research team has collaborated with Beihang University,A prototype of the urinary ion analyzer has been designed and entered the testing phase.

Peng Yaguang told VCBeat’s Orange Bureau, “We have currently conducted small-sample clinical trials. Based on the trial data, the correlation between the results obtained from our prototype urinary ion detector and those from overseas sweat detectors is>0.7"Next, we will continue to expand the sample size and broaden clinical trials, striving to obtain medical approval as soon as possible to benefit more patients."

Although the hospital provided substantial support for the commercialization of the urinary ion analyzer, Peng Yaguang believes that,"Information Asymmetry"is the greatest obstacle to the translation of research findings.

With the sheer volume of hospital projects, it is challenging to precisely match each one with suitable collaborators despite the willingness to do so. In most cases, researchers must rely on their own efforts to identify reliable partners.

Many researchers can only connect with enterprises by leveraging their personal networks or participating in innovation competitions and academic conferences. However, the range of companies reachable through such channels remains highly limited, and successful collaborations are rare. Peng Yaguang discovered through discussions with peers that this situation is not an isolated case.

Peng Yaguang told VCBeat’s Orange Bureau, “Scientific achievements are like our children; we all cherish them as treasures. However, whether they are truly valuable depends on the response from the market and enterprises. Yet, for clinicians, it remains difficult to obtain such information at present,”It’s not just me; perhaps the entire industry is waiting for a solution.”

Currently, Peng Yaguang is seeking suitable partners for the urinary ion analyzer to facilitate technology transfer and accelerate its clinical application.