Benefiting from the improvement of living standards, the upgrading of medical consumption, the promotion of medical reform and the support of national industrial policies, the current In Vitro Diagnosis (IVD) has received more and more attention due to its huge future development space. Stable growth rates and huge development space continue to attract capital into this segment. As an in vitro diagnostic instrument based on the important hardware of the IVD industry, its iterative upgrade speed is also accelerating, and it continues to put higher demands on its testing speed, accuracy and stability. TDK-Lambda combines its low-noise, high-reliability products with local technical service offerings to provide a total solution for the power subsystems within the core of IVD instruments.
1 Overview:
Clinical diagnosis is an important means to confirm the etiology in modern medicine. It is mainly divided into in vitro diagnosis and in vivo diagnosis. At present, more than 80% of clinical diagnosis of diseases depends on in vitro diagnosis. Generalized in vitro diagnosis refers to products and services that obtain diagnostic information by detecting biological samples (blood, body fluids, tissues, etc.) of the human body outside the human body. The narrow in vitro diagnostic industry mainly refers to in vitro diagnostic related products, including in vitro diagnostic reagents and in vitro diagnostic equipment.
2. Classification of in vitro diagnostic instruments:
The basic principle of in vitro diagnosis is to use the reagent and biological sample to carry out biochemical reaction in vitro. According to the corresponding in vitro diagnostic instrument, the intensity of biochemical reaction between the reagent and the biological sample is determined in vitro, and then the nature and quantity index of the biological sample are inferred, and the index is The normal physiological state interval values ​​are compared to determine the physiological state of the human body. Although different in vitro diagnostic methods have the same basic principles, their specific testing principles have significant differences.
According to different test principles, in vitro diagnosis includes biochemical diagnosis, immunodiagnosis, molecular biological diagnosis, hematological diagnosis, microbial diagnosis, urine diagnosis, blood coagulation diagnosis and the like. The corresponding in vitro diagnostic instruments mainly include biochemical analyzer, chemiluminescence immunoassay analyzer, real-time fluorescence quantitative PCR instrument, blood analyzer, microplate reader, flow cytometer and the like.
In vitro diagnostics can be divided into central laboratory and point-of-area testing (POCT) depending on the application site. Central laboratory applications include hospital laboratory and third-party laboratories (ICL), while immediate testing (POCT) applications include hospital operating rooms, ICU wards, emergency rooms, clinics, nursing homes, and homes. Instant detection differs greatly from central laboratory applications in terms of immediacy and ease of operation and compatibility of reagents with analytical instruments.
At present, biochemical diagnosis, immunodiagnosis and molecular biology diagnosis in the domestic market are the three major areas of clinical in vitro diagnosis.
3. Typical architecture of in vitro diagnostic equipment:
In vitro diagnostic instruments typically have built-in complex detection systems, including sample flow control subsystems, optical detection subsystems, environmental control subsystems, automatic control and signal processing subsystems, power supply subsystems, and user graphical interface (GUI) subsystems. Wait.
Although the overall internal architecture of the instrument is similar, there are some differences in the internal system architecture of different in vitro diagnostic instruments because of the differences in the specific testing principles of various in vitro diagnostic techniques.
The following figure shows the internal system block diagram of a typical biochemical analyzer, including subsystems such as biochemical detection, sample flow control, temperature control, signal processing, power supply, and GUI. The biochemical detection system includes a spectrophotometer and an electrochemical module. The sample flow control system includes sample collection and movement, reagent flow control, sample cup and line cleaning. The temperature control system provides a biochemical reaction environment for simulating human body temperature for samples and reagents. The signal processing system provides multi-channel data analysis processing by the DSP on the motherboard. The power supply system includes an AC/DC filter, an off-line switching power supply (AC-DC), and a DC switching power supply (DC-DC).
The chemiluminescence immunoassay analyzer includes a sample subsystem, a incubation subsystem, a centrifugal cleaning subsystem, an optical detection subsystem, a user interface subsystem, a signal processing subsystem, a power subsystem, and the like.
The real-time fluorescence quantitative PCR instrument includes a basic PCR part consisting of heating wire, temperature acquisition and temperature treatment, and a fluorescence detection part consisting of an excitation light source, a photomultiplier tube, and signal acquisition and processing, and is composed of data acquisition and system analysis software. The upper computer part, the power supply system, etc.
4. Main design considerations and challenges of in vitro diagnostic equipment:
The main design of in vitro diagnostic instruments is currently considered diagnostic speed, accuracy and sensitivity.
The measurement speed of in vitro diagnostic equipment is an important indicator considering the economic benefits of actual use. The temperature control subsystem, signal processing subsystem and sample flow control subsystem have a great influence on the measurement speed. Because the system temperature has a great influence on the reaction rate, it is required that the in vitro diagnostic instrument internal incubation system not only can quickly heat up and cool down, but also has the ability to lock at a specific precise temperature point. In addition, high-speed multi-channel signal processing, software algorithms, etc. are one of the important factors affecting the measurement speed. The rapid movement of the internal sample of the instrument and the rapid transfer and cleaning of the reaction waste liquid also significantly limit the diagnostic speed of the system.
In the in vitro diagnostic test, it is often necessary to keep the biological sample ambient temperature within the body temperature range and meet the high precision within 0.1 °C to ensure that the bioenzyme activity in the cuvette is at its peak. In order to ensure high consistency of measurement results, accurate biological sample and reagent volume control is important. This requires the instrument's internal automatic control system to have precise step and position control, providing accurate level detection, pressure detection and more.
As the technology continues to iteratively upgrade, the collection of in vitro diagnostic test samples is becoming more and more measurable. How to extract effective information from weak biochemical detection signals in complex electromagnetic environment, which puts higher and higher requirements on instrument sensitivity and internal noise level.
5, in vitro diagnostic equipment power subsystem requirements and TDK-Lambda overall power solution:
In order to maximize the measurement speed of the in vitro diagnostic instrument, the temperature control subsystem needs to establish an ambient temperature suitable for biochemical reactions in the shortest time. The traditional constant AC or DC voltage is used to control the temperature control mode of the heating wire. The actual working accuracy and heating speed are difficult to meet the requirements of the continuously improved index.
The internal movement of the instrument and the faster transfer and cleaning of the reaction waste require more powerful motors, vacuum pumps and solenoid valves. The high stability and high precision of the measurement require an internal control system. Accurate step and position control. When the two parts of the circuit are powered by the same power supply, the stability of the switching power supply when providing a large current load is very high.
The high sensitivity of in vitro diagnostic equipment requires that its internal power supply system not only provides a low noise and stable power supply, but also has the ability to filter out external interference.
In order to meet the above requirements for speed, accuracy and sensitivity, the internal power subsystem of the instrument will face many challenges such as low noise, large dynamic load, wide range regulation, high stability and high anti-interference.
In the face of temperature control subsystem heating rate and temperature control accuracy challenges, TDK-Lambda high-power SWS-L series' own PV function can adjust the output voltage in a wide range, greatly improving the temperature control system characteristics. The SWS-L series power supply output voltage can be flexibly adjusted within a wide range of 20%-120% by external analog control. When the temperature control system needs high-speed temperature rise, control the SWS-L series power supply to output 120% of rated voltage. Because the heating wire load characteristics are basically constant, the heating power at this time is 1.44 times higher than the ordinary constant voltage heating power. This can well meet the needs of the rapid temperature rise of the temperature control subsystem. When the temperature is close to the set target, it is often necessary to precisely adjust the step value of the temperature control to gradually approach the set target. When the output voltage of the SWS-L series is adjusted to 20% of the rated value, the theoretical temperature control step value is only 4% of the conventional constant voltage temperature control mode under the same minimum PWM duty cycle. This greatly improves the temperature control resolution and significantly improves the temperature control accuracy, which is beneficial to the temperature control system to lock the test environment temperature at the optimal working point, to maintain the biological enzyme activity at the peak state, and further accelerate the biochemical reaction speed.
TDK-Lambda's new CUS-M series medical power supply, with an efficiency of 94%, has obtained medical safety certification and meets 2*MOPP. The CUS200M and CUS350M series of fanless natural cooling power supplies are widely used in the medical industry to maintain consistent stability and high immunity to interference while providing large dynamic load currents.
The AC filter provided by TDK-Lambda not only makes the whole test instrument system more resistant to interference, but also provides a strong guarantee for the system to meet EMC standards. The ultra-small size on-board DC filter saves board space while providing a low-noise power supply environment for each subsystem inside the instrument, and helps to improve the overall detection sensitivity of the instrument.
The following figure shows the overall solution for the internal power subsystem of an in vitro diagnostic instrument provided by TDK-Lambda.
6, summary
The power supply system in the in vitro diagnostic instrument is the basic platform for the reliable operation of other subsystems. The rapidity, high precision, high sensitivity and other indicators required by the instrument all place high demands on the basic power system.
TDK-Lambda is a professional power supplier with more than 40 years of industry experience, with a factory, R&D center and extensive sales and service network in the local market. In addition to providing a high standard of various switching power supplies, filters and other products, it also provides an overall power system solution. We can use a wide range of product lines combined with years of industry application experience to solve a series of power subsystem design challenges faced by in vitro diagnostic instrument customers, helping them to maintain core competitiveness in the rapidly growing in vitro diagnostic industry.
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