Application of FGL1 protein in preparation of kit for diagnosing allergic rhinitis

Abstract

The invention discloses application of FGL1 protein in preparation of a kit for diagnosing allergic rhinitis. It is found that the FGL1 protein content in the serum of a healthy subject and the FGL1 protein content in the serum of an allergic rhinitis patient are obviously different, and the FGL1 protein content in the serum of the allergic rhinitis patient is obviously higher than that of the healthy subject. A further diagnosis efficacy test shows that the FGL1 protein can effectively diagnose and distinguish healthy subjects and allergic rhinitis patients, the diagnosis accuracy is high, the FGL1 protein can be used for developing a kit for diagnosing allergic rhinitis, and the objectivity is obviously improved compared with an existing diagnosis method.

Description

Technical Field

[0001] The present invention belongs to the field of disease diagnosis, relates to the discovery and application of disease diagnosis markers, and specifically relates to the use of FGL1 protein in preparing a kit for diagnosing allergic rhinitis. Background Art

[0002] Allergic rhinitis, also known as allergic rhinitis, is an allergic disease of the nasal mucosa and can cause a variety of complications. Allergic rhinitis is a common chronic inflammation of the upper respiratory tract. The prevalence of this disease is high worldwide. About 500 million people suffer from allergic rhinitis worldwide. The disease is mostly found in children and young adults, and there is no significant difference in the incidence between men and women. This disease can also induce asthma. Patients with allergic rhinitis have a 3 to 5 times higher risk of developing asthma than those without a history of rhinitis.

[0003] In order to improve the objectivity of the diagnosis of allergic rhinitis, the present invention is proposed. Summary of the invention

[0004] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a use of FGL1 protein for preparing a kit for diagnosing allergic rhinitis.

[0005] The above-mentioned purpose of the present invention is achieved through the following technical solutions:

[0006] Use of FGL1 protein in preparing a kit for diagnosing allergic rhinitis

[0007] Preferably, the kit is a serum detection kit.

[0008] Preferably, the kit contains a detection reagent for FGL1 protein.

[0009] Beneficial effects:

[0010] The present invention found that there was a significant difference in the FGL1 protein content in the serum of healthy subjects and patients with allergic rhinitis, and the FGL1 protein content in the serum of patients with allergic rhinitis was significantly higher than that of healthy subjects. Further diagnostic efficacy tests showed that the FGL1 protein can effectively diagnose and distinguish healthy subjects from patients with allergic rhinitis, with a high diagnostic accuracy, and can be used to develop a kit for diagnosing allergic rhinitis, which is significantly more objective than existing diagnostic methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 ROC curve for FGL1 protein diagnosis in the training set to distinguish healthy subjects from patients with allergic rhinitis;

[0012] Figure 2 This is the sample distribution diagram for predicting healthy subjects vs allergic rhinitis patients based on FGL1 protein in the validation set. DETAILED DESCRIPTION

[0013] The essential contents of the present invention are described in detail below in conjunction with the embodiments, but the protection scope of the present invention is not limited thereto.

[0014] 1. Experimental samples and reagents

[0015] Thirty-one healthy subjects and 34 patients with allergic rhinitis were collected. Healthy subjects were normal people with healthy physical examinations, and patients with allergic rhinitis were diagnosed according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis. The two groups were matched in age, gender, and body mass index, with no significant differences. The subjects or patients were randomly divided into training set samples (18 healthy subjects and 18 patients with allergic rhinitis) and validation set samples (13 healthy subjects and 16 patients with allergic rhinitis).

[0016] Exclusion criteria:

[0017] ① Patients with other acute diseases or uncontrolled chronic diseases; ② Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system; ③ Patients with mental illness and unable to cooperate; ④ Pregnant or lactating women, or those preparing for pregnancy; ⑤ Those who have participated in other clinical trials within the past month; ⑥ Those who are unwilling to accept this study.

[0018] Main experimental reagents:

[0019] The ELISA reagent for measuring FGL1 protein was purchased from RayBiotech., Inc.

[0020] 2. Experimental Methods

[0021] 1. Collection and storage of serum samples

[0022] Fasting peripheral blood was collected from healthy subjects and patients with allergic rhinitis in the early morning and placed in a test tube without anticoagulant. The blood was naturally coagulated for 30-60 minutes at room temperature. After the blood coagulated, it was centrifuged at 2000 rpm for 10 minutes. The upper clear serum liquid was carefully aspirated into a sterile lyophilized tube, labeled, and stored in a -80°C refrigerator for later use.

[0023] 2. ELISA determination of FGL1 protein content in serum

[0024] The content of FGL1 protein in each serum sample was determined strictly according to the ELISA reagent assay instructions.

[0025] 3. Data processing method

[0026] The ROC curve of FGL1 protein in the test set for distinguishing healthy subjects from patients with allergic rhinitis was established, and the area under the curve (AUC) and 95% confidence interval were calculated. Logistic regression was used to establish a regression equation to generate a set of new variables logit[P]. After logit[P]=Ln [p / (1-p)] The predicted probability p was obtained by transformation, and the ROC curve analysis was performed on the new variable. In the validation set, the diagnostic accuracy of FGL1 for allergic rhinitis was calculated using the best cut-off value obtained by the ROC curve as the threshold.

[0027] 3. Experimental Results

[0028] 1. Differences in serum levels of FGL1 protein in healthy subjects and patients with allergic rhinitis

[0029] In the training set, there were significant differences in the levels of FGL1 protein in the serum of healthy subjects VS patients with allergic rhinitis. The absolute level of FGL1 in the serum of patients with allergic rhinitis was significantly increased. The measurement results are shown in Table 1.

[0030] Table 1

[0031] Group FGL1 content (ng / mL) Allergic rhinitis 251.41±271.29 Healthy subjects 18.15±8.64

[0032] 2. ROC curve of FGL1 protein diagnosis for distinguishing healthy subjects from patients with allergic rhinitis

[0033] The FGL1 protein content (X) in the training set samples was used as the independent variable, and the groups (i.e., healthy subjects and patients with allergic rhinitis) were used as the dependent variable. Logistic regression was performed on the FGL1 protein content in the serum samples of allergic rhinitis and healthy subjects, and the logistic regression equation Ln was obtained. [p / (1-p)] =0.218X-8.270. Then, the absolute content of FGL1 protein in each serum sample is substituted into the logistic regression equation to obtain the regression prediction probability p of each serum sample. The possible regression prediction probability p is used as the diagnostic point to calculate the sensitivity and specificity, and the ROC curve is drawn accordingly (e.g. Figure 1 The AUC was 0.9938, the sensitivity was 1, and the specificity was 0.9444. The Wieden index was calculated based on the coordinates of the ROC curve = specificity + sensitivity - 1. The predicted probability p value corresponding to the maximum value of the Wieden index was the best cut-off value of 0.6444 for distinguishing healthy subjects from patients with allergic rhinitis.

[0034] The area under the ROC curve (AUC) has been widely recognized as an inherent accuracy indicator for evaluating the authenticity of diagnostic tests. When AUC is 0.5, it has no diagnostic significance; when AUC is between 0.5 and 0.7, it indicates a low diagnostic accuracy; when AUC is between 0.7 and 0.9, it indicates a medium diagnostic accuracy; when AUC>0.9, it indicates a high diagnostic accuracy.

[0035] 3. Verify the accuracy of FGL1 protein in diagnosing allergic rhinitis

[0036] In the validation set, the best cut-off value obtained above was used as the diagnostic threshold to predict the serum samples of allergic rhinitis patients VS healthy subjects. The number of correctly predicted samples divided by the total number of samples was the accuracy of FGL1 protein in distinguishing allergic rhinitis patients VS healthy subjects. The accuracy of FGL1 protein in distinguishing allergic rhinitis patients VS healthy subjects was 93.10% (27 / 29). The sample distribution diagram is shown in Figure 2 shown.

[0037] In summary, there is a significant difference in the FGL1 protein content in the serum of healthy subjects and patients with allergic rhinitis, and the FGL1 protein content in the serum of patients with allergic rhinitis is significantly higher than that of healthy subjects. Further diagnostic efficacy tests show that FGL1 protein can effectively diagnose and distinguish healthy subjects from patients with allergic rhinitis, with a high diagnostic accuracy, and can be used to develop a kit for diagnosing allergic rhinitis to improve diagnostic objectivity.

[0038] The purpose of the above-mentioned embodiments is to specifically introduce the essential content of the present invention, but those skilled in the art should know that the protection scope of the present invention should not be limited to the specific embodiments.

Claims

1. Use of FGL1 protein in preparing a kit for diagnosing allergic rhinitis.

2. The use according to claim 1, wherein the kit is a serum detection kit.

3. The use according to claim 1, wherein the kit contains a detection reagent for FGL1 protein.

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