CN211978947U - Candida mannan detection kit - Google Patents

Abstract

The utility model discloses a candida mannan detect reagent box, including first box body, second box body and test strip, be equipped with visual window, sample loading port, first recess and spout on the first box body, with the grafting piece fixed connection elastomeric element of first recess size looks adaptation, with the slider of spout size looks adaptation is fixed on the second box body, be equipped with the second recess on the second box body, swing joint test strip in the second recess, the test strip includes the PVC bottom plate, the PVC bottom plate is connected with the reaction membrane, the reaction membrane both ends are connected with fluorescence conjugate pad and coarse fibre filter paper respectively, be equipped with detection line and quality control line on the reaction membrane, fluorescence conjugate pad is connected with the sample pad. The utility model discloses, have characteristics easy and simple to handle more, low cost, specificity is good, sensitivity is high, and can replace the test strip and make kit circulation use.

Description

Candida mannan detection kit

Technical Field

The utility model belongs to the technical field of external fungi detects, concretely relates to candida mannan detect reagent box.

Background

Invasive Fungal Infections (IFI) have become increasingly one of the leading causes of death in patients with malignant tumors in recent years. The pathogenic bacteria of the most common Invasive Fungal Infections (IFI) in the clinic today are candida, aspergillus and cryptococcus. The candida is a fungus widely existing in the nature, and is a main pathogenic bacterium causing serious deep fungal infection of patients with low immunity. In 1999, 2003, Pagano L et al, retrospectively examined 11802 Italy patients with 18 hematological disease centers, found that diagnosed and clinically diagnosed Invasive Fungal Infections (IFI) accounted for 4.6% of the total cases, yeast accounted for 35.7%, Candida accounted for 91.1% of yeast infections, IFI patients had a total mortality of 39%, and Candida infections accounted for 33%. Totorrano AM, et al, 3.2006-2008 4.2008, investigation of 38 ICU invasive fungal infection patients in 27 hospitals in Italy showed Candida 82.8% of invasive fungal infections and 46% of gross mortality of invasive candidiasis. The research evidence at home and abroad shows that the incidence rate of invasive mycosis is increased year by year, the infection rate of aspergillus is higher than that of candida in hemopathy patients, and the infection rate of candida in non-hemopathy patients is higher than that of aspergillus. The main reasons for this are that the patients are often accompanied by serious basic diseases, the body immunity is low, and the treatment is not timely due to the delayed diagnosis and missed diagnosis of the invasive mycosis caused by the limitation of the existing detection technology, which results in high morbidity and mortality of the invasive mycosis.

Since the clinical symptoms of invasive mycoses are not specific, great difficulties are posed to their diagnosis and treatment. The traditional fungus microscopic examination is the simplest, direct and economically applicable diagnosis method, which comprises direct microscopic examination and staining microscopic examination, the microscopic examination positive has diagnosis significance, and the method has the defects that the positive rate is low, and the microscopic examination negative cannot exclude diagnosis. The fungus culture is a basic method for fungus examination and is also a diagnostic gold standard, pathogenic bacteria can be separated from clinical specimens, whether fungus infection exists or not and the type of the infected fungus can be determined, the defects of direct microscopic examination can be overcome, meanwhile, the morphology, the microscopic structure, the physiological characteristics, the biochemical characteristics, the molecular structure and the like of the fungus can be fully researched in the culture and identification process to judge the genus and the species, and the separated strains can be stored and established in a fungus bank for convenient communication, so that the guidance is provided for the clinic, a foundation is laid for scientific research, the fungus culture consumes long time, is often polluted by other microorganisms, and the reliability is not high. CT examinations are expensive and typical CT shows a middle-to-late stage of the disease process. The tissue reaction of fungal infection has no specificity, and the diagnosis of mycosis only has reference value, and the diagnosis can be confirmed only when the fungus is found in pathological tissues. However, the pathological biopsy is a traumatic examination, and has high cost, difficult adoption by patients and poor clinical feasibility. None of the above fungal detection methods can meet the requirements for early diagnosis of IFI, so that the clinical evidence for early diagnosis of IFI is very lacking. Therefore, the key point for improving the diagnosis rate and cure rate of invasive mycosis is to find a simple, convenient, rapid, cheap and high-sensitivity and specificity diagnosis method.

The patent with publication number CN109085353A discloses a Candida albicans colloidal gold test card and its application, the test card includes test paper strip and test card shell, the test paper strip includes colloidal gold membrane, cellulose nitrate membrane, sample pad, water absorption pad, PVC offset plate, sample pad, colloidal gold membrane, cellulose acetate membrane and water absorption pad paste on PVC offset plate in proper order, sample pad and colloidal gold membrane are side by side, cellulose acetate membrane one end slightly intersects with colloidal gold membrane, the other end slightly intersects with water absorption pad, the test paper strip is through cutting into the rectangular with test card width slightly narrow, will again rectangular test paper strip is installed in rectangular flat shell's test card shell, be equipped with application of sample window and test result display window on the test card shell, the sample pad is located application of sample window, the colloidal gold membrane is located test result display window. The detection card can be effectively used for detecting candida albicans, and the method is simple, convenient and quick. However, the rapid detection product developed based on the colloidal gold labeling technology has the problems of low sensitivity, qualitative or semi-quantitative property, large batch difference and the like, and the detection card can not replace a test strip for recycling.

Therefore, based on the defects of the above methods, the development of a kit which is simpler and more convenient to operate, low in cost, high in sensitivity and recyclable is more and more necessary, and the efforts of the technicians in the field are also directed.

SUMMERY OF THE UTILITY MODEL

The utility model provides a to the not enough of prior art existence, the utility model aims at providing candida mannan detect reagent box to solve the problem that proposes in the above-mentioned background art, the utility model provides a candida mannan detect reagent box has characteristics simple and convenient, low cost, that the specificity is good, sensitivity is high more, and can replace the test strip back circulation use kit, but the single detection, easily popularization is the deep fungal infection quick, efficient detection device that the diagnosis candida arouses.

In order to achieve the above object, the utility model provides a following technical scheme: the candida mannan detection kit comprises a first box body, a second box body and a detection strip, wherein a visual window, a sample adding port and a sliding groove are arranged on the first box body, a sliding block matched with the sliding groove in size is fixed on the second box body, a second groove is formed in the second box body, the detection strip is movably connected in the second groove and comprises a PVC bottom plate, the PVC bottom plate is connected with a reaction membrane, two ends of the reaction membrane are respectively connected with a fluorescence conjugate pad and coarse fiber filter paper, the reaction membrane is provided with a detection line and a quality control line, and the fluorescence conjugate pad is connected with a sample pad.

Adopt above-mentioned technical scheme, at first in inserting the second recess of second box body with test strip one end, then insert the spout of first box body with the slider on the second box body, begin to promote the second box body and make the slider slide in the spout, finally make the test strip enter into first box body along with the second box body, the kit equipment is accomplished, carry out the application of sample through the application of sample mouth and detect, observe the testing result through the visual window, after the detection, slide the second box body, take out the test strip from the second recess, kit accessible replacement test strip recycles. The arrangement of the box body is convenient for protecting the detection strip and the sample to be detected, greatly reduces the possibility of pollution and ensures the accurate result; the arrangement of the sliding block and the sliding groove is convenient for the relative movement of the first box body and the second box body and the replacement of the detection strip; the arrangement of the visual window is convenient for observing the detection line and the quality control line.

Furthermore, a first groove is formed in the first box body, an elastic part is fixedly connected with the inserting block matched with the first groove in size, and the elastic part is a rubber body or a plate spring. The first groove and the inserting block are of a detachable structure, so that the detection strip can be flexibly used according to the requirement of stabilizing the detection strip; the elastic component and the second groove are convenient for fixing the detection strip, so that a sample to be detected accurately falls on a sample pad of the detection strip, the flow path of the sample to be detected is ensured to be the sample pad, a fluorescence combination pad and a reaction membrane, and the result is ensured to be accurate.

Furthermore, a first handle is arranged on the first box body, a second handle is arranged on the second box body, and the length of the second handle is larger than that of the first handle. The second handle is longer than the first handle, so that the relative movement of the second box body on the first box body is facilitated, and the replacement of the detection strip is further facilitated.

Furthermore, the first handle and the second handle are respectively provided with a through groove, and a fixing piece matched with the through groove in size is inserted into the through groove. The fixing piece is arranged in the through groove, so that the first box body and the second box body are fixed and cannot slide relatively, and the kit is convenient to transport and store.

Furthermore, the fixing piece is provided with 1-2 clamping blocks. The setting of joint piece makes the mounting can the joint fix at logical inslot, the firm and dismantlement of kit of being convenient for.

Furthermore, the fixing part is hinged to one end of the abutting plate, and the other end of the abutting plate is fixed on the fixing part through a spring. Make the spring compressed through pressing to support the board, and then make the mounting can get into logical inslot to fix at logical inslot through the spring joint, the firm and dismantlement of kit of being convenient for.

Further, the widths of the second box body, the PVC base plate, the reaction membrane, the fluorescence conjugate pad, the sample pad and the coarse fiber filter paper are as follows from big to small in sequence: a second box body, a PVC bottom plate, a reaction film, coarse fiber filter paper, a fluorescence conjugate pad and a sample pad. This width setting for the sample of examining flows to the fluorescence combination thing pad of broad from narrower sample pad very fast on, flows to the widest reaction membrane again, thereby makes the sample of examining be difficult for flowing to other places so that pollute the second box body, finally makes the second box body can direct simple replacement test strip carry out cyclic utilization.

Further, the fluorescent conjugate pad is coated with a mouse anti-candida mannan antibody marked by fluorescent microspheres, and the concentration of the mouse anti-candida mannan antibody is 0.1-1 mg/mL.

Further, the reaction membrane is a nitrocellulose membrane.

Further, the detection line is coated with a mouse anti-candida mannan antibody, and the concentration of the mouse anti-candida mannan antibody is 2-10 mg/mL.

Further, the quality control line is coated with goat anti-mouse IgG polyclonal antibody, and the concentration of the goat anti-mouse IgG polyclonal antibody is 4-10 mg/mL.

The utility model discloses following beneficial effect has:

1. the utility model discloses candida mannan detect reagent box, the setting of box body is convenient for protect the test strip and wait to examine the sample, the very big degree reduces contaminated possibility; the arrangement of the sliding block and the sliding groove is convenient for the relative movement of the first box body and the second box body and the replacement of the detection strip; the handles with different lengths are arranged to facilitate the relative movement of the box body; the arrangement of the through groove and the fixing piece on the handle is convenient for fixing and simple assembling and disassembling of the box bodies, so that the replacement of the detection strips and the recycling, storage and transportation of the kit are convenient; the first groove and the inserting block are of detachable structures, so that flexible use is facilitated according to the requirement of stabilizing the detection strip; the elastic component and the second groove are convenient for fixing the detection strip, so that a sample to be detected accurately falls on a sample pad of the detection strip, the flow path of the sample to be detected is ensured to be the sample pad, a fluorescence combination pad and a reaction membrane, and the result is ensured to be accurate.

2. The utility model discloses candida mannan detect reagent box has characteristics that the operation is more simple and convenient, low cost, specificity is good, sensitivity is high on the whole, but the single-part detection, easily popularizes, is the quick, the efficient detection device of deep fungal infection that the diagnosis candida arouses, to patient's early diagnosis, clinical examination all has important using value to be suitable for early acute infection auxiliary diagnosis and epidemiology investigation and application.

Drawings

FIG. 1 is a sectional view showing the structure of the Candida mannan detection kit of the present invention;

FIG. 2 is a view of the first case shown in FIG. 1;

FIG. 3 is a right side view of FIG. 2;

FIG. 4 is a structural view of the second box body in FIG. 1

FIG. 5 is a left side view of FIG. 4;

FIG. 6 is a top view of the test strip of the candida mannan detection kit of the present invention;

fig. 7 is a schematic structural diagram of a candida mannan detection kit through groove and a fixing member adapted to the size thereof according to embodiment 1 of the present invention;

fig. 8 is a schematic structural view of a candida mannan detection kit through groove and a fixing member adapted to the size thereof according to embodiment 2 of the present invention;

fig. 9 is a schematic structural diagram of the candida mannan detection kit according to embodiment 3 of the present invention, which includes a through groove and a fixing member adapted to the size of the through groove.

Number in the figure: 1. a first case; 2. a second box body; 3. a visual window; 4. a sample addition port; 5. a chute; 6. a groove; 7. a PVC base plate; 8. a fluorescent conjugate pad; 9. a sample pad; 10. a reaction film; 11. detecting lines; 12. a quality control line; 13. coarse fiber filter paper; 14. a resisting plate; 15. a clamping block; 16. a second handle; 17. a first handle; 18. a spring; 19. a through groove; 20. a second groove; 21. an insertion block; 22. a slider; 23. an elastic member; 24. and a fixing member.

Detailed Description

The present invention will be described in detail with reference to the accompanying drawings and examples.

Example 1

The candida mannan detection kit in this embodiment includes a first box 1, a second box 2 and a detection strip, as shown in fig. 1 and 2, the first box 1 is provided with a visual window 3, a sample addition port 4, a first groove 6, a sliding groove 5 and a first handle 17, an insertion block 21 matched with the first groove 6 in size is fixedly connected with an elastic component 23, and the elastic component 23 is a rubber body. As shown in fig. 1 and 3, a second groove 20, a sliding block 22 and a second handle 16 are arranged on the second box body 2, wherein the size of the sliding block 22 is matched with that of the sliding groove 5, the second handle 16 is longer than the first handle 17, and a detection strip is inserted into the second groove 20. As shown in fig. 1 and 4, the detection strip comprises a PVC bottom plate 7 with a width from large to small, a reaction membrane 10, a coarse fiber filter paper 13, a fluorescence conjugate pad 8 and a sample pad 9, wherein the reaction membrane 10 is a nitrocellulose membrane, and is provided with a detection line 11 and a quality control line 12, and the width setting is convenient for absorption, reaction and flow of a sample to be detected, so as to avoid polluting the second box body 2 as much as possible. Wherein the first handle 17 and the second handle 16 are respectively provided with a through slot 19, and are connected by inserting a fixing member 24 into the through slot 19. As shown in fig. 5, a clamping block 15 is arranged on the fixing member 24, the size and shape of the through groove 19 are the same as the cross section of the insertion part of the fixing member 24, and the first box body 1 and the second box body 2 are detachably connected and fixed through the sliding block 22, the sliding groove 5, the through groove 19 and the fixing member 24, so that the replacement of the detection strips and the recycling of the reagent kit are facilitated, and the transportation and storage of the reagent kit are also facilitated.

When replacing the detection strip, make joint piece 15 aim at logical groove 19 through rotatory mounting 24, then extract mounting 24 from leading to groove 19, promote the first in command 17, slide out slider 22 from spout 5, the detection strip of pegging graft in second recess 20 also along with second box body 2 from first box body 1, extract the detection strip, if the kit is not contaminated by the sample to be examined, direct insert new detection strip to second recess 20 can, insert slider 22 in spout 5, make second box body 2 take new detection strip to slide into first box body 1, PVC bottom plate 7 of detection strip supports on elastomeric element 23, after logical groove 19 on first in command 17 and the second in command 16 aligns, insert mounting 24, rotatory joint piece 15 makes it place in the position of non-logical groove 19, so far, the detection strip replacement finishes, the kit equipment finishes.

Specifically, the fluorescent conjugate pad 8 is coated with a mouse anti-candida mannan antibody labeled with a fluorescent microsphere. Wherein the fluorescent conjugate pad 8 was prepared as follows:

the mouse anti-candida mannan antibody is coupled with the fluorescent microsphere to prepare a mouse anti-candida mannan antibody solution marked by the fluorescent microsphere. Adjusting the concentration of the mouse anti-candida mannan antibody solution marked by the fluorescent microspheres to be 500 mug/mL, soaking the fluorescent conjugate pad 8 in 1.5 mL/strip, paving the fluorescent conjugate pad 8, drying for 3 hours at 37 ℃, and storing at room temperature.

The preparation method of the mouse anti-candida mannan antibody marked by the fluorescent microspheres comprises the following steps:

adding a proper amount of fluorescent microspheres into 0.05M boric acid buffer solution with the pH value of 8.0 and uniformly mixing;

simultaneously adding a proper amount of EDC and NHS, uniformly mixing and stirring for 15 minutes;

adding a mouse anti-candida mannan antibody of 500 mu g/mL, and stirring for 40 minutes;

then 10% bovine serum albumin is added to the final concentration of 1%, and the mixture is stirred for 15 minutes;

10000rpm/min, centrifuging for 15 minutes at 4 ℃, and carefully discarding the supernatant;

adding 1/2 volumes of fluorescent microsphere conjugate diluent of original volume (original volume is calculated by fluorescent microsphere volume), wherein the fluorescent microsphere conjugate diluent is prepared by dissolving 5g of disodium hydrogen phosphate, 0.5g of sodium dihydrogen phosphate, 5g of bovine serum albumin, 8g of sodium chloride and 0.5g of casein in 1L of deionized water and uniformly mixing.

Specifically, the reaction membrane 10 is a nitrocellulose membrane, the detection line 11 is coated with a mouse anti-candida mannan antibody, and the quality control line 12 is coated with a goat anti-mouse IgG polyclonal antibody. Wherein the reaction membrane 10 is prepared as follows:

diluting the mouse anti-candida mannan antibody to a preferable coating concentration of 2mg/mL by using a coating diluent; diluting goat anti-mouse IgG polyclonal antibody to a preferred coating concentration of 4mg/mL by using a coating diluent; spraying the two coating solutions onto the reaction film 10 by a film dispenser, wherein the spraying amount is 0.1 muL/mm, and a detection line 11 and a quality control line 12 are respectively formed; the coated reaction film 10 was dried at 37 ℃ for 3 hours and stored at room temperature. Wherein the coating dilution is 0.05M phosphate buffer.

The use of the kit is as follows:

1. preparation before detection: and (3) before the detection, the kit and the sample to be detected are restored to room temperature.

2. Preparing a sample to be detected: the whole blood is collected by finger tip or vein. The whole blood sample to be detected is collected and then is used without preservation. The serum sample to be tested is collected from the vein by a conventional method. The sample to be detected in the blood plasma can be treated by adopting heparin, sodium citrate and EDTA. The serum or plasma sample to be detected can be stored at 4 ℃ within 5 days. The sample to be detected can be stored for at least 3 months at the temperature of minus 20 ℃. The sample to be tested should be protected from hemolysis or repeated freeze-thawing. The turbid or precipitated sample to be detected should be detected after centrifugation or filtration clarification.

3. Detecting a sample to be detected:

(1) taking out the kit and horizontally placing the kit on a table board;

(2) adding 10 mu L of serum or plasma or whole blood sample to be detected to the sample pad 9 from the sample adding port 3, and adding 100 mu L of sample diluent to be detected, wherein the sample diluent to be detected is 0.05M phosphate buffer solution; the kit is horizontally placed on the table board again;

(3) and (3) irradiating the film by using a small ultraviolet flashlight with the wavelength of 365nm through the visual window 3 within 15-20 minutes, and interpreting the result.

(4) And (3) judging a detection result:

negative: color development only occurs at the position of the control line.

Positive: and the quality control line and the detection line are colored.

And (4) invalidation: no color development occurred at the position of the control line.

The effectiveness of the kit is verified as follows:

1. and (3) detecting the negative and positive coincidence rate:

(1) and detecting 10 portions of candida mannan positive finger control serum, wherein the detection results are positive. The candida mannan detection kit in the embodiment has a better positive coincidence rate.

(2) And detecting 10 candida mannan negative control sera, wherein the detection results are negative. The candida mannan detection kit in the embodiment has better negative coincidence rate.

Wherein the preparation method of the quality control serum comprises the following steps:

firstly, collecting quality control serum:

1) collecting serum more than 35mL (without obvious hemolysis, jaundice, fat blood or polluted serum);

2) heating at 60 deg.C for 1 hr for inactivation;

3) centrifuging, filtering, and removing precipitate;

4) diluting: when dilution is needed, normal human serum is used for dilution;

5) when the quality control serum is replaced, the quality control serum and the original quality control serum to be replaced are continuously calibrated for at least 3 times;

6) subpackaging, marking and storing: subpackaging with 1.5mL centrifuge tubes, 1 mL/tube, 35 tubes in total, sealing, labeling, and freezing at-20 ℃.

Second quality control serum identification

1) 10 parts of candida mannan negative serum: the negative serum is collected from serum of healthy blood donors, is identified as negative serum by a commercial candida mannan detection kit (enzyme linked immunosorbent assay), and 10 parts of the negative serum is selected as antibody negative quality control serum.

2) 10 parts of candida mannan positive serum: a commercial candida mannan antibody detection kit (enzyme linked immunosorbent assay) is identified as candida mannan positive serum, the detection result is analyzed, and 10 parts of weak positive serum, 4 parts of medium positive serum and 3 parts of strong positive serum are selected as antibody positive quality control serum.

2. And (3) sensitivity detection:

the minimum detection limit instructs serum detection, and the minimum detection limit serum stock solution is prepared according to the following steps of 1: 8, detecting after dilution, and detecting the result to be positive. The candida mannan detection kit in the embodiment has better sensitivity.

Wherein the lowest detection limit quality control serum: and (3) performing serial dilution on one of the weak positive serums when the s/c value (sample value/cut-off value) is about 2.6, and when the dilution is 1: the serum can still be detected at 8 days, and the series of the serum is the serum with the lowest detection limit. In order to maintain the consistency of the minimum detection limit serum in the future, weak positive with s/c value of about 2.6 is selected for serial dilution during selection of the minimum detection limit serum stock solution so as to maintain the consistency among batches.

3. And (3) precision detection:

the precision serum is measured in parallel by 10 kits, the color development speed and the intensity of each kit are consistent, and the uniformity is not different. The candida mannan detection kit in the example is better in precision.

Wherein the seminal serum: a Candida mannan weakly-positive serum (s/c value of about 3.4) was selected as the seminal serum.

4. And (3) specific detection:

the candida mannan detection kit in this example was used to detect samples containing endogenous interfering substances and potential cross-reacting substances, with the following results:

antinuclear antibodies, anti-mitochondrial antibodies, anti-double-stranded DNA antibodies, hepatitis B virus surface antigen antibodies, hepatitis C virus antibodies, syphilis antibodies, HIV antibodies, cryptococcus capsular polysaccharides, and aspergillus galactomannans do not interfere with the product. The candida mannan detection kit in the embodiment has high specificity.

5. And (3) stability detection:

in the long-term stability experiment process, the product performance index requirement can still be met after the product is dried at 4-30 ℃ and stored in the dark for 14 months; in the accelerated stability experiment process, the detection result can still meet the product performance index requirement after 16 days at 37 ℃. The candida mannan detection kit in the embodiment has better stability.

The candida mannan detection kit in the embodiment has the following advantages:

1. the detection is quick and simple: the whole detection operation of the kit only needs 15-20 minutes, and only needs to drip the sample to be detected to the sample pad to be detected, irradiate the sample pad with a small ultraviolet flashlight with the wavelength of 365nm, and wait for the result. Does not need professional training, is suitable for clinical and household use, can quickly screen patients, and is suitable for early acute infection auxiliary diagnosis, epidemiological investigation and the like.

2. Higher sensitivity and specificity: candida mannan weakly-positive sera (s/c values around 2.6) were diluted to 1: 8, the protein can still be detected, which shows that the protein has higher sensitivity; and the reagent kit only shows positive results on candida mannan positive serum samples, but shows negative results on serum samples infected by other pathogens, and has good specificity.

3. Higher precision: the multiple detection strips detect the same sample to be detected in parallel, the color development speed and the intensity of each detection strip are consistent, the uniformity is not different, and the detection strip has good precision.

4. Good stability: the product is dried at 4-30 ℃ and stored in dark for 14 months, or stored at 37 ℃ for 14 days, and still meets the detection standard.

From the above, the candida mannan detection kit provided by the embodiment has the advantages of rapid and simple detection, no need of special equipment, only 15-20 minutes of whole operation time, higher sensitivity and specificity, and suitability for clinical detection, epidemiological investigation, on-site general investigation and the like.

Example 2

The candida mannan detection kit in the embodiment comprises a first box body 1, a second box body 2 and a detection strip, wherein the elastic component 23 is a plate spring, as shown in fig. 6, two clamping blocks 15 are symmetrically arranged on the fixing component 24, and the size and the shape of the through groove 19 are the same as the cross section of the insertion part of the fixing component 24. When the detection strip is replaced, the fixing piece 24 is rotated to enable the two clamping blocks 15 to be aligned to the through groove 19, and then the fixing piece 24 can be pulled out of the through groove 19. The symmetrically arranged clamping blocks 15 enable the fixing piece 24 to be connected with the through groove 19 more stably. In addition, the fluorescent conjugate pad 8 was coated with a mouse anti-candida mannan antibody labeled with fluorescent microspheres, the concentration of the mouse anti-candida mannan antibody was 1 mg/mL. The detection line 11 is coated with a mouse anti-candida mannan antibody, and the concentration of the mouse anti-candida mannan antibody is 8 mg/mL. The quality control line 12 was coated with goat anti-mouse IgG polyclonal antibody at a concentration of 10 mg/mL. The rest is the same as the embodiment 1.

Example 3

The candida mannan detection kit in the embodiment comprises a first box body 1, a second box body 2 and a detection strip, wherein the elastic component 23 is a rubber body, as shown in fig. 7, the fixing member 24 is hinged with one end of the abutting plate 14, the other end of the abutting plate 14 is fixed on the fixing member 24 through the spring 18, the through groove 19 is circular, and the size of the through groove is slightly larger than the cross section of the insertion part of the fixing member 24. The spring 18 is compressed by pressing the abutting plate 14, so that the fixing member 24 can enter the through groove 19, when the fixing member 24 is long, the abutting plate 14 and the spring 18 are in the through groove 19, the spring 18 abuts the abutting plate 14 in the through groove 19, and the fixing member 24 is fixed in the through groove 19. When the fixing piece 24 is short, the abutting plate 14 and the spring 18 penetrate out of the through groove 19, the spring 18 is released, and the abutting plate 14 is blocked outside the through groove 19, so that the fixing piece 24 is fixed in the through groove 19. When the test strip is replaced, the retaining plate 14 is pressed to compress the spring 18 so that the retaining plate 14 enters the through groove 19, and the fixing piece 24 can be pulled out of the through groove 19. In addition, the fluorescent conjugate pad 8 was coated with a mouse anti-candida mannan antibody labeled with fluorescent microspheres, the concentration of the mouse anti-candida mannan antibody was 0.1 mg/mL. The detection line 11 is coated with a mouse anti-candida mannan antibody, and the concentration of the mouse anti-candida mannan antibody is 10 mg/mL. The quality control line 12 was coated with goat anti-mouse IgG polyclonal antibody at a concentration of 8 mg/mL. The rest is the same as the embodiment 1.

The detection principle of the kit is as follows:

by adopting the technical principle of fluorescence immunochromatography, a detection line 11 on a reaction membrane 10 (nitrocellulose membrane) is coated with a mouse anti-candida mannan antibody, a quality control line 12 is coated with a goat anti-mouse IgG polyclonal antibody, and a fluorescent microsphere-labeled mouse anti-candida mannan antibody is coated on a fluorescent conjugate pad 8. The method is used for qualitatively detecting the candida mannan in a sample to be detected of whole blood or serum (plasma).

When a positive sample to be detected is detected, the candida mannan antigen in the sample to be detected can be combined with a mouse anti-candida mannan antibody marked by the fluorescent microspheres to form an immune complex, and the complex and the sample to be detected flow forwards in the nitrocellulose membrane due to the chromatography effect. When the compound passes through the detection line 11, the compound is combined with the coated mouse anti-candida mannan antibody to form 'fluorescent microspheres-mouse anti-candida mannan antibody-candida mannan antigen-candida mannan antibody' for agglutination and color development, the residual fluorescent microspheres mark the combination of the mouse anti-candida mannan antibody and the goat anti-mouse IgG polyclonal antibody coated by the quality control line 12 for agglutination and color development, and when a negative sample to be detected is detected, the sample to be detected does not contain candida mannan combination, so that an immune compound can not be formed, and only the color can be developed at the quality control line.

It should be finally noted that the above embodiments are only used for illustrating the technical solutions of the embodiments of the present invention and not for limiting the same, and although the embodiments of the present invention are described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the embodiments of the present invention can still be modified or replaced with equivalents, and these modifications or equivalent replacements cannot make the modified technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1. The candida mannan detection kit comprises a first box body (1), a second box body (2) and a detection strip, it is characterized in that a visual window (3), a sample adding port (4) and a sliding chute (5) are arranged on the first box body (1), a sliding block (22) which is matched with the sliding chute (5) in size is fixed on the second box body (2), a second groove (20) is arranged on the second box body (2), a detection strip is movably connected in the second groove (20), the detection strip comprises a PVC bottom plate (7), the PVC bottom plate (7) is connected with a reaction film (10), the two ends of the reaction membrane (10) are respectively connected with a fluorescence conjugate pad (8) and a coarse fiber filter paper (13), the reaction membrane (10) is provided with a detection line (11) and a quality control line (12), and the fluorescence conjugate pad (8) is connected with a sample pad (9).

2. The candida mannan detection kit according to claim 1, wherein a first groove (6) is formed in the first box body (1), an insertion block (21) with a size matched with that of the first groove (6) is fixedly connected with an elastic component (23), and the elastic component (23) is a rubber body or a plate spring.

3. The candida mannan detection kit according to claim 1, wherein a first handle (17) is provided on the first box body (1), a second handle (16) is provided on the second box body (2), and the length of the second handle (16) is greater than the length of the first handle (17).

4. The candida mannan detection kit according to claim 3, wherein the first handle (17) and the second handle (16) are respectively provided with a through groove (19), and a fixing member (24) with a size matched with that of the through groove (19) is inserted into the through groove (19).

5. The candida mannan detection kit according to claim 4, wherein the fixing member (24) is provided with 1-2 clamping blocks (15).

6. The candida mannan detection kit according to claim 4, wherein the fixing member (24) is hinged to one end of the resisting plate (14), and the other end of the resisting plate (14) is fixed on the fixing member (24) through a spring (18).

7. The candida mannan detection kit according to claim 1, wherein the width of the second box body (2), the PVC base plate (7), the reaction membrane (10), the fluorescence conjugate pad (8), the sample pad (9) and the coarse fiber filter paper (13) is as follows from large to small: a second box body (2), a PVC bottom plate (7), a reaction membrane (10), coarse fiber filter paper (13), a fluorescence combination pad (8) and a sample pad (9).

8. The candida mannan detection kit according to claim 1, wherein the fluorescent conjugate pad (8) is coated with a mouse anti-candida mannan antibody labeled with fluorescent microspheres, and the concentration of the mouse anti-candida mannan antibody is 0.1-1 mg/mL.

9. The candida mannan detection kit according to claim 1, wherein the reaction membrane (10) is a nitrocellulose membrane, and the detection line (11) is coated with a mouse anti-candida mannan antibody, the concentration of the mouse anti-candida mannan antibody being 2-10 mg/mL.

10. The candida mannan detection kit according to claim 1, wherein the quality control line (12) is coated with goat anti-mouse IgG polyclonal antibody, and the concentration of the goat anti-mouse IgG polyclonal antibody is 4-10 mg/mL.

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