Handheld point-of-care testing (POCT) flow type gene analysis system

Abstract

The invention relates to a handheld point-of-care testing (POCT) flow type gene analysis system. The system comprises a thermal gradient microreactor, a smart phone wide field fluorescence imaging device, a microfluid driver, an electronic control system, a power supply assembly and a light avoiding shell, wherein the thermal gradient microreactor is used for amplifying a sample, and a fluorescence detection area is formed on the upper surface of the thermal gradient microreactor; the smart phone wide field fluorescence imaging device is used for exciting the sample to generate fluorescent light and recording a fluorescence image; the microfluid driver is used for quantitatively extracting the sample into the thermal gradient microreactor; the electronic control system is respectively connected with the thermal gradient microreactor, the smart phone wide field fluorescence imaging device, the microfluid driver and the power supply assembly; the light avoiding shell comprises a heat insulation bottom plate; the thermal gradient microreactor, the microfluid driver, the power supply assembly and the electronic control system are arranged on the heat insulation bottom plate; the smart phone wide field fluorescence imaging device is arranged right above the thermal gradient microreactor. The handheld POCT flow type gene analysis system is simple in structure, small in volume, and convenient to operate, can be used in the field, is capable of enabling the detection process / results to be directly seen, is capable of realizing high-speed, high-sensitivity, diverse and real-time nucleic acid detection, and belongs to the technical field of in vitro molecular diagnosis.

Description

technical field [0001] The invention belongs to the technical field of in vitro molecular diagnosis, in particular to a hand-held POCT flow gene analysis system. Background technique [0002] POCT (point of care testing) is generally called point-of-care testing. It is a subdivision of in vitro diagnostics (IVD). With its advantages of convenience and speed, it can quickly obtain diagnostic results near patients and has become a rapidly developing industry in recent years. Emerging fields. The POCT currently under development is mainly divided into three generations according to its technical characteristics: the first generation of POCT based on rapid diagnostic test strips (such as blood glucose test strips, early pregnancy test strips, etc.), and the first generation of POCT based on cassette nucleic acid amplification. The second generation of POCT, the third generation of POCT based on the application of smart phones. Compared with the previous two generations of POCT...

AI Technical Summary

Problems solved by technology

However, such POCT gene analysis systems currently under development include systems based on time-domain polymerase chain reaction (PCR) and systems based on isothermal amplification. Due to the inherent characteristics of their respective technologies, both types of technologies have limitations. some restrictive bottlenecks

Time-domain PCR: It is essentially equivalent to the miniaturization of traditional thermal cyclers. Its thermal cycle requires precise and repeated temperature rises and falls, and thermal elements (or structures) have their own thermal inertia. These factors usually lead to a large amount of time and energy consumption. Complicated temperature control, rising cost, bulky thermal design

Isothermal amplification: On the one hand, the amplification process does not require thermal cycling, and the sensitivity, accuracy, and quantification of its detection are extremely dependent on the duration of the amplification process in time. Usually, only the reaction system for specific samples can be established and The corresponding time-sustained scale lacks universality, so there are difficulties in practical operation; on the other hand, it is difficult to reliably detect the amplified product. At present, the amplified product mainly relies on endpoint detection (such as electrophoresis, etc.), although Quantitative detection can be carried out by monitoring the accumulation of signals such as fluorescence or solution turbidity during the amplification process, but the specificity of its detection is sacrificed, because any non-specific or epiphytic products can also accumulate the above detection signals, so Such quantitative tests carry the risk of false positives

As a new microfluidic nucleic acid amplification technology, airspace PCR uses "space exchange time" to allow the sample reaction solution to repeatedly pass through two or three constant temperature zones to achieve the thermal cycle required for PCR, eliminating the need for precise and repeated heating and cooling. It avoids the thermal hysteresis of the thermal system itself, and has significant advantages in terms of thermal cycle speed, system energy consumption, temperature control, and overall size. However, the genetic analysis device based on this technology has not yet reached the stage of POCT application. The main performances are: ( 1) Insufficient integration, still relying on bulky offline equipment and resources, such as: pump source, temperature control system, computer, desktop detector and power supply, etc.; (2) Single function, most of which only have the function of nucleic acid amplification, lacking criticality On-line analytical capabilities include real-time quantitative detection and product identification

Obviously, the third-generation POCT gene analysis instruments that have been developed so far still have some inconveniences and defects, which urgently need to be further developed and improved.

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