CN116338157A - Clamp type helicobacter pylori detection device - Google Patents
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Abstract
The invention relates to a card type helicobacter pylori detection device which comprises a detection assembly and a processing assembly. The detection component is composed of at least two photomultiplier tube coupled plastic scintillators and is used for measuring the sum of the two types of card samples to be detected 14 C, related nuclear pulse value, wherein a gap between the shell and the photomultiplier tube of the detection assembly is filled with lead sand so as to reduce background and detection lower limit; the processing component is capable of responding to the AND from the detection component 14 C related nuclear pulse value, and determining the negative and positive of the sample to be tested through one or more preset helicobacter pylori algorithms. The invention provides a helicobacter pylori detection device based on a double scintillation detector, which combines a multiparameter helicobacter pylori algorithm, remarkably improves the accuracy and stability of a detection result, and forms a helicobacter pylori detection device with accurate and reliable magnitude and strong anti-interference capability 14 Novel C nuclide measurement technology.
Description
Technical Field
The invention relates to the technical field of helicobacter pylori detection, in particular to a clamping type helicobacter pylori detection device.
Background
Helicobacter pylori is a spiral, micro-anaerobic, very demanding bacterium for growth conditions. The first successful separation from gastric mucosal biopsies of patients with chronic active gastritis in 1983 is the only species of microorganism currently known to survive in the human stomach. On day 10 and 27 of 2017, the world health organization International cancer research institute publishes a list of carcinogens and helicobacter pylori (infection) was listed. In 2022, a new edition of "carcinogen list" published in the united states, helicobacter pylori was listed as a "definitive carcinogen".
Prevention and control of gastric cancer has been increasingly attracting attention. Studies indicate that helicobacter pylori is one of the most common bacterial pathogens that occurs in the gastric pylorus region of humans.
It is counted that the occurrence rate of atrophic gastritis and gastric cancer of the population with early age of the primary infection of helicobacter pylori is high, and the helicobacter pylori infection and the death rate of gastric cancer are in parallel relation. Helicobacter pylori is parasitic in gastric mucosal tissue, 67% -80% of gastric ulcers and 95% of duodenal ulcers are caused by helicobacter pylori. Common symptoms in patients with chronic gastritis and peptic ulcer are: after eating, the upper abdomen is full, uncomfortable or painful, and other bad symptoms such as belch, abdominal distention, acid regurgitation, anorexia and the like are often accompanied. Some patients may also have recurrent severe abdominal pain, minor upper gastrointestinal bleeding, etc. Therefore, the experts consider that the helicobacter pylori infected person is discovered early, and the helicobacter pylori is timely and effectively killed by the antibiotics, thereby having great significance for preventing and controlling gastric cancer.
CN113311008A discloses a visual multifunctional helicobacter pylori detector, which comprises a GM counting tube acquisition system, a core processor system and a man-machine interaction system, wherein the GM counting tube acquisition system comprises a GM tube high-voltage power supply unit, a signal acquisition and processing unit and a micro photoelectric switch detection unit; the core processor system comprises a Cortex core processor unit, a type_C encryption unit, an RGB lamp visual prompting unit NRF wireless receiving and transmitting unit, a USB_A interface unit, a USB_B interface unit and an RMII network interface unit. The technical scheme adopts a net counting measurement mode to detect helicobacter pylori existing in a sample, but the detection means is single and limited by the detection efficiency and sensitivity of a GM counting tube detector, and the statistical fluctuation of the measurement count is large, so that the proportion of false positive or false negative of the detection is high.
CN102338757A discloses helicobacter pylori 14 The detection method comprises the following steps: collecting exhaled gases from a patient 14 C, performing operation; the said 14 C decays to produce beta rays and converts the beta rays into pulsed electrical signals by a solid-state flash detector; counting the pulsed electrical signals; and judging whether helicobacter pylori exists or not based on the counting of the pulse electric signals. The technical proposal does not use a liquid absorbent containing methanol, thus avoiding the risk of pouring the corrosive toxic liquid absorbent into the suction inlet; no toxic cancerogenic substances such as toluene (dimethylbenzene) and the like are used, so that the method has no harm to operators and patients and no pollution to the environment, and belongs to an environment-friendly product; and the degree of automation is high, and the operation is simple. But it has the disadvantage that: the processing technology of the low-energy beta pulse is easy to be noisy and disturbed, and cannot restrain the influence of high-energy alpha and beta rays generated by natural radionuclides in the air on a measurement result. The invention suppresses noise and interference through digital pulse processing, and develops pulse retorting technology to suppress high-energy alpha and beta rays generated by natural radionuclides in the air.
14 The C-urea breath detection method is a safe and cost-effective method, but is currently based on 14 C-urineThe instrument working principle of the element expiration detection method is generally that the Geiger-Miller (G-M) count, the Geiger-Miller count method is large in statistical fluctuation, unstable in background and influenced by environmental temperature and humidity conditions, false positive or false negative is easily judged, and the accuracy of detection is urgently improved. It is even possible that the radon daughter is radioactive, which results in a high proportion of false positives or false negatives, because the gas-collecting card adsorbs the radon daughter in the air.
The method aims at solving the problems of large statistical fluctuation of measurement, poor repeatability of measurement results, insufficient accuracy of detection results of weak positive cases and the like in the conventional Geiger-Maitreya counting method. The invention is based on scintillation detection technology, improves pairs 14 The detection efficiency of the low-energy beta rays emitted by C provides an accurate and reliable method with strong anti-interference capability 14 The novel technique of C nuclide measurement is applied to the measurement of helicobacter pylori.
Furthermore, there are differences in one aspect due to understanding to those skilled in the art; on the other hand, since the applicant has studied a lot of documents and patents while making the present invention, the text is not limited to details and contents of all but it is by no means the present invention does not have these prior art features, but the present invention has all the prior art features, and the applicant remains in the background art to which the right of the related prior art is added.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a card type helicobacter pylori detection device, which aims at solving at least one or more technical problems existing in the prior art.
The invention aims at combining the detection requirement of early discovery and prevention of helicobacter pylori to study high sensitivity 14 The novel technology for detecting the C-urea exhalate improves the capability and level of the existing detection method based on the principle.
In order to achieve the above object, the present invention provides a card-type helicobacter pylori detection apparatus comprising:
the detection assembly is composed of at least two photomultiplier tube coupling plastic scintillators and is used for measuring the nuclear pulse value related to helicobacter pylori in a sample to be detected, wherein the sample to be detected is coupled between at least one pair of photomultiplier tube coupling plastic scintillators;
and the processing component is used for responding to the nuclear pulse value related to the helicobacter pylori from the detection component and determining the negative and positive of the sample to be detected through a preset helicobacter pylori algorithm.
Preferably, determining the yin-yang of the sample to be tested by the preset helicobacter pylori algorithm comprises:
acquiring accumulated measurement time and target count of a sample to be measured;
if the accumulated measurement time reaches a preset upper measurement limit, calculating a net count value, and determining the negative and positive of the sample to be measured according to the net count value;
If the target count reaches the preset upper measurement limit, calculating a positive index, and determining the negative and positive of the sample to be tested according to the positive index.
In particular, the timing net counting algorithm has statistical fluctuation on the data result, so that the condition of yin-yang jump possibly occurs for a critical respiratory card; the equal-precision time algorithm has the advantages that the weak positive card and the weak negative card reach the target counting speed very slowly, and the measurement time is too long, so the multi-parameter helicobacter pylori algorithm adopted by the invention overcomes the defects of the prior method, combines the advantages of the two, and can flexibly realize the aim of each type according to the data condition 14 The exhalation card with the content C is processed and analyzed, a corresponding detection conclusion is obtained, and the system can be automatically and flexibly adapted according to the data result in actual measurement, so that the harmony and unification of the measurement efficiency and the measurement precision are achieved.
Specifically, when a multiparameter helicobacter pylori algorithm is used, first the measurement time (e.g., 250 s) and which target count is reached first are monitored: if the measurement time reaches first, calculating a net count value C, judging negative if the C is smaller than a net count threshold value, and ending the measurement, otherwise, continuing the measurement; if the target count is reached first, calculating a positive index HPI, wherein the HPI is smaller than a positive threshold, and the HPI is positive, and if the HPI is larger than a negative threshold, the HPI is negative, and the measurement is finished. Otherwise, the target count is increased in a stepping way, and the measurement is continued.
When the measurement time is greater than the cutoff time (such as 600 s), if the positive index HPI value is between the positive threshold and the negative threshold, calculating a net count value (total count minus background) of the total measurement time; if the net count value is smaller than the total time threshold value, the result is negative; otherwise, the result is positive, and the measurement is finished. The high probability of the negative card reaches the measurement time first, the high probability of the positive card reaches the target count first, the high probability of the expiration card at the fuzzy juncture (such as the net count falling near the threshold value) enters the algorithm for iteratively improving the measurement precision part, the measurement time is prolonged at this time, the precision is improved, and the measurement accuracy is effectively improved.
Secondly, the detection assembly provided by the invention adopts a design structure of the horizontal symmetrical double detectors, and has extremely close fixed detection distance on the premise that the unique design of the detection assembly meets the light-shielding requirement, so that higher detection efficiency is ensured, and meanwhile, the consistency of each detection efficiency is also ensured. Through full test and verification, the size and thickness of the scintillator are the optimal solution under the current condition, and the scintillator has lower sensitivity to the environment gamma rays and lower background under the premise of unchanged efficiency.
In contrast, the prior art is specific to helicobacter pylori 14 The system or method for measuring C generally cannot simultaneously meet the characteristics of light shielding, low background, high detection efficiency, constant detection distance, low manufacturing cost and the like of the detector. Specifically, the shielding module shell provided by the invention adopts aluminum alloy, lead sand is poured into the shell, instead of thickening shielding materials outside the photomultiplier, on the premise of not obviously improving the cost, the background and the detection lower limit are reduced, the measurement accuracy is effectively improved, and especially, the lead sand filling also enables the production, the manufacture and the assembly to be simpler, and the manpower and the material resources to be saved. On the other hand, the whole detection assembly forms a metal enclosed space, not only meets the light-shielding requirement, but also greatly improves the electromagnetic interference resistance and ensures the stability of the detector.
Preferably, determining the negative-positive property of the sample to be tested according to the positive index comprises:
detecting a sample to be detected, and acquiring sample card measurement time DT and critical standard card measurement time BT which reach control precision;
obtaining a positive index according to the definition of the positive index associated with the sample card measurement time DT and the critical standard card measurement time BT;
and determining the negative and positive of the sample to be tested according to the difference degree between the positive index and the preset threshold value.
In particular, achieving control accuracy may be achieving an accumulated count target. Further, the smaller the positive index, the shorter the sample card measurement time DT, 14 the higher the C content.
Specifically, in the present invention, the definition formula of the positive index can be expressed as:
HPI＝DT×(1+U rel1 )/[BT×(1+U rel2 )]
wherein HPI represents a positive index of helicobacter pylori; u (U) rel1 Expansion uncertainty representing sample card measurement time DT, expansion factor k=2 or 3; u (U) rel2 The expansion uncertainty of the critical standard card measurement time BT is represented, the expansion factor k=2 or 3.
Preferably, determining the yin-yang of the sample to be measured according to the difference between the positive index and the preset threshold value comprises:
and if the positive index is smaller than or equal to a first threshold value, determining that the sample to be detected is positive.
And if the positive index is larger than the second threshold value, determining that the sample to be tested is negative.
When the positive index is between the first threshold value and the second threshold value, the detection result is suspected;
and judging the negative and positive of the sample to be detected according to the accuracy improvement iterative algorithm under the condition that the detection result is suspected.
Preferably, determining the negative-positive property of the sample to be measured from the net count value comprises:
acquiring a total count A and a coincidence count M of the detection component;
determining a net count value of the sample to be tested according to the total count A and the coincidence count M;
And determining the negative and positive of the sample to be tested according to the difference degree between the net count value and the preset threshold value.
Preferably, determining the net count value of the sample to be measured from the total count a and the coincidence count M comprises:
C＝A-M-B
wherein, C is the net count, A is the total count of the double detectors, B is the background, and M is the coincidence count.
Preferably, determining the yin-yang of the sample to be measured according to the difference between the net count value and the preset threshold value comprises:
if the net count value is smaller than the lower threshold value, determining that the sample to be detected is negative;
if the net count value is greater than the upper threshold value, determining that the sample to be detected is positive;
and if the net count value is between the upper threshold value and the lower threshold value, determining that the sample to be detected is a suspected case.
Preferably, the accuracy-improving iterative algorithm is an iterative algorithm related to a preset measurement duration or measurement accuracy, and specifically comprises setting an accuracy control limit value, and comparing the time when the measurement standard card, the background card and the sample card reach the accuracy limit value to determine the negative and positive of the sample to be measured.
In particular, the iterative algorithm may be based on precision lifting, which may be to increment the count target.
Preferably, the accuracy boost iterative algorithm is an iterative algorithm related to a preset measurement duration or measurement accuracy.
Specifically, in the present invention, the accuracy-improving iterative algorithm can be expressed as:
HPI(L～H)＝f(D,T,B,U)
Wherein D is the precision limit; t is the longest duration; b is background; u is the measurement result spread uncertainty of the instrument for the critical standard limit sample.
Preferably, judging the yin-yang of the sample to be measured according to the accuracy-improving iterative algorithm includes:
increasing a target count value and determining a positive index of a sample to be tested;
if the detection result of the sample to be detected is determined to be suspected based on the difference between the positive index and the preset threshold, continuing to step the target count value until the detection result of the sample to be detected is negative or positive.
Preferably, the present invention also relates to a method for detecting helicobacter pylori, comprising:
acquiring accumulated measurement time and target count of a sample to be measured;
if the accumulated measurement time reaches a preset upper measurement limit, calculating a net count value, and determining the negative and positive of the sample to be measured according to the net count value;
if the target count reaches the preset upper measurement limit, calculating a positive index, and determining the negative and positive of the sample to be tested according to the positive index.
Preferably, determining the negative positive of the sample to be tested according to the positive index may comprise:
detecting a sample to be detected, and acquiring sample card measurement time DT and critical standard card measurement time BT which reach control precision;
Obtaining a positive index according to the definition of the positive index associated with the sample card measurement time DT and the critical standard card (such as blank card) measurement time BT;
and determining the negative and positive of the sample to be tested according to the difference degree between the positive index and the preset threshold value.
Aiming at the defects of the traditional helicobacter pylori measuring instrument based on the Geiger counting method, the invention researches, tests and selects the scintillation material, improves the comparison of the scintillation material 14 The detection efficiency of the low-energy beta rays emitted by the C is improved; a coupling method of the scintillation material and the low-noise high-gain photomultiplier is designed, and the collection efficiency of scintillation light is improved. The invention provides a positive index discrimination algorithm, improves the discrimination robustness of the detection result, and combines with the breath sample 14 C nuclide characteristics, carrying out helicobacter pylori expiration detection on radionuclide in sample 14 C, establishing an absolute measurement method based on a coincidence measurement principle, and forming a constant value with accurate and reliable magnitude and strong anti-interference capability 14 Novel technique for C-nuclide measurement, and thus, helicobacter pylori expiration detection is proposed 14 C, realizing the functions of controlling the instrument, monitoring samples, judging positive results, giving a detection report and the like by the fixed value measurement principle prototype. The invention greatly improves the reliability of detection, has verification on the principle of the related technology, has great value in further development and has wide application prospect.
Drawings
FIG. 1 is a schematic diagram showing the construction of a card-type helicobacter pylori detection device according to a preferred embodiment of the present invention;
FIG. 2 is a schematic illustration of an isometric construction of a probe assembly according to a preferred embodiment of the present invention;
FIG. 3 is a schematic elevational view of a probe assembly according to a preferred embodiment of the present invention;
FIG. 4 is a schematic diagram showing the operation of detecting helicobacter pylori using the card-type helicobacter pylori detection device according to the preferred embodiment of the present invention;
FIG. 5 is a schematic diagram showing the workflow of helicobacter pylori detection using a multiparameter helicobacter pylori index algorithm according to a preferred embodiment of the invention.
List of reference numerals
100: a chassis; 101: a first detector; 102: a second detector; 103: a sample tank; 200: a control panel; 201: an operation unit; 202: an instruction unit; 203: a printing module; 204: an audio module; 205: a limit switch; 206: and a power supply module.
Detailed Description
The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby making clear and defining the scope of the present invention.
First, a part of nouns involved in the present invention will be explained.
NC mode: net count measurement mode.
EUM mode: and an equal precision measurement mode.
MP-HPI algorithm measurement mode: multi-parameter helicobacter pylori index algorithm measurement mode.
The invention develops the helicobacter pylori test expiration sample according to the scintillation method 14 Study content of the C measuring instrument, and related embodiments are presented.
Example 1
The invention provides a card type helicobacter pylori detection device. Alternatively, the invention provides a system for helicobacter pylori detection. In particular, the invention relates to a card type helicobacter pylori detector.
According to a preferred embodiment, as shown in FIG. 1, the helicobacter pylori detection device of the present invention includes at least a detection module (101; 102) and a processing module (200). The detection component (101; 102) and the processing component (200) are electrically and/or signally connected to each other. Further, as shown in FIG. 1, both the detection assembly (101; 102) and the processing assembly (200) are mounted within the chassis 100 as a base and for protection and containment.
In particular, the detection assembly may be comprised of a pair of high stability photomultiplier tubes coupled with a high performance plastic scintillator. In particular, the photomultiplier tube coupling high-performance plastic scintillator has the advantages of high detection efficiency, quick response and the like.
According to a preferred embodiment, referring to fig. 2 and 3, the detection unit of the present invention may comprise a first detector 101 and a second detector 102 arranged opposite each other. Alternatively, the first detector 101 and the second detector 102 are mirror images. Alternatively, the first detector 101 and the second detector 102 may be NaI detectors.
Further, referring to fig. 1 to 3, a sample slot 103 for receiving a sample card is provided between the first probe 101 and the second probe 102. Alternatively, the first detector 101 and the second detector 102 are arranged in a symmetrical manner with respect to the sample tank 103. Alternatively, the sample cell 103 for placing the sample card is provided with the first detector 101 and the second detector 102.
According to a preferred embodiment, referring to fig. 2, the sample well 103, the first detector 101 and the second detector 102 are arranged on a base. Further, the sample well 103 is disposed at an end of a breath card slide on the surface of the base. The first detector 101 and the second detector 102 are arranged on both sides of the respiratory card slideway. In particular, the first detector 101 and the second detector 102 are movably arranged on both sides of the respiratory card slideway.
According to a preferred embodiment, referring to fig. 1, the first detector 101 and the second detector 102 are electrically or signally connected to the control panel 200. The control panel 200 is integrated with a processing unit. Specifically, the processing unit may determine, according to a preset detection algorithm, the yin-yang properties of the sample to be tested for substance data related to helicobacter pylori in the sample cards collected by the first detector 101 and the second detector 102.
According to a preferred embodiment, the processing unit can detect whether helicobacter pylori is contained in the sample to be tested by means of a plurality of measurement modes. In particular, the present invention provides at least three measurement modes. Specifically, the measurement modes adopted by the processing unit may include: (1) NC mode (net count measurement mode): judging the negative and positive of the sample to be tested according to the net count of the sample card; (2) EUM mode (equal precision measurement mode): judging the negative and positive of the sample to be measured by setting a precision control limit value and comparing the measurement time; and (3) MP-HPI algorithm measurement mode (multiparameter helicobacter pylori index algorithm measurement mode): and judging the negative and positive of the sample to be tested based on a multiparameter helicobacter pylori index algorithm.
According to a preferred embodiment, the processing unit processes the signals, so that various measurement modes such as timing measurement, equal-precision measurement and the like are realized, a multi-parameter helicobacter pylori index (MP-HPI) algorithm and a measurement mode are established, and accurate and reliable detection of card samples is realized.
According to a preferred embodiment, referring to FIG. 1, the helicobacter pylori detection device of the present invention may further include an operation section 201, an indication section 202, a printing module 203, an audio module 204, a limit switch 205, and a power module 206. Each of the functional modules/units/components is electrically or signally connected to the control panel 200.
According to a preferred embodiment, in the present invention, the operation portion 201 may be a touchable operation panel. Various input and output operations related to sample detection can be performed by the operation section 201. The indicator 202 may be a signal indicator light capable of generating a variable light. The indication unit 202 can provide a prompt message to the operator regarding the state of the detection device. The printing module 203 may be used to output the sample detection result. The audio module 204 may be, for example, a buzzer, a speaker, etc. Various items of information related to the sample detection input and output result can be output through the audio module 204. Limit switch 205 may be used to control the positional relationship of the detector and the sample card. The power module 206 may be used to provide system power.
According to a preferred embodiment, the helicobacter pylori detection device of the present invention may further comprise a shielding module. In particular, the shielding module may comprise an electromagnetic shielding module and a radiation shielding module. The shielding module can ensure that the detection performance and the background stability of the helicobacter pylori detection device/system provided by the invention are stable.
According to a preferred embodiment, the invention studies the change in background count rate and stability by varying the thickness of the radiation shielding lead in order to reduce interference of cosmic rays and external radiation with the background of the system and reduce background fluctuations. On the basis of the existing shielding device (30 mm-thick lead shielding), 20kg of lead sand is added, so that the absolute value of the background can be further reduced, but the relative standard deviation (statistical fluctuation) of the background is almost unchanged, so that the existing shielding of the device can meet the requirements, and the additional shielding is not significant. In particular, the shielding thickness of the prototype used in the invention (lead shielding thickness is not increased any more) 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 interval.
The helicobacter pylori detection device/system provided by the invention can be used for conveniently changing samples, and can meet the light chamber structure and principle model machine structure of strict light-shielding conditions. The system software integrates the functions of measurement control, data transmission, TDCR algorithm realization, positive determination of the final result of helicobacter pylori and the like.
Example 2
Based on the helicobacter pylori detection device provided in embodiment 1, this embodiment provides a method for helicobacter pylori detection, which may include:
and detecting a sample to be detected to obtain sample card measurement time DT reaching control precision and critical standard card measurement time BT reaching control precision.
And obtaining the positive index according to a definition formula of the positive index.
And comparing the obtained positive index with a threshold value to judge the yin and yang of the sample to be tested.
Alternatively, the helicobacter pylori detection method provided in the present embodiment may be:
judging the negative and positive of the sample to be tested according to the net count of the sample card;
or setting a precision control limit value, and comparing the measurement time to judge the negative and positive of the sample to be measured;
or judging the negative and positive of the sample to be tested based on a multiparameter helicobacter pylori index algorithm.
Specifically, the negative and positive of the sample to be tested are judged to be NC mode by the net count size of the sample card. And setting an accuracy control limit value, and comparing the measurement time to judge that the negative and positive of the sample to be measured are in the EUM mode. And judging the negative positive of the sample to be tested as an MP-HPI algorithm measurement mode based on a multiparameter helicobacter pylori index algorithm.
According to a preferred embodiment, the method step of discriminating the yin and yang of the sample to be tested based on the multiparameter helicobacter pylori index algorithm comprises the step of obtaining a positive index based on a definition formula of the positive index, wherein the definition formula of the positive index is:
HPI＝DT×(1+U rel1 )/[BT×(1+U rel2 )]；
wherein HPI represents a positive index of helicobacter pylori; DT represents the sample card measurement time to control accuracy; BT represents critical standard card measurement time to control accuracy; u (U) rel1 Representing the expansion uncertainty of DT, the expansion factor k=2 or 3; u (U) rel2 Representing the expansion uncertainty of BT, the expansion factor k=2 or 3.
According to a preferred embodiment, after obtaining the positive index, the negative positive of the sample to be tested can be determined according to the following manner:
and when the positive index is smaller than or equal to the first threshold value, the detection result is positive.
And when the positive index is larger than the second threshold value, the detection result is negative.
When the positive index is between the first threshold value and the second threshold value, the detection result is suspected;
and judging the negative and positive of the sample to be detected at least based on the accuracy improvement iterative algorithm under the condition that the detection result is suspected.
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 0.75 or less, the detection result is positive. When the positive index is greater than 0.9, the detection result is negative. Alternatively, the detection result is negative when the positive index is between the second threshold and the third threshold. In particular, the third threshold may be 1.1. When the positive index is between 0.75 and 0.9, the detection result is suspected.
For example, if the measured time DT to 300 is 290s, positive index:
i.e. 0.97>0.90, the measurement result of the current sample card is negative.
Alternatively, if the measured time DT to 300 is 150s, positive index:
i.e. 0.50<0.75, the measurement result of the current sample card is positive.
Alternatively, if the measured time DT reaching 300 is 240s, the positive index:
i.e. 0.75<0.80<0.90, the measurement result of the current sample card is suspected. Further, when the measurement result is suspected, entering an accuracy improvement iterative algorithm to continuously judge the yin and yang of the sample to be measured. Specifically, the iterative algorithm may be based on precision lifting, which may be to increment a count target.
According to a preferred embodiment, the helicobacter pylori detection method provided in this example may further be: setting the maximum measurement time or precision limit to terminate the precision improvement iterative algorithm, wherein iteration termination and yin-yang judgment are multi-parameter functions, and the formula is as follows:
HPI(L～H)＝f(D,T,B,U)；
wherein D is the precision limit; t is the longest duration; b is background; u is the measurement result spread uncertainty of the instrument for the critical standard limit sample.
For example, the net count measurement period is 250s, with an equal accuracy target count 300.
If the current sample card is judged to be suspected, the target count is increased by 10 steps, when the target count reaches 310, the HPI value is continuously calculated, the negative and positive are judged, and the measurement is finished until the judgment of the negative or positive is made. If the sample measurement result is still suspected after the step calculation, the step 10 iterative measurement is continued.
When the suspected sample measurement time accumulation reaches 600s, if the negative and positive of the sample cannot be judged according to the HPI value, calculating a net count C of 600 s:
C＝A 600s total count -M 600s coincidence count -B 600s background
If: c >600s threshold, the judgment result of the sample card is positive, and the measurement is finished;
otherwise: c is less than 600s threshold, the judgment result of the sample card is negative, and the measurement is finished.
In particular in a sample card 14 The higher the C content, the faster the target count D is reached and the shorter the detection time. Also, a detection time limit (e.g., 250 s) is set for obvious negative cards, without having to accumulate a target count to make a determination. Specifically, when the detection time reaches 250s, if the difference between the accumulated count of the sample card and the background blank card is smaller than 40, the sample card can be directly judged to be negative.
The MP-HPI algorithm measurement mode realizes the optimization of judgment accuracy and judgment time, and solves the problem of accurate judgment of negative and positive sample card under various environmental conditions. Preferably, in the case that the detection result is suspected, the weak positive card between the positive and negative coefficient thresholds is set for the longest measurement time (e.g., 600 s). After the accumulated measurement time reaches 600s, a net count C of the sample card 600s is calculated (C can also be further converted into 250 s). And (3) introducing a net count judging method, judging positive if the weak net count is larger than a threshold (for example, the threshold of 250s is 50), and judging negative if the weak net count is not larger than the threshold.
Compared with the traditional net counting measurement method and the equal-precision measurement method, the multi-parameter helicobacter pylori index algorithm adopted by the invention has the following advantages: (1) the detection result is more accurate and reliable, the problem that the detection result of the suspected case jumps back and forth between negative and positive is obviously reduced, and the discrimination capability of the suspected case is improved; (2) the rapid screening and detection capability of positive cases is improved, namely the sample with higher counting rate is basically obtained, the shorter the time for achieving target counting is, the smaller the HPI value is, and therefore the more serious the case is, the faster the detection speed is.
The MP-HPI measuring method adopted by the invention is optimized and improved by an equal-precision algorithm, is customized according to the specificity of the helicobacter pylori measuring field, can self-adaptively finish the measurement in advance or automatically increase the measuring time, and improves the measuring precision. Meanwhile, the invention combines two methods of an equal-precision algorithm and a net count algorithm (the total count minus the background is equal to the net count), fully considers the measurement response of various sample cards and aims at 14 The sample cards with different C contents have corresponding measurement measures, and the measurement accuracy can be ensured on the premise of ensuring the measurement accuracy.
According to a preferred embodiment, the method for judging the yin-yang of the sample to be tested according to the net count size of the sample card can comprise the following steps: the net count is equal to the total count of the dual detectors minus the coincidence count, and minus the instrument self-test background. The method can be concretely expressed as follows:
C＝A-M-B；
Wherein, C is the net count, A is the total count of the double detectors, B is the background, and M is the coincidence count.
According to a preferred embodiment, after a net count is obtained, the determination of yin-yang may be performed according to the following judgment:
and when the net count is smaller than the lower threshold value, judging that the sample card is negative.
And when the net count is greater than the upper threshold value, judging that the sample card is positive.
And when the net count is between the upper threshold value and the lower threshold value, judging that the sample card is a suspected case.
For example, background B with periods 250s,250s is 140, the lower threshold is 40, and the upper threshold is 70.
If the coincidence count M is 80 and the total count is 240, then the net count: c=240-80-140=20; and 20<40, the measurement result of the current sample card is negative.
Alternatively, if the coincidence count M is 80 and the total count is 340, then the net count: c=340-80-140=120; and 120>70, the measurement result of the current sample card is positive.
Alternatively still, if the coincidence count M is 80 and the total count is 260, then the net count: c=260-80-140=60; and 40<60<70, the measurement result of the current sample card is suspected. Further, when the measurement result is suspected, entering an accuracy improvement iterative algorithm to continuously judge the yin and yang of the sample to be measured. Specifically, the iterative algorithm may be based on precision lifting, which may be to increment a count target.
According to a preferred embodiment, the net count measurement mode default measurement duration may be 250s, which may be settable in the range of 10s to 9999 s. 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.
According to a preferred embodiment, at the end of the sample measurement mode measurement, the net count C is automatically calculated and the negative-positive of the sample card is determined in combination with the upper and lower thresholds. The purpose of the blank card measurement mode is to check the value of the instrument background B and its stability, and to display the background measurement result at the end of the measurement.
Preferably, the negative and positive of the sample to be tested are discriminated based on a multiparameter helicobacter pylori index algorithm.
For example, the net count measurement period is 250s, with an equal accuracy target count 300.
Example 1: if the measurement time reaches 250s but does not reach the target count, calculating a net count C, judging the negative and positive of the sample to be measured, and entering an accuracy improvement iterative algorithm when the sample to be measured is judged to be suspected.
Example 2: if the total count reaches the equal-precision target count 300 but the measurement time does not reach 250s, calculating an HPI value, judging negative positive, and entering a precision lifting iterative algorithm when judging to be suspected.
Example 3: if the sample card is judged to be suspected, in the precision iterative lifting algorithm, the target count is increased by 10 steps, the HPI value is calculated each time the target count is reached, the negative and positive are judged, and the measurement is finished if the negative or positive is judged. The iterative measurement is continued while the measurement result is still suspected.
Example 4: if the accumulation of the suspected sample measurement time reaches 600s, the HPI value can not judge negative and positive, and then calculating the net count C of 600 s:
C＝A 600s total count -M 600s coincidence count -B 600s background
If: c >600s threshold, the judgment result of the sample card is positive, and the measurement is finished;
otherwise: c is less than 600s threshold, the judgment result of the sample card is negative, and the measurement is finished.
According to a preferred embodiment, the precision lifting iterative algorithm is an iterative algorithm associated with a preset measurement duration or measurement precision. Specifically, the method step of setting the accuracy control limit value and comparing the measurement time to determine the negative and positive of the sample to be measured may include: and comparing the time when the measurement standard card, the background card and the sample card reach the precision limit to judge whether the measured sample is positive or negative.
Specifically, the equal-precision measurement mode is a method for identifying the negative or positive of a sample to be measured by setting a precision control limit value and comparing the measurement time. Based on the current experimental results, the accuracy limit (parameter D) is generally set to 400 under laboratory conditions. And comparing the time when the measurement standard card, the background card and the sample card reach the precision limit to judge whether the measured sample is positive or negative. In particular, in the equal-precision measurement mode, the higher the precision setting is, the more accurate the detection result is, but the longer the correspondingly consumed detection time is.
According to a preferred embodiment, the method for detecting helicobacter pylori provided in this example further comprises an instrument self-test background. Specifically, the number of self-tests may be set to 3 to 10 times, for example.
In particular, FIG. 4 shows a schematic workflow of helicobacter pylori detection by means of a card-type helicobacter pylori detection device under a preferred embodiment, specifically:
s1: starting up, and performing self-checking of the instrument (performing background detection operation);
s101: the detection component detects whether a sample is inserted into the sample groove 103, if so, the step S102 is executed, otherwise, the step S2 is executed;
s102: the processing unit outputs an inquiry signal for confirming whether the sample card is a blank card, the operation part 201 can determine whether the sample card is the blank card, and if the sample card is not the blank card, the sample card is taken out and then self-inspected;
s103: if the blank sample card or the sample card is taken out, executing the step S1;
s2: the processing unit performs self-checking normal judgment, if the step S3 is executed normally, otherwise, the step S201 is executed;
s201: the processing unit prompts the troubleshooting of the fault, detects whether the fault is solved, if so, the step S1 is executed, otherwise, the step S202 is executed;
s202: ending the self-checking, prompting the processing unit to check the fault, detecting whether the fault is solved, if so, executing the step S1, otherwise prompting to contact the relevant service personnel;
S3: the detection component detects the state of the sample to be detected;
s4: the detection component detects whether a sample is inserted into the sample groove 103, if so, the step S5 is executed, otherwise, the step S3 is executed;
s5: starting detection, if the sample card is extracted before detection, executing step S501, otherwise executing step 502;
s501: prompting that the sample card is drawn out, stopping detection, and executing step S3;
s502: detecting the end of background deduction, judging a threshold value, and executing step S503;
s503: if the detection result is greater than the upper threshold, executing step S504, otherwise executing step S505;
s504: judging the sample to be tested as positive (HP+), and executing step S509;
s505: if the measurement result is smaller than the lower threshold, executing step S506, otherwise executing step S507;
s506: judging that the sample to be tested is negative (HP-), and executing step S509;
s507: judging the detection times when the detection result is between the lower threshold value and the upper threshold value, executing step S508 if the actual detection times are less than or equal to the set detection times, re-detecting if the actual detection times are more than the set detection times, and executing step S502;
s508: the processing unit judges the negative and positive of the sample to be detected according to the net count of the sample card, comprehensively sets the detection number to detect and judge the negative and positive of the sample to be detected, outputs a C value and executes the step S3;
S509: the instruction printing module 203 outputs the detection judgment result, returns to the to-be-detected state after the operation is finished, displays the last detection result, and executes step S6;
s6: the processing unit inquires whether to return to the main menu, if not, the last detection result is kept to be displayed, otherwise, the step S601 is executed;
s601: the processing unit inquires whether to execute the sample detection, if yes, the step S3 is executed, otherwise, the step S602 is executed;
s602: the processing unit inquires whether background detection is executed, if yes, the state to be detected of the blank card is detected, whether a sample is inserted into the sample groove 103 is judged, step S605 is executed, and otherwise step S603 is executed;
s603: the processing unit inquires whether to execute data inquiry, if yes, the background data and the detection data are inquired, otherwise, the step S604 is executed;
s604: the processing unit sets an instrument, and modifies the detection period, the system time and the upper and lower thresholds;
s605: starting detection, ending the detection, displaying the detection result, and executing step S606;
s606: the processing unit inquires whether the current detection result is calculated as a blank sample background value and is used for deducting the background, if yes, the current detection result is calculated as the background, and the step S3 is executed, otherwise, the step S3 is executed.
In particular, the troubleshooting described in step S201 above includes, for example, excessive tube count, drawer light leakage, or other problems affecting the measurement.
In particular, the troubleshooting described in the above step S202 includes, for example, light leakage, a high count sample card inside, environmental noise, and other fault factors.
In particular, the set detection number in step S507 is preferably 3 in the present invention. It will be appreciated that the set detection number may be other values according to actual requirements.
In particular, in step 605, the detection result at the time of displaying the end of detection may be manually saved as the instrument background.
Further, FIG. 5 shows a schematic workflow of helicobacter pylori detection using MP-HPI algorithm (multiparameter helicobacter pylori index algorithm) under a preferred embodiment, specifically:
s7: the detection component detects the sample card;
s8: the processing unit judges whether the sample count value reaches the target count D, if yes, the step S9 is executed, otherwise, the step S15 is executed;
s9: the processing unit judges whether the HPI value of the sample is larger than the positive coefficient, if yes, the step S10 is executed, otherwise, the step S16 is executed;
s10: the processing unit judges whether the HPI value of the sample is larger than a negative coefficient, if so, the step S11 is executed, otherwise, the step S17 is executed;
S11: step-by-step increasing target count, and continuing detection;
s12: the processing unit judges whether the detection time is greater than the cut-off time, if yes, the step S13 is executed, otherwise, the step S11 is executed;
s13: the processing unit judges the magnitude relation between the C value and the net count threshold, if the C value is larger than the net count threshold, the step S16 is executed, and if the C value is smaller than the net count threshold, the step S17 is executed;
s14: outputting a detection result after the calculation is finished;
s15: the processing unit judges whether the time length is more than 250S and less than the target count, if yes, the magnitude relation between the C value and the net count threshold is judged, and if the C value is more than the net count threshold, the step S16 is executed; if the C value is smaller than the net count threshold, executing step S17, if not, accumulating the target count;
s16: judging positive, and executing step S14;
s17: and step S14 is executed if the determination is negative.
In particular, a control test study was performed on a system for helicobacter pylori detection according to the present invention with a geiger counter, and the measurement results were as follows:
(1) Detection efficiency test
The standard card with the test activity of 100Bq is repeatedly measured for 10 times on the helicobacter pylori detection device/system and the GM principle measuring instrument respectively, the measurement result is recorded, and the detection efficiency is calculated.
The detection device/system of the present invention tests the detection efficiency by the net count measurement mode, and the results are shown in table 1:
table 1 test of detection efficiency and test result comparison
In particular, it can be seen from table 1: the detection efficiency of the detection device/system of the invention is higher than that of the GM principle measuring instrument.
(2) Exemplary sample card yin-yang testing
3 blank cards, negative cards, weak positive cards, medium positive cards and strong positive cards were tested respectively with the detection device/system and GM principle measuring instrument of the present invention, and the measurement results obtained are shown in tables 2 and 3:
table 2 test and results alignment of typical sample cards
Parameter description: the HPI index is more than 0.9 and is negative, the HPI index is more than or equal to 0.75 and less than or equal to 0.9 and is suspected (suspected positive), and the HPI index is less than 0.75 and is positive;
in particular, it can be seen from table 2 that: the detection device/system and the GM principle measuring instrument provided by the invention can accurately judge the negative and positive of the sample card. More importantly, in the measuring process, for 14 The higher the C content of the gas collecting card, the shorter the MP-HPI mode measurement time adopted by the detection device/system of the invention, which shows that the detection sensitivity of the invention is higher.
Table 3 test and results alignment of typical sample cards
In particular, it can be seen from table 3: the detection device/system and the GM principle measuring instrument can accurately judge the yin-yang of the sample card, and the net count of the positive card measured by the detection device/system is higher than that of the GM principle measuring instrument, which also shows that the detection efficiency of the invention is higher.
(3) Measurement repeatability
The blank card, the weak positive card, the medium positive card, and the strong positive card were repeatedly measured 10 times on the detection device/system of the present invention and the GM principle measuring instrument, respectively, and the results are shown in table 4.
Table 4 system measurement repeatability
In particular, according to table 4: whether the blank card is measured and the same Zhang Kashi is measured, the repeated measurement of the detection device/system is obviously superior to that of the GM principle measuring instrument, and the stability and consistency of the invention are better.
It should be noted that the above-described embodiments are exemplary, and that a person skilled in the art, in light of the present disclosure, may devise various solutions that fall within the scope of the present disclosure and fall within the scope of the present disclosure. It should be understood by those skilled in the art that the present description and drawings are illustrative and not limiting to the claims. The scope of the invention is defined by the claims and their equivalents. The description of the invention encompasses multiple inventive concepts, such as "preferably," "according to a preferred embodiment," or "optionally," all means that the corresponding paragraph discloses a separate concept, and that the applicant reserves the right to filed a divisional application according to each inventive concept.
Claims (10)
1. A card helicobacter pylori detection device, comprising:
a detection assembly, which is composed of at least one pair of photomultiplier tube coupled plastic scintillators and is used for measuring the nuclear pulse value related to helicobacter pylori of a sample to be detected, which is coupled between the at least one pair of photomultiplier tube and the coupling body of the plastic scintillators;
and the processing component is capable of determining the negative and positive of the sample to be tested through a preset helicobacter pylori algorithm in response to the nuclear pulse value related to helicobacter pylori from the detection component.
2. The card type helicobacter pylori detection device according to claim 1, wherein the determination of the yin-yang property of the sample to be detected by the preset helicobacter pylori algorithm comprises:
acquiring accumulated measurement time and target count of a sample to be measured;
if the accumulated measurement time reaches a preset upper measurement limit, calculating a net count value, and determining the negative and positive of the sample to be measured according to the net count value;
if the target count reaches a preset upper measurement limit, calculating a positive index, and determining the negative and positive of the sample to be tested according to the positive index.
3. The card helicobacter pylori detection device according to claim 1 or 2, characterized in that the determination of the yin-yang of the sample to be detected based on the positive index comprises:
Obtaining sample card measurement time DT and critical standard card measurement time BT of a sample to be measured reaching control precision;
determining a positive index based on the sample card measurement time DT and the critical standard card measurement time BT;
and determining the negative and positive of the sample to be tested based on the difference degree between the positive index and a preset threshold value.
4. A card helicobacter pylori detection according to any one of claims 1 to 3, characterized in that the determination of the yin-yang of the sample to be detected based on the degree of difference of the positive index and a preset threshold value comprises:
if the positive index is smaller than or equal to a first threshold value, determining that the sample to be detected is positive;
if the positive index is larger than the second threshold value, determining that the sample to be tested is negative;
when the positive index is between the first threshold value and the second threshold value, determining that the detection result is suspected;
and judging the negative and positive of the sample to be detected according to an accuracy-improving iterative algorithm under the condition that the detection result is suspected.
5. The card type helicobacter pylori detection device according to any one of claims 1 to 4, characterized in that the judgment of the yin-yang of the sample to be detected according to the accuracy-improving iterative algorithm comprises:
increasing a target count value, and determining a positive index of a sample to be tested based on the sample card measurement time DT and the critical standard card measurement time BT;
If the detection result of the sample to be detected is determined to be suspected based on the difference degree between the positive index and the preset threshold value, continuing to step the target count value until the detection result of the sample to be detected is negative or positive.
6. The card type helicobacter pylori detection device according to any one of claims 1 to 5, characterized in that when the cumulative measurement time of the sample to be detected reaches a preset upper measurement limit and it is determined that the measurement result of the sample to be detected is still suspected based on the degree of difference between the positive index and a preset threshold, a net count value of the sample to be detected at the preset upper measurement limit is calculated, and negative-positive of the sample to be detected is determined based on the net count value.
7. The card type helicobacter pylori detection apparatus according to any one of claims 1 to 6, characterized in that the determination of the yin-yang of the sample to be detected based on the net count value comprises:
acquiring a total count A and a coincidence count M of the detection component;
determining a net count value of the sample to be tested according to the total count A and the coincidence count M;
and determining the negative and positive of the sample to be tested according to the difference degree between the net count value and a preset threshold value.
8. The card type helicobacter pylori detection apparatus according to any one of claims 1 to 7, characterized in that the determining the yin-yang of the sample to be detected based on the degree of difference between the net count value and a preset threshold value comprises:
If the net count value is smaller than a lower threshold value, determining that the sample to be tested is negative;
if the net count value is larger than the upper threshold value, determining that the sample to be detected is positive;
and if the net count value is between the upper threshold value and the lower threshold value, determining that the sample to be detected is suspected.
9. A method for detecting helicobacter pylori, comprising:
acquiring accumulated measurement time and target count of a sample to be measured;
if the accumulated measurement time reaches a preset upper measurement limit, calculating a net count value, and determining the negative and positive of the sample to be measured according to the net count value;
if the target count reaches a preset upper measurement limit, calculating a positive index, and determining the negative and positive of the sample to be tested according to the positive index.
10. The method for detecting helicobacter pylori according to claim 9, characterized in that the determination of the yin-yang of the sample to be detected based on the positive index comprises:
obtaining sample card measurement time DT and critical standard card measurement time BT of a sample to be measured reaching control precision;
determining a positive index according to the sample card measurement time DT and the critical standard card measurement time BT; and determining the negative and positive of the sample to be tested according to the difference degree between the positive index and a preset threshold value.
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| CN202310330140.4A Pending CN116338157A (en) | 2022-09-23 | 2023-03-30 | Clamp type helicobacter pylori detection device |
| CN202311195656.9A Pending CN117233365A (en) | 2022-09-23 | 2023-09-15 | Helicobacter pylori detection system and method based on positive index |
| CN202311197863.8A Pending CN117233366A (en) | 2022-09-23 | 2023-09-15 | Radon daughter screening system and method for helicobacter pylori detection |
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