CN110174512B - Application of sCD163 detection reagent in syphilis detection and kit comprising same - Google Patents

Abstract

The invention relates to an application of an sCD163 detection reagent in syphilis detection and a kit comprising the same. Specifically, the application of the sCD163 detection reagent in preparing a reagent composition or a kit for detecting syphilis. In addition, the invention also provides a syphilis detection kit, which comprises a detection reagent for detecting the sCD163 level in a biological sample. The invention can be used for diagnosis, typing, staging, curative effect evaluation and/or prognosis evaluation of syphilis, particularly nerve syphilis, and has the advantages of reliability, convenience, quickness and the like.

Description

Application of sCD163 detection reagent in syphilis detection and kit including the same

This application is a divisional application of a Chinese invention patent application entitled "Application of sCD163 Detection Reagent in Syphilis Detection and Kit Including the Reagent" and the application number is "201810297764.X".

technical field

The invention relates to the technical field of biomedicine, in particular to the application of sCD163 in the detection of neurosyphilis.

Background technique

The CD163 molecule is located on monocytes-macrophages and belongs to a scavenger receptor. CD163 is involved in the immune physiological process of the body, and is related to the occurrence and development of porcine reproductive and respiratory syndrome virus, for example. It is now generally believed that CD163 is the receptor of pathogens.

CD163 is a transmembrane glycoprotein with a molecular weight of 130kDa. Within the cysteine-rich repeat sequence, every 6-8 cysteine residues are connected by disulfide bonds and translated by a single exon. It belongs to B Type scavenger receptor member. The extracellular CD163 is rich in 9 cysteine domains, a type I transmembrane segment and a short intracellular cytoplasmic tail, each cysteine domain is composed of an α-helix as the core composed of 5-6 β-sheets. Soluble CD163 (soluble CD163, sCD163) is considered to be formed by the shedding of CD163 molecules on the monocyte-macrophage membrane, and it appears in serum or tissue fluid and is easy to detect. It was found by mass spectrometry that the structure of sCDl63 covered 94% of the extramembrane structure of CDl63.

At present, CD163 mainly appears in animal disease research. CD163 is more considered as a pathogen receptor. The purpose of many studies is to use CD163 receptor to block its binding to, for example, porcine reproductive and respiratory syndrome virus or other viruses. , preventing the virus from entering the target cell to avoid infection.

However, the research of CD163 is still in its infancy, and many functions of it have not been deeply understood. According to the current research, CD163 may have a dual role in physiology and pathology. On the one hand, CD163 can affect the maturation and differentiation of red blood cells. After binding as a receptor for certain molecules, it may cause phagocytes to secrete a large number of cytokines, improve the body's immunity, and also remove certain metabolites from the body. Immunomodulators are benign to animal organisms. On the other hand, CD163 mediates the infection of some pathogens as a receptor and may cause the proliferation of tumor cells, which again shows its pathological role.

However, at present, the relationship between CD163 and syphilis has never been reported, let alone its role in the pathogenesis of syphilis, whether it plays a physiological role as an immunomodulator or a pathological role of a pathogenic receptor or does not play any role at all. unknown.

Syphilis is a systemic disease caused by Treponema pallidum. Syphilis is generally divided into three stages: primary syphilis (such as infection site ulcers or chancroid), secondary syphilis (including but not limited to rash, mucocutaneous lesions, and lymphadenopathy), and tertiary syphilis (such as cardiac lesions or gum swellings). The incidence of syphilis has been increasing year by year in recent years. Although the quality of life of syphilis patients has been significantly improved and the mortality rate has decreased significantly with the promotion and application of penicillin therapy, syphilis is still a Class B infectious disease that should be highly regarded.

Because Treponema pallidum is not easy to survive outside the human body, it will die immediately after boiling, and it can be easily killed by general disinfectants such as dry soapy water and alcohol, so it cannot be cultured in vitro at present. The inability of Treponema pallidum to be cultured in vitro limits the spread and invasion of Treponema pallidum to a certain extent, but it also makes the study of Treponema pallidum and the study of syphilis disease very difficult and unchanged. Therefore, the current diagnosis and treatment of syphilis And there is little progress in prognosis research.

Latent syphilis, also known as latent syphilis, has an epidemiological history of multiple sexual partners and unsafe sex; or a history of sexually associated syphilis infection, so the risk of infection is high. The clinical manifestations are without any symptoms and signs of syphilis. If the disease period is within 2 years, it shall be judged according to the following criteria: ① In the past 2 years, the non-Treponema pallidum antigen test with clear records has changed from negative to positive, or its titer has increased by 4 times or higher than the original. ②In the past 2 years, there are clinical manifestations consistent with primary or secondary syphilis. ③Have a history of sexual contact with a suspected or confirmed primary or secondary syphilis, or a sexual partner suspected of early latent syphilis in the past 2 years. If the disease period is more than 2 years, it will be judged according to the following criteria: there is no evidence that the infection has been acquired in the past 2 years or the disease period cannot be judged. Both primary syphilis chancroid and secondary syphilis are self-limiting and generally leave no traces. If treatment is unsuccessful or unsuccessful, it will enter the stage of latent syphilis.

Neurosyphilis is a chronic systemic infectious disease caused by Treponema pallidum (TP) invading the central nervous system. The course of the disease can occur in various stages of syphilis (including early syphilis), manifested as cranial nerve dysfunction, meningitis, stroke, acute changes in mental status, hearing and vision loss. Diagnosis needs to be based on a comprehensive analysis of the patient's medical history, clinical manifestations, laboratory and imaging examinations. Serum and cerebrospinal fluid-related indicators have certain specificity and sensitivity.

Syphilis is known as the greatest imitator, and the clinical manifestations of neurosyphilis are also complex and changeable, with nonspecific symptoms, including almost all symptoms and signs in neurology, including neurology, ophthalmology, dermatology, Psychiatry and other departments have similar clinical manifestations, so the misdiagnosis rate of neurosyphilis is high, reaching 55.6%. For example, unexplained cerebral infarction in young adults caused by neurosyphilis, epilepsy and intellectual disability in young adults may be misdiagnosed. Therefore, neurosyphilis may be misdiagnosed. Correct diagnosis and prompt treatment are very important.

Neurosyphilis can be divided into asymptomatic neurosyphilis (Asymptomatic Neurosyphilis, ANS) and symptomatic neurosyphilis. Asymptomatic neurosyphilis is defined as a positive plasma test for syphilis with abnormal cerebrospinal fluid, but no neurological symptoms and signs. It is speculated that about 33.5% of syphilis patients have neurosyphilis, including about 13.5% of asymptomatic neurosyphilis, which usually occurs 12 to 18 months after infection and is the initial stage of neurosyphilis, asymptomatic neurosyphilis Patients with syphilis are more likely to develop symptomatic neurosyphilis than those with normal cerebrospinal fluid. Therefore, suspicious patients should be examined for cerebrospinal fluid for early detection and early treatment to avoid the progression of asymptomatic neurosyphilis to symptomatic neurosyphilis.

There is currently no gold standard for diagnosing neurosyphilis, and although laboratory tests are helpful in the diagnosis of neurosyphilis, no single test is available for the diagnosis of neurosyphilis in all cases. The diagnosis of neurosyphilis requires a comprehensive analysis of the patient's medical history, clinical manifestations, laboratory and imaging examinations, and further testing is often required for patients with clinical symptoms of neurosyphilis. According to reports, there are many markers that can reflect damage to the central nervous system, such as beta amyloid precursor protein and beta amyloid protein, myelin basic protein, neuron-specific enolase, microtubule-associated protein tau, etc. There are also some changes in neurosyphilis patients, but there are problems such as poor specificity.

In view of the complex clinical manifestations of syphilis, especially neurosyphilis, and the high rate of misdiagnosis, there is a great need for a reagent and method that can quickly, easily and accurately diagnose syphilis, especially neurosyphilis. Moreover, since Treponema pallidum cannot be cultured in vitro, further research on it is restricted, which makes such a reagent or method more significant and valuable.

SUMMARY OF THE INVENTION

A first aspect of the present invention provides a syphilis detection kit, the kit includes a detection reagent for detecting the level of sCD163 in a biological sample.

The second aspect of the present invention provides the use of a detection reagent for detecting the level of sCD163 in a biological sample in preparing the kit according to the first aspect of the present invention.

By studying the sCD163 level of biological samples from neurosyphilis patients, the inventors found for the first time that there is a certain correlation between abnormal sCD163 levels and the course of syphilis and the occurrence of related symptoms, so it has great clinical significance for syphilis. Since the level of sCD163 in the biological samples from the neurosyphilis patient group was significantly different from the sCD163 level in the biological samples from the non-neurosyphilis patient group, it indicated that the sCD163 in the biological samples from the syphilis patients with different clinical types or stages Levels are different. The levels of sCD163 in biological samples of patients are different, and the degree of immune response and immune damage are also different. Therefore, syphilis, especially neurosyphilis, can be early diagnosed, classified and staging, curative effect evaluation and/or prognosis evaluation based on sCD163 levels.

Description of drawings

Figure 1 shows the mean levels of CSF sCD163 in NS patients (n=12) and S patients (n=14). Among them, NS means neurosyphilis; S means latent syphilis.

Figure 2 shows the results of statistical analysis of sCD163 levels in the cerebrospinal fluid of patients in the NS and S groups. Among them, NS means neurosyphilis; S means latent syphilis.

Figure 3 shows the cerebrospinal fluid pNF-H and NF-L levels of patients in the NS and S groups. Among them, NS means neurosyphilis; S means latent syphilis.

Detailed ways

In order to make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. However, the described embodiments are some, but not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.

The first aspect of the present invention provides the application of the sCD163 detection reagent in the preparation of a reagent composition or kit for detecting syphilis.

In some embodiments, the detection reagent is a detection reagent for qualitative detection or quantitative detection of sCD163 in biological samples. In some preferred embodiments, the detection reagent is an antibody against sCD163. In some more preferred embodiments, the antibody is an anti-human sCD163 antibody. Further preferably, the antibody is a polyclonal antibody or a monoclonal antibody, most preferably a monoclonal antibody. The monoclonal antibody may be known, eg, the monoclonal antibody included in the sCD163 ELISA detection kit available from commercial reagent companies such as affymetrix ebioscience.

In addition, sCD163 can also be qualitatively and quantitatively analyzed by flow cytometry. Moreover, compared with the traditional ELISA technology that can only detect one indicator, the flow multi-factor detection technology can simultaneously detect multiple indicators from one sample. The representative technologies are Luminex and BD CBA (cytometric bead array system, CBA), and FlowCytomix technology under eBioscience. The detection principle of flow cytometry is the same as that of sandwich immunoassay. Fluorescent microspheres are coated with selected antigen-specific antibodies. The antibody-coated microsphere mixture is incubated with the sample. The analyte in the sample (such as cytokines, etc.) binds to the antibody coated on the microspheres. A mixture of biotinylated antibodies that specifically bind to the analyte bound to capture antibodies (microspheres). Finally, Streptavidin-PE was added to combine with biotin for fluorescence detection. Flow cytometry differentiates microsphere populations based on the size of the microspheres and the intensity of fluorescent labeling.

(Neurofilament light)ELISA(Enzyme immunoassayfor quanlitative determination of human Neurofilament light(NF-L)protein incerebrosphinal fluid)(LBL international GME)所述；pNF-H(例如来自血或脑脊液的pNF-H)的检测试剂可以如商用试剂盒Human Phosphorylated Neurofilament H ELISA试剂盒(BioVendor-Laboratornímedicína a.s.)所述。更优选的是，所述第二检测试剂为用于选自由RPR检测、TPPA或TPHA检测、FTA-ABS检测和NF-L检测、pNF-H检测组成的组的梅毒检测方法的检测试剂；进一步优选的是，所述第二检测试剂为用于RPR检测、TPPA检测和/或FTA-ABS检测的检测试剂。FTA-ABS以及TPPA是诊断梅毒螺旋体感染特异性指标，一般认为脑脊液FTA-ABS阴性可以排除神经梅毒，该指标结合sCD163检测结果，能够增加诊断神经梅毒的敏感性和特异性。In some preferred embodiments, the kit further includes an optional second detection reagent, which is selected from the group consisting of VDRL (venereal disease research laboratory) detection, USR ( unheated serum regain (plasma reagin)) detection, TRUST (toluidine redunheated serum test (toluidine red plasma without heating test)) detection, RPR (rapid plasma regain (rapid plasma reagin)) detection, FTA- ABS (fluorescent treponemal antibody-absorption) detection, TPHA (Treponema pallidum hemagglutination assay) detection, TPPA (Treponema pallidum particle agglutination assay) detection, pNF- Detection reagents for one or more syphilis detection methods of the group consisting of H detection and NF-L detection, these syphilis detection methods and the reagents used therefor are known. For example, VDRL detection, USR detection, TRUST detection, RPR Detection, FTA-ABS detection, TPHA detection and TPPA detection and the reagents used can all be as described in industry standards such as the diagnostic criteria for syphilis (WS 273-2007). NF-L (for example from biological samples such as blood or cerebrospinal fluid) NF-L) detection reagents can be commercial kits such as

(Neurofilament light) ELISA (Enzyme immunoassay for quanlitative determination of human Neurofilament light (NF-L) protein incerebrosphinal fluid) (LBL international GME) is described; detection reagents for pNF-H (eg, pNF-H from blood or cerebrospinal fluid) can be as follows Commercial kit Human Phosphorylated Neurofilament H ELISA kit (BioVendor-Laboratornímedicína as). More preferably, the second detection reagent is a detection reagent for a syphilis detection method selected from the group consisting of RPR detection, TPPA or TPHA detection, FTA-ABS detection and NF-L detection, pNF-H detection; further Preferably, the second detection reagent is a detection reagent for RPR detection, TPPA detection and/or FTA-ABS detection. FTA-ABS and TPPA are specific indicators for diagnosing Treponema pallidum infection. It is generally believed that a negative FTA-ABS in cerebrospinal fluid can exclude neurosyphilis. The combination of this indicator and sCD163 test results can increase the sensitivity and specificity of diagnosing neurosyphilis.

In other embodiments, the kit further includes detection reagents for detecting cerebrospinal fluid proteins and/or cerebrospinal fluid leukocytes.

In some embodiments, the kit further includes detection reagents for detection of pNF-H (phosphorylated neurofilament heavy chain) or NF-L (neurofilament light chain), such as anti-human pNF-H or NF -L monoclonal antibody. The inventors found that pNF-H or NF-L is closely related to sCD163, so it can be used for combined diagnosis to improve the diagnostic accuracy.

In other embodiments, the kit is used to detect the level of sCD163 in a biological sample, and the biological sample is cerebrospinal fluid. In some more preferred embodiments, the biological sample is from a human biological sample, more preferably a sample from a syphilis patient or a suspected syphilis patient. In the case of quantitatively detecting sCD163 in a biological sample, the biological sample is preferably cerebrospinal fluid, in order to improve the detection sensitivity and accuracy.

In some embodiments, the kit is used for the genotyping detection of syphilis, for example, syphilis can be differentiated into neurosyphilis and non-neurosyphilis such as latent syphilis, or further differentiated into symptomatic neurosyphilis, asymptomatic neurosyphilis, non-neurosyphilis Neurosyphilis such as latent syphilis.

In some preferred embodiments, the syphilis is neurosyphilis. Since biological samples such as cerebrospinal fluid from patients with neurosyphilis have sCD163 levels corresponding to different stages or different severities of syphilis. Thus, in this case, neurosyphilis can be classified (eg, neurosyphilis or non-neurosyphilis, further, eg, symptomatic neurosyphilis, asymptomatic neurosyphilis, or latent syphilis) or staged based on the level of sCD163 detected . Since the level of sCD163 is much higher than the current detection limit, it is possible to type or stage syphilis, especially neurosyphilis, with high sensitivity by detecting the level of sCD163 in, for example, cerebrospinal fluid. Diagnosis (such as early diagnosis or early exclusion), early classification and staging of syphilis, especially neurosyphilis, and accurate quantitative evaluation of the efficacy of neurosyphilis treatment programs (especially when the biological sample is cerebrospinal fluid), For example, the evaluation of prognostic effect. In some embodiments, the syphilis is symptomatic neurosyphilis, since high expression levels in biological samples such as cerebrospinal fluid from patients with symptomatic neurosyphilis are readily detectable with high sensitivity and accuracy. Thus, in some preferred embodiments, the biological sample is cerebrospinal fluid, and the detection is a quantitative detection of the severity and/or prognostic effect of neurosyphilis. In addition, in some preferred embodiments, the kit is a kit for early diagnosis, classification and staging, efficacy evaluation and/or prognosis evaluation of syphilis, especially neurosyphilis.

A second aspect of the present invention provides a syphilis detection kit, which includes a detection reagent for detecting the level of sCD163 in a biological sample. In some preferred embodiments, the detection reagent is an antibody against sCD163; more preferably, the antibody is an antibody against human sCD163; further preferably, the antibody is a polyclonal antibody or a monoclonal antibody; Most preferred are monoclonal antibodies. It is also preferred that the kit further includes a second detection reagent, which is selected from the group consisting of VDRL detection, USR detection, TRUST detection, RPR detection, TPHA or TPPA detection, FTA-ABS detection, ELISA The detection reagent of one or more syphilis detection methods of the group consisting of detection and NF-L detection; preferably, the second detection reagent is selected from RPR detection, TPHA or TPPA detection, FTA-ABS detection and The detection reagent of the syphilis detection method of the group consisting of NF-L detection; more preferably, the second detection reagent is a detection reagent for FTA-ABS detection and/or TPPA detection.

In the diagnosis of syphilis (including early diagnosis, classification and staging, efficacy evaluation and/or prognosis evaluation, etc.), neurosyphilis patients can be classified and staged according to the level of sCD163 in the cerebrospinal fluid (ie, the classification and/or staging of neurosyphilis). ). Alternatively, neurosyphilis patients can be prognostically assessed based on the difference in CSF sCD163 prognosis relative to pre-treatment (or referred to as pre-treatment). Therefore, in some specific embodiments, the present invention provides a syphilis detection kit, the kit includes a detection reagent for detecting the level of sCD163 in cerebrospinal fluid, and is used for typing, staging or prognostic assessment of neurosyphilis patients . The present invention also provides the application of the detection reagent in preparing a kit for typing and staging neurosyphilis patients (ie, typing and/or staging neurosyphilis) or evaluating prognosis.

In addition, in the diagnosis of neurosyphilis (including early diagnosis, classification and staging, efficacy evaluation and/or prognosis evaluation, etc.), the level of sCD163 in cerebrospinal fluid can be independently or selected from the level of pNF-H, NF-L, and RPR in cerebrospinal fluid. One or more indexes in the group consisting of titer, cerebrospinal fluid leukocyte level and cerebrospinal fluid protein level are used in combination for early diagnosis, classification and staging, efficacy evaluation and/or prognosis evaluation of syphilis, especially neurosyphilis. Therefore, in some specific embodiments, the present invention provides a syphilis detection kit, the kit includes: a first detection reagent for detecting the level of sCD163 in cerebrospinal fluid; an optional second detection reagent, the first detection reagent The second detection reagent is used to detect one or more indicators selected from the group consisting of pNF-H, NF-L level, cerebrospinal fluid RPR titer, cerebrospinal fluid leukocyte level and cerebrospinal fluid protein level.

In the present invention, cerebrospinal fluid pNF-H level, cerebrospinal fluid NF-L level, cerebrospinal fluid sCD163 level, cerebrospinal fluid RPR titer, cerebrospinal fluid leukocyte count, cerebrospinal fluid protein content are all detected by known detection methods. For example, pNF-H, NF-L, and sCD163 can be measured by commercial kits, and other indicators can be measured according to the methods specified in my country's industry standard syphilis diagnostic criteria (WS273-2007).

Example

1. General clinical data of the patient

The patients in this study were diagnosed with neurosyphilis or latent syphilis according to the WS 273-2007 diagnostic criteria for syphilis.

2. Sample acquisition

According to the conditions of the enrolled patients, with the informed consent of the patients, 5ml of cerebrospinal fluid was collected by lumbar puncture, which was divided into cryopreservation tubes, coded and marked, and stored in a -80°C refrigerator.

3. Detection method

(Neurofilament light)ELISA(Enzyme immunoassay for quanlitative determinationof human Neurofilament light(NF-L)protein in cerebrosphinal fluid)(LBLinternational GME)根据说明书进行检测。脑脊液pNF-H的检测采用HumanPhosphorylated Neurofilament H ELISA试剂盒(BioVendor-Laboratornímedicínaa.s.)并按照所附的厂家的说明书进行检测。脑脊液RPR滴度、脑脊液蛋白检测和脑脊液白细胞的检测根据WS 273-2007所述的方法进行。The detection methods used in the examples are all known. Among them, the detection of NF-L in cerebrospinal fluid adopts

(Neurofilament light) ELISA (Enzyme immunoassay for quanlitative determination of human Neurofilament light (NF-L) protein in cerebrosphinal fluid) (LBLinternational GME) was performed according to the instructions. The detection of cerebrospinal fluid pNF-H was performed using Human Phosphorylated Neurofilament H ELISA kit (BioVendor-Laboratornímedicínaa.s.) and according to the attached manufacturer's instructions. Cerebrospinal fluid RPR titers, cerebrospinal fluid protein detection and cerebrospinal fluid leukocyte detection were performed according to the methods described in WS 273-2007.

Cerebrospinal fluid sCD163 levels were detected using the Human SCD163 ELISA kit purchased from affymetrix ebioscience and according to the instructions therein.

4. Detection content

Twelve patients in the neurosyphilis group had sCD163 levels detected, and 14 patients in the latent syphilis group had sCD163 levels detected. Cerebrospinal fluid NF-L levels, cerebrospinal fluid pNF-H levels, cerebrospinal fluid RPR titers, cerebrospinal fluid protein levels, and cerebrospinal fluid leukocyte levels were also detected in these patients.

5. Results and Analysis

Figure 1 shows the mean levels of CSF sCD163 in NS patients (n=12) and S patients (n=14). As can be seen from Figure 1, the average level of sCD163 in the cerebrospinal fluid of patients with neurosyphilis reached 798.3 pg/ml, while the average level of sCD163 in the cerebrospinal fluid of patients with latent syphilis was 34.5 pg/ml. That is to say, the level of sCD163 in the cerebrospinal fluid of patients with neurosyphilis is 23 times that of patients with recessive syphilis! Therefore, by measuring the level of sCD163 in the cerebrospinal fluid of syphilis patients, neurosyphilis patients can be very easily distinguished from those with latent syphilis, so it can be used for syphilis patient typing, for example, syphilis patients are classified according to the level of sCD163 in cerebrospinal fluid. patients with neurosyphilis and latent syphilis.

Figure 2 shows the results of statistical analysis of sCD163 levels in the cerebrospinal fluid of patients in the NS and S groups. Among them, the median level of sCD163 in the neurosyphilis group was 151.81ng/ml; the median level of sCD163 in the latent syphilis group was 12.86ng/ml; the level of sCD163 in the neurosyphilis group was higher than that in the latent syphilis group, with statistical significance (P<0.001). It can be seen that this result is consistent with the results obtained in Figure 1, and it also confirms that syphilis patients can be classified according to the level of sCD163 in the cerebrospinal fluid of syphilis patients.

Moreover, after correlation analysis, it was found that the level of sCD163 was correlated with syphilis stage, and the correlation coefficient was r=0.680, P<0.001. Therefore, the level of sCD163 in the cerebrospinal fluid of syphilis patients can be used for syphilis staging in syphilis patients.

The inventors have confirmed in other studies that pNF-H and NF-L are good markers that can sensitively indicate nerve damage, and can be used for early diagnosis, classification and staging, efficacy evaluation and evaluation of syphilis, especially neurosyphilis. and/or prognostic assessment, their levels can reflect the severity of nerve damage in patients with neurosyphilis (see Figure 3). Therefore, the present invention further detects the levels of pNF-H and NF-L, and conducts a correlation analysis between them and the level of sCD163. The results showed that sCD163 was highly correlated with the level of NF-L in cerebrospinal fluid (r=0.803, P<0.001) and the level of CD14 in cerebrospinal fluid (r=0.859, P<0.001) (the level of CD14 in cerebrospinal fluid can also be used for the detection of syphilis. Separate application for technical solution). In addition, the level of sCD163 was also correlated with the level of pNF-H in cerebrospinal fluid (r=0.662, P<0.001), which was also statistically significant. It can be seen that, as a marker for syphilis detection, sCD163 has similar effects as pNF-H, NF-L and CD14.

The inventors also detected cerebrospinal fluid RPR titer, cerebrospinal fluid protein, and cerebrospinal fluid leukocytes. The results showed that sCD163 was highly correlated with cerebrospinal fluid RPR titer (r=0.778, P<0.001), cerebrospinal fluid protein (r=0.812, P<0.001), and was also closely related to cerebrospinal fluid leukocytes (r=0.617, P=0.001), and positive correlation. Therefore, the sCD163 assay can be used to diagnose syphilis patients instead of the above-mentioned existing assays.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, but not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that it can still be The technical solutions described in the foregoing embodiments are modified, or some technical features thereof are equivalently replaced; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims (7)

1. The application of a sCD163 detection reagent in the preparation of a reagent composition or a kit for detecting human neurosyphilis, the kit is used for detecting the level of sCD163 in a biological sample, and the sCD163 detection reagent is an antibody against human sCD163, The biological sample is cerebrospinal fluid, and the antibody is a polyclonal antibody or a monoclonal antibody. 2. application according to claim 1, is characterized in that, described test kit also comprises the second detection reagent, described second detection reagent is for being selected from VDRL detection, USR detection, TRUST detection, RPR detection, TPHA Or detection reagents for one or more syphilis detection methods in the group consisting of TPPA detection, FTA-ABS detection, pNF-H detection, and NF-L detection. 3. application according to claim 2 is characterized in that, described second detection reagent is for being selected from RPR detection, TPHA or TPPA detection, FTA-ABS detection, pNF-H detection and NF-L detection composition A set of detection reagents for the syphilis detection method. The application according to claim 2, wherein the second detection reagent is a detection reagent for RPR detection, TPPA detection and/or FTA-ABS detection. 5. The application according to claim 1, wherein the test kit is used for staging and typing of syphilis. 6. The application according to claim 1, wherein the test kit is used for the screening of neurosyphilis patients and latent syphilis patients. 7. The application according to claim 1, wherein the kit is used for early diagnosis, classification and staging, efficacy evaluation and/or prognosis evaluation of neurosyphilis.

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