The demand for rapid, accurate, and decentralized diagnostic solutions has accelerated innovations in point-of-care testing (POCT), particularly for infectious diseases such as COVID-19. The H-care POCT Molecular Diagnostic System represents a significant advancement in this space, delivering precise nucleic acid detection through its integration of microfluidics and isothermal amplification technologies. This system offers not only speed and accuracy but also the flexibility and portability required for effective diagnostics in a wide range of settings, from clinics to remote locations.

System Components and Overview

The H-care POCT system is composed of three primary elements:

1.H-care Kit– A ready-to-use nucleic acid isothermal amplification reagent set.
2.H-care Device– A highly compact, portable device equipped to control reaction conditions and monitor molecular amplification in real-time via light absorbance.
3.H-care App– A user-friendly mobile application that connects via Bluetooth to the device, offering instant result interpretation and data management.
Together, these components form a cohesive molecular diagnostic platform tailored for in vitro diagnostics (IVD), enabling healthcare providers to deliver rapid, accurate, and actionable results.

Cutting-edge Technology: RT-LAMP

At the heart of the H-care system is Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP), a robust molecular technique designed for rapid amplification of nucleic acids at a constant temperature. Unlike PCR, which requires thermal cycling, RT-LAMP operates at a single temperature, which simplifies the design and operation of diagnostic devices while maintaining high diagnostic accuracy and sensitivity.

Key attributes of RT-LAMP technology include:

• 98% Accuracycomparable to RT-PCR, ensuring confidence in detecting even low concentrations of viral nucleic acids.

• Ultra-sensitive Detection: The system can detect as low as 40 copies per reaction, providing high sensitivity for early-stage infection detection or low viral loads.

Device Features and Specifications

• Compact Design: Weighing only 160g, the H-care device is highly portable, with dimensions of 82 mm x 52 mm x 115 mm, making it ideal for use in various point-of-care settings, including pharmacies, clinics, and even in-the-field testing.

• Fast Turnaround: Following nucleic acid release from the sample in just 10 minutes, the amplification process is completed within 45 minutes, making the system capable of delivering results in less than an hour.

• Room Temperature Operation: The system does not require cold chain storage, as the reagents and the device can be stored and transported at temperatures ranging from 10°C to 30°C. This significantly reduces logistical challenges and costs, particularly in low-resource settings.

• Bluetooth Connectivity: The H-care device integrates seamlessly with the H-care App via Bluetooth, enabling real-time data transfer and result interpretation directly on a smartphone, enhancing accessibility and user interaction.

Sample Collection and Workflow

The workflow is streamlined and user-friendly, ensuring ease of use even in non-laboratory environments:

1.Specimen Collection: Oropharyngeal or anterior nasal swab specimens are obtained from the patient.

2.Sample Preparation: After collecting the sample, it is mixed with the nucleic acid releasing agent, followed by a 10-minuteincubation at room temperature to ensure efficient release.

3.Amplification and Detection: The prepared sample is loaded into the H-care device, where the RT-LAMP reaction is initiated. The device monitors real-time light absorbance, which correlates to the amplification of the target nucleic acid.

4.Result Interpretation: The results are visually indicated by flashing lights on the device, or they can be checked via the H-care App, providing a clear, straightforward user experience.

Advantages of the H-care System

Ease of Use and Accessibility: The H-care system is designed for minimal operator intervention, making it accessible for non-specialized personnel in various healthcare settings, from small clinics to pharmacies. This increases its utility in decentralized healthcare delivery.

Portable and Lightweight: At just 160g, the device is exceptionally portable, allowing for mobile testing in remote or resource-limited environments without the need for complex infrastructure.

No Cold Chain Requirements: The ability to store and transport reagents and the device at room temperature enhances the system’s logistical efficiency, particularly in regions where maintaining a cold chain is challenging.

Rapid Diagnostic Results: The total time from sample collection to result generation is under one hour, making the system invaluable in time-sensitive situations, such as during outbreaks or in emergency care settings.

High Sensitivity and Accuracy: With a limit of detection (LoD) of just 40 copies/reaction and a diagnostic accuracy of 98%, the system delivers high confidence in its results, ensuring that even low viral loads are detected, reducing the risk of false negatives.

Remote and Real-time Monitoring: The Bluetooth-enabled H-care App allows for real-time data sharing and remote monitoring, facilitating integration with healthcare information systems and enabling clinicians to make prompt, data-driven decisions. This feature also supports centralized data collection in large-scale screening programs.


The H-care POCT Molecular Diagnostic System represents a major advancement in point-of-care molecular diagnostics. With its combination of cutting-edge RT-LAMP technology, portability, and ease of use, it is ideally suited for use in diverse settings, including decentralized and resource-constrained environments. Its high accuracy, sensitivity, and rapid turnaround times make it an essential tool for effective disease detection and outbreak management, particularly in situations where rapid and reliable results are crucial. The H-care system’s ability to provide diagnostic results without the need for complex laboratory infrastructure positions it as a key player in the future of molecular diagnostics.

In the future, Hzymes biotech will always remember its original intention and persist in meticulous cultivation in the IVD field. It will adhere to independent research and development, accelerate the construction of a world-class specialty enzyme production platform, and achieve import substitution of core enzyme raw materials in the field of biomedicine in China. It will collaborate with leading biopharmaceutical companies to expand their global presence and contribute to the advancement of the industry.