Some standard content:
Health Industry Standard of the People's Republic of China
WS/T229—2002
Physical, chemical and microscopic examination of urine2002-04-20 Issued
Issued by the Ministry of Health of the People's Republic of China
Implemented on 2002-07-01
WS/T229—2002
Physical, chemical and microscopic examination of urine is a commonly used clinical test, but the analysis methods of each test item are various and the interference factors are complex. It is not possible to have a corresponding standard to regulate it.
This standard will be implemented from July 1, 2002. This standard is proposed by the Medical Administration Department of the Ministry of Health.
The drafting unit of this standard: General Hospital of the People's Liberation Army. The main drafters of this standard: Cong Yulong, Deng Xinli, Ma Junlong. This standard is entrusted by the Ministry of Health to the Ministry of Health Clinical Laboratory Center for interpretation. 1 Scope
Health Industry Standard of the People's Republic of China
Physical, chemical and microscopic examination of urineWS/T229—2002
This standard specifies the determination methods of physical, chemical and sediment analysis of urine, related materials and equipment and their quality control. This standard is applicable to routine tests in clinical laboratories. 2 Definitions
This standard adopts the following definitions.
2.1 Urine test strip
Urine test strip is supported by a plastic film, on which one or more reaction membrane blocks are attached. Through color reaction with urine, one membrane block can detect one urine component.
2.2 Timed urine specimen
Urine specimen collected during a specified time period. The starting point and duration of the time period may be subject to special provisions. 3 Materials and Instruments
3.1 Materials
Containers, test tubes, and slides used for urine analysis must be labeled to facilitate identification of patient specimens. All materials used for urine analysis must be free of particles.
3.1.1 Collection containers. See 4.5.1 and 4.5.2 for specific regulations. 3.1.2 Centrifuge tubes
3.1.2.1 Centrifuge tubes can be made of plastic or glass. 3.1.2.2 Centrifuge tubes must be long enough to prevent urine specimens from spilling during centrifugation. 3.1.2.3 Centrifuge tubes must be clean and transparent to facilitate visual inspection of urine. 3.1.2.4 Centrifuge tubes must have volume scales with an accuracy of 0.1 mL. 3.1.2.5 The volume of a centrifuge tube must be greater than 12 mL and should be less than 15 mL. 3.1.2.6
The mouth of the test tube must be sealed to prevent the liquid in the test tube from splashing out and the formation of aerosols. 3.1.2.7
The centrifuge tube should have a conical or narrow bottom to facilitate the concentration of sediment. 3.1.2.8 The centrifuge tube is free of chemical contamination. 3.1.2.9 It is recommended to use disposable centrifuge tubes. 3.1.3 Pipette
Pipette must be clean and cannot be reused. 3.1.4 Urine sediment plate
Urine sediment plate must be standardized with a calibrated small space to accommodate a quantitative sediment liquid. Easy to use and can be purchased as a commodity. Urine sediment plate cannot be reused. The inspection method of dropping sediment solution on an ordinary glass slide and then covering it with a cover glass cannot provide standardized and reproducible results.
Approved by the Ministry of Health of the People's Republic of China on April 20, 2002 and implemented on July 1, 2002
3.1.5 Urine test strips
3.1.5.1 Do not use test strips that have expired. WS/T229-2002
3.1.5.2 The test strips should be stored in the container provided by the manufacturer, and the storage container should not be changed. 3.1.5.3 Do not store the test strips in direct sunlight or in a humid place. 3.1.5.4 The container for storing the test strips should be sealed. The storage temperature should follow the manufacturer's recommendations. Take out a small amount of test strips from the container each time, and cover the container immediately after taking out. Unused test strips should not be put back into the container.3.1.5.54
3.1.5.6 Test strips in different containers cannot be mixed. 3.1.5.7 The chemical reaction membrane on the test strip cannot be touched. 3.2 Instruments
3.2.1 Microscope
3.2.1.1 A double-simple microscope should be used.
3.2.1.2 Built-in light source.
3.2.1.3 A stage that can mechanically move the slide. 3.2.1.4 It has 40x and 10x objective lenses and a 10x eyepiece. 3.2.1.5 If there are multiple microscopes in the same laboratory, the magnification of the objective lens and eyepiece of each microscope should be consistent. 3.2.2 Instrument for reading urine test strip results
3.2.2.1 The instrument for reading urine test strip results should be a photometric analyzer that measures reflected light. It reads the results by measuring the reflected light of the reaction membrane on the test strip.
3.2.2.2 The urine test strip result interpretation instrument should be able to measure the color change of each reaction membrane block on the urine test strip while excluding the interference of other colors, and can interpret the results within a specific time to prevent the results from changing over time. 3.2.2.3 Before using the instrument, the manufacturer's operating instructions should be carefully read, and the instrument's operating instructions should be followed, and the quality assurance measures provided should be strictly implemented.
3.2.2.4 Keep the instrument clean. If it is contaminated by urine, it should be cleaned immediately. 3.2.2.5 According to the manufacturer's regulations, the instrument should be regularly maintained, including the optical and mechanical parts. 3.2.2.6 Calibrate the instrument according to the manufacturer's regulations. 3.2.3 Centrifuge
3.2.3.1 There should be a cover on the top. The cover should be closed during centrifugation to ensure safety. 3.2.3.2 The temperature inside the centrifuge should be between 15°C and 25°C. 3.2.3.3 The relative centrifugal force of the centrifuge can be stabilized at 400g. 3.2.3.4 The relative centrifugal force of the centrifuge should be calibrated regularly. 3.3 Quality control materials for urine chemical analysis
3.3.1 Quality control materials for urine chemical analysis are multi-component quality control materials. 3.3.2 Both normal and abnormal quality control materials must be used at the same time. If the test result of a normal quality control material is abnormal, or the test result of an abnormal quality control material is normal, both are out of control. The measurement result of a certain membrane block of the quality control material and the target value are normal within ±1 membrane block, otherwise it is out of control. 3.3.3 Quality control must be performed once a day. Quality control must be performed once a box of test strips is replaced. 3.3.4 When a batch of test strips is replaced, the quality control results of the two batches of test strips must be compared. 3.3.5 The value of the quality control material should be within the detectable range of the method used by the laboratory. 3.3.6 Inter-laboratory quality evaluation must be participated in.
4 Collection and transportation of urine specimens
4.1 Personnel collecting urine specimens
4.1.1 Random urine specimens, 24-hour urine specimens, and timed urine specimens can be collected by patients themselves, but they must be instructed by medical staff. 2
WS/T229—2002
4.1.2 Catheterized urine specimens and suprapubic puncture urine specimens must be completed by patients with the assistance of doctors or nurses. 4.2 Instructions before patients collect urine specimens themselves Before patients collect urine specimens, laboratory staff, doctors or nurses must instruct patients and introduce the correct method of collecting specimens and relevant precautions. When verbal communication is not possible, written instructions shall be given; for non-Chinese speakers, other methods of explanation shall be used.
4.2.1 Inform patients to wash their hands and do other necessary cleaning before collecting specimens. 4.2.2 Give the patient a urine specimen container, mark it with a mark that can identify the patient, and have the patient check it. 4.2.3 Inform the patient of the amount of urine specimen required. 4.2.4 Inform the patient that urine must not be contaminated by genital secretions, pubic hair, dust, oil, washing liquid, etc. 4.2.5 Inform the patient to cover the container after collecting the specimen to prevent urine from overflowing. 4.3 Collection of urine specimens
4.3.1 There is no special time regulation for the collection of random urine specimens, but the patient must have enough urine. 4.3.2 Collection of the first urine specimen in the morning
Collect the first urine of the patient after getting up.
4.3.3 When collecting a time-period urine specimen, the patient should be informed of the starting and ending points of the time period. The time-period urine specimen should include all urine discharged by the patient during that time period. If necessary, inform the patient of the precautions for specimen storage. 4.4 Collection of urine specimens from infants and young children
The collection bag can be attached to the skin of the infant's genitals with an adhesive. The adhesive should have minimal irritation to the infant's skin. 4.5 Specimen collection and transportation containers
4.5.1 The collection and transportation containers should be clean, leakproof, and made of transparent, inert materials that do not react with urine components. The containers and their sealing devices should not contain interfering substances.
4.5.2 Specimen collection and transportation containers cannot be reused. 4.5.3 The volume of the collection container is greater than 50 mL, with a shaped opening greater than 4.0 cm in diameter and a wide bottom. 4.5.4 The transport container has a safe and secure sealing device that is easy to operate and open. 4.5.5 Labeling
The specimen storage container must be labeled, and the labeling content must include: the patient's full name, the specimen-specific code that can identify the patient, and the time the specimen was collected. The label should be attached to the container, not to its lid. 4.5.6 Preservatives
Try not to use preservatives. If urine analysis cannot be performed within 2 hours after specimen collection, and the components to be analyzed in the urine are unstable, specific chemical preservatives can be added to the specimen. 4.6 Transportation and Storage of Urine Specimens
4.6.1 During transportation and storage, it should be ensured that the object to be analyzed in the urine specimen does not change. 4.6.2 Urine analysis is best completed within 2 hours after specimen collection. To conduct multiple analyses, urine should be packaged separately, and different transportation and storage methods should be selected according to different analytical purposes.
4.7 Acceptance of urine specimens
4.7.1 Laboratory staff must check whether the urine specimens are qualified. 4.7.1.1 Whether the label content of the specimens sent for examination is consistent with the test form filled out by the doctor. 4.7.1.2 Whether the time from collecting the specimens to receiving the specimens is too long. 4.7.1.3 Whether the specimen container meets the requirements. 4.7.1.4 Whether the specimen is contaminated.
4.7.1.5 Whether the specimen volume is sufficient.
4.7.2 If the specimen is unqualified, you should contact the doctor or nurse immediately. Unqualified specimens cannot be discarded before reaching an agreement with the doctor or nurse.
4.8 Collection and storage of 24h urine specimens
WS/T229--2002
4.8.1 Urine specimens should be collected in one or more clean, wide-opening, dark-colored containers with a capacity greater than 3L. 4.8.2 The collection container should be labeled with the patient's full name, test item, and the start and end time of specimen collection. 4.8.3 When the urine collection is finished, the patient should empty the bladder, and the urine bag should be emptied when collecting through a catheter. 4.8.4 During the collection process, the collected urine should be placed at 2℃～8℃. For patients with urinary catheters, if it is not an emergency, the urine bag should be placed on ice. If it is an emergency, the urine bag should be emptied at intervals and the urine should be placed at 2C～8C. 5 Physical examination of urinebzxZ.net
5.1 The volume of adult urine specimens should be greater than 12mL. The specimen disk for infants and young children should be greater than 5mL. 5.2 Specimens stored at 2°C to 8°C should be placed at room temperature for a period of time before examination. Specific regulations for specimen collection and transportation are shown in Chapter 4 of this standard.
5.3 Abnormal color, turbidity, and odor must be reported. The laboratory should establish a set of special terms to describe various colors, turbidity, and odors. 5.4 Urine specific gravity
Urine specific gravity refers to the mass-to-dispersion ratio of the same volume of urine to water at the same temperature. Urine specific gravity is expressed as a numerical value. The routine urine specific gravity determination in clinical laboratories can be carried out by refractometer method, harmonic vibration method, and dry chemical colorimetry. These three methods indirectly calculate the urine specific gravity by measuring a certain indicator of urine.
5.4.1 Principle of refractometer determination of urine specific gravity: The amount of dissolved solids in a solution is proportional to the refractive index. The refractometer should be calibrated. Contrast agents, high molecular weight substances, proteins, and glucose increase the relative density (specific gravity) of urine. If the urine contains the above substances, the measurement results should be corrected. 1g/L protein increases urine density by 0.0003, 1g/L glucose increases urine relative density (specific gravity) by 0.0004. 5.4.2 Principle of harmonic vibration method for determining urine relative density (specific gravity): The speed of sound wave conduction in solution is proportional to the density of solution. Harmonic vibration method is easy to automate, has good correlation with refractometer method, and is not affected by urine turbidity. 5.4.3 Principle of dry chemical colorimetric strip method for determining urine density: Electrolytes in urine release cations, which exchange with hydrogen ions in the ion exchanger in the test strip to release hydrogen ions, which then react with the acid-base indicator in it. The electrolyte concentration in urine can be inferred based on the color displayed by the indicator, and the density is represented by the electrolyte concentration. Its determination is affected by urine pH, middle molecules The amount of compounds has a greater impact. It is only suitable for normal physical examination and screening of newly diagnosed patients. When using urine density to judge renal function, the refractometer method should be used. 6 Chemical examination of urine
6-1 In routine laboratories, the chemical examination of urine can be carried out by the test strip method. Its main analysis contents include: ketone bodies, albumin, glucose, leukocyte esterase, hemoglobin, nitrite, pH, bilirubin, urobilinogen, density (specific gravity). 6.2 The urine specimen for chemical examination by the test strip method should preferably be uncentrifuged, evenly mixed, and clear first urine at a temperature between 15°C and 25°C. Random urine specimens can also be used. For other specimen regulations, please refer to Chapter 4. 6.3 Use of urine chemical examination strips
6.3.1 Different manufacturers produce urine for chemical examination Test strips for liquid chemistry examinations and test strips of different batches produced by the same manufacturer are not equivalent. Before using the test strips, read the product instructions carefully and operate strictly according to the instructions. 6.3.2 The reaction time between the test strips and urine must strictly follow the provisions of the product instructions. 6.3.3 The sensitivity and specificity of the test strips for detecting each component must be accurately mastered. 6.3.4 Manual reading of test strips is subject to individual differences among operators. When reading manually, a suitable light source should be selected and the test strips should be placed close to the colorimetric card. 6.3.5 A variety of substances can interfere with the reaction between the test strips and the chemical components in urine, and the conditions for false negatives and false positives should be understood. 6.4 Confirmation test
Confirmation test for detecting chemical components in urine with test strips refers to detecting the corresponding chemical components using a method different from that of the test strips. Components. The confirmatory test for urine albumin is the sulfosalicylic acid method. The confirmatory test for urine glucose is the glucose oxidase quantitative method. The confirmatory test for urine bilirubin is the Harrison method. The confirmatory test for urine white blood cells and red blood cells is the urine sediment microscopic examination. 4
7 Urine sediment examination
7.1 Specimens for urine sediment examination
WS/T229-2002
7.1.1 The first urine specimen in the morning is the best. Random urine can be used for emergency patients. 7.1.2 Casts, red blood cells, and white blood cells are easily dissolved in alkaline urine with a relative density (specific gravity) of less than 1.010. Urine that has been placed under non-cold conditions for more than 2 hours cannot be used for sediment examination. 7.1.3 The test specimen volume is 10ml. If the specimen volume is less than 10mL, it should be noted in the result report. 7.2 Each laboratory should formulate a system to stipulate that each member shall use the same method and operating procedures to perform urine sediment examination. 7.3 The urine specimen is centrifuged for 5 minutes, and the relative centrifugal force is about 400g. After centrifugation, the volume of the liquid remaining at the bottom of the centrifuge tube should be 0.2mL after the supernatant is poured out.
7.4 Transparent disposable special plastic plates should be used as much as possible for urine sediment examination. See 3.1.4 for specific regulations. Report the results in terms of the number of sediment components per unit volume.
7.5 The method of slide and cover glass can also be used for urine sediment examination: 20tL of mixed sediment is dropped onto a slide, covered with an 18mm×18mm cover glass, and then examined under a microscope. At least 20 fields of view of the whole film at low power (10×10) are used to calculate the average value of casts in each field of view, and at least 10 fields of view of various cells at high power (40×10) are used to calculate the lowest to highest. Urine crystals are reported as 10, 10+10, 10+10+10 for each high power field of view. 7.6 Examination contents of urine sediment
7.6.1 Cellular components: red blood cells, white blood cells, phagocytes, epithelial cells, etc. Epithelial cells include renal tubular epithelial cells, transitional epithelial cells, squamous epithelial cells, multinucleated giant cells, etc. 7.6.2 Casts: transparent casts, fine casts, granular casts, waxy casts, bacterial casts, product casts, fat casts, mixed casts, renal insufficiency casts, etc.
7.6.3 Crystals: amorphous crystals, phosphate crystals, calcium oxalate crystals, uric acid crystals, etc. 7.6.4 Bacteria, parasites, yeasts.
7.6.5 Sperm, mucus
7.6.6 Special requirements of clinicians.
7.7 If the clinician does not require a urine microscopic examination and the urine appearance and turbidity are positive, if the urine test strip results meet the following conditions at the same time: ① the white blood cell result is negative; ② the nitrite result is negative; ③ the urine protein result is negative; ④ the red blood cell result is negative.The results of the white blood cell and red blood cell examination are equivalent to the results of the microscopic examination of urine white blood cells and red blood cells, and laboratory staff do not need to perform microscopic examination of urine.
WS/T229-2002
People's Republic of China Health
Industry Standard
Urine Physics, Chemistry and Sediment Analysis
WS/T229—2002
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