CN110174512B

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

Info

Publication number: CN110174512B
Application number: CN201910444180.5A
Authority: CN
Inventors: 许东梅; 伦文辉
Original assignee: Beijing Ditan Hospital
Current assignee: Beijing Ditan Hospital
Priority date: 2018-04-04
Filing date: 2018-04-04
Publication date: 2022-06-03
Anticipated expiration: 2038-04-04
Also published as: CN108535479A; CN108535479B; CN110174512A

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 comprising same

The application is a divisional application of a Chinese invention patent application with the invention name of ' application of sCD163 detection reagent in syphilis detection and a kit comprising the reagent ' and the application number of ' 201810297764.

Technical Field

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

Background

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

CD163 is a transmembrane glycoprotein with a molecular weight of 130kDa, is linked by disulfide bonds in 6-8 cysteine residues within a cysteine-rich repeat sequence, is translated by a single exon, and belongs to a member of the class B scavenger receptor. Extracellular CD163 is rich in 9 cysteine domains, an I-type transmembrane segment and a short intracellular cytoplasmic tail, each consisting of 5-6 β -sheets centered on an α -helix. Soluble CD163(soluble CD163, sCD163) is believed to be formed by shedding of CD163 molecules from the membrane of monocytes macrophages, and is present in serum or interstitial fluid and is readily detectable. The structure of sCDl63 was found to cover 94% of the extra-membrane structure of CDl63 by mass spectrometry studies.

CD163 is currently predominantly present in animal disease studies, and CD163 is considered more as a pathogen receptor, and many studies are aimed at using the CD163 receptor to block its binding to, for example, porcine reproductive and respiratory syndrome virus or other viruses, and to prevent the virus from entering target cells to avoid infection.

However, the study of CD163 is still in its infancy and its numerous functions are not well understood. According to current studies, CD163 may have a physiopathological dual role. On one hand, CD163 can affect the mature differentiation of erythrocytes, and after being combined with receptors of certain molecules, the CD163 can cause phagocytes to secrete a large amount of cytokines, improve the immunity of the organism, and can also eliminate certain metabolites of the organism and the like. On the other hand, CD163, as a receptor, mediates infection by certain pathogens and may cause proliferation of tumor cells, which in turn shows its pathological role.

However, at present, the relationship between CD163 and syphilis has not been reported, and it is unknown what role it plays in the onset of syphilis, whether it plays a physiological role of an immunomodulator or a pathological role of a pathogenic receptor, or does not play any role at all.

Syphilis is a systemic disease caused by treponema pallidum. Syphilis is generally divided into three stages: stage one syphilis (such as ulcer at infection site or chancroid), stage two syphilis (including but not limited to rash, skin mucosa lesion and lymph node lesion), and stage three syphilis (such as heart lesion or gummy swelling). The incidence of syphilis is increasing year by year in recent years, and although the quality of life of syphilis patients is remarkably improved and the mortality rate is remarkably reduced with the popularization and application of penicillin treatment, syphilis still is a type B infectious disease which should be highly regarded.

Because the treponema pallidum is not easy to survive outside a human body and dies immediately after boiling, the treponema pallidum can be killed easily by common disinfectants such as dry soapy water, alcohol and the like, so that the treponema pallidum 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 some extent, but also makes the study of treponema pallidum and the study of syphilis disease extremely difficult and invariable, so the current diagnosis, treatment and prognosis study of syphilis is not greatly advanced.

Recessive syphilis, also known as latent syphilis, has an epidemiological history of multiple sexual partners and insecurity; or the sex is accompanied by the infection history of syphilis, so the infection risk is large. The clinical manifestations are symptoms and signs without any plum toxicity. In the case of a disease stage within 2 years, the disease stage is judged according to the following criteria: in the past 2 years, there are well-documented tests of non-treponema pallidum antigens that switch from negative to positive, or whose titers have been raised 4-fold or higher than before. ② within the last 2 years, there is clinical manifestation according with first or second stage syphilis. Third, in the past 2 years, there was a history of sexual contact with suspected or diagnosed primary or secondary syphilis, or suspected early recessive syphilis. In the case where the disease period is 2 years or more, the disease period is judged according to the following criteria: there is no evidence of acquired infection or failure to diagnose stage in the past 2 years. The first stage syphilis chancroid and the second stage syphilis rash are self-limiting and generally leave no trace, and if the treatment fails or is unsuccessful, the stage of recessive syphilis is entered.

The 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), and is manifested by cranial nerve dysfunction, meningitis, stroke, acute changes of mental state, hearing and vision deterioration, and the like. Diagnosis requires comprehensive analysis based on the patient's medical history, clinical presentation, laboratory and imaging examinations, etc. The related indexes of serum and cerebrospinal fluid have certain specificity and sensitivity.

Syphilis is called as the most powerful imitator, the clinical manifestations of the neurosyphilis are also complex and variable, the symptoms are not specific, almost all various symptoms and signs in neurology can be included, and similar clinical manifestations of neurology, ophthalmology, dermatology, psychiatry and the like can appear, so that the misdiagnosis rate of the neurosyphilis is high and reaches 55.6%, for example, cerebral infarction of unknown reasons of young and strong years caused by the neurosyphilis, epilepsy, intellectual disability and the like appearing in young and strong years can be misdiagnosed, and therefore, correct diagnosis and timely treatment of the neurosyphilis are very important.

The Neurosyphilis can be classified into Asymptomatic Neurosyphilis (ANS), symptomatic Neurosyphilis, and the like. Asymptomatic neurosyphilis refers to positive plasmatic examination of syphilis, with abnormalities in cerebrospinal fluid, but without symptoms and signs of the nervous system. It is presumed that about 33.5% of syphilis patients are neurosyphilis including about 13.5% of asymptomatic neurosyphilis, which usually occurs 12 to 18 months after infection and is the initial stage of neurosyphilis, and asymptomatic neurosyphilis patients progress to symptomatic neurosyphilis more easily than those with normal cerebrospinal fluid, and therefore, examination of cerebrospinal fluid should be performed on suspected patients to find early treatment in the early stage and avoid progress of asymptomatic neurosyphilis to symptomatic neurosyphilis.

There is no current gold standard for diagnosing neurosyphilis, and although laboratory tests are helpful for the diagnosis of neurosyphilis, no single test method is available for the diagnosis of neurosyphilis in all cases. The diagnosis of the neurosyphilis needs comprehensive analysis according to the medical history, clinical manifestations, laboratory and imaging examinations of patients, and further tests are often needed for patients with clinical symptoms of the neurosyphilis. Many markers capable of reflecting central nervous system injury are reported, such as beta amyloid precursor protein and beta amyloid, myelin basic protein, neuron-specific enolase, microtubule-associated protein tau, etc., and these markers have some changes in patients with neurosyphosis, but all have problems such as poor specificity, etc.

In view of the complex clinical manifestations and high misdiagnosis rate of syphilis, especially neurosyphilis, there is a great need for a reagent and a method for diagnosing syphilis, especially neurosyphilis, quickly, conveniently and accurately. In addition, as the treponema pallidum can not be cultured in vitro, the deeper research on the treponema pallidum is limited, so that the reagent or the method has more significance and has great value.

Disclosure of Invention

The invention provides a syphilis detection kit in a first aspect, and the kit comprises a detection reagent for detecting the sCD163 level in a biological sample.

In a second aspect, the invention provides the use of a detection reagent for detecting the level of sCD163 in a biological sample in the preparation of a kit according to the first aspect of the invention.

The inventor of the present invention has studied the sCD163 level of a biological sample from a patient with syphilis, and has found for the first time that there is a certain correlation between the abnormal sCD163 level and the course of syphilis and the occurrence of related symptoms, and thus the present invention has great clinical significance for syphilis. Since the sCD163 levels in biological samples from the group of patients with neurosyphilis were statistically different compared to the sCD163 levels in biological samples from the group of patients with non-neurosyphilis, it is suggested that sCD163 levels in biological samples from different clinically typed or staged syphilis patients are different. The sCD163 level in the biological samples of patients is different, and the immune response degree and the immune injury degree are also different, so that the syphilis, especially the neural syphilis, can be subjected to early diagnosis, classification and staging, curative effect evaluation and/or prognosis evaluation according to the sCD163 level.

Drawings

Fig. 1 shows mean levels of cerebrospinal fluid sCD163 in NS patients (n-12) and S patients (n-14). Wherein NS represents neurosyphilis; s represents recessive syphilis.

FIG. 2 shows the results of statistical analysis of the levels of sCD163 in cerebrospinal fluid of NS and S group patients. Wherein NS represents neurosyphilis; s represents recessive syphilis.

FIG. 3 shows the levels of cerebrospinal fluid pNF-H and NF-L in NS and S groups of patients. Wherein NS represents neurosyphilis; s represents recessive syphilis.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. The described embodiments are, however, a subset of the embodiments of the invention and not all embodiments of the invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.

The invention provides an application of an sCD163 detection reagent in preparation of a reagent composition or a kit for detecting syphilis.

In some embodiments, the detection reagent is a detection reagent for qualitative or quantitative detection of sCD163 in a biological sample. In some preferred embodiments, the detection reagent is an antibody against sCD 163. In some more preferred embodiments, the antibody is an antibody against human sCD 163. It is further preferred that the antibody is a polyclonal antibody or a monoclonal antibody, most preferably a monoclonal antibody. The monoclonal antibodies may be known, for example, as included in the sCD163ELISA test kits available from commercial reagents companies (e.g., affymetrix ebioscience).

In addition, sCD163 can also be qualitatively and quantitatively analyzed using flow cytometry. Moreover, compared with the traditional ELISA technology which can only detect one index, the flow-type multi-factor detection technology can realize the simultaneous detection of multiple indexes from one sample. Representative of these are Luminex and BD CBA (cellular bead array system, CBA), and the FlowCytomix technology under the heading eBioscience corporation. The detection principle of flow cytometry is the same as that of sandwich immunoassay. The fluorescent microspheres are coated with selected antigen-specific antibodies. The antibody-coated microsphere mixture is incubated with the sample. The analyte (such as cytokine) in the sample is bound to the antibody coated on the microsphere. The biotin-labeled antibody mixture is specifically bound to the sample bound to the capture antibody (microsphere). And finally adding Streptavidin-PE, and combining with biotin for fluorescence detection. The flow cytometer distinguishes microsphere groups according to the size of the microspheres and the strength of the fluorescent label.

In some preferred embodiments, the kit further comprises an optional second detection reagent for a detection reagent selected from the group consisting of VDRL (venereal disease research laboratory) detection, USR (unheated serum regain (blood)Plasma non-heating-required reactivity)), a TRUST (toluidine red plasma non-heating test), an RPR (rapid plasma reactive protein), an FTA-ABS (fluorescent spirochete antibody uptake), a TPHA (Treponema pallidum agglutination assay), a TPPA (Treponema pallidum agglutination assay), a pNF-H assay, and an NF-L assay, and reagents therefor are known. For example, VDRL assay, USR assay, TRUST assay, RPR assay, FTA-ABS assay, TPHA assay, and TPPA assay and reagents used therein can be described in industry standards such as the syphilis diagnostic standard (WS 273-2007). The NF-L (e.g., NF-L in a biological sample such as blood or cerebrospinal fluid) detection reagent can be, for example, a commercial kit

(Neuroxilent light) ELISA (Enzyme immunological for qualitative determination of human Neuroxilent light (NF-L) protein in temporal fluidic flow) (LBL International GME); the detection reagent for pNF-H (e.g., pNF-H from blood or cerebrospinal fluid) can be as described in the commercial kit Human Phosphorylated neuroflament H ELISA kit (BioVendor-laboratory Primary Zinc A.s.). 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, NF-L detection, pNF-H detection; it is further preferred that the second detection reagent is a detection reagent for RPR detection, TPPA detection and/or FTA-ABS detection. FTA-ABS and TPPA are specific indexes for diagnosing treponema pallidum infection, generally speaking, cerebrospinal fluid FTA-ABS negative can eliminate nerve syphilis, and the indexes can increase sensitivity and specificity for diagnosing nerve syphilis by combining with sCD163 detection results.

In still other embodiments, the kit further comprises a detection reagent for detecting cerebrospinal fluid protein and/or cerebrospinal fluid leukocytes.

In some embodiments, the kit further comprises a detection reagent for detecting pNF-H (phosphorylated neurofilament protein heavy chain) or NF-L (neurofilament protein light chain), such as a monoclonal antibody against human pNF-H or NF-L. The research of the inventor finds that pNF-H or NF-L is closely related to sCD163, and therefore, the pNF-H or NF-L can be used for combined diagnosis to improve the diagnosis accuracy.

In some further embodiments, the kit is for detecting the level of sCD163 in a biological sample, and the biological sample is cerebrospinal fluid. In some more preferred embodiments, the biological sample is derived from a human, more preferably from a syphilitic patient or a suspected syphilitic patient. In case of quantitative detection of sCD163 in a biological sample, preferably the biological sample is cerebrospinal fluid, to improve detection sensitivity and accuracy.

In some embodiments, the kit is used for typing detection of syphilis, for example, syphilis can be distinguished as neurosyphilis and non-neurosyphilis such as recessive syphilis, or further distinguished as symptomatic neurosyphilis, asymptomatic neurosyphilis, non-neurosyphilis such as recessive syphilis, and the like.

In some preferred embodiments, the syphilis is neurosyphilis. Since biological samples of patients with neurosyphilis, such as cerebrospinal fluid, have sCD163 levels that correspond to different periods or different severity of syphilis. Thus, in this case, it is possible to classify (e.g., neurosyphilis or non-neurosyphilis, further, e.g., symptomatic neurosyphilis, asymptomatic neurosyphilis or recessive syphilis) or stage) the neurosyphilis according to the detected level of sCD 163. Since the content of sCD163 level is much higher than the detection limit that can be currently detected, syphilis, especially neurosyphus, can be typed or staged with high sensitivity by detecting sCD163 level in e.g. cerebrospinal fluid, early diagnosis (e.g. early confirmation or early elimination) of patients suspected to be syphilis can be performed, typing and staging of syphilis, especially neurosyphus, can be performed early, and the efficacy of a neurosyphus treatment regimen can be accurately quantified (especially in case the biological sample is cerebrospinal fluid), e.g. the assessment of the prognostic effect. In some embodiments, the syphilis is symptomatic neurometavirus, because the level of expression in a biological sample, e.g., cerebrospinal fluid, of a patient with symptomatic neurometavirus is high, allowing easy detection with high sensitivity and high 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, typing staging, efficacy evaluation and/or prognosis evaluation of syphilis, particularly of neurosyphilis.

In a second aspect, the present invention provides a syphilis detection kit comprising a detection reagent for detecting the level of sCD163 in a biological sample. In some preferred embodiments, the detection reagent is an antibody against sCD 163; more preferably, the antibody is an anti-human sCD163 antibody; further preferably, the antibody is a polyclonal antibody or a monoclonal antibody; most preferred are monoclonal antibodies. It is further preferred that the kit further comprises a second detection reagent for one or more syphilis detection methods selected from the group consisting of VDRL detection, USR detection, TRUST detection, RPR detection, TPHA or TPPA detection, FTA-ABS detection, ELISA detection, NF-L detection; preferably, the second detection reagent is a detection reagent for a syphilis detection method selected from the group consisting of RPR detection, TPHA or TPPA detection, FTA-ABS detection, and NF-L detection; more preferably, the second detection reagent is a detection reagent for FTA-ABS detection and/or TPPA detection.

In the diagnosis (including early diagnosis, classification and staging, efficacy evaluation and/or prognosis evaluation and the like) of syphilis, patients with neurosyphotosis can be classified and staged according to the level of cerebrospinal fluid sCD163 (i.e., neurosyphotosis is classified and/or staged). Alternatively, the prognosis of patients with neurosyphilis can be assessed by the difference between the prognosis of sCD163 in cerebrospinal fluid and the prognosis (or called pre-treatment). Thus, in some specific embodiments, the present invention provides a syphilis detection kit, which includes a detection reagent for detecting the level of sCD163 in cerebrospinal fluid, and is used for typing staging or prognosis evaluation of a patient with neurosyphilis. The invention also provides application of the detection reagent in preparing a kit for typing and staging (namely typing and/or staging) or prognosis evaluation of the patient with the neurosyphilis.

In addition, in diagnosing (including early diagnosis, staging, efficacy evaluation and/or prognosis evaluation, etc.) the cerebrospinal fluid sCD163 level may be used for early diagnosis, staging, efficacy evaluation and/or prognosis evaluation of syphilis, especially of neurosyphus, independently or in combination with one or more indicators selected from the group consisting of the pNF-H, NF-L level, the cerebrospinal fluid RPR titer, the cerebrospinal fluid leukocyte level and the cerebrospinal fluid protein level. Thus, in some embodiments, the present invention provides a syphilis detection kit, comprising: a first detection reagent for detecting the level of cerebrospinal fluid sCD 163; optionally a second detection agent for detecting one or more indicators selected from the group consisting of pNF-H, NF-L level, cerebrospinal RPR titer, cerebrospinal leukocyte level, and cerebrospinal protein level.

In the present invention, the level of pNF-H in cerebrospinal fluid, the level of NF-L in cerebrospinal fluid, the level of sCD163 in cerebrospinal fluid, the RPR titer in cerebrospinal fluid, the number of leukocytes in cerebrospinal fluid, and the amount of protein in cerebrospinal fluid are all determined by known detection methods. For example, pNF-H, NF-L, sCD163 can be measured by a commercial kit, and other indexes can be measured by a method specified by the national industry standard syphilis diagnostic standard (WS 273-.

Examples

1. General clinical data of patients

Patients in this study were diagnosed with either neuro-or occult syphilis according to WS 273-2007 syphilis diagnostic criteria.

2. Sample acquisition

According to the condition of patients to be grouped, 5ml of cerebrospinal fluid is reserved by lumbar puncture under the informed consent of the patients, split charging is carried out by using a freezing tube, coding and marking are carried out, the cerebrospinal fluid is stored in a refrigerator at the temperature of minus 80 ℃, and finally unified detection is carried out, so that batch errors of sample detection are avoided.

3. Detection method

The detection methods employed in the examples are all known. Wherein the NF-L of the cerebrospinal fluid is detected

(Neuroxilent light) ELISA (Enzyme immunoassay for quantitative determination of human Neuroxilent light (NF-L) protein in temporal fluidic flow) (LBL International GME) was performed according to the instructions. Detection of cerebrospinal fluid pff-H was performed using a Human Phosphorylated neuroflament H ELISA kit (biovector-laboratory i.n. a. s.) and following the attached manufacturer's instructions. The detection of the RPR titer, the cerebrospinal protein and the cerebrospinal leukocytes was carried out according to the method described in WS 273-.

Cerebrospinal fluid sCD163 levels were performed using the Human sCD163ELISA detection kit purchased from affymetrix ebioscience and according to the instructions therein.

4. Detecting content

In the patients of the neurosyphilis group, 12 patients were tested for sCD163 level, and in the recessive syphilis group, 14 patients were tested for sCD163 level. The level of cerebrospinal fluid NF-L, the level of cerebrospinal fluid pNF-H, the cerebrospinal fluid RPR titer, the level of cerebrospinal fluid protein and the level of cerebrospinal fluid leukocytes of these patients were also examined.

5. Results and analysis

Fig. 1 shows mean levels of cerebrospinal fluid sCD163 in NS patients (n ═ 12) and S patients (n ═ 14). As can be seen from FIG. 1, the mean level of sCD163 in cerebrospinal fluid of patients with neurosyphilis reached 798.3pg/ml, whereas the mean level of sCD163 in cerebrospinal fluid of patients with occult syphilis reached 34.5 pg/ml. That is, the sCD163 level in cerebrospinal fluid of patients with neurosyphilis was 23 times higher than that of patients with occult syphilis! Therefore, by measuring the level of sCD163 in the cerebrospinal fluid of syphilis patients, neurosyphenics can be very easily distinguished from recessive syphilis patients, and thus can be used for typing of syphilis patients, for example, classifying the syphilis patients into neurosyphenics and recessive syphilis patients according to the level of sCD163 in the cerebrospinal fluid.

FIG. 2 shows the results of statistical analysis of the levels of sCD163 in cerebrospinal fluid of NS and S group patients. Wherein the median of sCD163 level in the neuromyelitis test group is 151.81 ng/ml; the median sCD163 level in the recessive syphilis group was 12.86 ng/ml; the sCD163 level in the neurosyphilis group was higher than that in the recessive syphilis group and was statistically significant (P < 0.001). It can be seen that this result is consistent with the results obtained in FIG. 1, and it was also confirmed that typing could be performed based on sCD163 levels in cerebrospinal fluid of syphilis patients.

Furthermore, correlation analysis shows that the sCD163 level is related to syphilis stage, the correlation coefficient r is 0.680, and P is less than 0.001. Therefore, sCD163 levels in cerebrospinal fluid of syphilis patients can be used for syphilis staging of syphilis patients.

In additional studies, the inventors have demonstrated that pNF-H and NF-L are good markers capable of sensitively indicating nerve damage, and can be used for early diagnosis, typing and staging, efficacy evaluation and/or prognosis evaluation of syphilis, especially of the neurosyphilis, the levels of which can reflect the severity of nerve damage of the patient with the neurosyphilis (see FIG. 3). Therefore, the invention further detects the level of pNF-H and NF-L and analyzes the correlation with the sCD163 level. As a result, sCD163 was found to be highly correlated with cerebrospinal fluid NF-L level (r ═ 0.803, P <0.001) and cerebrospinal fluid CD14 level (r ═ 0.859, P <0.001) (cerebrospinal fluid CD14 level can be used for detection of syphilis as well, and the technical proposal application based on this finding was filed). In addition, sCD163 levels are also correlated with cerebrospinal fluid pNF-H levels (r ═ 0.662, P <0.001) and are also statistically significant. It can be seen that sCD163 has similar effects to those of pNF-H, NF-L and CD14 as a marker for detecting syphilis.

The inventor also detected the RPR titer of cerebrospinal fluid, cerebrospinal fluid protein and cerebrospinal fluid leucocyte. As a result, sCD163 was found to be highly correlated with cerebrospinal RPR titer (r ═ 0.778, P <0.001), cerebrospinal protein (r ═ 0.812, P <0.001), closely correlated with cerebrospinal leukocytes (r ═ 0.617, P ═ 0.001), and positively correlated. Therefore, syphilis patients can be diagnosed using the sCD163 assay instead of the existing assays described above.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims

The application of an sCD163 detection reagent in preparing a reagent composition or a kit for detecting human neurosyphilis, wherein the kit is used for detecting the level of sCD163 in a biological sample, the sCD163 detection reagent is an anti-human sCD163 antibody, the biological sample is cerebrospinal fluid, and the antibody is a polyclonal antibody or a monoclonal antibody.
2. The use according to claim 1, wherein the kit further comprises a second detection reagent which is a detection reagent for one or more syphilis detection methods selected from the group consisting of VDRL detection, USR detection, TRUST detection, RPR detection, TPHA or TPPA detection, FTA-ABS detection, pNF-H detection, NF-L detection.
3. The use according to claim 2, wherein the second detection reagent is a detection reagent for a syphilis detection method selected from the group consisting of RPR detection, TPHA or TPPA detection, FTA-ABS detection, pNF-H detection and NF-L detection.
4. Use 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 use according to claim 1, wherein the kit is for staging syphilis.
6. The use according to claim 1, wherein the kit is used for screening of patients with neuro-syphilis and patients with occult syphilis.
7. The use according to claim 1, wherein the kit is used for early diagnosis, typing and staging, efficacy evaluation and/or prognosis evaluation of the neurosyphilis.