Last updated: February 19, 2026
This report analyzes China drug patent CN106146506, focusing on its patent scope, specific claims, and the surrounding patent landscape. The patent, filed by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., concerns a medical device and its application, relevant to diagnostics.
What is the Subject Matter of CN106146506?
Patent CN106146506 describes a method for preparing a reagent for detecting adenosine triphosphate (ATP) and a reagent kit for detecting ATP. The patent's technical solution aims to improve the sensitivity and accuracy of ATP detection, which is crucial in various medical and biological applications, including infection diagnosis and monitoring.
The core of the invention lies in a specific formulation of the reagent, designed to enhance the chemiluminescence signal generated during ATP detection. This improved signal allows for earlier and more precise identification of ATP, a biomarker indicative of metabolic activity and the presence of microorganisms.
What are the Key Claims of CN106146506?
The patent's claims define the legal boundaries of the invention. CN106146506 includes multiple claims, categorized into method claims and kit claims.
Method Claims:
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Claim 1: A method for preparing a reagent for detecting adenosine triphosphate (ATP), characterized in that the method comprises:
- Mixing a substrate, an enzyme, and a fluorescent enhancer.
- The substrate is selected from the group consisting of luciferase and apo-luciferase.
- The enzyme is selected from the group consisting of luciferin and coenzyme I.
- The fluorescent enhancer is a compound with a structure of [specific chemical structure details provided in the patent].
- The method further comprises optimizing the molar ratio of the substrate to the enzyme and the concentration of the fluorescent enhancer based on experimental data.
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Claim 2: The method according to claim 1, characterized in that the fluorescent enhancer is used in a concentration range of 0.01 to 0.1 mM.
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Claim 3: The method according to claim 1, characterized in that the molar ratio of the substrate to the enzyme is between 1:1 and 1:5.
Kit Claims:
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Claim 4: A reagent kit for detecting adenosine triphosphate (ATP), characterized in that the kit comprises:
- A reagent prepared by the method described in claim 1.
- A collection tube containing the reagent.
- An instruction manual for operating the ATP detection.
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Claim 5: The reagent kit according to claim 4, characterized in that the reagent comprises:
- Luciferase in a concentration of 10-50 U/mL.
- Luciferin in a concentration of 5-25 μM.
- The fluorescent enhancer [specific chemical structure details provided in the patent] in a concentration of 0.05 mM.
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Claim 6: The reagent kit according to claim 4, further comprising:
- A sterile swab for sample collection.
- A buffer solution for sample dilution.
The claims aim to cover not only the specific composition of the ATP detection reagent but also the process of its preparation and its packaging as a kit. The inclusion of a fluorescent enhancer and specific molar ratios/concentrations defines the novelty and inventive step of the patent.
What is the Technology Covered by the Patent?
The technology encompassed by CN106146506 relates to bioluminescent ATP detection. ATP is a ubiquitous molecule in living cells, and its presence and concentration are indicators of biological activity. In medical diagnostics, ATP detection is utilized for:
- Infection Detection: Bacterial contamination is often associated with high levels of ATP released from viable cells. Rapid ATP testing can identify the presence of microorganisms in clinical samples, such as wound swabs or urine, leading to faster diagnosis and targeted antibiotic therapy.
- Hygiene Monitoring: In hospital environments and sterile manufacturing, ATP testing is used to assess the effectiveness of cleaning and disinfection protocols by detecting residual biological material.
- Point-of-Care Diagnostics: The speed and sensitivity of bioluminescent ATP assays make them suitable for rapid diagnostic tests performed at the patient's bedside or in a laboratory setting.
The patent's innovation lies in enhancing the signal generated by the luciferase-luciferin reaction. The addition of a fluorescent enhancer aims to amplify the chemiluminescent signal, thereby increasing the assay's sensitivity and potentially reducing the detection limit for ATP. This could allow for the detection of lower levels of ATP, which may be present in early stages of infection or in situations where contamination is minimal.
What is the Patent Landscape for ATP Detection Reagents in China?
The patent landscape for ATP detection reagents in China is characterized by active research and development, driven by the growing demand for rapid diagnostics and hygiene monitoring solutions. Several entities, including research institutions and commercial companies, are pursuing patent protection for novel formulations, improved detection methods, and specific applications of ATP detection technology.
Key trends in the Chinese patent landscape for ATP detection include:
- Novel Reagent Formulations: Patents focus on improving the stability, sensitivity, and specificity of reagents by introducing new substrates, enzymes, enhancers, or stabilizers.
- Detection Method Improvements: Innovations in assay formats, detection technologies (e.g., integration with microfluidics, advanced optical systems), and data processing are being patented.
- Specific Applications: Patents are also filed for the application of ATP detection in particular fields, such as medical diagnostics (e.g., for specific pathogens), food safety, environmental monitoring, and industrial hygiene.
- Commercial Players: Major domestic and international companies operating in the diagnostics and life sciences sectors are active in filing patents in this area. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., the assignee of CN106146506, is a significant player in China's medical device market, indicating a strategic interest in advancing diagnostic technologies.
Competitive Analysis
While CN106146506 focuses on a specific reagent composition and preparation method, other patents in China may cover:
- Different ATP Detection Mechanisms: Alternative biochemical pathways or physical methods for detecting ATP.
- Broad ATP Detection Kits: Patents that cover a wider range of components or applications not specifically addressed by CN106146506.
- End-User Devices: Patents for the instruments and readers used to quantify the chemiluminescent signal.
- Specific Sample Types or Analytical Targets: Patents tailored to detecting ATP in particular biological matrices or correlating ATP levels with specific clinical conditions.
Companies seeking to enter or expand in the Chinese ATP detection market must conduct thorough freedom-to-operate analyses to avoid infringing existing patents. The granted claims of CN106146506, particularly regarding the inclusion and concentration of the fluorescent enhancer and the specific molar ratios, define its competitive space.
What is the Significance of the Fluorescent Enhancer in the Patent?
The inclusion of a fluorescent enhancer is a critical element of patent CN106146506. In bioluminescent systems like ATP detection, the reaction between luciferase and luciferin produces light. A fluorescent enhancer is a compound that absorbs energy from the excited intermediate in the chemiluminescent reaction and then re-emits it as fluorescence. This process can:
- Amplify the Signal: The fluorescence emission can be more intense or at a different wavelength, potentially increasing the overall light output detected.
- Improve Signal-to-Noise Ratio: By shifting the emission wavelength or enhancing the signal, it can help differentiate the desired signal from background noise.
- Increase Sensitivity: A stronger signal allows for the detection of lower concentrations of ATP, making the assay more sensitive.
The patent specifies that the fluorescent enhancer is a compound with a particular chemical structure and that its concentration and the molar ratios of substrate to enzyme are optimized. This specificity suggests that the inventors have identified a particular class of compounds or a specific compound that provides a synergistic effect when used with the standard luciferase-luciferin system for ATP detection. The claims therefore focus on this defined composition and its preparation.
What are the Potential Commercial Implications?
The commercial implications of patent CN106146506 are tied to its ability to enhance ATP detection performance.
- Improved Diagnostic Accuracy: A more sensitive ATP detection reagent could lead to earlier and more accurate diagnoses of infections or conditions where ATP levels are indicative. This is particularly relevant for point-of-care testing, where rapid and reliable results are paramount.
- Market Differentiation: If the reagent kit offers superior sensitivity or reliability compared to existing products, it can provide Shenzhen Mindray Bio-Medical Electronics Co., Ltd. with a competitive advantage in the Chinese market.
- Licensing Opportunities: The patent could be a basis for licensing agreements, allowing other companies to use the technology in their products in exchange for royalties, provided they operate within the scope of the claims.
- Market Entry Barriers: For competitors, the patent creates a barrier to entry for products that utilize the specific formulation or preparation method described in the claims.
- Cost-Effectiveness: While not explicitly stated in the claims, improvements in sensitivity can sometimes lead to reduced reagent consumption per test or faster testing times, potentially impacting the overall cost-effectiveness of ATP detection.
The commercial success will depend on the actual performance of the reagent in real-world applications, market adoption rates, and the competitive environment of ATP detection products in China.
Key Takeaways
- Patent CN106146506 covers a method for preparing and a reagent kit for detecting adenosine triphosphate (ATP).
- The core innovation involves the use of a specific fluorescent enhancer and optimized molar ratios of substrate to enzyme to improve ATP detection sensitivity.
- The technology is applicable to medical diagnostics, hygiene monitoring, and other fields requiring rapid and accurate assessment of biological activity.
- The Chinese patent landscape for ATP detection is active, with multiple players pursuing innovation and protection.
- The patent's claims define a specific technical space that competitors must navigate.
Frequently Asked Questions
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What is the expiration date of patent CN106146506?
The filing date of CN106146506 is September 13, 2016. Based on standard patent terms in China, the patent is expected to expire 20 years from the filing date, which would be September 13, 2036.
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Does the patent claim the ATP detection instrument itself?
No, the patent CN106146506 explicitly claims the method for preparing an ATP detection reagent and the reagent kit. It does not claim the instrument or apparatus used to read the results of the ATP detection.
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What specific chemical structure does the "fluorescent enhancer" refer to?
The patent document CN106146506 provides a specific chemical structure for the fluorescent enhancer. A thorough review of the patent's detailed description and chemical formulas would be required to ascertain this precise structure.
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Can a company use a standard luciferase-luciferin assay for ATP detection in China without infringing this patent?
A company can generally use a standard luciferase-luciferin assay if it does not incorporate the specific elements claimed in CN106146506, particularly the defined fluorescent enhancer and optimized molar ratios. However, a comprehensive freedom-to-operate analysis considering all relevant patents would be necessary for definitive assurance.
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What are the potential applications beyond medical diagnostics for the technology disclosed in CN106146506?
Beyond medical diagnostics, the technology can be applied to food safety testing (detecting microbial contamination), environmental monitoring (assessing water quality or surface hygiene), and industrial quality control (e.g., in pharmaceutical manufacturing or cosmetics).
Cited Sources
[1] Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2017). Method for preparing reagent for detecting adenosine triphosphate and reagent kit. China Patent CN106146506.
