A radon progeny identification system and method for Helicobacter pylori detection

Abstract

The present invention relates to a radon progeny identification system and method for Helicobacter pylori detection. The system at least includes a detection unit, which is used to detect a processed sample card to obtain nuclear pulse data, wherein before the sample card is placed in the detection unit, the radon progeny are prevented from attaching by changing the static voltage of the sample card and / or the radon progeny concentration of the environment. After the sample card is manufactured, the present invention uniformly applies a certain positive static electricity to reduce the adsorption force of the radon progeny. In particular, if the sample card is contaminated by the radon progeny, it can still be identified. The sample card thus treated has the ability to suppress the measurement result from being false positive in an environment with normal radon concentration.

Description

Technical Field

[0001] The present invention relates to the technical field of Helicobacter pylori detection, and in particular to a radon progeny identification system and method for Helicobacter pylori detection. Background Art

[0002] From 1900, when Dorn.FE proved that the radioactivity in the air was caused by a radioactive gas released by the decay of radium, to 1923, when the radioactive gas was officially named radon at the International Chemical Conference, the research on radon and its daughters has been going on for more than a century at home and abroad. Radon, including three natural radioactive isotopes, Rn-222, Rn-220 and Rn-219, are decay products of the three major natural radioactive elements, uranium series, thorium series and actinium series.

[0003] In the prior art, for the detection of Helicobacter pylori, the existing detection method is to collect the patient's exhaled gas through a sample card, and place the sample card in a dedicated Helicobacter pylori tester for testing to obtain data results that can characterize the level of Helicobacter pylori. The commonly used detection method is the carbon 14-urea respiration method, which is based on the Geiger-Mueller counting principle, obtains the discharge and pulse generated by a specific object under ionization, and uses the pulse signal counting as a basis for calculating the level of the specific object. However, although the traditional carbon 14-urea respiration method can relatively accurately identify the corresponding results when the sample card is strongly positive or strongly negative, there are also some problems. For example, when the sample card is weakly positive or weakly negative, it is difficult for the test equipment to distinguish the positive and negative of the sample card whose value is relatively close to the middle position, and there is also a situation where the same sample card has different positive and negative results between two tests. More specifically, there will be a false positive situation, that is, the test result of the subject who does not have the corresponding detected condition is positive even if he does not take a drug that can make him blow out the gas with the detected condition.

[0004] Theoretically, the test result of the sample card that collects its gas should be negative, but the actual measurement result is unexpectedly positive. After research on this scheme, it was found that one of the reasons for the above problem is the presence of a certain amount of radon progeny in the environment. As a natural radioactive element, radon progeny will decay to produce alpha particles and high-energy beta particles, all of which will be detected by the tester. In particular, Helicobacter pylori breath cards are very likely to carry negative static electricity, thereby strongly adsorbing environmental radon progeny. In this case, even if there is no C-14 radionuclide in the sample card, counts will be generated on the instrument. When the count rate exceeds the judgment threshold, the displayed result is positive. Therefore, how to avoid the interference of radon progeny during the detection process, and further, to distinguish the interference data generated by it from the normal detection data or reduce its interference in the data, has become an urgent problem to be solved.

[0005] Chinese patent CN204556539U discloses a device for detecting Helicobacter pylori by using a breath test method, including a central control system and a C-14 carbon dioxide detection terminal. The central control system includes a controller, and the C-14 carbon dioxide detection terminal includes a power supply and a radiation detector, a signal amplification circuit, a single-channel pulse amplitude analysis circuit, a pulse counting circuit, and a processor connected in sequence. The radiation detector, the signal amplification circuit, the single-channel pulse amplitude analysis circuit, the pulse counting circuit, and the processor are all connected to the power supply and powered by the power supply, and the processor is connected to the controller of the central control system. The overall structure of the patent is compact, and the collection and measurement work are all carried out in the C-14 carbon dioxide detection terminal during application. The measurement process is simple, fast, easy to operate, and will not cause pollution to the environment. However, the defect of the patent is that it determines whether the human body is infected with Helicobacter pylori by counting the β particles generated by the decay of C-14. The patent does not take into account that the decay of radon daughters in the air will also produce high-energy β particles, resulting in its count value exceeding the actual count value on the gas collection card, so that some gas collection cards are misjudged as positive, and false positive problems are prone to occur.

[0006] Chinese patent CN108333336A discloses a CO 2 The Helicobacter pylori detector is an integrated detector of the concentration device and the GM tube (Geiger-Muller counter tube). The detector includes a small compressor, a filter, a CO 2 Concentration device and GM tube test space, the compressor pressurizes the subject's breathing gas and sends it to the filter, the filter filters out the liquid water mixed in the breathing gas and sends it to the CO 2 The concentration device carries out CO 2 The concentrated and purified breath enters the GM tube test space for C-14 content testing. The method of using the patented detector to detect Helicobacter pylori is simple and convenient. Compared with the prior art, the patent has the advantages of higher measurement sensitivity, significantly better "signal-to-noise ratio" than the plug-in type, simple structure, easy use, green and environmentally friendly, and no cross-contamination. It is a Helicobacter pylori detector that integrates membrane separation technology and GM method. However, the defects of this patent are: it is more complicated to use and cannot be used for the detection of more samples. Its detection rate is slow, and the statistical fluctuations measured by the Geiger-Muller counting method are large, the background is unstable and affected by the environmental temperature and humidity conditions, and it is very easy to misjudge the positive and negative, resulting in false positives or false negatives. The accuracy of the test needs to be improved urgently.

[0007] The prior art has not yet addressed the issue of radon progeny contaminating sample cards and affecting the positive / negative judgment of Helicobacter pylori. The present invention is intended to provide a radon progeny identification system and method for Helicobacter pylori detection, which prevents radon progeny from attaching to sample cards and identifies false counts generated by radon progeny decay through radon progeny contamination positive / negative judgment rules, thereby accurately eliminating them from normal detection data and significantly reducing false positive sample cards.

[0008] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology. Summary of the invention

[0009] In view of the deficiencies of the prior art, the present invention provides a radon progeny identification system for Helicobacter pylori detection, characterized in that it includes at least a detection unit, and the detection unit is used to detect a processed sample card to obtain nuclear pulse data. Preferably, before the sample card is placed in the detection unit, the radon progeny are prevented from attaching by changing the static voltage of the sample card and / or the radon progeny concentration of the environment. After the sample card is manufactured, the present invention uniformly applies a certain amount of positive static electricity to reduce the "power" of adsorbing radon progeny. The sample card thus processed has the ability to suppress the measurement result as a false positive in an environment with normal radon concentration.

[0010] According to a preferred embodiment, the method of changing the static voltage of the sample card at least includes applying static voltage and removing static electricity. The present invention treats the sample card by applying positive static electricity or by other technical means that can prevent radon daughters from attaching, thereby avoiding negative static electricity on the sample card and solving the problem that the existing Helicobacter pylori detection method is prone to false positives.

[0011] According to a preferred embodiment, the method of changing the radon progeny concentration of the environment at least includes: placing the sample card in a low radon concentration environment, or reducing the radon progeny concentration in the environment where the sample card is located.

[0012] According to a preferred embodiment, the electrostatic voltage is applied to the sample card in the following manner: the sample card is charged with positive static electricity by actively applying positive static electricity on the window film of the sample card. Preferably, the window film is provided with an elimination layer for applying electrostatic voltage, so that the sample card is charged with positive static electricity when the window film is torn off from the sample card. The electrostatic polarity and voltage of the window film of the present invention are both within a preferred range, and the false positive problem of the sample card is effectively prevented at the conventional concentration level of radon progeny. Even if exposed to a radon gas environment, too much radon and radon progeny will not be adsorbed. The present invention prevents the adhesion of radon progeny aerosol with positive static electricity after the window film is torn off from the sample card by setting a window film and applying an antistatic liquid, thereby reducing the generation of false positives. In particular, a protective film can be added outside the window film, which can prevent radon progeny from contaminating the breath card. After the protective film is torn off before the test, the radon progeny are also taken away.

[0013] According to a preferred embodiment, the sample card is made of a conductive material to avoid negative charge accumulation when the window film causes the sample card to carry positive static electricity. The present invention also avoids the accumulation of negative charge on the sample card by manufacturing the sample card (including the window film) as a conductive sample card, thereby avoiding false positives.

[0014] According to a preferred embodiment, the method of removing static electricity at least includes: making the sample card electrically neutral, or making the sample card in an ion wind environment.

[0015] According to a preferred embodiment, the system further includes: a calculation unit for receiving the nuclear pulse data sent by the detection unit and processing and calculating the positive and negative of the sample card. The detection unit determines a number of corresponding threshold counts based on the counting parameters of several signal groups. Preferably, when the counting rate of the determined middle threshold count is greater than the first judgment threshold, and / or when the middle threshold count is greater than the second judgment threshold within a predetermined first time, the calculation unit performs positive and negative judgment on the sample card based on the positive and negative judgment rule of radon daughter contamination. The positive and negative judgment rule of radon daughter contamination established by the present invention can significantly suppress the influence of radon daughters on the detection results. This scheme is not only improved from the physical equipment level of the detection, but also improved from the algorithm aspect. It can significantly identify the false counts generated by the decay of radon daughters, so as to accurately remove them from the normal detection data, effectively ensure the accuracy of the detection results, significantly reduce the occurrence of false positives and positive and negative jumps, and significantly improve the accuracy of the detection results.

[0016] According to a preferred embodiment, several of the signal groups are divided according to several of the thresholds, and the detection unit counts the signals in the signal groups corresponding to the thresholds to obtain the nuclear pulse data. Preferably, the calculation unit determines the positive and negative of the sample card based on the nuclear pulse data, and corrects the positive and negative judgment result of the sample card based on the positive and negative judgment rule of radon daughter contamination. The positive and negative judgment rule of radon daughter contamination is different from the conventional positive and negative judgment rule at least in the judgment threshold and judgment condition. Due to the different concentrations of radon daughters attached to the sample card, the alpha particles and high-energy beta particles generated by the decay of radon daughters will be detected by the detection unit, causing the detection unit to generate the same count as the C-14 radioactive nuclide, thereby misjudging the total count of the sample card. When the misjudged total count exceeds the judgment threshold, the sample card has a false positive.

[0017] According to a preferred embodiment, several signal groups are divided according to a set low threshold, a middle threshold and a high threshold. Preferably, the radon daughter contamination positive and negative judgment rule is: when the count rate of the middle threshold count is greater than the first judgment threshold, the sample card is judged to be contaminated by radon daughters, otherwise the sample card is judged not to be contaminated by radon daughters; when the preset first time is reached, if the middle threshold count is greater than the second judgment threshold, the sample card is judged to be contaminated by radon daughters, otherwise the sample card is judged not to be contaminated by radon daughters. In order to avoid accidental fluctuations, the radon daughter contamination positive and negative judgment rule in the present invention sets the first judgment threshold and the second judgment threshold related to radon daughter contamination, thereby judging whether the sample card is contaminated by radon daughters.

[0018] According to a preferred embodiment, the radon daughter contamination positive / negative judgment rule further comprises: when it is judged that the sample card is contaminated by radon daughters, the positive / negative judgment of the sample card is performed based on the weak β net count of the sample card and the judgment k value.

[0019] According to a preferred embodiment, when the judgment k value of the sample card contaminated by radon daughters is less than the first radon daughter threshold, the sample card contaminated by radon daughters is judged to be negative; when the judgment k value of the sample card contaminated by radon daughters is greater than the second radon daughter threshold, the sample card contaminated by radon daughters is judged to be positive; when the judgment k value of the sample card contaminated by radon daughters is greater than or equal to the first radon daughter threshold and less than or equal to the second radon daughter threshold, the positive and negative nature of the sample card contaminated by radon daughters is judged by lengthening the measurement time or combining the net count C. The present invention judges the positive and negative nature of the sample card contaminated by radon daughters by lengthening the measurement time or combining the net count C. The above scheme can remove the false positive sample card contaminated by radon daughters from the sample card of normal detection, thereby ensuring the accuracy of the final detection result and preventing the generation of false positives.

[0020] The present invention relates to a radon progeny identification method for Helicobacter pylori detection, the method comprising: detecting a processed sample card to obtain nuclear pulse data. Preferably, before the sample card is placed in the detection unit, the radon progeny are prevented from attaching by changing the static voltage of the sample card and / or the radon progeny concentration of the environment in which the sample card is located.

[0021] According to a preferred embodiment, the method of changing the static voltage of the sample card at least includes applying static voltage and removing static electricity, and adding a window protective film to the breath card. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a structural schematic diagram of a preferred embodiment of a radon progeny identification system for Helicobacter pylori detection of the present invention;

[0023] Figure 2 It is a false positive sample card decay curve diagram of a preferred embodiment of a radon daughter identification system for Helicobacter pylori detection of the present invention;

[0024] Figure 3 It is a schematic diagram of the axial structure of a detection unit of a radon daughter identification system for Helicobacter pylori detection of the present invention;

[0025] Figure 4 It is a schematic diagram of the main structure of a detection unit of a radon daughter identification system for Helicobacter pylori detection according to the present invention;

[0026] Figure 5 It is a simplified module structure schematic diagram of a preferred embodiment of a radon progeny identification system for Helicobacter pylori detection of the present invention;

[0027] Figure 6 It is a schematic diagram of the engineering process of a preferred embodiment of the present invention for detecting Helicobacter pylori using a radon progeny identification system for detecting Helicobacter pylori;

[0028] Figure 7 It is a schematic diagram of the engineering process of a preferred embodiment of the present invention in which a radon progeny identification system for Helicobacter pylori detection adopts the MP-HPI measurement method to perform Helicobacter pylori detection.

[0029] Reference numerals list

[0030] 101: first detection component; 102: second detection component; 103: sample slot; 104: photomultiplier tube; 105: scintillator; 106: housing; 107: housing 2: control module; 201: touch screen; 202: indicator light; 203: printer; 204: buzzer; 205: limit switch; 3: shielding unit. DETAILED DESCRIPTION

[0031] The following is a detailed description with reference to the accompanying drawings.

[0032] First, some nouns involved in the present invention are explained.

[0033] NC mode: Net counting measurement mode.

[0034] EUM mode: equal precision measurement mode.

[0035] MP-HPI algorithm measurement mode: Multi-parameter Helicobacter pylori index algorithm measurement mode.

[0036] In the prior art, for the detection of Helicobacter pylori, the existing detection method is to collect the patient's exhaled gas through a sample card, and place the sample card in a dedicated Helicobacter pylori tester for testing to obtain data results that can characterize the level of Helicobacter pylori. The commonly used detection method is the carbon 14-urea respiration method, which is based on the Geiger-Mueller counting principle, obtains the discharge and pulse generated by a specific object under ionization, and uses the pulse signal counting as a basis for calculating the level of the specific object. However, although the traditional carbon 14-urea respiration method can relatively accurately identify the corresponding results when the sample card is strongly positive or strongly negative, there are also some problems. For example, when the sample card is weakly positive or weakly negative, it is difficult for the test equipment to distinguish the positive and negative of the sample card whose value is relatively close to the middle position, and there is also a situation where the same sample card has different positive and negative results between two tests. More specifically, there will be a false positive situation, that is, the test result of the subject who does not have the corresponding detected condition is positive even if he does not take a drug that can make him blow out the gas with the detected condition. Theoretically, the test result of the sample card that collects the gas should be negative, but the actual measurement result is unexpectedly positive. After research on this scheme, it was found that one of the reasons for the above problem is the presence of a certain amount of radon progeny in the environment. As a natural radioactive element, radon progeny will decay to produce alpha particles and high-energy beta particles, all of which will be detected by the tester. In this case, even if there is no C-14 radionuclide in the sample card, the instrument will generate counts. When the count rate exceeds the judgment threshold, the displayed result is positive. Therefore, how to avoid the interference of radon progeny during the detection process, and further, to distinguish the interference data generated by it from the normal detection data or reduce its interference in the data, has become an urgent problem to be solved in the prior art.

[0037] The present invention proposes that natural radioactive radon daughters are the root cause of false positive results of instrument measurement, and since negative static electricity is coupled with radon daughters, if negative charges are accumulated on the sample card, the probability of false positives will be greatly increased. Since the sample card itself is not conductive, negative static electricity is easily generated in the manufacturing and blowing of the sample card, and coupling with radon daughters can easily cause false positive problems.

[0038] The present invention observes the detection process of the Helicobacter pylori tester in the prior art. After the false positive count occurs, the fluctuation range obviously exceeds the background fluctuation level, and the count decays over time and returns to the background level in 2 to 3 hours. Combined with the random effect characteristics of the false positive situation and the high counting rate in the closed indoor space, the present invention proposes that natural short-lived radionuclides (natural radon and its daughters) cause the occurrence of false positive counts.

[0039] Based on the above defects, the prior art has not yet raised the issue of radon progeny contaminating sample cards and affecting the positive and negative judgment of Helicobacter pylori. The present invention hopes to propose a radon progeny identification system and method for Helicobacter pylori detection, by treating the sample card to prevent radon progeny from attaching, and identifying the false counts generated by radon progeny decay through radon progeny contamination positive and negative judgment rules, thereby accurately eliminating interference data from normal detection data and significantly reducing the occurrence of false positive sample cards.

[0040] Example 1

[0041] The present invention provides a radon daughter identification system for Helicobacter pylori detection. The system at least includes a detection unit, which is used to detect a processed sample card to obtain nuclear pulse data. Preferably, the sample card is processed in a manner that enables the sample card to prevent radon daughter attachment. Preferably, before the sample card is placed in the detection unit, the radon daughter attachment is prevented by changing the static voltage of the sample card and / or the radon daughter concentration of the environment in which it is located. In order to avoid false positives, the present invention uniformly applies a certain positive static electricity after the sample card is manufactured, thereby reducing the "power" of adsorbing radon daughters. The sample card thus processed has the ability to suppress the measurement result from being false positive in an environment with a normal radon concentration. It should be noted that in addition to applying positive static electricity to prevent radon daughter attachment, it is also possible to reduce the false positive problem of the sample card used for Helicobacter pylori detection by establishing an environment with a low radon concentration.

[0042] Preferably, the method of changing the static voltage of the sample card at least includes applying static voltage and removing static electricity. Preferably, the method of changing the radon progeny concentration of the environment at least includes: placing the sample card in a low radon concentration environment, or reducing the radon progeny concentration in the environment where the sample card is located. The above-mentioned low radon concentration environment refers to an environment where the radon progeny concentration is close to zero or less than 100 Bq / m3 An environment with a high radon progeny concentration. Preferably, the method of removing static electricity at least includes: making the sample card electrically neutral, or making the sample card in an ion wind environment. The present invention processes the sample card, and the processing method includes applying positive static electricity or placing it in a low radon concentration environment or removing static electricity through an ion blower to process the sample card and its environment by technical means that can prevent radon progeny from attaching, thereby resisting radon progeny attachment and reducing the false positive problem of Helicobacter pylori detection. The formation of the above-mentioned low radon concentration environment, or reducing the radon progeny concentration includes: filling the environment with an inert gas such as nitrogen to discharge radon progeny. In addition, since the sample card is very easy to attach negative static electricity during transportation after manufacture, the sample card is also prone to false positive problems in air with normal radon concentration. The present invention processes the sample card by applying positive static electricity or by other technical means that can prevent radon progeny from attaching, so as to avoid the sample card from being attached with negative static electricity, and solves the problem that the existing Helicobacter pylori detection method is prone to false positives.

[0043] like Figure 2 The false positive sample card decay curve shown in the figure shows the change of the count rate of the gas collection card for continuous measurement of adsorbed radon daughters with the count C of the detection unit measurement cycle (250s). As the gamma energy peak of the radon daughter related to the false positive sample card decreases, the count rate of the false positive sample card returns to the background level.

[0044] Existing sample cards are prone to negative static electricity during the manufacturing process. If a sample card with negative static electricity is exposed to air with normal radon concentration, it will adsorb more radon progeny, causing a typical false positive phenomenon. If the window film of the sample card has negative static electricity, its negative static electricity has a stronger ability to adsorb radon progeny. In particular, the ordinary film on the existing sample card is easy to cause the sample card to carry negative static electricity after the ordinary film is torn off the sample card. When the sample card (or window film) has negative static electricity and is placed in a radon environment, the negative static electrode is easy to adsorb radon progeny and produce a strong false positive.

[0045] According to a preferred embodiment, the sample cards are processed as follows: positive static electricity is applied to the sample cards in at least one step between the time when the sample cards are manufactured and the time when the sample cards are unpacked for collecting the breath of the test subject and placed in the detection unit. The addition of positive static electricity effectively eliminates the attachment of radon daughter aerosols with positive static electricity, thereby reducing the generation of false positives.

[0046] According to a preferred embodiment, positive static electricity is applied to the sample card in the following manner: the sample card is charged with positive static electricity by actively applying positive static electricity on the window membrane of the sample card. The window membrane of the sample card adsorbs radionuclides in the air, which results in a positive test result. Preferably, positive static electricity is applied to the sample card in the following manner: the sample card is charged with positive static electricity with a deterministic method by actively applying positive static electricity on the window membrane of the sample card. The above certainty refers to the ability to actively apply positive static electricity to the sample card with a high probability. After the sample card is manufactured, it is very easy to carry negative static electricity due to the subsequent transportation and use process. Therefore, how to actively apply positive static electricity to the sample card with a high probability in a low-cost manner is a very important technical means.

[0047] According to a preferred embodiment, an elimination layer for applying static voltage is provided on the window film. The elimination layer refers to a component or fluid such as a coating or a physical conductive layer that can eliminate negative static electricity. In the present invention, preferably, the elimination layer can be an antistatic liquid. Preferably, the window film is coated with an antistatic liquid so that the sample card is charged with positive static electricity when the window film is torn off from the sample card. Preferably, the window film can be a single or double hole film. Preferably, the window film can be made of materials such as synthetic paper, milky white PE or coated paper. Preferably, milky white PE. Preferably, the window film can be surface treated. The above surface treatment is, for example, oiling the front side, oiling the back side, oiling both sides or not oiling. The surface treatment is preferably oiling the front side or not oiling. The electrostatic polarity and voltage of the window film after the above treatment are both within a preferred range, and the false positive problem of the sample card is effectively prevented at the conventional concentration level of radon progeny. Even if exposed to a radon gas environment, too many radon progeny will not be adsorbed. Preferably, when the window film is torn off from the sample card, a relatively strong positive static electricity of 4 to 16 kV can be applied to the sample card. The present invention prevents the adhesion of radon daughter aerosol with positive static electricity after the window film is torn off from the sample card by means of the provided window film and the coated antistatic liquid, thereby reducing the generation of false positives.

[0048] According to a preferred embodiment, the sample card is made of a conductive material to avoid negative charge accumulation when the window film makes the sample card positively charged with static electricity. The present invention also avoids the accumulation of negative charge on the sample card by manufacturing the sample card (including the window film) as a conductive sample card, thereby avoiding false positives.

[0049] The present invention also relates to a radon daughter identification method for Helicobacter pylori detection, the method comprising: detecting a processed sample card to obtain nuclear pulse data. Preferably, the sample card is processed in the following manner: applying positive static electricity to the sample card in at least one link between the sample card being manufactured and the sample card being unpacked for collecting the breath of the test subject and being placed in a detection unit.

[0050] According to a preferred embodiment, the method further comprises: after the manufacture of the plurality of sample cards, processing the plurality of sample cards to uniformly apply positive static electricity, and additionally affixing a layer of protective film.

[0051] Natural radioactive radon progeny are the root cause of false positive instrument measurement results. The decay of radon progeny produces alpha particles and high-energy beta particles, which will be detected by the detection unit or other Helicobacter pylori detection instruments. Even if there is no C-14 radionuclide in the sample card, counts will be generated on the detection unit or other Helicobacter pylori detection instruments. When the count rate exceeds the judgment threshold, the displayed result is positive, resulting in a false positive. Negative static electricity is coupled with radon progeny, which greatly increases the probability of false positives. Even if the radon concentration meets the relevant standards (i.e., less than 100Bq / m 3 ) environment, sample cards with negative static electricity of several hundred or even tens of volts will also actively adsorb radon progeny, thus leading to false positives. The reason for the above phenomenon is that positively charged bound or unbound radon progeny in the air are easily adsorbed by the surface of the sample card with negative static electricity. The present invention applies positive static electricity to the sample card or uses other technical means that can prevent radon progeny from adhering to the sample card, so that the sample card obtained thereby has a strong anti-false positive ability. Even after the sample card has been packaged, transported, unpacked and exhaled, it still has a certain amount of positive static electricity, thereby preventing the occurrence of false positive sample cards.

[0052] Example 2

[0053] This embodiment is a further improvement on Embodiment 1, and the repeated contents will not be repeated here.

[0054] On the basis of the above-mentioned measures for processing the sample card, the present invention also uses a measurement method with amplitude discrimination capability to effectively discriminate radon progeny based on the characteristic that the alpha particles and high-energy beta energy released by radon progeny are significantly higher than the C-14 beta energy, thereby further enhancing and amplifying the effect of preventing false positives of radon progeny.

[0055] According to a preferred embodiment, the system further comprises: a calculation unit for receiving the nuclear pulse data sent by the detection unit and processing and calculating the positive and negative of the sample card. Preferably, the detection unit determines several corresponding threshold counts based on the counting parameters of several signal groups. Preferably, when the counting rate of the determined middle threshold count is greater than the first judgment threshold, and / or when the middle threshold count is greater than the second judgment threshold within a predetermined first time, the calculation unit judges the positive and negative of the sample card based on the radon daughter contamination positive and negative judgment rule. The judgment principle is that the middle threshold of the sample card is stable under normal circumstances, and only when the sample card is contaminated by radon daughters, the threshold will rise significantly. Therefore, the present invention compares the middle threshold count with the second judgment threshold as the basis for determining whether the sample card is contaminated by radon daughters. Preferably, several signal groups are divided according to the set low threshold, middle threshold and high threshold. That is, several signal groups are divided according to energy signal partitions. Preferably, only the signals in the corresponding signal group are counted under each threshold. The radon progeny pollution positive and negative judgment rule established in the present invention can significantly suppress the influence of radon progeny on the detection results. This scheme has been improved not only from the physical equipment level of detection, but also from the algorithm level. It can significantly identify the false counts caused by the decay of radon progeny, thereby accurately eliminating them from normal detection data, and can effectively ensure the accuracy of the detection results, significantly reduce the occurrence of false positives and positive and negative jumps, and significantly improve the accuracy of the detection results.

[0056] Preferably, the several signal groups include at least a first signal group, a second signal group and a third signal group. Preferably, the first signal group includes at least a weak β signal, a strong β signal, a γ signal and an α signal. Preferably, the first signal group is used for the case where the amplitude of the signal detected by the detection unit is greater than a low threshold. Preferably, the second signal group includes at least a strong β signal, a γ signal and an α signal. Preferably, the second signal group is used for the case where the amplitude of the signal detected by the detection unit is greater than a medium threshold. Preferably, the third signal group includes at least a γ signal and an α signal. Preferably, the third signal group is used for the case where the amplitude of the signal detected by the detection unit is greater than a high threshold. Specifically, signals with energy greater than the low threshold include all valid signals: weak β, strong β, α and γ signals; signals with energy greater than the medium threshold: strong β, α and part of the y signal; signals with energy greater than the high threshold: part of the γ signal.

[0057] According to a preferred embodiment, several signal groups are set according to several thresholds. Preferably, the several thresholds include at least a low threshold, a middle threshold and a high threshold. Preferably, the beta rays of C-14 cause a weak beta signal, and the count of the weak beta signal is equal to the total count of the low threshold minus the total count of the middle threshold, and the high threshold count is temporarily idle. The formula is:

[0058] Weak Beta 净计数 =L 低阈值总计数 -M中阈值总计数 -BCnt 本底

[0059] Among them, weak β 净计数 is the net count of weak β signals; L 低阈值总计数 is the total count of the low threshold; M 中阈值总计数 BCnt is the total count of the middle threshold; 本底 As the background.

[0060] According to a preferred embodiment, the detection unit counts the signals in the signal group corresponding to the threshold values ​​to obtain nuclear pulse data. Preferably, the calculation unit determines the positive and negative of the sample card based on the nuclear pulse data, and corrects the positive and negative judgment result of the sample card based on the positive and negative judgment rule of radon progeny contamination. Preferably, the positive and negative judgment rule of radon progeny contamination is different from the conventional positive and negative judgment rule at least in the judgment threshold and judgment condition. Due to the different concentrations of radon progeny attached to the sample card, the alpha particles and high-energy beta particles generated by the decay of radon progeny will be detected by the detection unit, causing the detection unit to generate the same count as the C-14 radioactive nuclide, thereby misjudging the total count of the sample card. When the misjudged total count exceeds the judgment threshold, the sample card has a false positive.

[0061] Preferably, the radon daughter contamination positive and negative judgment rule is: based on the count rate of the middle threshold count and / or the middle threshold count within a predetermined first time, the sample card is judged to be contaminated by radon daughters. Preferably, the count rate of the middle threshold count refers to the middle threshold count cps. The above cps refers to counts per second, that is, counts per second, which is a unit of radioactivity. The middle threshold count cps refers to the degree of change in the carbon isotope ratio in the exhaled gas measured by the detection unit during the breath detection process. In this embodiment, the Helicobacter pylori infection of the subject is determined by using C-14 labeling. The radioactivity of C-14 in the exhaled gas reflects the Helicobacter pylori infection. The middle threshold 250s count of the normal sample card will not exceed 130, that is, the middle threshold count cps will not exceed 0.52 after stabilization. The above middle threshold count cps stability means that within a certain period of time (for example, 80s), the change in the middle threshold count cps is small, indicating that the carbon isotope ratio in the exhaled gas has reached an equilibrium state. To avoid accidental fluctuations, the radon daughter contamination positive and negative judgment rule in the present invention sets the first judgment threshold of radon daughter contamination to 0.64. Preferably, when the count rate of the middle threshold count is greater than the first judgment threshold, the sample card is judged to be contaminated by radon daughters. Preferably, when the count rate of the middle threshold count is less than or equal to the first judgment threshold, the sample card is judged to be not contaminated by radon daughters. The above-mentioned first time refers to the preset middle threshold count time. The first time can be flexibly adjusted. In this embodiment, the first time is set to 250s and the second threshold is set to 130. Preferably, in the process of detecting the sample card, when the preset first time is reached, if the middle threshold count is greater than the second judgment threshold, the sample card is judged to be contaminated by radon daughters. Preferably, when the preset first time is reached, if the middle threshold count is less than or equal to the second judgment threshold, the sample card is judged to be not contaminated by radon daughters.

[0062] Preferably, the positive and negative judgment rule of radon daughter contamination is also: when it is judged that the sample card is contaminated by radon daughters, the positive and negative of the sample card is judged based on the weak β net count of the sample card and the judgment k value. Preferably, the calculation formula for judging the k value is:

[0063] k=(L-BCnt) / M

[0064] Preferably, the calculation formula of weak beta net count is:

[0065] C=L-BCnt-M

[0066] Among them, k represents the judgment k value; C represents the weak beta net count; BCnt represents the 250s weak beta background count; L represents the low threshold total count; M represents the medium threshold count. Under normal circumstances, the M count rate is relatively stable, and it increases abnormally after being contaminated by radon daughters.

[0067] Integrating the above calculation formulas, we can get:

[0068] C=(k-1)×M

[0069] The middle threshold count M of the normal positive sample card is about 100, that is, when the net count C of the normal positive sample card is 40, 50 and 60, the corresponding judgment k value should be 1.4, 1.5 and 1.6. However, since the sample card that has reached the preset first time and whose middle threshold count is greater than the second judgment threshold has been contaminated by radon progeny. The judgment k value of the sample card contaminated by radon progeny will increase abnormally. The judgment k value on the actual blank card is distributed near 1, that is, the net count C of the actual blank card is equal to zero. The judgment k value of the normal positive sample card is greater than 1.6. Since the judgment k value of the false positive sample card will increase abnormally, the judgment k value of the positive and negative judgment of the sample card also needs to be adjusted accordingly.

[0070] Based on the judgment k value of the false positive sample card, preferably, when the judgment k value of the sample card obtained is greater than or equal to the first radon daughter threshold and less than or equal to the second radon daughter threshold, the positive and negative nature of the sample card contaminated by radon daughters is judged by lengthening the measurement time or combining the net count C. Preferably, the above-mentioned first radon daughter threshold can be set to 1.4. Preferably, the above-mentioned second radon daughter threshold can be set to 1.8. Preferably, when the judgment k value of the sample card contaminated by radon daughters obtained is less than 1.4, the sample card contaminated by radon daughters is judged to be negative. Preferably, when the judgment k value of the sample card contaminated by radon daughters obtained is greater than 1.8, the sample card contaminated by radon daughters is judged to be positive. When the judgment k value of the sample card contaminated by radon daughters is greater than 1.8, the sample card is a true strong positive sample card, and its net count C and judgment k value are both large, so it is judged to be positive. Preferably, when the judgment k value of the sample card contaminated by radon daughters obtained is greater than or equal to 1.4 and less than or equal to 1.8, the sample card contaminated by radon daughters is judged to be a weak positive sample card. The weak positive sample card, that is, its positive and negative properties are disturbed by the contamination of radon daughters, and its positive and negative properties cannot be accurately judged. In this regard, the positive and negative properties of the sample card contaminated by radon daughters are judged by lengthening the measurement time or combining the net count C. Through the above scheme, the false positive sample card contaminated by radon daughters can be removed from the sample card of normal detection, thereby ensuring the accuracy of the final test result and preventing the generation of false positives. In particular, for the weak positive card contaminated by radon daughters and having a low C-14 content, when the above methods are all unable to accurately determine the quality, eliminate the negative static electricity of the sample card (or apply positive static electricity), and place it in a low radon environment for 3 hours before measuring it again. After 3 hours, ensure that the radon daughters are almost completely decayed, and the measurement result will not be affected.

[0071] Example 3

[0072] This embodiment is a further improvement on the above-mentioned embodiment, and the repeated contents will not be repeated here.

[0073] According to a preferred embodiment, Figure 1 and Figure 5 The detection unit shown includes a first detection component 101 and a second detection component 102. The first detection component 101 and the second detection component 102 are arranged in a mirror image. Preferably, the first detection component 101, the second detection component 102 and the computing unit are electrically connected and / or communicatively connected to each other. Further, the system also includes a housing 106 for protecting and accommodating the first detection component 101, the second detection component 102 and the computing unit. Preferably, the detection unit can be composed of the first detection component 101 and the second detection component 102. Preferably, the first detection component 101 and the second detection component 102 are respectively composed of a photomultiplier tube 104 with high stability coupled with a high-performance plastic scintillator 105. The above-mentioned photomultiplier tube 104 refers to a PMT photomultiplier tube. The first detection component 101 and the second detection component 102 are arranged in pairs, and have the advantages of high detection efficiency and fast response. Preferably, the first detection component 101 and the second detection component 102 can also be other detectors with energy resolution capabilities, such as NaI detectors and semiconductor detectors such as PIPS, Si-pin, and Si-PM. Preferably, the housing 107 of the detection unit is fully enclosed by aluminum alloy, which is beneficial for the detector to resist electromagnetic interference and improve the stability of the output signal of the detector.

[0074] According to a preferred embodiment, Figure 1 , Figure 3 and Figure 4 As shown, a sample slot 103 for placing a sample card is provided between the first detection assembly 101 and the second detection assembly 102. Alternatively, the first detection assembly 101 and the second detection assembly 102 are arranged symmetrically with the sample slot 103 as an axis. Preferably, the first detection assembly 101, the second detection assembly 102 and the sample slot 103 are arranged in the casing 106. The sample slot 103 serves as a breathing card slideway, and the first detection assembly 101 and the second detection assembly 102 are placed on both sides of the breathing card slideway. Preferably, the first detection assembly 101 and the second detection assembly 102 are electrically connected or communicated with the control module 2. The control module 2 is integrated with a processor. Preferably, the processor can determine the positive and negative properties of the sample to be tested according to a preset algorithm to the data of the sample card collected from the first detection assembly 101 and the second detection assembly 102. Preferably, the control module 2 can also be communicated to a touch screen 201, an indicator light 202, a printer 203, a buzzer 204 and a limit switch 205.

[0075] According to a preferred embodiment, in the present invention, the calculation unit can detect whether the sample to be tested contains Helicobacter pylori through at least three measurement modes. Specifically, the measurement modes used by the calculation unit include: 1. NC mode (net count measurement mode): judging the positive and negative nature of the sample to be tested by the net count size of the sample card; 2. EUM mode (equal precision measurement mode): judging the positive and negative nature of the sample to be tested by setting the precision control limit and comparing the measurement time; 3. MP-HPI algorithm measurement mode (multi-parameter Helicobacter pylori index algorithm measurement mode): judging the positive and negative nature of the sample to be tested based on the multi-parameter Helicobacter pylori index algorithm.

[0076] The calculation unit of the present invention processes the signal, realizes various measurement modes such as timing measurement and equal-precision measurement, establishes a multi-parameter Helicobacter pylori index (MP-HPI) algorithm and measurement mode, and realizes accurate and reliable detection of card-type samples.

[0077] According to a preferred embodiment, the system of the present invention also includes a shielding unit 3 for electromagnetic shielding and radiation shielding to ensure the detection performance and background stability of the system. In order to reduce the interference of cosmic rays and external radiation on the system background and reduce background fluctuations, the present invention studies the changes in background counting rate and stability by changing the thickness of lead used for radiation shielding. On the basis of the existing shielding device of the present invention (30mm thickness lead shielding), 20kg of lead sand is added. Even if the absolute value of the background can be further reduced, the relative standard deviation (statistical fluctuation) of the background has almost no change. Therefore, the existing shielding of the device can meet the requirements, and it is not meaningful to add additional shielding. The shielding thickness of the current prototype used in the present invention (no need to increase the lead shielding thickness) can control the average value of the background to an acceptable level on the basis of ensuring the absolute value of the background, and the fluctuation range is also in a reasonable range.

[0078] The Helicobacter pylori detection device / system provided by the present invention can easily change samples, and is provided with a light chamber structure and a principle prototype structure that meet strict light-proof conditions. The system software of the present invention integrates measurement control, data transmission, TDCR algorithm implementation, and judgment of whether the final result of Helicobacter pylori is positive.

[0079] Example 4

[0080] This embodiment is a further improvement on the above-mentioned embodiment, and the repeated contents will not be repeated here.

[0081] According to a preferred embodiment, this embodiment provides a method for detecting Helicobacter pylori, which may include:

[0082] The sample to be tested is detected to obtain the sample card measurement time DT that reaches the control accuracy and the critical standard card measurement time BT that reaches the control accuracy.

[0083] The positive index is obtained according to the definition formula of the positive index.

[0084] The obtained positive index is compared with the threshold value to determine the positive or negative nature of the sample to be tested.

[0085] Alternatively, the Helicobacter pylori detection method provided in this embodiment may also be:

[0086] The positive or negative nature of the sample to be tested is determined by the net count size of the sample card;

[0087] Or set precision control limits and compare measurement time to determine the positive or negative nature of the sample to be tested;

[0088] Or determine the positive or negative nature of the sample based on a multi-parameter Helicobacter pylori index algorithm.

[0089] Specifically, the NC mode is to judge the positive or negative of the sample to be tested by the net count size of the sample card. The EUM mode is to set the accuracy control limit and compare the measurement time to judge the positive or negative of the sample to be tested. The MP-HPI algorithm measurement mode is used to judge the positive or negative of the sample to be tested based on the multi-parameter Helicobacter pylori index algorithm.

[0090] According to a preferred embodiment, the method steps for determining the positive and negative nature of the sample to be tested based on the multi-parameter Helicobacter pylori index algorithm include obtaining the positive index based on the definition formula of the positive index, wherein the definition formula of the positive index is:

[0091] HPI=DT×(1+U rel1 ) / [BT×(1+U rel2 )];

[0092] Wherein, HPI represents the positive index of Helicobacter pylori; DT represents the sample card measurement time that reaches the control accuracy; BT represents the critical standard card measurement time that reaches the control accuracy; U rel1 represents the expanded uncertainty of DT, with expansion factor k = 2 or 3; U rel2 Represents the expanded uncertainty of BT, with the expansion factor k=2 or 3.

[0093] The two expanded uncertainties in the above algorithm formula represent the relative standard deviation (standard deviation / mean) of the measurement time of the exhalation card and the blank card, respectively, which is the standard uncertainty. When the expansion factor is 2, the confidence level of the positive respiratory card detected is 95%; when the expansion factor is 3, the confidence level of the positive respiratory card detected is 99%. The expanded uncertainty and expansion factor introduced by the algorithm formula are only used to represent and evaluate the fluctuation range of the measurement results, and are not used in the actual measurement calculation of the present embodiment.

[0094] The relative standard deviation is calculated after multiple measurements of the system. The relative standard deviation of the blank card is relatively stable, but the relative standard deviation of the breath cards with different C-14 contents is slightly different. When analyzing the data of specific continuous multiple measurements, it is calculated that the expansion factor of the present invention can be 2 and 3 for analysis respectively.

[0095] According to a preferred embodiment, the simplified calculation formula of the positive index is:

[0096] HPI=DT / BT

[0097] At the same precision (target count), the amount of C-14 content determines the length of DT, which to a certain extent avoids the statistical fluctuation problem caused by timed measurement (250s).

[0098] According to a preferred embodiment, after obtaining the positive index, the positive or negative nature of the sample to be tested can be determined according to the following method:

[0099] When the positive index is less than or equal to the first threshold, the test result is positive.

[0100] When the positive index is greater than the second threshold, the test result is negative.

[0101] When the positive index is between the first threshold and the second threshold, the test result is suspected;

[0102] Among them, when the test result is suspicious, the positive or negative nature of the sample to be tested is determined at least based on the accuracy improvement iterative algorithm.

[0103] According to a preferred embodiment, the first threshold is set to 0.75 in the present invention. The second threshold is set to 0.9. Specifically, when the positive index is less than or equal to 0.75, the test result is positive. When the positive index is greater than 0.9, the test result is negative. Alternatively, when the positive index is between the second threshold and the third threshold, the test result is negative. In particular, the third threshold can be 1.1. When the positive index is between 0.75 and 0.9, the test result is suspected.

[0104] According to a preferred implementation, the Helicobacter pylori detection method provided in this embodiment can also be: setting the maximum measurement time or accuracy limit to terminate the accuracy improvement iterative algorithm, and the iteration termination and positive and negative judgment are functions of multiple parameters, and the formula is:

[0105] HPI(L~H)=f(D, T, B, U);

[0106] Where D is the accuracy limit; T is the maximum time; B is the background; and U is the expanded uncertainty of the instrument's measurement results for the critical standard limit sample.

[0107] For example, the net count measurement period is 250s, and the equal-precision target count is 300.

[0108] If the current sample card is judged as suspected, the target count will be incremented by 10. When the target count reaches 310, the HPI value will continue to be calculated and the positive or negative will be judged until it is judged as negative or positive. If the sample measurement result is still suspected after the above step calculation, the iterative measurement will continue with 10 steps.

[0109] In particular, the higher the C-14 content in the sample card, the faster the target count D is reached, and the shorter the detection time. Similarly, a detection time limit (such as 250s) is set for obviously negative cards, and it is not necessary to accumulate the target count before making a judgment. Specifically, when the detection time reaches 250s, if the difference between the cumulative count of the sample card and the background blank card is less than 40, the sample card can be directly judged as negative.

[0110] The MP-HPI algorithm measurement mode optimizes the judgment accuracy and judgment time, and solves the problem of accurate judgment of the positive and negative nature of sample cards under various environmental conditions. Preferably, when the test result is suspected, the weak positive card between the positive and negative coefficient thresholds is set to the longest measurement time (such as 600s). After the cumulative measurement time reaches 600s, the net count C of the sample card for 600s is calculated (C can also be further converted to 250s). The net count judgment method is introduced. If the weak net count is greater than the threshold (such as the threshold of 250s is 50), it is judged as positive, otherwise it is judged as negative.

[0111] The multi-parameter Helicobacter pylori index algorithm adopted in the present invention has the following advantages compared with the traditional net count measurement method and the equal-precision measurement method: ① The test results are more accurate and reliable, which significantly reduces the problem of suspected case test results jumping back and forth between negative and positive, and improves the ability to distinguish suspected cases; ② Improves the rapid screening and detection capabilities of positive cases. In essence, the higher the count rate of the sample, the shorter the time to reach the target count and the smaller the HPI value. Therefore, the higher the C-14 content in the case, the faster the detection speed.

[0112] The MP-HPI measurement method adopted by the present invention is optimized and improved by the equal precision algorithm, and is tailored according to the particularity of the Helicobacter pylori measurement field, and can adaptively end the measurement in advance or automatically increase the measurement time to improve the measurement accuracy. At the same time, the present invention also combines the equal precision algorithm and the net counting algorithm (total count minus background equals net count) two methods, fully considering the measurement countermeasures of various sample cards, and has corresponding measurement measures for sample cards with different C-14 contents, and can also ensure the measurement accuracy while ensuring the measurement accuracy.

[0113] According to a preferred embodiment, the method of judging the positive or negative of the sample to be tested by the net count size of the sample card may include: the net count is equal to the total count of the dual detectors minus the coincidence count, and then minus the instrument self-test background. Specifically, it can be expressed as:

[0114] C = AMB;

[0115] Where C is the net count, A is the total count of the dual detectors, B is the background, and M is the coincidence count.

[0116] According to a preferred embodiment, after the net count is obtained, the positive or negative determination can be performed according to the following judgment method:

[0117] When the net count is less than the lower threshold, the sample card is judged to be negative.

[0118] When the net count is greater than the upper threshold, the sample card is judged to be positive.

[0119] When the net count is between the upper and lower thresholds, the sample card is judged as a suspected case.

[0120] According to a preferred embodiment, the default measurement duration of the net count measurement mode may be 250s, and the duration may be set within the range of 10s to 9999s. Further, in order to facilitate verification of the measurement results, the net count measurement mode may be further divided into a sample measurement mode and a blank card measurement mode.

[0121] According to a preferred embodiment, when the sample measurement mode is finished, the net count C is automatically calculated, and the positive and negative of the sample card is judged in combination with the upper and lower thresholds. The purpose of the blank card measurement mode is to check the value and stability of the instrument background B, and the background measurement result is displayed at the end of the measurement.

[0122] According to a preferred embodiment, the precision improvement iterative algorithm is an iterative algorithm related to a preset measurement time or measurement precision. Specifically, the method step of setting a precision control limit and comparing the measurement time to judge the positive or negative nature of the sample to be tested may include: comparing the time for the measurement standard card, the background card and the sample card to reach the precision limit to judge whether the sample to be tested is positive or negative.

[0123] Specifically, the equal precision measurement mode is a method of distinguishing whether the sample to be tested is negative or positive by setting a precision control limit and comparing the measurement time. Based on the current experimental results, under laboratory conditions, the precision limit (parameter D) is generally set to 400. The time taken by the standard card, background card and sample card to reach the precision limit is compared to determine whether the sample to be tested is positive or negative. In particular, in the equal precision measurement mode, the higher the precision setting, the more accurate the test result, but the corresponding detection time is longer.

[0124] According to a preferred embodiment, the Helicobacter pylori detection method provided in this embodiment further includes an instrument self-checking background. Specifically, the number of self-checks can be set to at least 2 times, for example. Preferably, the number of self-checks is set to 3 to 10 times.

[0125] According to a preferred embodiment, the theoretical relationship formula of each parameter for determining the positive or negative of a sample to be tested based on the multi-parameter Helicobacter pylori index algorithm of the present invention is:

[0126] HPI=DT / BT

[0127] DT = target count / cps

[0128] cps=(LM) / 250s

[0129]

[0130]

[0131] Among them, DT represents the time taken for the cumulative count to reach the target count (the sample card measurement time in the MP-HPI algorithm measurement mode); BT represents the time taken for the blank card to reach the target count (the background time or the critical standard card measurement time). In particular, the counts in this method refer specifically to weak β counts minus high-energy counts.

[0132] Example 5

[0133] This embodiment is a further improvement on the above-mentioned embodiment, and the repeated contents will not be repeated here.

[0134] According to a preferred embodiment, Figure 6 As shown, the system of the present invention performs Helicobacter pylori detection according to at least the following steps:

[0135] S1: Turn on the machine, and perform self-test (perform background test operation);

[0136] S101: The detection component detects whether a sample is inserted into the sample slot 103. If a sample is inserted into the sample slot 103, step S102 is executed, otherwise step S2 is executed;

[0137] S102: The processing unit outputs an inquiry signal to confirm whether the sample card is a blank card. The touch screen 201 can be used to determine whether the sample card is a blank card. If it is not a blank sample card, the sample card is taken out and then self-checked;

[0138] S103: if the sample card is blank or the sample card has been taken out, execute step S1;

[0139] S2: The processing unit performs a self-check to determine if it is normal. If so, it executes step S3; otherwise, it executes step S201;

[0140] S201: The processing unit prompts to troubleshoot the fault and detects whether the fault is solved. If the fault is solved, execute step S1, otherwise execute step S202;

[0141] S202: The self-check ends, and the processing unit prompts to troubleshoot the fault and detect whether the fault is solved. If the fault is solved, step S1 is executed; otherwise, a prompt is given to contact relevant service personnel;

[0142] S3: The detection component detects the status of the sample to be tested;

[0143] S4: The detection component detects whether a sample is inserted into the sample slot 103. If a sample is inserted into the sample slot 103, execute step S5, otherwise execute step S3;

[0144] S5: Start testing. If the sample card is pulled out before testing, execute step S501, otherwise execute step S502;

[0145] S501: prompting that the sample card has been drawn out, stopping the test, and executing step S3;

[0146] S502: After the detection is completed, the background is subtracted, a threshold value is determined, and step S503 is executed;

[0147] S503: If the detection result is greater than the upper threshold, execute step S504, otherwise execute step S505;

[0148] S504: Determine that the sample to be tested is positive (HP+), and execute step S509;

[0149] S505: If the measurement result is less than the lower threshold, execute step S506, otherwise execute step S507;

[0150] S506: Determine that the sample to be tested is negative (HP-), and execute step S509;

[0151] S507: If the detection result is between the lower threshold and the upper threshold, the detection times are judged. If the actual detection times are ≤ the set detection times, step S508 is executed. If the actual detection times are > the set detection times, re-detection is performed and step S502 is executed.

[0152] S508: The processing unit determines the positive or negative nature of the sample to be tested based on the net count size of the sample card, comprehensively sets the detection number to detect and determine the positive or negative nature of the sample to be tested and outputs the C value, and executes step S3;

[0153] S509: instruct the printer 203 to output the detection result, and after the operation is completed, return to the waiting state and display the last detection result, and execute step S6;

[0154] S6: The processing unit inquires whether to return to the main menu. If not, the last test result is displayed. Otherwise, step S601 is executed.

[0155] S601: The processing unit inquires whether to perform sample testing, if so, executes step S3, otherwise executes step S602;

[0156] S602: the processing unit inquires whether to perform background detection. If so, the blank card is detected for testing, and it is determined whether a sample is inserted into the sample slot 103, and step S605 is executed. Otherwise, step S603 is executed.

[0157] S603: The processing unit inquires whether to perform data query. If yes, query the background data and the detection data. Otherwise, execute step S604.

[0158] S604: The processing unit performs instrument settings, modifies the detection cycle, system time, and upper and lower thresholds;

[0159] S605: Start the test, display the test result after the test, and execute step S606;

[0160] S606: The processing unit inquires whether to count the current test result as the background value of the blank sample for background deduction. If so, save it as the background and execute step S3; otherwise, directly execute step S3.

[0161] In particular, the troubleshooting described in the above step S201 includes, for example, excessive tube count, light leakage from the drawer, or other problems that affect the measurement.

[0162] In particular, the troubleshooting described in the above step S202 includes, for example, light leakage, high-count sample cards, environmental noise and other fault factors.

[0163] In particular, the set detection number described in the above step S507 is preferably 3 in the present invention. It can be understood that, according to actual needs, the set detection number can also be other values.

[0164] In particular, in the above step S605, the test result displayed at the end of the test can be manually saved as the instrument background.

[0165] According to a preferred embodiment, Figure 7 As shown, the system of the present invention uses the MP-HPI measurement method to detect Helicobacter pylori according to at least the following steps:

[0166] S7: The detection unit detects the sample card;

[0167] S8: The processing unit determines whether the target count D is reached, and if so, executes step S9, and if not, executes step S15;

[0168] S9: The processing unit determines whether the HPI value is less than the positive coefficient, and if so, executes step S10; if so, executes step S16;

[0169] S10: The processing unit determines whether the HPI value is greater than the negative coefficient, if it is less, execute step S11, if it is greater, execute step S17;

[0170] S11: Increase the target count step by step and continue measuring;

[0171] S12: The processing unit determines whether the measurement time is greater than the cut-off time, and if so, executes step S13, and if not, executes step S11;

[0172] S13: The processing unit determines the relationship between the C value and the net count threshold. If the C value is greater than the net count threshold, step S16 is executed; if the C value is less than the net count threshold, step S17 is executed;

[0173] S14: Calculation is completed and the result is output;

[0174] S15: The processing unit determines whether the duration is greater than 250s and less than the target count. If so, the processing unit determines the relationship between the C value and the net count threshold. If the C value is greater than the net count threshold, the processing unit executes step S16. If the C value is less than the net count threshold, the processing unit executes step S17. If not, the target count is accumulated.

[0175] S16: judged as positive, execute step S14;

[0176] S17: Judge as negative, and execute step S14.

[0177] Throughout the text, the features referred to as “preferably” are merely optional and should not be understood as having to be set. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.

[0178] It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention specification and its drawings are illustrative and do not constitute a limitation on the claims. The scope of protection of the present invention is defined by the claims and their equivalents. The present invention specification contains multiple inventive concepts, such as "preferably", "according to a preferred embodiment" or "optionally", all of which indicate that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to file a divisional application based on each inventive concept.

Claims

1. A radon progeny identification system for Helicobacter pylori detection, characterized in that: The method comprises at least a detection unit for detecting a processed sample card to obtain nuclear pulse data, and a calculation unit for receiving the nuclear pulse data sent by the detection unit and judging the positive and negative of the sample card, wherein the detection unit determines a plurality of corresponding threshold counts based on counting parameters of a plurality of signal groups, the calculation unit determines the positive and negative of the sample card based on the nuclear pulse data, and corrects the positive and negative judgment result of the sample card based on the positive and negative judgment rule of radon daughter contamination, wherein: Before the sample card is placed in the detection unit, the radon progeny are prevented from attaching by changing the static voltage of the sample card and / or the radon progeny concentration of the surrounding environment. Several signal groups are divided according to the set low threshold, medium threshold and high threshold, among which, The rule for judging the positive and negative nature of radon progeny pollution is: In the case where the count rate of the middle threshold count is greater than the first judgment threshold, it is judged that the sample card is contaminated by radon progeny, otherwise it is judged that the sample card is not contaminated by radon progeny; When the preset first time is reached, if the middle threshold count is greater than the second judgment threshold, it is determined that the sample card is contaminated by radon progeny; otherwise, it is determined that the sample card is not contaminated by radon progeny. In the case where it is determined that the sample card is contaminated by radon daughters, the positive or negative nature of the sample card is determined based on the weak β net count of the sample card and the determination k value.

2. The radon progeny identification system for Helicobacter pylori detection according to claim 1, characterized in that: The manner of changing the electrostatic voltage of the sample card at least includes applying positive static electricity and removing static electricity.

3. The radon progeny identification system for Helicobacter pylori detection according to claim 1 or 2, characterized in that: Ways to change the radon progeny concentration in the environment include at least: Place the sample card in a low radon concentration environment, or The concentration of radon progeny in the environment where the sample card is located is reduced.

4. The radon progeny identification system for Helicobacter pylori detection according to claim 1, characterized in that: The detection unit counts signals in the signal group corresponding to a number of the thresholds and the thresholds to obtain the nuclear pulse data.

5. The radon progeny identification system for Helicobacter pylori detection according to claim 1, characterized in that: In the case where the judgment k value of the sample card contaminated by radon progeny is less than the first radon progeny threshold, judging the sample card contaminated by radon progeny as negative; In the case where the judgment k value of the sample card contaminated by radon progeny is greater than the second radon progeny threshold, judging the sample card contaminated by radon progeny as positive; When the judgment k value of the sample card contaminated by radon progeny is greater than or equal to the first radon progeny threshold and less than or equal to the second radon progeny threshold, the positive or negative nature of the sample card contaminated by radon progeny is judged by extending the measurement time or combining the net count C.

6. A radon progeny identification method for Helicobacter pylori detection, characterized in that: The method uses the radon daughter identification system for Helicobacter pylori detection according to any one of claims 1 to 5, and the method comprises: detecting the processed sample card to obtain nuclear pulse data, wherein: Before the sample card is placed in the detection unit, the radon progeny are prevented from attaching by changing the static voltage of the sample card and / or the radon progeny concentration of the surrounding environment.

7. The radon progeny identification method for Helicobacter pylori detection according to claim 6, characterized in that: The manner of changing the electrostatic voltage of the sample card at least includes applying positive static electricity and removing static electricity.

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