Innovative Point-of-Care Diagnostics Empowering Primary Healthcare: Emerging Technologies and Market Leaders

Recently, the “2019 China Primary Healthcare Innovation Practice Summit,” co-hosted by VCBeat and VBInsight, was held in Guangzhou. Experts, scholars, entrepreneurs, and investors from the healthcare industry gathered to discuss topics related to primary healthcare.

Driven by the tiered diagnosis and treatment policy, the primary-level medical device market has begun to expand significantly. According to data from VCBeat, over the past six months, 13 primary healthcare institutions recorded medical device procurement totaling approximately RMB 18.94 million. Procurement expenditures at Level I hospitals primarily ranged between RMB 1 million and RMB 3 million, with the majority allocated to in vitro diagnostic products.

Even without precise estimates, it is evident that the grassroots medical device market is a force to be reckoned with. This growing market presents substantial industrial opportunities. How can companies establish product advantages, operate market channels, and grasp future development trends? Guests at the Forum on Grassroots Testing, Diagnosis, and Operations shared their insights. Below are excerpts from their viewpoints:

Deputy Secretary-General of the China Association of Medical Equipment, Dong Shukui

China is a major consumer of antibiotics, and long-term reliance on antibiotic anti-inflammatory drugs has become a habit among both patients and physicians. The volume of antibiotic use in China consistently ranks among the highest globally. Per capita antibiotic consumption in China reaches approximately 138 grams, compared to only 13 grams in the United States; thus, China’s antibiotic usage has remained 5–8 times higher than that of developed Western countries.

China’s annual production of antibiotic drugs stands at 33,000 metric tons. The minimum proportion of antibiotic use in China is 30%, reaching 50% in primary care hospitals. In rural areas of China, the use and misuse of antibiotics are quite prevalent.

Although relevant national ministries have repeatedly emphasized the necessity of standardized medication practices and prohibited the misuse of antibiotics and hormones, implementing these measures at the grassroots level of medical service institutions remains highly challenging, primarily due to insufficient public awareness.

Many primary care hospitals, community service stations, and village clinics possess only the most basic examination equipment and tools, making it impossible to rapidly obtain accurate diagnostic results for certain patients. Primary care physicians must rely solely on their clinical experience to diagnose conditions, severely lacking access to rapid, portable, advanced diagnostic devices. Furthermore, their technical capabilities are limited to a few specific tests, rendering them nearly unable to meet the demands of comprehensive general practice diagnosis.

To address this situation, the industry has introduced white blood cell (WBC) counting in recent years to assist primary care physicians in making rapid diagnoses and reducing antibiotic use.。

The WBC series white blood cell analyzers and their accompanying in vitro diagnostic kits, developed by Jiangsu Konsun Biotechnology, have received expert certification and demonstrated strong performance in primary care settings.

This device integrates advanced microfluidic technology with the need for point-of-care white blood cell (WBC) diagnostics. It enables rapid WBC detection within three minutes in hospital emergency departments and primary care settings, facilitating tiered diagnosis and treatment for patients and meeting the demand for immediate test results in emergency care. With stable performance and user-friendly operation, the device functions independently of other equipment, allowing for on-site testing of venous and capillary blood samples anytime and anywhere. This capability optimizes resource utilization and promotes the rational use of antimicrobials in remote and grassroots healthcare facilities.

Zhang Zhuo, Co-founder and CEO of Siduoke

The medical background and environment at the primary care level differ vastly from those in tertiary (Grade 3A) hospitals. To ensure that diagnostic products are effectively utilized when deployed to primary care settings, innovative strategies are essential. In particular, given that users at this level may not possess the same proficiency as those in tertiary or secondary (Grade 2A) hospitals, innovators must carefully consider how to make these products user-friendly and reliable, thereby ensuring a comfortable and confident user experience.

Stakeholders in primary care medical equipment across different regions, manufacturers, and application areas must all consider how to address the following issues:First,First, improve cost-effectiveness to ensure affordability for primary healthcare institutions. Second, facilitate the transition of usage scenarios by educating users on proper operation and handling procedures. Third, enhance portability; since primary care physicians frequently conduct house calls, designing diagnostic devices to be as pocketable as a stethoscope would provide greater convenience for medical practitioners.。

Handheld ultrasound devices were born out of this.

The Sdtek handheld ultrasound system integrates the entire chip-based color Doppler probe into a single device, enabling it to perform routine clinical examinations of the liver, gallbladder, pancreas, spleen, and kidneys in hospital settings., it can also be used for examinations of superficial structures, such as the thyroid, breast, systemic superficial blood vessels, muscles, certain bones, the musculoskeletal system, and pediatric applications. Currently, the device weighs only 300 grams, making it portable; images can be uploaded, allowing physicians to interpret them on smartphones or tablets. This ensures affordability and ease of use for primary healthcare institutions.

Additionally,Ultrasound is a highly non-standardized diagnostic procedure, and primary-care physicians often lack sufficient operational experience. To address this issue,, Siduoke has added a camera module to its device. During remote consultations, experts can directly provide instructional guidance on whether physicians’ operations are standardized; this service can be implemented as long as primary care institutions are connected with experts from tertiary hospitals.

Meanwhile, to help primary care physicians improve their diagnostic capabilities, Siduoke will collaborate with artificial intelligence experts to launch an AI module in the future.

Founder of Chuanghuai Medical, Zhuang Bin

The most critical technology for POCT devices is microfluidics. Chuanghuai Medical has introduced novel thinking, new technologies, and fresh concepts in the design, manufacturing, and industrial definition of microfluidic chips. The integration of these three elements has enabled Chuanghuai Medical to continuously launch a series of microfluidic POCT products with the lowest costs globally.

Building on this foundation, Chuanghuai Medical has developed the world’s only four-in-one instrument capable of simultaneously reading sensors from four modalities: optical, electrical, chromatic, and imaging. These sensor types respectively convert cellular, blood, or other biological signals into optical, electrical, chromatic, and image-recognition signals.

This approach unifies all laboratory medicine chips into four series, standardizes these chip platforms, and creates an open system for the POCT industry, with this single four-in-one instrument serving as the complete primary care laboratory. This groundbreaking initiative is pushing POCT to its ultimate potential.

Not only that,Chuanghuai Medical continues to evolve POCT into POCS, a concept first proposed and named by Chuanghuai.。

The full spectrum of healthcare scenarios encompasses three categories of individuals:Patients provide clinical information during sample collection; laboratory technologists operate instruments to perform tests, while laboratory physicians review abnormal results and recommend appropriate differential diagnostic items; the test report is issued to clinicians, who finalize the diagnosis and treatment.

However, this system is absent at the primary healthcare level and in home settings. Laboratory medicine is an independent specialty, and it is inappropriate for clinicians and patients to assume the responsibilities of laboratory physicians. In fact, if accurate laboratory data could be reliably obtained, neither clinicians nor patients would wish to perform all laboratory testing tasks themselves.

Therefore, the essence of POCT is that it forces clinicians and patients to perform the work of laboratory technicians, which is unreasonable; a more practical alternative is POCS.

To meet the testing needs at the primary care level, Chuanghuai Medical offers a new concept device known as POCS (point-of-care sensor), where the “sensor” refers to a microfluidic chip, thereby upgrading point-of-care testing to an online laboratory model. It addresses all primary-care testing challenges through an all-in-one “four-in-one” analyzer and biochip technology.。

As this instrument is fully parametric and universally compatible, it is highly suitable for use as infrastructure, with multiple funding sources available for procurement.As a commercial manufacturer that has fully mastered world-leading microfluidic medical chip sensors and achieved ultra-large-scale, high-precision mass production, Chuanghuai Medical can generate revenue simply by selling its mass-produced biochips. This model eliminates the need for primary healthcare institutions to hire laboratory physicians or purchase four-in-one POCT devices capable of comprehensive parameter testing.

Primary care physicians use Chuanghuai Medical’s biochips and four-in-one instruments to perform sample collection and signal conversion, then upload the digital test signals via a digital interface to the clinical laboratory. The laboratory conducts centralized testing, quality control, and review, and subsequently returns the reports.

Zhang Yang, Co-founder, Executive Director, and President of Hengdao Pathology

Insufficient pathological diagnostic capacity in primary healthcare institutions is one of the key factors limiting patient visits, surgical volumes, return visit rates, and hospitalization rates at primary-level hospitals.

On the one hand, the lack of intraoperative frozen section pathology diagnostic capabilities prevents primary healthcare institutions from performing surgeries that require rapid frozen diagnosis to determine subsequent surgical procedures, thereby limiting the types and scope of surgeries they can offer. On the other hand, inconclusive routine pathology diagnoses lead to patient attrition at these hospitals. Therefore, Hengdao Pathology empowers primary healthcare institutions by providing comprehensive pathology diagnostic services.

Hengdao Pathology is the first medical institution in China to obtain a license for an independent third-party pathology diagnostic center. Its large-scale pathology diagnostic center built in Shanghai covers an area of 2,500 square meters, making it currently the largest single pathology diagnostic center in China. All services related to pathology diagnosis can be completed at this center. Its core diagnostic center and co-built regional centers together form a nationwide service coverage.

Hengdao Pathology currently boasts six renowned expert partners, 30 full-time medical and technical staff, and 53 frontline practicing pathologists. It covers 13 of the most comprehensive pathology subspecialties in China and operates a full-spectrum pathology platform encompassing cytology, histology, molecular diagnostics, immunology, tumor microenvironment analysis, and digital telepathology.

Digital remote pathology diagnosis has been proven through years of practice to be an effective solution for decentralizing pathological diagnostic services and addressing manpower shortages.Preparation of slides at primary care facilities, uploading of scanned images, and data transmission via the internet, followed by diagnosis at the pathology center and report feedback. This constitutes a complete workflow; however, challenges and issues arise during implementation.

First,The uniqueness of pathological diagnosis lies in the need for tissue sampling and slide preparation, which is a non-standardized process involving manual intervention. This situation is exacerbated by insufficient investment in pathology services and limited quality control capabilities.，There is a high risk of issues in specimen collection and slide preparation; therefore, the primary focus during actual operations should be on standardizing these processes.。

Second, the digital remote upload also introduces a challenge: pathologists experience differences when viewing slides under a microscope versus on a screen. Although tissue sections are very thin, microscopic observation conveys three-dimensional information due to effects such as light and shadow, whereas digitized whole-slide images become purely two-dimensional representations. As a result, the information content is somewhat less rich than that obtained through direct microscopic examination, posing significant challenges for pathologists. Consequently, the diagnosis of digitally transmitted remote slides, particularly intraoperative frozen section diagnosis, requires pathologists with extensive practical experience.

Furthermore,Intraoperative frozen section analysis requires issuing a report within 30 minutes, which poses a significant challenge for pathologists and operating institutions.. This also implies a question: how should legal liability be determined in the event of a misdiagnosis? These are all tests for pathology diagnostic centers.

As China’s first third-party pathology diagnosis center, Hengdao Pathology has accumulated extensive pathological data over several years of development, laying a solid foundation for the research and development of AI-based diagnostic algorithms and models. Currently, Hengdao Pathology has achieved remarkable results in algorithms and models for gastrointestinal tumor diagnosis, early cancer screening, and quantitative analysis of immunohistochemistry.

Huang Yixin, Co-founder of Zhiyuan Huitu

China has 3,000 retinal disease specialists, 70% of whom are located in major cities. How to leverage the remaining 30% to address the ophthalmic diagnosis, treatment, and prevention needs of the grassroots population is a challenge that many institutions and enterprises are striving to solve.

Zhiyuan Huitu’s solution is:

Step 1: Leverage artificial intelligence technology to replicate the diagnostic capabilities of senior ophthalmology experts as closely as possible, a approach that has received high recognition from these experts;

Step 2:Identify hospitals that are willing and equipped to conduct eye disease screening. Integrate the largely mature AI software with hospital equipment and personnel. Continuously refine the product based on physician feedback in real-world clinical settings to enhance its applicability.

For instance, many physicians at primary care hospitals only discover that fundus photographs fail to meet diagnostic requirements when generating diagnostic reports, by which time patients have already left the consultation room and cannot be recalled for retaking the images. To address this issue, Zhiyuan Huitu’s AI-based diagnostic system has incorporated an automatic image quality assessment feature for fundus photographs, in addition to its diagnostic capabilities. This enables physicians at primary care hospitals to identify image quality issues immediately and arrange for retakes while patients are still present.

Step 3: During implementation at certain hospitals, Zhiyuan Huitu identified that some issues could be addressed through technical solutions, while others required establishing connectivity between primary care hospitals and tertiary hospitals.Thus, Zhiyuan Huitu has completed its transformation from a pure technology company into an integrated solutions provider.

It not only provides basic AI-powered ophthalmic screening software to primary care hospitals but also enables Zhiyuan Huitu to leverage fundus image reading centers at tertiary hospitals to help primary care facilities address any uncertainties arising during the screening process. In this way, by combining AI with remote human expertise, it effectively helps primary care hospitals resolve the challenges of fundus disease screening.

Once technical issues are resolved and the consultation workflow is streamlined, Zhiyuan Huitu will further productize its comprehensive ophthalmic disease screening solution, delivering it to governments, professional societies, and healthcare institutions to assist them in conducting large-scale population-based eye disease screening.

Jiang Yang, Marketing Director at Huamai Xingwei

There are some issues in the POCT market:

First,Insufficiently precise, the test data from many devices differ significantly from those of large-scale diagnostic equipment, and sometimes even contradict them, causing confusion for physicians and increasing the risk of misdiagnosis during the medical diagnostic process.

Second,Lack of a Reliable Quality Control System, different environments and temperatures can all affect test results. From a physician’s perspective, inaccurate and unreliable results are even worse than not performing the test at all, as problematic data can impair or mislead clinical judgment.

Microfluidics and chemiluminescence miniaturize large-scale diagnostic equipment., miniaturized onto a single chip. The traditional medical testing pathway involves blood collection first, followed by sending the blood samples to a laboratory for processing, and finally reporting the test results back to clinical practitioners. This process entails numerous personnel and steps.

Huamai Xingwei employs microfluidic chemiluminescence technology to perform point-of-care testing by applying a single drop of blood onto a reagent card. The reagent card can be understood as a “lab-on-a-chip,” a highly miniaturized laboratory that utilizes the same methodological principles as large-scale analytical instruments. Advances in new technologies have made the miniaturization and integration of testing environments a reality.

Once the chip-based reagent cartridge completes its transport and reaction processes, mechanical errors are significantly reduced, minimizing the impact on the experimental environment. Microfluidic chemiluminescence technology can even be applied in space environments; even if the equipment is tilted, the impact on test results remains minimal. This constitutes the advantage of microfluidic chemiluminescence detection.

Huamai Xingwei is also dedicated to the research and development of reagent cards, continuously expanding its portfolio of diagnostic assays. To date, five reagent cards have obtained registration certificates, while more than 20 additional assays are currently under development and pending regulatory approval.

As a leading domestic manufacturer of micro chemiluminescence analyzers, Huamai Xingwei has developed the M2 Microfluidic Chemiluminescence Analyzer, which integrates three core technologies: “microfluidics, chemiluminescence, and magnetic microparticles.” As the world’s first microfluidic chemiluminescence analysis system, it features precise, miniaturized, and user-friendly operation. Weighing only 5 kg, its testing accuracy is comparable to that of large-scale chemiluminescence assay instruments.