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WS/T 662-2020: Technical requirements for clinical body fluids analysis
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Technical requirements for clinical body fluids analysis
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WS/T 662-2020
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Basic data | Standard ID | WS/T 662-2020 (WS/T662-2020) | | Description (Translated English) | Technical requirements for clinical body fluids analysis | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Word Count Estimation | 14,137 | | Date of Issue | 2020-03-26 | | Date of Implementation | 2020-10-01 | | Regulation (derived from) | State-health communication (2020) No. 3 | | Issuing agency(ies) | National Health Commission | WS/T 662-2020: Technical requirements for clinical body fluids analysis---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical requirements for clinical body fluids analysis
ICS 11.020
C 50
WS
People's Republic of China Health Industry Standard
Technical requirements for clinical body fluid testing
2020-03-26 released
2020-10-01 implementation
Issued by the National Health Commission of the People's Republic of China
Foreword
This standard was drafted in accordance with the plan given in GB/T 1.1-2009.
The main drafting units of this standard. Clinical Laboratory Center of National Health Commission, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Zhong
Longhua Hospital Affiliated to Medical University, Yangpu Hospital Affiliated to Tongji University, Yunnan Provincial Clinical Laboratory Center, Peking University People's Hospital, Sun Yat-sen University
The First Affiliated Hospital, West China Hospital of Sichuan University.
The main drafters of this standard. Peng Mingting, Xiong Lifan, Hu Xiaobo, Zhou Wenbin, Li Chenbin, Li Zhi, Niu Hua, Wang Hui, Jiang Huan, Su Jun.
Technical requirements for clinical body fluid testing
1 Scope
This standard specifies the clinical examination of body fluid specimens such as cerebrospinal fluid, serous cavity fluid, joint cavity fluid, stool, semen, and vaginal secretions.
skills requirement.
This standard applies to clinical laboratories that carry out the testing of the above-mentioned types of body fluid samples.
2 Technical requirements for cerebrospinal fluid inspection
2.1 Specimen collection, transportation and storage
2.1.1 The laboratory should discuss with the clinic and formulate standard operating procedures for the collection and processing of cerebrospinal fluid specimens.
2.1.2 The clinician should indicate the relevant information of the location where the cerebrospinal fluid sample was collected (such as the lumbar spine or ventricle) on the application form.
2.1.3 Sterile test tubes should be used for the collection of cerebrospinal fluid specimens (glass containers should not be used for specimens used for cytological examination).
Collect enough specimens and divide them into 3 to 4 test tubes. Each tube should take 3 mL to 5 mL. Generally, no anticoagulant is needed.
2.1.4 The first tube is used for chemical and immunological examinations (such as protein, glucose, etc.), the second tube is used for microbiological examination, and the third tube is used
For cell counting and classification counting. If other examinations (cytopathological examinations, etc.) are required, the fourth tube specimen should be collected. If the first tube is mixed
Puncture bleeding should not be used for the diagnosis of diseases based on protein tests (such as multiple sclerosis).
2.1.5 If it is not possible to collect a sufficient amount of specimens, it is not necessary to carry out sub-packaging, and the inspection items are determined by the doctor; if microbiological examination is required, it is preferable
Do it first, and then perform other checks as soon as possible.
2.1.6 The cerebrospinal fluid samples should be transported as soon as possible at room temperature, and the cell count and classification count should be completed within 1 hour to avoid cell destruction.
damage. Only specimens used for protein and nucleic acid analysis can be stored in frozen conditions (below -20 ℃).
2.1.7 The specimens of cerebrospinal fluid microbiology examination should not be refrigerated. They should be submitted for examination immediately at room temperature or inoculated at the patient's bedside.
2.2 Physical examination
The physical examination of cerebrospinal fluid mainly includes color, transparency, and coagulability. The laboratory shall stipulate the standard terminology for the description and report of cerebrospinal fluid physical examination indicators.
2.3 Chemical and immunological examination
2.3.1 The chemical examination of cerebrospinal fluid mainly includes glucose, protein, chloride, enzyme determination and protein electrophoresis, etc. The immunological examination mainly
Including immunoglobulin, myelin basic protein determination, etc.
2.3.2 The laboratory should pay attention to the differences in sensitivity and specificity of the detection methods of different principles for each item, and select appropriate methods to carry out the detection.
2.3.3 When performing the determination of CSF glucose, albumin and immunoglobulin, it is advisable to detect the corresponding substances in the serum at the same time to calculate the CSF
/Serum glucose ratio, cerebrospinal fluid/serum albumin quotient (Qalb), cerebrospinal fluid/serum IgG quotient (QIgG) and IgG index (that is, the ratio of QIgG to Qalb).
2.4 Cytological examination
2.4.1 Manual cell counting
2.4.1.1 It is advisable to use a quantitative blood cell counting plate with a marked volume for cell counting, including total cell count, red blood cell count, and nucleated cells
Counting and classification of nucleated cells.
2.4.1.2 The specimens with normal appearance do not need to be diluted, and the turbid and bloody specimens need to be diluted 1.10～1.200, the dilution factor is even higher
(When needed). For cell counting, use isotonic saline to dilute the specimen; for nucleated cell count, use 3% glacial acetic acid to process the specimen.
2.4.1.3 The cell count is performed according to the following procedures.
a) Mix the specimens thoroughly, and mix them with a rotary stirrer before filling (the time should not exceed 2 min～5 min) or mix upside down manually
Do it for 10-15 times to avoid cell damage caused by excessive shaking and no air bubbles.
b) Take a small amount of well-mixed specimens respectively, fill them into the counting pools on both sides of the counting plate (make sure the counting plate is clean), and let stand for 5 min~
10 min (the length of time depends on the effect of cell precipitation).
c) Use a low power lens (10×) to browse the cell distribution. The cell distribution should be even (the difference in the number of cells in each large square should not exceed
More than 10), the cells should not overlap, otherwise they should be refilled.
d) Select a suitable area under high magnification (40×) to count cells as soon as possible. The principle of determining the cell counting area of each counting cell
Yes. If it is estimated that the number of cells in the 9 large squares is less than.200, then count 9 large squares (the counting area is equivalent to 9mm2);
If it is estimated that the number of cells in 9 large squares is greater than.200, then count the large squares with 4 corners (the counting area is equivalent to 4mm2);
If it is estimated that the number of cells in a large square is greater than.200, count the 4 corners in the central large square and 1 middle square in the center (count
The area is equivalent to 0.2mm2). When counting the pressure line cells, you should follow the principle of "count the top but not the bottom, count the left but not the right".
2.4.1.4 The red blood cell count and the nucleated cell count should be completed in the same counting pool, and the average value of the two counting pools should be taken for reporting.
2.4.2 Instrumental cell counting
See Appendix A for the requirements of instrumental cell counting.
2.4.3 Cell morphology examination
2.4.3.1 The cell smear should be completed within 4 hours after the specimen is collected. If it exceeds 4 hours, the result report should be marked with "cell classification and counting results may be unreliable".
2.4.3.2 It is advisable to use a cytocentrifugal smear machine (cell spinner) to prepare smears for cell morphological examination, and use the spinner before dropping the specimen.
Add 1 drop of 22% albumin solution (sterile) to the specimen room to enhance the adhesion of cells to the slide.
2.4.3.3 After preparation, the smear should be dried naturally at room temperature, and modified Wright staining should be carried out.
2.4.3.4 When performing cell morphology inspection, it should be able to correctly identify. mature red blood cells, nucleated red blood cells; neutrophils, eosinophils,
Basophils, mast cells; lymphocytes, reactive lymphocytes, plasma cells; monocytes, macrophages; intraventricular lining cells,
Meningeal cells; malignant tumor cells (primordial cells, lymphoma cells, non-hematopoietic tumor cells, etc.); bacteria, fungi and parasites, etc.
2.4.3.5 Nucleated cells (including various types of hematopoietic cells, lining cells, tumor cells and atypical cells) should be classified and counted.
The result is reported as a percentage. When the cell type cannot be determined, it can be classified as "atypical cells" and described in the report.
2.4.3.6 When malignant tumors are suspected, tumor cells should be searched for the entire film. When suspected tumor cells are found, the clinician should be notified for further cytopathological examination.
2.5 Pathogenic examination
2.5.1 Smear inspection
For turbid or purulent cerebrospinal fluid, direct smears and staining microscopy can be used. For colorless and transparent cerebrospinal fluid without obvious turbidity, cytocentrifugation should be used
Centrifuge with a smear machine (cell spinner). Centrifuge the cerebrospinal fluid sample to take the precipitate and smear it, and find Streptococcus pneumoniae and grape by Gram stain
For cocci and streptococci, methylene blue staining looks for Neisseria meningitidis, acid-fast staining looks for Mycobacterium tuberculosis, and ink staining looks for Cryptococcus.
For patients with suspected parasitic infections, attention should be paid to finding fluke eggs, amoebic trophozoites, and cysticercus.
2.5.2 Pathogen culture
Choose appropriate medium and culture conditions for common bacteria, fastidious bacteria, Mycobacterium tuberculosis or fungi culture, clinically suspected brain abscess
Anaerobic bacteria culture is appropriate at times. All the cerebrospinal fluid cultured should be tested for pathogenic bacteria at the same time.
2.5.3 Antigen detection
It can detect antigens of pathogenic bacteria such as Neisseria meningitidis, Streptococcus pneumoniae, Cryptococcus, etc., and the test results should be combined with the results of smear examination and pathogen culture
Explain together that the positive of cerebrospinal fluid cryptococcal antigen is of diagnostic significance; the positive of other antigens is an important diagnostic prompt, which should be combined with medical history, clinical manifestations,
Comprehensive judgment of other examinations of cerebrospinal fluid (cytology, smear and culture, chemistry, etc.).
2.5.4 Nucleic acid detection
When necessary, the laboratory can use molecular biology methods such as PCR to detect the nucleic acid of pathogenic bacteria such as Mycobacterium tuberculosis and Neisseria meningitidis.
3 Technical requirements for inspection of serous cavity effusion
3.1 Specimen collection, transportation and storage
3.1.1 Serous effusion includes pleural effusion, ascites, pericardial effusion, etc. The laboratory should work with the clinic to formulate standards for specimen collection and processing
Operate procedures and provide correct specimen collection containers and anticoagulants (if necessary) to the clinic. The specimen collection requirements for different inspection items are shown in Table 1.
3.1.2 The specimens should be submitted for inspection as soon as possible at room temperature; the specimens for cell count and classification count should be tested as soon as possible.
The colored specimens should be stored at 2 ℃～8 ℃, and the test should be completed within 48 hours.
3.2 Physical examination
The physical examination of serous cavity effusion mainly includes color, transparency and coagulability. The laboratory should specify the physical examination index description of serous effusion
Normative terminology for descriptions and reports.
3.3 Chemical and immunological examination
3.3.1 The chemical examination of serous cavity effusion mainly includes protein, lactic acid, glucose and enzymatic determination; immunological examination mainly includes tumor
Markers, immunoglobulin determination, etc.
3.3.2 Glucose determination should be completed within 1 h after specimen collection, specimens that cannot be detected in time should be collected with sodium fluoride anticoagulation tube;
The academic inspection should be completed within 2 hours; the corresponding substances in the serum samples should be tested and compared at the same time.
3.3.3 pH testing should not be performed on severely purulent specimens.
3.4 Cytological examination
3.4.1 The cytological examination of serous cavity effusion mainly includes cell count and classification count.
3.4.2 Excessive cell numbers, turbid or bloody specimens should be diluted with isotonic saline; specimens with clots cannot be used for cell counting and analysis.
Class count, but it can be used for cytopathological examination. It is necessary to gently agitate the clot to release the cells and wash it.
3.4.3 Refer to 2.4.1.3 for cell counting method.
3.4.4 Cell classification and counting should be used to prepare smears by cytocentrifugation. The cells should be washed first to increase the number of cells in the smear and maintain the fineness.
Cell morphology. The smear is naturally dried. It is advisable to use the modified Wright staining method to perform cell classification and count. When suspicious malignant cells are found, they should be
Inform the clinic to send for cytopathological examination in time; when crystals are found, it should be noted in the report.
3.5 Pathogenic examination
When infection is suspected, all specimens should be smeared and cultured by Gram stain. If anaerobe infection is suspected, add anaerobic bacteria culture; ascites,
The puncture fluid for liver abscess should be routinely cultured with anaerobic bacteria. When parasitic infection is suspected, the specimen should be centrifuged and the sediment should be smeared.
Liang Rui’s staining method is used to check for the presence of microfilaria, hydatid hydatid cysts and small hooks, and amoebic trophozoites.
4 Technical requirements for joint cavity effusion inspection
4.1 Specimen collection, transportation and storage
4.1.1 The laboratory should work with the clinic to formulate standard operating procedures for the collection and processing of joint effusion specimens, and provide the clinic with correct
This collection container and anticoagulant.
4.1.2 When collecting multi-tube specimens, the first tube should be a test tube without anticoagulant, 4 mL ~ 5 mL should be collected, and observe whether it is solidified, and centrifuge to collect
The supernatant is subjected to chemical and immunological examinations (such as glucose, albumin and lipids, rheumatoid factor and complement determination, etc.); the second tube should use liver
Sodium sodium (25 U/mL) or EDTA solution for anticoagulation, 1 mL～3 mL should be collected when used for cell counting, classification counting and crystal identification, such as
At the same time, 4 mL～5 mL should be collected for cytopathological examination, and lithium heparin, oxalate or EDTA powder should be used for anticoagulation, which may affect crystallization
Check results; the third tube should use heparin (25 U/mL) for anticoagulation, or use polyanethole sodium (SPS) anticoagulant or no anticoagulant
The coagulant test tube should be collected from 4 mL to 5 mL for microbiological examination.
4.1.3 When the amount of specimens is too small to complete all the inspections, communication with the clinic should be conducted in time, and specimens should not be rejected.
4.1.4 Specimens should be submitted for inspection as soon as possible at room temperature and the inspection should be completed.
4.2 Physical examination
The physical examination of joint cavity effusion mainly includes color, transparency, viscosity, and coagulability. The laboratory should specify the physical examination of joint effusion
Check the description of the indicators and the standard terms of the report.
4.3 Chemical and immunological examination
4.3.1 The chemical examination of joint cavity effusion mainly includes the determination of glucose, uric acid, lactic acid, lipid and protein, etc. The immunological examination mainly includes
Including autoantibodies and rheumatoid factors; when conducting chemical and immunological examinations, the corresponding substances in serum samples should be detected and compared.
4.3.2 Glucose determination should be completed within 1 h, and samples that cannot be detected in time should be collected with sodium fluoride anticoagulation tube.
4.4 Cytology and crystallographic examination
4.4.1 Specimen processing
4.4.1.1 Joint cavity effusion is relatively viscous, it is advisable to use isotonic saline or hyaluronidase buffer to treat the specimen, such as per milliliter of joint cavity
Add 400 units of hyaluronidase to the effusion and incubate at 37°C for 10 min.
4.4.1.2 Excessive number of cells, turbid or bloody specimens should be diluted with isotonic saline; when counting nucleated cells, hypotonic
Saline (0.3%) destroys red blood cells, but acetic acid should not be used to prevent the formation of mucin clots and affect microscopic examination.
4.4.2 Smear inspection
It is advisable to use cytocentrifugation to prepare wet and stained smears (the smears are allowed to dry naturally and fixed with methanol for at least 5 min. The modified Wright
Staining method, cytology and crystallographic examination. It is advisable to use the dark field of the optical microscope or the polarized light microscope for crystal inspection (such as uric acid
Salt crystals, calcium pyrophosphate crystals), attention should be paid to distinguish dust particles, scratches, fragments and pathological crystals.
4.4.3 Cell count
The cell counting method is the same as that of the cerebrospinal fluid cell count, and the detection should be completed within 1 h after the specimen is collected. The specimen of joint cavity effusion is more difficult to mix, but
Mix with a rotary mixer for 5 min to 10 min to avoid cell damage caused by excessive shaking.
4.5 Pathogenic examination
It should be used as a routine inspection item for joint cavity effusion. Centrifuge the specimen and take the pellet for Gram stain smear inspection to find out if there are pathogenic bacteria.
If necessary, select a suitable medium for bacterial or fungal culture based on clinical manifestations.
5 Technical requirements for stool inspection
5.1 Specimen collection, transportation and storage
5.1.1 The laboratory should provide patients with specimen collection instructions (oral or written) and specimen collection containers that meet the requirements. Should be used disposable,
A container with a lid, sealable, clean, dry, non-leaking, not easy to break, opening and suitable capacity. Specimens used for bacterial culture inspection should
Use sterile containers, and clearly marked.
5.1.2 Fresh and abnormal stools with attached mucus, pus, and blood should be selected as much as possible (should be kept in multiple parts, the size of a broad bean), and avoid
Contamination of urine and foreign objects (such as toilet paper, toilet water, strong detergents, deodorants, etc.). The collected specimens should be within 1 h (summer) or
Submit for inspection within 2 hours (winter).
5.1.3 The fecal occult blood test should send specimens for inspection every day for 3 consecutive days (when applicable), and submit specimens from 2 parts of the stool for inspection each time (placed in
In the same specimen container). Do not use digital rectal examination specimens.
5.1.4 The specimens for bacterial examination should be collected at the early stage of the disease and before antibiotics are used. The specimens for patients with diarrhea should be taken in the acute phase (within 3 days)
collection. Specimens for anaerobic culture should be sent for inspection as soon as possible, and inoculated at the bedside if necessary.
5.1.5 The specimens of protozoan trophozoites should be collected with soft stools containing pus and blood, and checked immediately after defecation. In winter, heat preservation measures should be taken for inspection;
When checking for pinworm eggs, use an anal swab to collect a specimen from the perianal fold at midnight or before defecation in the morning; when checking for schistosomiasis larvae, at least 30 g should be collected
Fresh feces; 24 hours of feces should be collected when checking the counts of parasites and eggs.
5.2 Physical examination
Stool physical examination includes at least the color and character of stool. The laboratory shall stipulate the standard terminology for the description and report of the fecal science examination index.
5.3 Chemical and immunological examination
5.3.1 Fecal occult blood test
5.3.1.1 The detection methods of fecal occult blood test include chemical method and immunological method. The sensitivity and specificity of different methods are different.
Before choosing a new method, its analytical performance should be clarified. When the test result of one method is not in accordance with clinical practice, another method should be used for verification.
5.3.1.2 The specimen shall be diluted with diluent or isotonic saline in the proportion required by the reagent instructions. When it is obvious that the tar
When the test result is negative, the dilution should be adjusted and the test should be performed again.
5.3.1.3 Use test strips for fecal occult blood test. The test strips should be stored under airtight and moisture-proof conditions and used within the validity period.
5.3.1.4 Before testing clinical specimens, indoor quality control of at least negative and weak positive levels should be carried out and the results should be in control. Should follow the instructions
The time and standard for the result judgment.
5.3.2 Other checks
Including fecal biliary, fecal bilogen and fat determination, pathogen immunological examination (such as Clostridium difficile antigen, virus antibody detection), etc.
5.4 Cytology and pathogenic examination
5.4.1 Smear inspection
5.4.1.1 Clean glass slides and fresh isotonic saline should be used to prepare specimen smears. The smears should be of a suitable thickness so that the writing on the paper can be seen through.
Appropriate, add a cover glass. Stain if necessary (for example, methylene blue staining should be used for white blood cell inspection).
5.4.1.2 According to the "battlement" sequence, first observe the whole film with a low-power lens, and then use a high-power lens to observe more than 10 fields of view to find various cells,
Pathological components such as parasite eggs, fungi, bacteria and protozoa.
5.4.1.3 When the parasite eggs are found, the morphological characteristics of the eggs shall be described. When encountering suspicious eggs or rare eggs, please ask superior inspectors to reply
Nuclear, or sent to a higher-tech laboratory for confirmation. Use egg collection method (applicable to all kinds of eggs), saturated salt water floating method (applicable
For the detection of hookworm eggs), centrifugal sedimentation or natural sedimentation methods can improve the detection rate of parasite eggs.
5.4.1.4 The result report should report whether there are pathological components, such as various cells, parasites and eggs, fungi and protozoa, etc. The cells should be "minimum
Number to highest number/HP" to report.
5.4.2 Pathogen culture
According to clinical manifestations, select the appropriate medium and culture conditions for the type of suspected pathogenic bacteria for fecal microbiology examination.
5.5 Automated stool inspection
5.5.1 Before the instrument is used for clinical specimen testing, the laboratory shall verify its performance, including (but not limited to) precision (where applicable),
Comparability with manual method inspection results (coincidence rate), visible component detection rate, etc.
5.5.2 The laboratory shall formulate and verify the rules for manual re-inspection.
6 Technical requirements for semen inspection
6.1 Specimen collection, transportation and storage
6.1.1 The laboratory shall provide patients with instructions for collection of semen specimens and specimen collection containers that meet the requirements. The specimen collection should be clean, dry,
Non-toxic to sperm, wide-mouth glass or plastic containers, specimens for microbial culture should be kept sterile.
6.1.2 After specimen collecti...
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