JM363402 PH TEST STRIPS
- Urine Analysis Strip Specification
Product Name
Common Name:Urine Test Strips
Trade Name: Urine Test Strips
English Name:Chemical Urinalysis Strips
Packing Specification
Model:4A ,10A,11A,12A,14A,100 doses/barrel
Intended Application
Used in clinical urine Glucose, bilirubin, ketone , specific gravity, PH, protein, urobilinogen, nitrite, leukocyte, ascorbic acid, Creatinine, calcium, calcium for qualitative and semi quantitative detection
Inspection Principles
The chemical reaction between test strip and urine produce color change, by colorimetric analysis, Concludes that the relative concentration of various measured substance.
Component
The urine analysis card is mainly composed of substrate, double-sided adhesive, test block
The main components of the test block per 100 urine test cards.
Glucose
Glucose oxidase (GOD) 700 I.U.
Peroxidase (POD) 175 P.U.
4-Aminoantipyrine(4-AAP) 14.0 mg
1-Naphthol-3,6-disulfonic acid, disodium salt 14.0mg
Protein
Tetrabromophenol bule (TBPB) 0.35mg
Bilirubin
2-Methyl-5-nitroaniline 1.9mg
Sodium nitrite 1.0mg
Urobilinogen
3,3-Dimethoxy-4,4-biphenylbis (diazonium tetrafluoroborate) 0.16 mg
pH
Bromocresol green 0.07 mg
Bromoxylenol blue 0.72mg
Specific Gravity
Di(2-ethylhexyl)phosphoric acid (D-2-EHPA) 8.0mg
Bromthymol blue 0.7mg
Blood
Cumene hydroperoxide (CHP) 30.0mg
3,3,5,5-Tetramethylbenzidine (TMBZ) 15.0mg
Ketones
Sodium nitroprusside 12.0mg
Nitrite
Sulfanilamide 3.9mg
N-1-Naphthylethylenediamine dihydrochloride(NEDA-2HCl) 0.3mg
Leukocytes
3-(N-Toluenesulfonyl-L-alanyloxy)indole(TAI) 0.49mg
2-Methoxy-4-(N-morpholino)benzenediazonium(MMB) 0.17mg
Micro albumin:
fluorescein dye 0.4mg;
Calcium:
o-cresol phthalocyanine complex one 2.5mg; buffers 176.0mg;
Creatinine:
3,5-nitrobenzoic acid 5.0mg; buffers 126.0mg;
Storage conditions and validity
Storage Conditions: 2 ºC ~ 30 ºC
non-corrosive gas environments dark, damp storage.
Duration: 18 months After opening period: three months.
Applicable instrument
Suitable for common type urine analyzer.
Specimen requirements
1, Collecting the fresh urine with a container , as far as possible to shorten the storage time (no more than four hours to place the urine), to test the urine after centrifugation without the full mix.
2, the container by the detergents, disinfectants after treatment, should be fully dry after use with clean water.
3, when you save a urine sample, can not add acid, alkaline preservatives.
4, refrigerated or frozen urine samples should be brought to room temperature was measured after sufficient mixing.
5, urobilinogen and bilirubin due to instability, please collect a urine sample was measured within one hour.
6, when measured nitrite, should take morning urine or urine retention is better than four hours in the bladder.
7, check urobilinogen, the urine can be collected at any time, but 2-4 in the afternoon as well, so when the urinary excretion of urobilinogen most.
Test method
visual colorimetry:
Will test all test area into the fresh urine is fully blending, and immediately took out
2, leaning against the edge of the test strip container side, slipped more than urine;
3, holding a test strip, compared with colorimetric bottle sign on the table, record the test results in its determination time;
4, normal working conditions: ambient humidity 10 ºC ~ 30 ºC; relative humidity RH = 60%.
Urine analyzer colorimetric methods:
Please click urine analyzer used in the operating instructions for testing.
reference value(Reference range)
| project |
reference range |
project |
reference range |
| Glucose(GLU) |
<2.8 mmol/L |
Blood(BLD) |
<10cells/μL |
| Bilirubin(BiL) |
0 μmol/L |
Urobilinogen(URO) |
3.2-16μmol/L |
| Ketone(Ket) |
0mmol/L |
Nitrite(NIT) |
0μmol/L |
| Protein(Pro) |
<0.15g/L |
Specific Gravity(SG) |
1.010-1.025 |
| Calcium(Ca) |
1.5-9.0 mmol/L |
creatinine(CRE) |
2.0-22.0mmol/L |
| Leukocyte(Leu) |
0cells/μL |
ascorbic acid (Vc) |
0 mmol/L |
| (PH) |
5.5-7.0 |
MicroAlbumin(MAC) |
<30mg/L |
The interpretation of the test results
Test result judge:
Sign specified time according to the bottle, with reference to the standard color code judgment test results and records. Suspicious, repeatable test, when positive urine specimen, need further examination
Glucose: The experimental area of glucose detection specificity, in addition to sugar, other substances in urine can not be any one of a positive detection result. Paper and can make positive color change reaction in the urine, if the ascorbic acid contained less than 0.28mmol / L, at least to the content of glucose 2.2mmol / L. If the urine can ascorbic acid concentrations greater than 2.84mmol / L, or ketone body concentrations higher than 4mmol / L glucose content in the sample 4-7mmol / L showed a false negative reactions. When the specific gravity of the urine increased, decreased glucose test reaction. Reactivity also due to temperature change. Under normal circumstances, there may be a small amount of glucose excreted via the kidneys, but this small amount is less than the detection sensitivity of the test strip.
Bilirubin: Under normal circumstances, can not be detected in the urine of bilirubin. If the presence of trace amounts of bilirubin in urine, abnormal enough to prompt the need for further examination. When some of the metabolites of drugs, such as pyridine metabolites and s- oxindole aldehyde acid can cause false positive results in urine ascorbic acid concentrations greater than 1.42mmol / L, can cause false negative results. When the results were negative hemolytic jaundice.
Ketone : This study flora acetoacetate in urine, but does not react with urine acetone and β- hydroxybutyrate. Normal urine sample is usually negative, some high gravity / low PH of the urine will increase its reactivity and trace ketones coloration. False positive or abnormal coloration seen in large volume of acetone gum benzene, acetone, plastic, α- keto acid into the sample levodopa metabolite contained in the sample or a dye.
Specific Gravity: The urine dipstick can determine the ratio of between 1.005 and 1.030, this method a good correlation with refraction coefficient method and its error is within 0.005. In order to increase the accuracy, when urine PH 6.5 or higher, plus 0.005 in their reading, and can automatically adjust the urine analyzer. In the urine test results from some nonionic ingredients, such as glucose, are not affected by opaque color dye. Highly buffer alkaline urine will be lower compared with other methods of numerical; When the protein in the urine (1-7.5 g/L), also can make rising proportion of the value.
Blood: This experiment of hemoglobin is very sensitive and can be used as a supplement to the microscopic examination. This paper is Vc interference formula, even if the content of ascorbic acid in the urine as high as 2.84 tendency for L, also won't appear false negative results. But for high density and high bad blood acid urine sample, reaction will have lower sensitivity. Occult blood should be distinguished from the menstrual period women's blood in the urine. Certain oxidizing pollutants, such as hypochlorite can lead to false positives, microbes associated with urinary tract infection in the peroxidase can also cause false positive results.
PH: PH test area usually within 1 unit test values. To the naked eye measurement range of 5.0-8.5, instrument measuring range is 5-9.
Protein: This test area than in albumin globulin, hemoglobin, this a zhou protein and glycoprotein is more sensitive, so the result of a "negative" cannot be ruled out this type of protein in the urine samples. Under normal circumstances, the kidney will drain a small amount of protein, but the conventional method can't check out, such as color than "trace" standard block deep means have proteinuria, need further examination. High alkaline urine buffer can lead to false positive results, if the urine samples by quaternary ammonium salt compounds or some cleaner, preservatives pollution can also cause false positive results
Urobilinogen:This test can detect in the urine concentration as low as 3 mu mol/L (approximately 0.2 Ehrlich) uric bravery of the original. In normal urine uric bravery original content is 3.2-16 mu mol/L. 32 mu mol/L could be the result of the from the normal to the abnormal changes of the critical value, need further examination. When the normal cannot be ruled out completely occlusive disorders of jaundice. In high concentration of urine aminobenzoic acid can cause atypical color reaction, urine exist formaldehyde can make for false negative results
Nitrite: This experimental area of nitrite is the specificity, don't react with normal urine excretion of other substances. The test is based on the premise that gram-negative bacteria effect and make the urine nitrate to nitrite. Any appear even pink should be judged positive results, shows a sample of more than 105 / mL number of gram-positive bacteria. However, the negative results cannot be said without the presence of bacteria in the urine, negative results seen in the transformation of nitrate bacteria, also may be due to urine is not enough time left in the bladder (4 hours) to complete the transformation of nitrate to nitrite. High proportion of urine can reduce the reactivity of this experiment, high bad blood acid (1.42 or higher tendency/L) can make urine nitrite a false negative result
Leukocyte: Urine samples of normal leukocytes were negative results. Positive results and appeared again and again, it is very important in clinic, the need for further examination. Due to pollution, vaginal discharge in women occasionally get a positive result in the urine sample. High glucose concentration (tendency for 160 / L) or high proportion of urine can reduce the result of the experiment, high concentrations of drugs (e.g., cephradine) can also cause false negative results.
Ascorbic acid: Ascorbic acid can be used to measure the content of 0, 50 mg/dL, through the test can know the level of ascorbic acid in the urine of glucose, bilirubin, occult blood, the influence degree of the determination of nitrite, etc. When urine sample contains antioxidants (such as potassium permanganate, sodium hypochlorite), will affect the sensitivity of this test
Creatinine: Under the condition of peroxides, creatinine and sulphate generate complex, catalytic hydroxyl peroxide isopropyl benzene and TMB, response range from orange to green, the color change of the final to blue, a color change is proportional to the content of creatinine
Calcium: Calcium ions in urine in alkaline conditions, combined with adjacent a phenolphthalein complexation ketone in the test paper, generating a complex of amaranth, adding suitable amount of the delta - hydroxyquinoline can eliminate interference magnesium ions
Micro albumin: Trace than globulin to albumin, hemoglobin, albumin project ~ Bence Jones's protein and mucin sensitive, so check out a "negative" result does not mean that do not have these proteins. This project can detect urinary albumin, sensitive to the sensitivity of other proteins than albumin low several times. For highly buffer, alkaline urine, are likely to get false positive results. If the urine is quaternary ammonium salt compounds and certain preservatives or detergent pollution can also cause false positives, visible to the naked eye hematuria may also affect protein test
The limitations of testing method
Urine analysis in the urine dipstick test method is limited to the various ingredients for qualitative and semi-quantitative measurement, so the products in clinical as auxiliary diagnosis methods, only not as on the basis of diagnosis and treatment of disease of disease of further confirmation should be combined with other testing means.
Physical Performance of Products
1,accuracy rating
Strip in urine analysis for detecting all the reference solution in different levels of the project, each concentration level determination of repeated 3 times, test results with the reference solution labeling values differ fact no more than one order of magnitude, the reverse differ, they shall not positive reference solution may appear negative results, negative reference solution may not be a positive result
2,repeatability
Randomly selected the same batch number analysis urine dipsticks are 20, to control the quality of 1 with positive urine liquid for testing, the results of each inspection project consistency of no less than 90%.
3,detection limit
Randomly selected the same batch number analysis urine dipsticks article 20, for each test project of the first non negative level test, the test results can not be negative (except proportion and PH)
4,analytical specificity
Randomly selected the same batch number analysis urine dipsticks article 20. Respectively, at the same time employ various testing project of the first non negative level reference solution, concentration of added vitamin C to 50 mg/dl, vitamin C is not the result of the test.
3,Detection limit and measurement range
| Strip area |
detection limit |
Measuring range |
| Glucose |
5mmol/L (100mg/dL) |
5-110mmol/L(100-2000mg/dL) |
| Bilirubin |
0.8mg/dL |
0.5-2.0mg/dL |
| )ketone |
1.0mmol/L (10mg/dL) |
0.5-16mmol/L(5-160mg/dL) |
| Blood |
15cells/ul |
10-200cells/ul |
| Protein |
15mg/dL |
15-2000mg/dL |
| Nitrite |
0.08mg/dL |
Weakly positive - strong positive |
| Leukocyte |
15cells/ul |
15-500cells/ul |
| urobilinogen |
16μmol/L
(1Ehrlich units/dl urine) |
3.2-128μmol/L
(0.2-8 Ehrlich units/dl urine) |
| VC |
14mg/dL |
10-50mg/dL |
| microalbumin |
30 mg/L |
30mg/L,80mg/L,150mg/L |
| creatinine |
4.4mmol/L |
0.9mmol/L,4.4mmol/L,
8.8mmol/L,17.7mmol/L,
26.5 mmol/L |
| calcium |
3.7 mmol/L |
1.25 mmol/L,3.7 mmol/L,
12.5 mmol/L |
This manual applies to other specifications of the paper
Attention
Test strip shall be stored in dry environment, should avoid direct sunlight, high temperature and humidity
Test paper in a desiccant inside the bottle, test paper should be timely after using out of the bottle
Please according to the time stated on the various projects to determine test results, in addition to white blood cells must be in 2 minutes and other projects are color within 1 minute. Color change after 2 minutes without clinical significance.
Such as paper not fully immersed in the urine, can cause color uneven, affect judgment
Paper from the urine, immediately slipped to excess urine, lest affect the results
In test sites have sexual material (acid, alkali, organic solvents, coal, etc.) or the use of oil, coal heating furnace, etc., will affect the correctness of the results.
Please in the bright place, such as fluorescent lamp) judgment result
By the time of glucose, occult blood (the) chlorate, bleaching powder, such as antioxidant effect, can be a false positive
When the urine sample is strongly basic, urine protein can be a false positive reactions, can be added to dilute acetic acid, make among them and after testing.
In the urine, such as a large number of ascorbic acid and nitrite, affects glucose, occult blood and bilirubin color reaction, but the product of Vc interference, the ascorbic acid concentration tendency for 2.84 / L, will not cause a false negatives of glucose, occult blood.
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