CN1159582C - Method for detecting total PSA value and total PSA gray zone value in whole blood or serum of human body and test paper for carcinoma of prostate - Google Patents
Method for detecting total PSA value and total PSA gray zone value in whole blood or serum of human body and test paper for carcinoma of prostate Download PDFInfo
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Abstract
The present invention relates to a method for testing the total PSA value and the total PSA gray zone value of whole blood or blood serum of a human body by utilizing detection technology with a monoclonal antibody and a colloidal gold immunochromatographic one-step method, and test paper for testing prostatic cancers by the method. The test paper of the present invention comprises two test lines having different test numerical values, namely the test line having the large numerical value and the test line having small numerical value, wherein the range of the numerical values between the test line having the large numerical value and the test line having the small numerical value can be used for testing the range of the gray zone values of the total PSA of the whole blood and the blood serum of the human body. When the total PSA of the whole blood or the blood serum has different concentrations in the process of measurement, different results are displayed, and thereby, the numerical value of the total PSA of the whole blood or the blood serum is judged to be above the range of the gray zone values, or under the range of the gray zone values or exactly in the range of the gray zone values. When the test paper is used for testing, samples to be tested are needed and do not need to be washed, any reagent does not need to be added into the samples, and furthermore, separation steps are not needed. The test paper of the present invention has the advantages of simple and convenient operation, easy judgment of the test result and high accuracy rate of the test result, is a new high-tech product for early diagnosing and generally testing prostatic cancers, and is suitable to be used for medical institutions, health care departments, families and personal daily life.
Description
Technical field: the present invention relates to a kind of utilize monoclonal antibody and colloidal gold immunochromatographimethod single stage method detection technique measure human whole blood or the total prostate characteristic of serum antigen (PSA) value, always (PSA) ash area value method and make the test paper that detects prostate cancer in this way.
Background technology: prostate cancer is the common disease frequently-occurring disease of middle-aging male.According to statistics, in the male cancer patient, the incidence of disease of prostate cancer is the highest, is the tertiary cause of the death except that lung cancer and colorectal cancer.Prostate characteristic antigen (PSA) is that molecular weight is the highly tissue-specific glycoprotein of having of 34KD, except being distributed in normal prostata tissue, hyperplastic prostate tissue, malignant prostate tissue, prostate metastatic carcinoma and prostate juice, and refining China and foreign countries, prostate characteristic antigen (PSA) is not present in other any normal structure, is not present in as in other cancers such as breast cancer, lung cancer, carcinoma of the colon and rectum, cancer of the stomach, cancer of pancreas and thyroid cancer yet.For the patient male sex of normal health and non-prostatic lesion, the content of its serum prostate characteristic antigen (PSA) all is lower than 4.0ng/ml.When patient suffers from the adjacent reproduction urethral tissue inflammation of prostate cancer, hyperplasia of prostate (BPH) or other, prostate characteristic antigen (PSA) concentration can raise in the blood, concerning most patients with prostate cancer, the rising of prostate characteristic antigen (PSA) is very remarkable, so prostate characteristic antigen (PSA) is the detection mark of effective prostate cancer so far.The prostate characteristic antigen (PSA) that detects in the blood is the diagnosis of carrying out prostate cancer, monitors generation, the development of its illness, estimates the effect after its treatment, and the important indicator that detects the recurrence rate after its chemotherapy or the radiotherapy.The kit that can be used for the detection of prostate characteristic antigen (PSA) serum at present has radio-immunity (RIA) kit, enzyme mark (ELISA) immune reagent kit, photochemistry immune reagent kit and fluorescent mark immunity kit etc.All need be equipped with corresponding instrument when using these kits, and require to have the professional and technical personnel to operate and to carry out.During mensuration, determination step is many, and the time is long, and the expense height is restricted the use of these methods.Also there is the test strips of measuring serum total prostate characteristic antigen (PSA) to occur at present abroad, but its product can only show sample in the situation that increases of prostate characteristic antigen (PSA), and there is the gray area phenomenon in measuring, prostate characteristic antigen (PSA) rising that promptly can't indicate and distinguish this moment when the total prostate characteristic of the serum in working sample antigen (PSA) is between 4-10ng/ml is because prostate cancer or other prostatic disorder such as hyperplasia of prostate etc. cause, must further distinguish with this most reliable existing conclusive evidence standard of prostate biopsy again, and 25% such crowd of only having an appointment in the reality might be a prostate cancer, this just means that those whole bloods or the total prostate characteristic of serum antigen (PSA) are positioned at gray area, being the total prostate characteristic of whole blood or serum antigen (PSA) also has to get rid of by prostate biopsy between other 75% the patient of 4-10ng/ml, and this bring the expense expenditure of unnecessary misery and great number can for undoubtedly these patients' body and mind.Prostate characteristic antigen (PSA) detection method that clinical examination is at present simultaneously used all is test sample with serum, brings difficulty for like this user who does not possess the serum preparation condition, also restriction
The use of existing method.
Summary of the invention: the defective that the objective of the invention is to overcome prior art, inventing a kind of Dan Ke of utilization falls antibody and colloidal gold immunochromatographimethod single stage method detection technique and measures human whole blood or the total prostate characteristic of serum antigen (PSA) value, the method for prostate characteristic antigen (PSA) ash area value always, and the test paper of realizing above purpose that utilizes this method to make.Two detection lines are arranged in the test paper, wherein the detection threshold of a detection line is set at 4ng/ml, the detection threshold of another detection line is set at 10ng/ml, during use, except that the needs sample, need not to use any reagent and specific apparatus, need not wash and take any separating step yet, simple to operate, quick, convenient, testing result judges that directly it detects accuracy rate up to more than 99%.Another object of the present invention is to invent a kind of serum of avoiding and separates trouble, and total prostate characteristic antigen (PSA) value, total prostate characteristic antigen (PSA) ash area value detection method and the prostate cancer of directly using whole blood to detect detect test paper.
The present invention finishes by following manner: prostate cancer detects test paper, include base plate, inhale sample film, nitrocellulose filter, collaurum film and water accepting layer, on base plate, be fixed with the cellulose nitrate rete, it is characterized in that being fixed with one section hydroscopic substance on cellulose nitrate rete top, constitute water accepting layer, two detection lines are arranged in the cellulose nitrate rete, article two, S at a certain distance between the detection line, constitute fractional value detection line and big numerical value detection line respectively, detection line is made by anti-prostate characteristic antigen prostate characteristic antigen (PSA) monoclonal antibody of two variable concentrations numerical value, at suction sample film and cellulose nitrate rete therebetween the collaurum rete is arranged, wherein contain the gold mark probe of useful another anti-prostate characteristic antigen (PSA) Monoclonal Antibody.Inhaling the whole blood test test paper of adding to divide the blood film just to constitute directly to measure the total prostate characteristic of whole blood sample antigen (PSA), total prostate characteristic antigen (PSA) ash area value on the sample film into one deck.
The total prostate characteristic of human whole blood or serum antigen (PSA) value, total prostate characteristic antigen (PSA) ash area value detection method is to include two different numerical value detection lines that detect on the detection test paper,, the detection line of bigger numerical and a detection line than fractional value, the detection line of bigger numerical and can measure the ash area value scope of human whole blood or the total prostate characteristic of serum antigen (PSA) than the numerical range between the fractional value detection line, during mensuration when whole blood or the total prostate characteristic of serum antigen (PSA) are variable concentrations, having different results shows, the numerical value of judging the total prostate characteristic of whole blood or serum antigen (PSA) thus is on the ash area value scope, still under the ash area value scope or just in time be positioned among the ash area value scope, detection may further comprise the steps:
A, test paper is inhaled the sample film end, and to insert in tested whole blood or the blood serum sample 0.5-1.0cm dark, keeping 10-30 to take out after second keeps flat, perhaps analyte sample fluid 2-3 is dripped directly to drop in and keep flat after test paper is inhaled the sample film end, observe detection line place and judged result after 5-30 minute;
B, when the concentration of total prostate characteristic antigen (PSA) in the sample during less than the detection threshold of fractional value detection line, two detection lines all do not develop the color, it is very low to illustrate that the subject suffers from the possibility of prostate cancer;
C, in sample the concentration of prostate characteristic antigen (PSA) more than or equal to the detection threshold of fractional value detection line, and during less than the detection threshold of big numerical value detection line, the colour developing of fractional value detection line, and big numerical value detection line does not develop the color, the content of total prostate characteristic antigen (PSA) is positioned at the ash area value scope in the interpret sample, subject's situation be can not determine, need further do the mensuration of free prostate gland characteristic antigen (PSA) and total prostate characteristic antigen (PSA) ratio;
D, when the concentration of prostate characteristic antigen (PSA) in the sample during more than or equal to the detection threshold of big numerical value detection line, fractional value detection line and big numerical value detection line develop the color simultaneously, illustrate that the subject suffers from prostate cancer probably, should further check.The detection threshold that the fractional value detection line sets is 4ng/ml, then can detect the Cmin value of total prostate characteristic antigen (PSA) gray area in the sample; The detection threshold that big numerical value detection line sets is 10ng/ml, then can detect in the sample Cmax value of total prostate characteristic antigen (PSA) gray area, the detection threshold numerical value that the detection threshold that the fractional value detection line is set in every test paper is set less than big numerical value detection line; The less fractional value detection line of setting detection threshold is right after hydroscopic substance and is positioned at the test paper end, and the detection threshold setting value of fractional value detection line is 4ng/ml, and the detection threshold setting value of big numerical value detection line is 10ng/ml.The detection threshold that the detection threshold of little detection line is set less than big numerical value detection line.
During use prostate cancer is detected the suction sample rete end of test paper and insert 10-30 second in tested whole blood or the blood serum sample, perhaps testing sample is directly dropped in and inhale sample rete end, then inhaling sample film (1) can make test paper possess the sample liquid of some, sample liquid is by the capillary action of nitrocellulose filter, sample liquid is carried to the other end from test paper one end, prostate characteristic antigen (PSA) in the course of conveying in the sample liquid at first combines with anti-prostate characteristic antigen (PSA) gold mark probe generation specificity in collaurum film (2) layer, continue transported to and reach detection line (3,4) time, again with detection line in another anti-prostate characteristic antigen (PSA) monoclonal antibody specificity of forming Sanming City smelting formula combine and stops, so the detection line place develops the color.When using whole blood sample, the branch blood film (8) of setting can separate the haemocyte in the blood with serum automatically, makes cell can not influence testing result, and detecting overall process need be with 5-30 minute.
Total prostate characteristic antigen (PSA) numerical value in detecting whole blood or serum is during less than 4ng/ml, and lower end detection line (3) and upper end detection line (4) do not develop the color; Total prostate characteristic antigen (PSA) numerical value in detecting whole blood or serum is during more than or equal to 4ng/ml, lower end detection line colour developing, and the total prostate characteristic antigen (PSA) in detecting whole blood or serum is when numerical value is equal to or greater than 10ng/ml, and the upper end detection line just develops the color.
Prostate cancer as invention detects the apparent redness of fractional value detection line (3) that the test paper lower end is set at 4ng/ml, and being set at the big numerical value detection line (4) of 10ng/ml, the upper end do not develop the color, then be presented at " ash area value " alleged in the patent specification, and might be general prostatic disorders, need to screen with (II) type test paper of inventor herein's invention.
Do not develop the color as two detection lines in the prostatic cancer early diagnosis test paper invented middle part, it is very low to illustrate that the detected person suffers from the possibility of prostatic disorders, needn't do further detection.
Two detection lines in prostatic cancer early diagnosis test paper middle part as invention all develop the color, and illustrate that total prostate characteristic antigen (PSA) numerical value surpasses 10ng/ml in detected person's whole blood or the serum, have probably suffered from prostate cancer, should further check immediately.
The colour developing principle that prostate cancer of the present invention detects the detection paper line is: utilize immunochromatography single stage method principle and monoclonal antibody technique, the a certain zone that in advance anti-prostate characteristic antigen (PSA) monoclonal antibody of finite concentration numerical value is fixed on nitrocellulose filter constitutes detection line, and another anti-prostate characteristic antigen (PSA) monoclonal antibody that will combine with collaurum, promptly anti-prostate characteristic antigen (PSA) gold mark probe stationary is in another zone of collaurum rete, during mensuration test paper is inhaled sample film one end and insert certain hour in tested whole blood or the blood serum sample, perhaps directly sample drop is being inhaled the sample film end, then inhaling sample film (1) can make test paper maintain the sample liquid of some, sample liquid can be by the capillary action of nitrocellulose filter, carry to the other end from test paper one end, prostate characteristic antigen (PSA) in course of conveying in the sample liquid at first with the collaurum rete in anti-prostate characteristic antigen (PSA) gold mark probe generation specific bond, when continuing transported to the detection line position on the nitrocellulose filter, combine with another anti-prostate characteristic antigen (PSA) monoclonal antibody specificity of forming Sanming City smelting formula in the detection line again, so stop, when contained prostate characteristic antigen (PSA) total amount in whole blood or the blood serum sample reaches the colour developing numerical value of setting or when above, the detection line colour developing, by setting two different detection lines that detect numerical value, differentiate the quantity that contains total serum in this whole blood or the blood serum sample, further specify the possibility that the tested person suffers from prostate cancer, detecting overall process need be with 5-30 minute.When measuring whole blood sample, the branch blood film (8) of setting can separate the haemocyte in the blood with serum automatically, to avoid in the blood haemocyte to the influence of test paper measurement result.
The prostate cancer of invention detects test paper owing to the setting value with a detection line is 4ng/ml, thereby the effective verification and measurement ratio of this test paper is brought up to more than 99%, and its detection accuracy improves greatly.Owing to set another detection line 10ng/ml, just make and can directly distinguish the gray area patient when measuring, exempted the unnecessary pathological biopsy misery of numerous patients, reduce the expenditure of testing cost, save detection time, be beneficial to and promote the use of.The trouble that the whole blood test test paper has avoided serum to separate has enlarged usable range, is particularly useful for health screening and realizes that family tests oneself and self-examination.By the invention of this test paper, can effectively improve the recall rate of prostate cancer, distinguish general prostatitis patient and prostate cancer patient, the prostate patient is in time cured, reduce the mortality ratio of middle-aging male prostate cancer.
Prostate cancer of the present invention detects test paper and has that detection speed is fast, accuracy is high, safe and simple, wieldy characteristics.During with this detection paper, except that need add sample, need not to add any reagent, need not wash yet, do not need separation steps, simple to operation, testing result is easy to judge, and testing result accuracy rate height is a kind of suitable medical institutions, health care department and family prostatic cancer early diagnosis used in everyday and generaI investigation high-tech product of new generation.
Description of drawings: below in conjunction with accompanying drawing, specifically detect step with regard to the embodiment of the invention and be further described.
Fig. 1 is a prostatic cancer early diagnosis test paper longitudinal sectional view of the present invention.
Fig. 2 is for after using detection paper whole blood shown in Figure 1 or blood serum sample, and two detection lines do not show red, illustrate that total prostate characteristic antigen (PSA) is less than the constitutional diagram of 4ng/ml in whole blood or the serum.
Fig. 3 is for after using detection paper whole blood shown in Figure 1 or blood serum sample, article one, setting value shows red for the 4ng/ml detection line, another setting value is that the 10ng/ml detection line does not develop the color, and illustrates that total prostate characteristic antigen (PSA) is in the constitutional diagram of 4-10ng/ml gray area in whole blood or the serum.
Fig. 4 is for after using detection paper whole blood shown in Figure 1 or blood serum sample, and two detection lines all show red, illustrates that total prostate characteristic antigen (PSA) is more than or equal to the constitutional diagram of 10ng/ml in whole blood or the serum.
Embodiment: (test paper manufacturing) preparation prostate cancer early detection test paper of the present invention.The anti-prostate characteristic antigen (PSA) of selecting self-produced (Yunda Biological Technology Co., Ltd., Kunming) for use or buying two kinds of different loci of (as U.S. Sigma company etc.) detects uses monoclonal antibody, and with a kind of preparation antibody gold label probe wherein, the antibody that another is prepared in advance is used to detect different numerical value whole bloods or the total prostate characteristic of serum antigen (PSA) is sprayed on certain zone of nitrocellulose filter (7) respectively, form two spacing distance S and be 1 centimetre detection line, choose long 100 millimeters, wide is 80 millimeters, thick is that 1 millimeter white PVC plastics are base plate (6), and pasting length in the centre earlier by double faced adhesive tape is 100 millimeters, wide be 30 millimeters be sprayed with two detection lines (3,4) nitrocellulose filter (7); Paste length again on the top of nitrocellulose filter (7) and be 100 millimeters, wide be 30 millimeters hydroscopic substance (as filter paper etc.), formation water accepting layer (5); What paste in the interlayer between nitrocellulose filter (7) and suction sample film (1) is collaurum film (2) layer, and it contains prepared antibody gold label probe.If prepare the whole blood test test paper then need to go up many stickup one decks and divide blood film (8) at suction sample rete (1).After stickup finishes, be cut into 80 millimeters long, the test strips of 2.5 mm wides, packing gets final product.
Embodiment (detection paper):
1, the total prostate characteristic antigen of preparation (PSA) is that the titer of 2ng/ml is as sample liquid, the total prostate characteristic antigen (PSA) in the test strips working sample of method for preparing is taked in use, assay method is: (1), test strips is inhaled sample film (1) one end insert sample liquid, the degree of depth is 0.5cm, keep taking out after 10 seconds, keep flat after 30 minutes and observe, no any colour band manifests on the test paper.(2), get above titer and directly drop in test strips and inhale sample film one end, keep flat after 30 minutes and observe, no any colour band manifests on the test paper.
2, the total prostate characteristic antigen of preparation (PSA) is that the titer of 6ng/ml is as sample liquid, the total prostate characteristic antigen (PSA) in the test strips working sample of method for preparing is taked in use, assay method is: (1), test strips is inhaled sample film (1) one end insert sample liquid, the degree of depth is 0.8cm, keep taking out after 15 seconds, keep flat after 20 minutes and observe, fractional value detection line (3) color band manifests on the test paper, and the big no colour band of numerical value detection line (4) manifests.(2), get above titer and directly drop in test strips and inhale sample film (1) one end, keep flat after 20 minutes and observe, fractional value detection line (3) color band manifests on the test paper, the big no colour band of numerical value detection line (4) manifests.
3, the total prostate characteristic antigen of preparation (PSA) is that the titer of 18ng/ml is as sample liquid, the total prostate characteristic antigen (PSA) in the test strips working sample of method for preparing is taked in use, assay method is: (1), test strips is inhaled sample film (1) one end insert sample liquid, the degree of depth is 0.9cm, keep taking out after 20 seconds, keep flat after 15 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all color band manifest.(2), get above titer and directly drop in test strips and inhale sample film (1) one end, keep flat after 15 minutes and observe, test paper fractional value detection line (3) and the equal color band of big numerical value detection line (4) manifest.
4, get patients serum 0.25ml and place the mensuration test tube, use takes the test strips of method for preparing to measure total prostate characteristic antigen (PSA) in the serum, assay method is: (1), test strips is inhaled sample film (1) one end insert in the serum, the degree of depth is 0.6cm, keep taking out after 10 seconds, keep flat after 12 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all do not have colour band to be manifested, and illustrates that the total prostate characteristic of this serum antigen (PSA) is less than 4ng/ml.(2), get above test serum and directly drop in test strips suction sample film one end, keep flat after 12 minutes and observe, test paper fractional value detection line (2) and big numerical value detection line (1) all do not have colour band to be manifested, and illustrates that the total prostate characteristic of this serum antigen (PSA) is less than 4ng/ml.
5, get patients serum 0.25ml and place the mensuration test tube, use takes the test strips of method for preparing to measure total prostate characteristic antigen (PSA) in the serum, assay method is: (1), test strips is inhaled sample film (1) one end insert in the serum, the degree of depth is 0.5cm, keep taking out after 12 seconds, keep flat after 10 minutes and observe, test paper fractional value detection line (3) color band manifests, and the big no colour band of numerical value detection line (4) manifests, and illustrates that the total prostate characteristic of this serum antigen (PSA) is between 4-10ng/ml.(2), get above test serum and directly drop in test strips suction sample film one end, keep flat after 10 minutes and observe, test paper fractional value detection line (3) color band manifests, and the big no colour band of numerical value detection line (4) manifests, and illustrates that the total prostate characteristic of this serum antigen (PSA) is between 4-10ng/ml.
6, get patients serum 0.25ml and place the mensuration test tube, use takes the test strips of method for preparing to measure total prostate characteristic antigen (PSA) in the serum, assay method is: (1), test strips is inhaled sample film (1) one end insert in the serum, the degree of depth is 0.6cm, keep taking out after 25 seconds, keep flat after 8 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all color band manifest, and illustrate that the total prostate characteristic of this serum antigen (PSA) is more than or equal to 10ng/ml.(2), get above test serum and directly drop in test strips suction sample film one end, keep flat after 8 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all color band manifest, and illustrate that the total prostate characteristic of this serum antigen (PSA) is more than or equal to 10ng/ml.
7, get patients blood 0.25ml and place the mensuration test tube, the total prostate characteristic antigen (PSA) in the whole blood test strips working sample of method for preparing is taked in use, assay method is: (1), test strips is inhaled sample film (1) one end insert in the blood sample, the degree of depth is 0.5cm, keep taking out after 15 seconds, keep flat after 15 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all do not have colour band to be manifested, and illustrates that total prostate characteristic antigen (PSA) is less than 4ng/ml in this whole blood sample.(2), get above whole blood sample and directly drop in test strips one end, keep flat after 15 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all do not have colour band to be manifested, and illustrates in this whole blood sample that always prostate characteristic antigen (PSA) is less than 4ng/ml.
8, get patients blood 0.25ml and place the mensuration test tube, the total prostate characteristic antigen (PSA) in the whole blood test strips working sample of method for preparing is taked in use, assay method is: (1), test strips is inhaled sample film (1) one end insert in the blood sample, the degree of depth is 0.8cm, keep taking out after 18 seconds, keep flat after 10 minutes and observe, test paper fractional value detection line (3) color band manifests, and the big no colour band of numerical value detection line (4) manifests, and illustrates that total prostate characteristic antigen (PSA) is between 4-10ng/ml in this whole blood sample.(2), get above whole blood sample and directly drop in test strips suction sample film one end, keep flat after 10 minutes and observe, test paper fractional value detection line (3) color band manifests, and the big no colour band of numerical value detection line (4) manifests, and illustrates that total prostate characteristic antigen (PSA) is between 4-10ng/ml in this whole blood sample.
9, get patients blood 0.25ml and place the mensuration test tube, the total prostate characteristic antigen (PSA) in the whole blood test strips working sample of method for preparing is taked in use, assay method is: (1), test strips is inhaled sample film (1) one end insert in the blood sample, the degree of depth is 0.8cm, keep taking out after 30 seconds, keep flat after 5 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all color band manifest, and illustrate that total prostate characteristic antigen (PSA) is more than or equal to 10ng/ml in this whole blood sample.(2), get above whole blood sample and directly drop in test strips suction sample film one end, keep flat after 5 minutes and observe, test paper fractional value detection line (3) and big numerical value detection line (4) all color band manifest, and illustrate that total prostate characteristic antigen (PSA) is more than or equal to 10ng/ml in this whole blood sample.
One, sensitivity is measured:
1, adopt the phosphate buffer preparation of PH7.4 to contain prostate characteristic antigen (PSA) 1,2,3,4,5, series standard liquid and the blank of 6ng/ml, randomly draw the test strips that adopts method for preparing to above titer and blank replicate determination three times, mensuration contains prostate characteristic antigen (PSA) 4,5, during the titer of 6ng/ml, the fractional value detection line of setting on the test paper (3) all should develop the color, and big numerical value line (4) does not develop the color, mensuration contains prostate characteristic antigen (PSA) 1,2, during the titer of 3ng/ml, fractional value detection line of setting on the test paper (3) and big numerical value line (4) all do not develop the color, and the mensuration sensitivity that fractional value detection line (3) is described is 4ng/ml.All do not develop the color in above mensuration empty contrast.
2, adopt the phosphate buffer preparation of PH7.4 to contain prostate characteristic antigen (PSA) 7,8,9,10,20, series standard liquid and the blank of 30ng/ml, randomly draw the test strips that adopts method for preparing to above titer and blank replicate determination three times, mensuration contains prostate characteristic antigen (PSA) 7,8, during the titer of 9ng/ml, the fractional value detection line of setting on the test paper (3) all should develop the color, and big numerical value line (4) does not develop the color, mensuration contains prostate characteristic antigen (PSA) 10,20, during the titer of 30ng/ml, fractional value detection line of setting on the test paper (3) and big numerical value line (4) all develop the color, and the mensuration sensitivity that big numerical value detection line (4) is described is 10ng/ml.All do not develop the color in above mensuration empty contrast.
Two, specific assay: (PAP), albumin (Albumin), alpha-fetoprotein (AFP), carcinomebryonic antigen (CEA), glycoprotein (Glycoprotein), human IgG, cholerythrin (Bilirubin), CA19-9, CA125 are added in the serum that does not contain prostate characteristic antigen (PSA), make that its concentration reaches 0,10,50,100 respectively, 200ng/ml, detect with test strips, its result is all negative, and above-mentioned material that may exist in cancer patient and the equal no cross reaction of this test paper are described.
Two, interference is measured: following material is added to the serum that does not contain prostate characteristic antigen (PSA) or contain in the serum of prostate characteristic antigen (PSA) 50ng/ml and test.Interfering material comprises: acetaminophenol 20mg/dl, acetoacetate 1500mg/dl, acetone 1250mg/dl, acetylsalicylic acid 20mg/dl, albumin 1.4g/dl, ampicillin 40mg/dl, vitamin C 40mg/dl, biotin 30 μ g/dl, caffeine 40mg/dl, codeine 5 μ g/ml, corfisol150ng/ml, creatinine200mg/dl, DHEAS10000ng/ml, estrone 25ng/ml, estradiol 25ng/ml, estriol 25ng/ml, ethanol 4000mg/dl, protoheme 30g/l, hedroxybulyric acid 100mg/dl, glucose 20g/l, oxalic acid 5000mg/dl, progesterone 50ng/ml, benzene Ba Bituo 10 μ g/ml, sallcysic acid1500mg/dl, Si Kebabituo 10 μ g/ml, sodium carbonate 1500mg/dl, sodium chloride 5000mg/dl, tetracycline 40mg/dl, urea 3500mg/dl, uric acid 10mg/dl.Every group of test done three parts.
The gained result is: all samples that does not contain prostate characteristic antigen (PSA) no matter whether contain interfering material, are negative findings; All samples that contains prostate characteristic antigen (PSA) 50ng/ml no matter whether contain interfering material, are positive findings, illustrate that they all do not have obvious interference to the mensuration of prostate characteristic antigen (PSA).
Prostate cancer of the present invention detects test paper owing to the setting value with a detection line is 4ng/ml, thereby the effective verification and measurement ratio of this test paper is brought up to more than 99%, and its detection accuracy improves greatly.Test paper of the present invention effectively separates general prostatitis patient and early prostate cancer patient, exempt the unnecessary pathological biopsy misery of patient, reduce the expenditure of testing cost, save detection time and testing cost, be beneficial to and promote the use of, can be used for health screening, can be used for also that family tests oneself or self-examination, can effectively improve the recall rate of prostate cancer, trouble prostatic disorders patient is in time cured, reduce the mortality ratio of middle-aging male prostate cancer.
1-inhales sample film; 2-collaurum film; 3-fractional value detection line; The big numerical value detection line of 4-; The 5-suction Layer; The 6-base plate; The 7-nitrocellulose filter; 8-divides the blood film; The big numerical value detection line of S-and fractional value detection line it Between distance.
Claims (3)
1, the total prostate characteristic of a kind of human whole blood or serum antigen value, total prostate characteristic antigen ash area value detection method, it detects on the test paper detection line, it is characterized in that on the detection test paper, including two different numerical value detection lines that detect,, a 10ng/ml detection line (4) and a 4ng/ml detection line (3), detection line is made of prostate-specific antibody, numerical range between 10ng/ml detection line (4) and 4ng/ml detection line (3) can be measured the ash area value scope of human whole blood or the total prostate characteristic of serum antigen, during mensuration when whole blood or the total prostate characteristic of serum antigen are variable concentrations, having different results shows, the numerical value of judging the total prostate characteristic of whole blood or serum antigen thus is on the ash area value scope, still under the ash area value scope or just in time be positioned among the ash area value scope, detection may further comprise the steps:
I. test paper being inhaled the sample film end, to insert in tested whole blood or the blood serum sample 0.5-1.0cm dark, keeping 10-30 to take out after second keeps flat, perhaps analyte sample fluid 2-3 is dripped directly to drop in and keep flat after test paper is inhaled the sample film end, observe detection line place and judged result after 5-30 minute;
Ii. when the concentration of total prostate characteristic antigen in the sample during less than the detection threshold of 4ng/ml detection line, 4ng/ml detection line (3) and 10ng/ml detection line (4) do not develop the color, and it is very low to illustrate that the subject suffers from the possibility of prostate cancer;
Iii. work as the detection threshold of the concentration of prostate characteristic antigen in the sample more than or equal to 4ng/ml detection line (3), and during less than the detection threshold of 10ng/ml detection line (4), 4ng/ml detection line (3) colour developing, and 10ng/ml detection line (4) does not develop the color, the content of total prostate characteristic antigen is positioned at the ash area value scope in the interpret sample, subject's situation be can not determine, need further do the mensuration of free prostate gland characteristic antigen and total prostate characteristic antigen ratio;
Iv. when the concentration of prostate characteristic antigen in the sample during more than or equal to the detection threshold of the detection line (4) of 10ng/ml, 4ng/ml detection line (3) and 10ng/ml detection line (4) develop the color simultaneously, illustrate that the subject suffers from prostate cancer probably, should further check.
2, a kind of human whole blood according to claim 1 or the total prostate characteristic of serum antigen value, total prostate characteristic antigen ash area value detection method, it is characterized in that the detection threshold that detection line (3) sets is 4ng/ml, then can detect the Cmin value of total prostate characteristic antigen gray area in the sample; The detection threshold that detection line (4) sets is 10ng/ml, then can detect the Cmax value of total prostate characteristic antigen gray area in the sample.
3, a kind of human whole blood according to claim 1 and 2 or the total prostate characteristic of serum antigen value, total prostate characteristic antigen ash area value detection method is characterized in that setting the less 4ng/ml detection line (3) of detection threshold and are right after hydroscopic substance and are positioned at the test paper end.
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| CNB011291745A CN1159582C (en) | 2001-12-08 | 2001-12-08 | Method for detecting total PSA value and total PSA gray zone value in whole blood or serum of human body and test paper for carcinoma of prostate |
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| CNB011291745A CN1159582C (en) | 2001-12-08 | 2001-12-08 | Method for detecting total PSA value and total PSA gray zone value in whole blood or serum of human body and test paper for carcinoma of prostate |
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| CN101609098B (en) * | 2008-06-16 | 2013-09-25 | 艾博生物医药(杭州)有限公司 | Method for detecting existence of analytes in biological sample |
| CN101469348B (en) * | 2008-08-29 | 2011-07-20 | 苏州福英基因科技有限公司 | In situ hybridization detection kit for early carcinoma of prostate, detecting method and use thereof |
| CN102012423A (en) * | 2009-09-04 | 2011-04-13 | 开物科技股份有限公司 | Biological detection test base material |
| CN101900733A (en) * | 2010-08-13 | 2010-12-01 | 中南大学 | Tumor marker colloidal gold immunochromatographic assay quantitative detection test paper and method for preparing same |
| CN102621302A (en) * | 2012-03-22 | 2012-08-01 | 四川省新成生物科技有限责任公司 | Linear immune detection film bar and manufacturing process thereof |
| AU2013202768B2 (en) * | 2012-10-18 | 2015-11-05 | Signal Pharmaceuticals, Llc | Treatment of cancer with TOR kinase inhibitors |
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| CN102928589A (en) * | 2012-11-15 | 2013-02-13 | 南京凯基生物科技发展有限公司 | Colloidal gold method detection test strip and reagent kit for IgG antibody of respiratory disease and preparation method of reagent kit |
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