CN114966056A - Kit and system for screening acute aortic dissection - Google Patents

Kit and system for screening acute aortic dissection Download PDF

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CN114966056A
CN114966056A CN202210641393.9A CN202210641393A CN114966056A CN 114966056 A CN114966056 A CN 114966056A CN 202210641393 A CN202210641393 A CN 202210641393A CN 114966056 A CN114966056 A CN 114966056A
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troponin
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贾禹
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West China Hospital of Sichuan University
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Abstract

The invention provides a kit for screening acute aortic dissection, which comprises a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting any one or more of IL-33, SST2 and MPO; and provides a system for screening acute aortic dissection. The invention can rapidly realize the screening of the acute aortic dissection by detecting a plurality of specific markers, has high specificity and sensitivity, and has important significance for clinical early diagnosis or auxiliary diagnosis of the acute aortic dissection.

Description

Kit and system for screening acute aortic dissection
Technical Field
The invention belongs to the field of in-vitro diagnostic reagents, and particularly relates to a kit and a system for screening acute aortic dissection.
Background
Aortic Dissection (AAD) is a common clinical cardiovascular emergency, and is mainly characterized in that blood enters the middle layer through aortic intimal lacerations on the basis of aortic medial degeneration, cystic necrosis or atherosclerosis, so that the aorta forms a pathological change of a separated true-false lumen. AAD typing is generally classified into Stanford a type (where the laceration is located in the ascending aorta) and Stanford B type (where the laceration is located in the descending aorta or the abdominal aorta) depending on the position of the laceration. In recent years, the incidence of chronic diseases such as hypertension increases and the population aging increases, the incidence of acute aortic dissection also tends to increase year by year, and the annual incidence reaches 5-30 per million. Studies have shown that approximately 48.6% of AAD patients die before admission, and 30% of AAD patients die during hospitalization. For untreated patients, the risk of mortality is about 21% within 24 hours, about 74% within 1 week and more up to 93% in 1 year. It is estimated that the risk of death in AAD patients increases by 1% -3% per 1 hour delay of treatment. On the basis of drug treatment, patients with type a AAD who received surgical intervention still had 23% early mortality and patients with type B AAD had 20% nosocomial mortality. Therefore, the implementation of medical measures for early diagnosis, early evaluation and early treatment is the key to improve the prognosis of the AAD patients, but the above links have a plurality of defects in the AAD diagnosis and treatment process.
Clinical diagnosis of AAD is based primarily on patient symptoms, physical examination, laboratory examination, and imaging examination. Since the typical symptoms of AAD are similar to those of Acute Chest Pain (ACP) diseases such as Acute Myocardial Infarction (AMI) and Pulmonary Embolism (PE), and some AAD patients have atypical clinical manifestations, they are prone to misdiagnosis and delay treatment of patients, and even improper treatment regimens are given, which increases the risk of death. The routine examination items for diagnosing AAD gold standard aorta CTA and MRA patients with non-acute chest pain are difficult to routinely develop in many primary hospitals. Therefore, the diagnosis of AAD in ACP diseases has been difficult for clinicians, and a simple and easy-to-operate diagnostic method with a high positive diagnosis rate is still lacking. In addition, the early assessment of AAD is mainly based on imaging anatomical parameters (maximum diameter of aorta, area or volume of false lumen, thrombus formation state of false lumen, etc.), mechanical indicators (hemodynamic state of aorta real lumen and false lumen and stress state of blood vessel wall), but such indicators are difficult to obtain early, and are not beneficial to early risk stratification and medical decision of patients. Therefore, the deep exploration of the pathogenesis and pathophysiological process of the AAD and the exploration of early screening and evaluation indexes can help to adopt intervention treatment measures as early as possible and change the current situation of high mortality of the AAD.
Disclosure of Invention
The invention aims to provide a kit and a system for screening acute aortic dissection.
The invention provides application of a detection reagent of a marker in an acute aortic dissection screening reagent, wherein the detection reagent of the marker consists of a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting any one or more of IL-33, SST2 and MPO.
Further, the detection reagent for the above marker is composed of a reagent for detecting oxygen saturation level of blood, a reagent for detecting troponin T and a reagent for detecting IL-33;
or, the detection reagent for the marker consists of a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting SST 2;
or, the detection reagent for the marker is composed of a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting MPO.
Further, the above-mentioned reagent for detecting troponin T is a hypersensitive troponin T detection reagent.
Further, the above-mentioned reagent for detecting troponin T is a reagent for detecting troponin T in serum; the reagent for detecting any one or more of IL-33, SST2 and MPO is a reagent for detecting IL-33, SST2 and/or MPO in blood plasma.
The invention also provides a kit for screening acute aortic dissection, which comprises a reagent for detecting the blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting any one or more of IL-33, SST2 and MPO.
Further, the above kit comprises a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting IL-33;
or, the kit comprises a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T, and a reagent for detecting SST 2;
or, the kit comprises a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting MPO.
Further, the above-mentioned reagent for detecting troponin T is a hypersensitive troponin T detection reagent.
The invention also provides a system for screening the acute aortic dissection, which comprises an input module, a discrimination module I, a discrimination module II and an output module;
an input module: inputting a marker detection result of the patient with acute chest pain; the marker is composed of blood oxygen saturation, troponin T and any one or more of IL-33, SST2 and MPO;
a discrimination module I: and judging whether the blood oxygen saturation and the content of troponin T in the serum in the detection result of the marker meet the following requirements: the blood oxygen saturation is more than or equal to 95 percent, and the troponin T is less than or equal to 51.3 ng/L;
and a discrimination module II: judging whether the content of IL-33, SST2 and/or MPO in the detection result of the marker meets the following requirements: IL-33 is more than or equal to 10.96pg/mL, SST2 is more than or equal to 29.20ng/mL and/or MPO is more than or equal to 1.37 RU/mL;
an output module: outputting whether the result is acute aortic dissection;
the input module is connected with the distinguishing module I, the distinguishing module I is respectively connected with the distinguishing module II and the output module, and the distinguishing module II is connected with the output module.
Further, if the judgment result of the judgment module I is yes, the detection result of the marker is input into the judgment module II for judgment; if the judgment result of the judgment module I is negative, outputting a non-acute aortic dissection result through an output module;
if the judgment result of the judgment module II is yes, outputting an acute aortic dissection result through an output module; if the judgment result of the judgment module II is negative, the non-acute aortic dissection result is output through the output module.
Further, the input module inputs the blood oxygen saturation, troponin T and IL-33 marker detection results of the patient with acute chest pain; the discrimination module II discriminates whether the content of IL-33 in the detection result of the marker meets the condition that IL-33 is more than or equal to 10.96 pg/mL;
or the input module inputs the blood oxygen saturation level, troponin T and SST2 marker detection results of the patient with acute chest pain; the judgment module II judges whether the content of the SST2 in the detection result of the marker meets the condition that the SST2 is more than or equal to 29.20 ng/mL;
or the input module inputs the blood oxygen saturation, troponin T and MPO marker detection results of the patient with acute chest pain; and the judging module II judges whether the MPO content in the marker detection result meets the condition that the MPO content is more than or equal to 1.37 RU/mL.
The invention has the beneficial effects that: the invention can rapidly realize the screening of the acute aortic dissection by detecting a plurality of specific markers, has high specificity and sensitivity, and has important significance for clinical early diagnosis or auxiliary diagnosis of the acute aortic dissection.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Drawings
Fig. 1 is a schematic diagram of a marker-based acute aortic dissection screening procedure.
Detailed Description
The raw materials and equipment used in the invention are known products and are obtained by purchasing commercial products.
Example 1 acute aortic dissection screening procedure
1. Detecting IL-33, sST2 or MPO of the patient suffering from acute chest pain, and detecting the blood oxygen saturation level and hypersensitive troponin T (Hs-cTNT) of the patient suffering from acute chest pain.
The detection method comprises the following steps: plasma IL-33, sST2 and serum hypersensitive troponin T were quantitatively determined by Enzyme-Linked Immunosorbent Assay (ELISA) using reagents for Enzyme-Linked Immunosorbent Assay.
The MPO marker is detected by using an anti-MPO antibody detection kit (HBO, MY00041), adopting a magnetic particle chemiluminescence immunoassay method, and utilizing an indirect method principle through an immunoassay two-step method.
And (3) testing the blood oxygen saturation: in the resting state of the patient, a fingerstall type photoelectric sensor is adopted, the sensor is clamped on the index finger or the ring finger of the left hand and the right hand, and after measurement is carried out on the two sides, the average value is obtained.
2. Adopting an acute aortic dissection screening system to perform discriminant analysis on the result
The detection result is input through the output module, the discrimination module I firstly discriminates the blood oxygen saturation degree and the high-sensitivity troponin T (Hs-cTNT) test result, if the blood oxygen saturation degree is more than or equal to 95% and the Hs-cTNT is less than or equal to 51.3ng/L, the discrimination module II is further discriminated, and if the conditions are not met simultaneously, the output module outputs the result: "non-acute aortic dissection".
The determination module II determines the markers IL-33, sST2 or MPO, and the following three determination schemes can be adopted:
scheme A: if the IL-33 is more than or equal to 10.96pg/mL, the result is output through an output module: "acute aortic dissection"; IL-33 is less than 10.96pg/mL, the result is output through an output module: "non-acute aortic dissection".
Scheme B: if the sST2 is more than or equal to 29.20ng/mL, the result is output through an output module: "acute aortic dissection"; sST2 < 29.20ng/mL, the output module outputs the result: "non-acute aortic dissection".
Scheme C: MPO is more than or equal to 1.37RU/mL, the result is output through an output module: "acute aortic dissection"; and if the MPO is less than 1.37RU/mL, outputting the result through an output module: "non-acute aortic dissection".
The schematic diagram is shown in fig. 1.
The beneficial effects of the present invention are demonstrated by the following experimental examples.
Experimental example 1 screening Performance analysis of the present invention
1. Experimental methods
1.1 study population
All acute chest pain patients meeting the inclusion criteria who are seen at the chest pain center of western hospital, Sichuan university, 12/1/00: 00 in 2019 to 1/23: 59 in 2021 were included. The questionnaires used and the informed consent were drawn up and signed on the basis of the "declaration of helsinki", and all patients and/or their clients signed the informed consent. The ethics of the study were approved by the ethics committee of the western hospital, university of Sichuan, under the examination of the ethics approval part number: examine No. 2019 (565).
1.2 inclusion criteria (to be met simultaneously):
patients who complain about the continuous chest and back pain;
the age > 18 years;
the initial onset time of acute chest pain is less than 3 days;
1.3 exclusion criteria (satisfying one or exclusion):
patients with combined tumor, hematologic diseases, infectious diseases, and autoimmune diseases;
patients with a surgical history in the last 1 month;
patients who have been diagnosed with AMI, AAD, PE;
chest pain due to trauma;
the patient is transferred after being treated outside the hospital;
patients participating in the study were rejected.
1.4 acute aortic dissection diagnostic criteria:
according to the definition of 'Chinese expert consensus on aortic dissection diagnosis and treatment standard' published in 2017, through clinical basic data such as medical history, symptoms, physical signs, electrocardiogram, biomarkers and the like, patients suspected of acute chest pain of AAD are preliminarily screened, CT radiography or magnetic resonance imaging is further adopted for definite diagnosis, and according to the fact that torn intima sheets, intimal lacerations or false cavities are observed, the basis for definite diagnosis is adopted.
1.5 screening by the methods of the invention
Acute aortic dissection screening was performed on the population included in the study, with reference to the screening protocol of example 1 (protocol A, B, C performed separately).
2. Results of the experiment
A total of 391 patients with chest pain were enrolled in the study, with a median age of 60(40-69) years and 113 (28.9%) women. There were 167 (42.7%) patients diagnosed with acute aortic dissection according to the acute aortic dissection diagnostic criteria, and 224 patients with non-acute aortic dissection.
The results of the screening according to the screening procedure of example 1 of the present invention are shown in table 1, and based on the screening procedures of IL-33 (protocol a), sST2 (protocol B), and MPO (protocol C) based on discrimination of blood oxygen saturation and hypersensitive troponin T content, the sensitivity of AAD was judged to be 0.838, 0.862, and 0.826, the specificity was judged to be 0.902, 0.938, and 0.862, and the accuracy was judged to be 0.875, 0.905, and 0.847, respectively, in all patients with chest pain.
TABLE 1 analysis of the diagnostic efficacy of AAD based on the screening procedure for IL-33, sST2, MPO
Figure BDA0003684259880000051
The results show that the sensitivity and specificity of the screening kit and the screening system for screening the acute aortic dissection are high, and the screening accuracy is high.
In conclusion, the invention can rapidly realize the screening of the acute aortic dissection by detecting a plurality of specific markers, has high specificity and sensitivity, and has important significance for clinical early diagnosis or auxiliary diagnosis of the acute aortic dissection.

Claims (10)

1. Use of a detection reagent for a marker in an acute aortic dissection screening reagent, wherein the detection reagent for the marker is composed of a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting any one or more of IL-33, SST2 and MPO.
2. The use according to claim 1, wherein the detection reagent for the marker is composed of a reagent for detecting oxygen saturation level of blood, a reagent for detecting troponin T, and a reagent for detecting IL-33;
or, the detection reagent for the marker consists of a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting SST 2;
or, the detection reagent for the marker is composed of a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting MPO.
3. Use according to claim 1 or 2, wherein the agent for detecting troponin T is a hypersensitive troponin T detection agent.
4. A kit for screening acute aortic dissection, which is characterized by comprising a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting any one or more of IL-33, SST2 and MPO.
5. The kit according to claim 4, comprising a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T, and a reagent for detecting IL-33;
or, the kit comprises a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T, and a reagent for detecting SST 2;
or, the kit comprises a reagent for detecting blood oxygen saturation, a reagent for detecting troponin T and a reagent for detecting MPO.
6. The kit according to claim 4 or 5, wherein the reagent for detecting troponin T is a hypersensitive troponin T detection reagent.
7. The kit according to claim 4 or 5, wherein the reagent for detecting troponin T is a reagent for detecting troponin T in serum; the reagent for detecting any one or more of IL-33, SST2 and MPO is a reagent for detecting IL-33, SST2 and/or MPO in blood plasma.
8. A system for screening acute aortic dissection is characterized by comprising an input module, a discrimination module I, a discrimination module II and an output module;
an input module: inputting a marker detection result of the patient with acute chest pain; the marker is composed of blood oxygen saturation, troponin T and any one or more of IL-33, SST2 and MPO;
a discrimination module I: and judging whether the blood oxygen saturation and the troponin T content in the marker detection result meet the following requirements: the blood oxygen saturation is more than or equal to 95 percent, and the troponin T is less than or equal to 51.3 ng/L;
and a discrimination module II: judging whether the content of IL-33, SST2 and/or MPO in the detection result of the marker meets the following requirements: IL-33 is more than or equal to 10.96pg/mL, SST2 is more than or equal to 29.20ng/mL and/or MPO is more than or equal to 1.37 RU/mL;
an output module: outputting whether the result is acute aortic dissection;
the input module is connected with the distinguishing module I, the distinguishing module I is respectively connected with the distinguishing module II and the output module, and the distinguishing module II is connected with the output module.
9. The system of claim 8, wherein if the discrimination result of the discrimination module I is yes, the marker detection result is input to the discrimination module II for discrimination; if the judgment result of the judgment module I is negative, outputting a non-acute aortic dissection result through an output module;
if the judgment result of the judgment module II is yes, outputting an acute aortic dissection result through an output module; if the judgment result of the judgment module II is negative, the non-acute aortic dissection result is output through the output module.
10. The system of claim 8, wherein the input module inputs the results of blood oxygen saturation, troponin T, and IL-33 marker detection for the patient with acute chest pain; the discrimination module II discriminates whether the content of IL-33 in the detection result of the marker meets the condition that IL-33 is more than or equal to 10.96 pg/mL;
or the input module inputs the blood oxygen saturation level, troponin T and SST2 marker detection results of the patient with acute chest pain; the judgment module II judges whether the content of the SST2 in the detection result of the marker meets the condition that the SST2 is more than or equal to 29.20 ng/mL;
or the input module inputs the blood oxygen saturation, troponin T and MPO marker detection results of the patient with acute chest pain; and the judging module II judges whether the MPO content in the marker detection result meets the condition that the MPO content is more than or equal to 1.37 RU/mL.
CN202210641393.9A 2022-06-08 2022-06-08 Kit and system for screening acute aortic dissection Pending CN114966056A (en)

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