CN105842240A - Saliva test card for semi-quantitatively detecting early chronic nephrosis and method thereof - Google Patents

Saliva test card for semi-quantitatively detecting early chronic nephrosis and method thereof Download PDF

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CN105842240A
CN105842240A CN201610330477.5A CN201610330477A CN105842240A CN 105842240 A CN105842240 A CN 105842240A CN 201610330477 A CN201610330477 A CN 201610330477A CN 105842240 A CN105842240 A CN 105842240A
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test card
color
card
saliva
microglobulin
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李智
李瑞红
费海波
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Sichuan University
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Sichuan University
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour

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Abstract

The invention discloses a saliva test card for semi-quantitatively detecting early chronic nephrosis and a method thereof. The test card simultaneously integrates the detection of three indexes: urea nitrogen, cystatin C and Beta2-microglobulin in saliva, and simultaneously semi-quantitatively judges the concentration ranges of three indexes by comparing different colors obtained after the urea nitrogen, cystatin C and Beta2-microglobulin in saliva are simultaneously subjected to chemical reaction with corresponding parts on the test card with that on the standard card cards, and further detects early renal functions. The test card further comprises a two-dimensional code, and the standard color chart, manufacturer and instructions of the test card can be obtained through scanning. The three indexes in saliva have good correlation with relevant indexes in serum, and the test card takes saliva as a sample solution, is rapid and simple, eliminates the problem of bacterial interference, can be applied to hospital emergency or families, in particular to renal function examinations of infants, the aged and critical patients, and meanwhile reduces the pain of patients due to venipuncture.

Description

The sputum test card of a kind of half-quantitative detection chronic nephropathy in early days and method thereof
Technical field
The invention belongs to disease in-vitro diagnosis category, particularly to sputum test card and the method thereof of a kind of half-quantitative detection chronic nephropathy in early days, can be used for hospital emergency, particularly the kidney function test of infant, old man and critical patient.
Background technology
At present, the prevalence rate of chronic disease, sickness rate the most all rise constantly, chronic be all attended by the generation of complication.CKD is the health problem generally existed in global range.In these patients CKD, have 44% be to be caused by diabetes, the patient of 86% is attended by least one complication, and major part CKD patient has cardiovascular disease.Additionally, end stagerenaldisease (dialysis) patient's spends 2% much larger than whole health care expenses.And blood urea nitrogen, bladder chalone C, β2-microglobulin are as the leading indicator of renal function, clinically through detecting renal function frequently with this three.
External nephropathy magazine research show bladder chalone C without tubular secretion, unrelated sex and ethnic group, 1 phase and 2 phase nephropathy that creatinine cannot detect can be detected, it is achieved CKD early diagnosis, treat in time, postpone its deterioration;When glomerular filtration rate (GFR) drops to less than the 50% of normal value, the concentration of blood urea nitrogen is significantly altered, suffer from uremic people in recent years to get more and more, periodic detection blood urea nitrogen is conducive to early finding the unusual condition of renal function, thus take remedy measures as early as possible, avoid deteriorating into serious dialysis period, also mitigate the burden of great number medical fee simultaneously;β2-microglobulin is reflection hypertension and the impaired sensitive indicator of diabetogenous nephrosis, can be that the clinical diagnosis of renal function mensuration, diabetic nephropathy etc. provides relatively morning, reliably index, and meanwhile, it is the sensitive indicator of reaction detection of glomeruli filtration function.
Since the eighties in 20th century, the these three index having experiment to show in the saliva of people in blood urea nitrogen, bladder chalone C, β2-microglobulin and serum successively has good dependency, its correlation coefficient, therefore can be with them as the index detecting renal function between 0.93 to 1.03.During traditional kidney function test, using vein haemospasia to detect, the patient for being in a bad way is typically necessary frequently blood drawing, and therefore arm to keep clean, avoids getting wet after blood drawing, prevents from infecting.Compared with traditional detection method, detection saliva can be avoided infection problem, need not draw blood again, convenient and swift, alleviates hardship and the hemorrhagic anemia of venous patient punctures.
The method of detection renal function index is a lot, and half-quantitative detection is easy quickly, and give the substantially content of certain element, i.e. certain element or something in analyte is amount main, a large amount of, middle, a small amount of and trace simultaneously, and value that need not be concrete.Their product form mainly has dry chemical method and enzyme process, conventional dry chemical method to include radioimmunology, chemoluminescence method, colloidal gold immunity chromatography etc. to detect him.Dry chemistry technology, the most tested composition and the chemical reaction of reagent, all complete on reagent paper, need not any extraneous add reagent, heat, numerous and diverse operation such as washing, differentiate have that it's too late the substantially content of something with the color change presented after chemical reaction, sputum test card and the method thereof of a kind of half-quantitative detection in this paper chronic nephropathy in early days use this dry chemical method to detect just.
Summary of the invention
The present invention provides sputum test card and method, the simple, intuitive of a kind of half-quantitative detection chronic nephropathy in early days, shortens the detection time, has obtained the substantially concentration range of blood urea nitrogen, bladder chalone C, β2-microglobulin, had higher accuracy rate.According to dependency between three kinds of indexs in saliva three kinds of indexs and serum, can quick detectable concentration scope by this test card, can be used for detecting Renal function in early period, the especially kidney function test of infant, old man and critical patient, alleviate the misery of venipuncture when patient draws blood, it is easy to operation simultaneously.
The present invention includes handheld terminal, blood urea nitrogen reaction and display part, bladder chalone C reaction and display part, support section, diffusion part, β2-microglobulin reaction and display part, Quick Response Code sweep test, by the reaction of this test card blood urea nitrogen and display part during use, bladder chalone C reaction and display part, the diaphragm seal that β2-microglobulin reaction and display part cover above tears, place in mouth, outside handheld terminal is maintained at, react with these three according to saliva and display part distribute biochemical reaction after the different colours that obtains and standard color card compare the substantially concentration range judging three kinds of indexs.
Described Quick Response Code sweep test, on handheld terminal, can be opened the link network address of this test card, check the configuration parameter of this test card by scanning, including operation instruction, manufacturer, standard colour chart, example etc., serves identification test card color of taking pictures future.
Described handheld terminal can be angled with support section, and the scope of convenient operation is 90 ° to 180 °.
The standard color card that described test card uses is divided into 6 zone, determination of urea nitrogen scope and resolution are 0mg/dL, 11.4mg/dL, 20.4mg/dL, 40.4mg/dL, 60.4mg/dL, 80.4mg/dL respectively, color from yellow is progressively deepened to blueness, respectively yellow, yellow green, green, cyan, aeruginous, blueness;Bladder chalone C determining scope and resolution are 0mg/L, 0.53mg/L, 0.79mg/L, 1.05mg/L, 1.31mg/L, 1.57mg/L, and color from light yellow is progressively deepened to redness, the most faint yellow, golden, orange, Fructus Lycopersici esculenti is red, orange red, red;β2-microglobulin measurement range and resolution are 0mg/L, 0.12mg/L, 0.28mg/L, 0.44mg/L, 0.60mg/L, 0.76mg/L, color is changed stepwise to yellow by redness, is respectively redness, Fructus Lycopersici esculenti redness, rose, coral red, gold, yellow.
Accompanying drawing explanation
Fig. 1 is the top view (keeping flat) that the present invention tests card.
Fig. 2 is the front view (keeping flat) that the present invention tests card.
Fig. 3 is that the present invention tests card portion of the handle and remainder schematic diagram (forward sight when side is put) at an angle of 90.
Fig. 4 is that the present invention tests card portion of the handle and remainder and is divided into the schematic diagram (overlooking when keeping flat) at 180 ° of angles.
Fig. 5 is the standard color card figure that the present invention tests card.
Detailed description of the invention
Such as Fig. 1, shown in 2, the present invention includes handheld terminal (1), blood urea nitrogen reaction and display part (2), bladder chalone C reaction and display part (3), support section (4), diffusion part (5), β2-microglobulin reaction and display part (7), Quick Response Code sweep test (8), during use, the diaphragm seal that this test card diffusion part (5) covers is torn, place in mouth, outside handheld terminal is maintained at, according to blood urea nitrogen in saliva, bladder chalone C, β2-microglobulin reacts with the blood urea nitrogen on test card respectively and shows part (2), bladder chalone C reaction and display part (3), the different colours obtained after β2-microglobulin reaction and display part (7) generation chemical reaction and the comparison of standard color card carry out the substantially concentration range of judge index.
Described Quick Response Code sweep test (8), on handheld terminal (1), can check the operation instruction of this test card, manufacturer, standard colour chart etc. by scanning, serves identification test card color of taking pictures future.
Described support section (4) plays supporting function, it is positioned at the bottom of this test card, being upwards handheld terminal (1), blood urea nitrogen reaction and display part (2) and acid-base value part of detecting (3), diffusion part (5) covers at blood urea nitrogen reaction and display partly (2) and acid-base value part of detecting (3) above.Wherein handheld terminal (1) and 1/5th compositions portion of the handle (6) of support section (4).
The indicator that described blood urea nitrogen reaction and display part (2) use is bromthymol blue, and its color change interval is pH6.0(yellow) ~ 7.6(blueness), the reagent of use mainly contains urase: 5u/cm2, now colored intensity is relatively good.
The indicator that described bladder chalone C reaction and display part (3) use is phenol red, and its color change interval is pH6.8(yellow) ~ 8.0(redness), the reagent of use mainly contains bladder chalone C catabolic enzyme: 10u/cm2
The indicator that described β2-microglobulin reaction and display part (7) use is methyl orange, and its color change interval is that pH3.1(is red) ~ 4.4(yellow), the reagent of use mainly contains β2-microglobulin catabolic enzyme: 5u/cm2
Described diffusion part (5) buffer agent contains hydrogen citrate two ferrum about 0.05mol/L, because the color gradient now reacting generation is big.
Such as Fig. 5, standard color card lastrow represents saliva blood urea nitrogen colorimetric, and middle row represents saliva bladder chalone C colorimetric, and last column represents saliva β2-microglobulin colorimetric, and from left to right color is deepened successively.
The principle of this test card detection saliva blood urea nitrogen is: during test, tear diaphragm seal, put in mouth, when the blood urea nitrogen contained in saliva spreads via the buffer agent of diffusion part (5), when reacting with reagent urase, produce ammonia, be combined with indicator bromthymol blue, forming coloured complex, color is directly proportional to urea nitrogen concentration.And urea nitrogen concentration normal range is 11.4 ~ 20.4mg/dL, when the color color than standard color card 0mg/dL is deep, during than 11.4mg/dL of light color, show that saliva urea nitrogen concentration is in 0 ~ 11.4mg/dL, now urea nitrogen concentration is lower than normal range, possible renal dysfunction or liver failure, it should remove examination in hospital;When the color color than standard color card 11.4mg/dL is deep, than 20.4mg/dL of light color time, show that saliva urea nitrogen concentration is in 11.4 ~ 20.4mg/dL, be now in normal range, represent health;When the color color than standard color card 20.4mg/dL is deep, than 40.4mg/dL of light color time, show that saliva urea nitrogen concentration is in 20.4 ~ 40.4mg/dL, now more higher than normal range, notes checking in time, to judge reason;When the color color than standard color card 40.4mg/dL is deep, than 60.4mg/dL of light color time, show that saliva urea nitrogen concentration is in 40.4 ~ 60.4mg/dL, the most higher, seek medical advice in time, treated as soon as possible, it is to avoid deteriorate further;When the color color than standard color card 60.4mg/dL is deep, during than 80.4mg/dL of light color, show that saliva urea nitrogen concentration is in 60.4 ~ 80.4mg/dL, the most higher, possibly into Uremic or property disease before the kidney such as disease, congestive heart failure after suffering from the kidneys such as nephritic disease, renal calculus such as chronic nephritis, renal function detection and other coherence checks do in Yao Qu hospital.
The principle of this test card detection bladder chalone C is: during test, tear diaphragm seal, put in mouth, when the bladder chalone C contained in saliva spreads via the buffer agent of diffusion part (5), when reacting with reagent bladder chalone C catabolic enzyme, produce alkaline matter, combination phenol red with indicator, forming coloured complex, color is directly proportional to bladder chalone C concentration.And in saliva bladder chalone C concentration normal range be 0.53 ~ 0.79mg/L, when the color color than standard color card 0mg/dL is deep, during than 0.53mg/L of light color, show that saliva bladder chalone C concentration is in 0 ~ 0.53mg/L, now bladder chalone C concentration is lower than normal range, clinical meaning is little, and examination in hospital need to be gone to examine;When the color color than standard color card 0.53mg/L is deep, than 0.79mg/L of light color time, show that saliva bladder chalone C concentration is in 0.53 ~ 0.79mg/L, be now in normal range, represent health;When the color color than standard color card 0.79mg/L is deep, than 1.05mg/L of light color time, show that saliva bladder chalone C concentration is in 0.79 ~ 1.05mg/L, now more higher than normal range, possibly into early stage chronic nephropathy, notes inspection in time, eliminating risk;When the color color than standard color card 1.05mg/L is deep, than 1.31mg/L of light color time, show that saliva bladder chalone C concentration is in 1.05 ~ 1.31mg/L, the most higher, seek medical advice in time, to judge whether to enter chronic nephropathy in mid-term, it is to avoid deteriorate further;When the color color than standard color card 1.31mg/L is deep, during than 1.57mg/L of light color, show that saliva bladder chalone C concentration is in 1.31 ~ 1.57mg/L, the most higher, possibly into renal failure phase or renal tubules pathological changes etc., renal function detection and other coherence checks do in Yao Qu hospital.
The principle of this test card detection β2-microglobulin is: during test, tear diaphragm seal, put in mouth, when the β2-microglobulin contained in saliva spreads via the buffer agent of diffusion part (5), when reacting with reagent β2-microglobulin catabolic enzyme, produce acidic materials, be combined with indicator methyl orange, forming coloured complex, color is directly proportional to β2-microglobulin concentration.And β2-microglobulin concentration normal range is 0.12 ~ 0.28mg/L, when the color color than standard color card 0mg/L is deep, during than 0.12mg/L of light color, show that saliva β2-microglobulin concentration is in 0 ~ 0.12mg/L, now β2-microglobulin concentration is lower than normal range, illustrating that glomerular filtration rate is the highest, diagnostic significance is not the biggest;When the color color than standard color card 0.12mg/L is deep, than 0.28mg/L of light color time, show that saliva β2-microglobulin concentration is in 0.12 ~ 0.28mg/L, be now in normal range, represent health;When the color color than standard color card 0.28mg/L is deep, during than 0.44mg/L of light color, show that saliva β2-microglobulin concentration is in 0.28 ~ 0.44mg/L, now more higher than normal range, may there is the risk of diabetic nephropathy, hypertensive nephropathy, note inspection in time;When the color color than standard color card 0.44mg/L is deep, than 0.60mg/L of light color time, show that saliva β2-microglobulin concentration is in 0.44 ~ 0.60mg/L, the most higher, it is probably acute injury of kidney, glomerule or renal tubules impaired, needs treated as soon as possible, it is to avoid deteriorate further;When the color color than standard color card 0.60mg/L is deep, during than 0.76mg/L of light color, show that saliva β2-microglobulin concentration is in 0.60 ~ 0.76mg/L, the most higher, possibly into renal failure phase, chronic nephritis or diabetic nephropathy etc., need to go to hospital to do kidney function test in time, to determine therapeutic scheme.

Claims (9)

1. the sputum test card of half-quantitative detection chronic nephropathy in early days and method thereof, it is characterized in that: this test card includes the reaction of handheld terminal (1), blood urea nitrogen and display part (2), bladder chalone C reaction and display part (3), support section (4), diffusion part (5), β2-microglobulin reaction and display part (7), Quick Response Code sweep test (8).
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterised in that: described test card can detect the substantially concentration range of blood urea nitrogen in saliva, bladder chalone C, β2-microglobulin simultaneously.
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterized in that: described test card Quick Response Code sweep test (8) is on handheld terminal (1), the link network address of this test card can be opened by scanning, check the operation instruction of this test card, manufacturer, standard colour chart, example etc., serve identification test card color of taking pictures future.
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterized in that: described test card total length is 10cm, width is 1cm, the wherein long 2cm of handheld terminal, the total length of remainder is 8cm, it is easy to carry, wherein handheld terminal (1) and 1/5th compositions portion of the handle (6) of support section (4).
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterized in that: the saliva blood urea nitrogen standard color card that described test card uses is divided into 6 zone, measurement range and resolution are 0mg/dL, 11.4mg/dL, 20.4mg/dL, 40.4mg/dL, 60.4mg/dL, 80.4mg/dL, color from yellow is progressively deepened to blueness, respectively yellow, yellow green, green, cyan, aeruginous, blueness.
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterized in that: the bladder chalone C standard color card that described test card uses is divided into 6 zone, measurement range and resolution are 0mg/L, 0.53mg/L, 0.79mg/L, 1.05mg/L, 1.31mg/L, 1.57mg/L, color from light yellow is progressively deepened to redness, the most faint yellow, golden, orange, Fructus Lycopersici esculenti is red, orange red, red.
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterized in that: the β2-microglobulin standard color card that described test card uses is divided into 6 zone, measurement range and resolution are 0mg/L, 0.12mg/L, 0.28mg/L, 0.44mg/L, 0.60mg/L, 0.76mg/L, color is changed stepwise to yellow by redness, is respectively redness, Fructus Lycopersici esculenti redness, rose, coral red, gold, yellow.
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterised in that: described handheld terminal (1) can be angled with support section (4), it is easy to the scope of operation is 90 ° to 180 °.
The sputum test card of a kind of half-quantitative detection the most according to claim 1 chronic nephropathy in early days and method thereof, it is characterized in that: described blood urea nitrogen reaction and display part (2), bladder chalone C reaction and display part (3), β2-microglobulin reaction and display part (7) be all the length of side be the square of 8mm, two-by-two at a distance of 1cm, they above for diffusion part (5), outside uses diaphragm seal to seal, when using this test card, again diaphragm seal is torn, make this three part be immersed in mouth simultaneously.
CN201610330477.5A 2016-05-18 2016-05-18 Saliva test card for semi-quantitatively detecting early chronic nephrosis and method thereof Pending CN105842240A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106991679A (en) * 2017-03-16 2017-07-28 四川大学 One kind quantifies recognition methods based on cloud platform urine test paper physical signs
CN110320158A (en) * 2018-03-30 2019-10-11 国际商业机器公司 Mobile chemical analysis

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DE2711201A1 (en) * 1977-03-15 1978-09-21 Kluthe Reinhold Kidney function testing device for home use - indicates urea content of saliva or urine by discolouration along length of probe
CN1749751A (en) * 2004-09-15 2006-03-22 王志洪 Test paper strip for measuring alcohol content in human saliva
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CN103525695A (en) * 2012-07-04 2014-01-22 长沙中生众捷生物技术有限公司 Portable kidney function detecting system
CN204422546U (en) * 2014-12-29 2015-06-24 霍普金斯医药研究院(北京)有限责任公司 Injury of kidney five in one test card
CN204925133U (en) * 2015-08-19 2015-12-30 天津脉络生物科技有限公司 Kidney dysfunction fluorescent quantitation detector

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2711201A1 (en) * 1977-03-15 1978-09-21 Kluthe Reinhold Kidney function testing device for home use - indicates urea content of saliva or urine by discolouration along length of probe
CN1749751A (en) * 2004-09-15 2006-03-22 王志洪 Test paper strip for measuring alcohol content in human saliva
CN2840040Y (en) * 2005-08-05 2006-11-22 桂林优利特医疗电子有限公司 Urine test paper
CN102707067A (en) * 2012-05-24 2012-10-03 蓝十字生物药业(北京)有限公司 Test strip for semi-quantitative detection of microalbuminuria
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106991679A (en) * 2017-03-16 2017-07-28 四川大学 One kind quantifies recognition methods based on cloud platform urine test paper physical signs
CN110320158A (en) * 2018-03-30 2019-10-11 国际商业机器公司 Mobile chemical analysis

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Application publication date: 20160810