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WS/T 489-2024: Guidelines for the testing of urine specimens in the clinical microbiology laboratory
Status: Valid WS/T 489: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| WS/T 489-2024 | English | 269 |
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Guidelines for the testing of urine specimens in the clinical microbiology laboratory
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WS/T 489-2024
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| WS/T 489-2016 | English | 479 |
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Laboratory diagnosis of urinary tract infections
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WS/T 489-2016
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PDF similar to WS/T 489-2024
Basic data | Standard ID | WS/T 489-2024 (WS/T489-2024) | | Description (Translated English) | Guidelines for the testing of urine specimens in the clinical microbiology laboratory | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.020 | | Word Count Estimation | 12,129 | | Date of Issue | 2024-05-09 | | Date of Implementation | 2024-11-01 | | Older Standard (superseded by this standard) | WS/T 489-2016 | | Issuing agency(ies) | National Health Commission | | Summary | This standard specifies the technical requirements for clinical microbiology laboratory testing of urine specimens. This standard applies to relevant institutions that conduct clinical microbiology laboratory testing of urine specimens. | WS/T 489-2016: Laboratory diagnosis of urinary tract infections---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.
Laboratory diagnosis of urinary tract infections
ICS 11.020C50
People's Republic of China Health Industry Standard
Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
2016-07-07 released
2016-12-15 implementation
Issued by the National Health and Family Planning Commission of the People's Republic of China
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Drafting organizations of this standard. Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, First Affiliated Hospital of Chinese People's Liberation Army General Hospital, Beijing Hospital,
Ruijin Hospital Affiliated to Shanghai Jiaotong University, Tianjin Public Security Hospital, Zhongshan Hospital Affiliated to Fudan University, Tongji Medical College Affiliated to Huazhong University of Science and Technology
Tongji Hospital, Beijing Electric Power Hospital, Hong Kong Mary Hospital.
The main drafters of this standard. Xu Yingchun, Dou Hongtao, Zhang Li, Chen Yu, Fan Xin, Jiang Wei, Hu Yunjian, Ni Yuxing, Wang Jinliang, Hu Bijie,
Sun Ziyong, Zhao Rui, Liang Haojun.
Clinical Microbiological Laboratory Diagnosis of Urinary Tract Infection
1 scope
This standard specifies the technical requirements for clinical microbiological testing of urine specimens.
This standard is applicable to microbiology laboratories that carry out bacterial culture, identification and drug susceptibility tests on urine specimens.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
And lower urinary tract infections (cystitis, urethritis); according to whether there are urinary tract abnormalities (such as obstruction, stones, deformities, vesicoureteral reflux, etc.) divided into complex
Sexual and uncomplicated urinary tract infections.
2.2
3 Specimen collection
3.1 General
It is advisable to collect morning urine and ask patients to drink less or no water before going to bed. Urine will be retained in the bladder for at least 4 hours, which can reduce the false negative rate. no
Patients with symptoms should collect morning urine for 3 consecutive days for examination. There are many factors affecting the quality of urine specimens, even if invasive urine collection is used
It may still be contaminated by normal flora of the skin, perineum or urethra, so reducing pollution is the key to ensuring the quality of urine specimens.
3.2 Clean mid-stage urine collection
After getting up in the morning, wash the perineum with soapy water. Women should separate the labia majora, and men should turn over the foreskin, wash carefully, and then rinse the urine with water.
Around the crossing. Discard the urine in the first stage, save about 10 mL of the urine in the middle stage and discharge it directly into a sterile container, and send it for inspection immediately, within 0.5h after collection
Inoculate. Patients with poor urine flow, long foreskins, or poor sanitary conditions are likely to cause urine specimen contamination. Clean mid-section urine is the easiest clinical
Urine specimen obtained.
3.3 Collection of suprapubic bladder puncture
The "gold standard" for evaluating bacterial infections in the bladder. Disinfect the skin from the umbilicus to the urethra, and perform local anesthesia on the skin at the puncture site; in the pubic symphysis and
Insert the needle into the filled bladder at the midline of the umbilicus, and draw about 20 mL of urine from the bladder; aseptically inject the urine into a sterile screw-top cup and send
To the laboratory. This method can be used to diagnose urinary tract anaerobic infections, and it is also used in pediatric patients, patients with spinal injuries, and patients who have not obtained clear culture results.
The most commonly used method for fruit patients.
3.4 Collection of indwelling catheter
Using aseptic technique to draw urine through a catheter with a syringe. Disinfect the sampling port of the urinary catheter first, and puncture with a syringe according to the aseptic method
The catheter is used to suck urine; if necessary, the catheter is clamped in the tube to collect urine specimens, but the clamping time cannot exceed 0.5 hours. Urine specimen cannot
The collection is collected by the drainage nozzle of the collection bag. Routine urine culture is of little significance for patients with long-term indwelling catheters. These patients usually
Will cultivate a large number of colonizing bacteria.
3.5 Collection of bladder catheterization
After local disinfection, a urinary catheter is inserted into the bladder through the urethra to collect urine, and the catheter is inserted strictly using aseptic techniques to avoid bacteria and discard
Collect the cultured urine after removing the 15ml-30ml urine that was first exported. Take care to avoid introducing lower urethral bacteria into the bladder through the catheter,
Lead to secondary infection.
3.6 Collection of urine collection bags for infants and young children
Since infants cannot control bladder contraction autonomously, they need to use a collection bag. This method is difficult to avoid the pollution of the normal flora of the perineum, which is easy to appear
False positive, so the negative urine culture result of this method is more meaningful. If the culture result is positive, bladder catheterization or suprapubic bladder can be used if necessary
The puncture method was used to collect urine samples to further confirm the presence or absence of urinary tract infection.
3.7 Other collection methods
Other less commonly used urine collection methods include ileal catheter catheterization, intermittent catheterization, nephrostomy, and ureterostomy.
Oral surgery, cystoscopy collection, etc.
4 Specimen identification
The patient’s basic information, collection method, collection time, preliminary clinical diagnosis (with or without clinical manifestations of urinary tract infection should be indicated), patient
Whether the person has ingested excessive water and the use of antibacterial drugs.
5 Transport of specimens
Urine specimens should be sent to the laboratory as soon as possible. If they cannot be delivered in time, they should be refrigerated at 4°C or added with preservatives (containing 0.5 mL of boric acid-glycerin).
Or boric acid-sodium formate), but neither can exceed 24h. Urine specimens with preservatives should be collected at least 3mL urine volume to avoid high concentrations
The preservatives have inhibitory or dilution effects on pathogenic microorganisms.
6 Receipt of specimens
The urine collection container is a wide-mouth, sterile and leak-proof container, and should be inoculated immediately after receiving the urine specimen. Chilled specimens cannot be used for gonorrhea
Cerebrum culture.
7 Rejection of specimens
7.1 Treatment of unqualified specimens
If you receive unqualified specimens, you should contact the clinician, indicate the reason for rejection and return it, and you can request to take the specimen again and make a record. If
If it is unqualified that no urine can be collected and culture is needed, it should be noted in the report, and it should be emphasized that the culture result is for reference only.
7.2 Circumstances of rejection of specimens
Circumstances of specimen rejection include.
a) The specimen identification does not match the application form, the identification is wrong or there is no identification;
b) The collection time and collection method are not provided;
c) The specimen collection time exceeds 2 hours without refrigerating at 4°C or adding preservatives;
d) The specimen is refrigerated at 4°C or preservatives have been added but it has exceeded 24 hours;
e) Collect urine samples continuously for 24 hours;
f) Tip culture of catheter;
g) The specimen is taken from the urine bag of the catheterized patient;
h) There is leakage in the container when the specimen is submitted for inspection;
i) In addition to the suprapubic bladder puncture method, other methods are used to collect specimens and apply for anaerobic bacteria culture.
8 Laboratory examination
8.1 Urine routine (indicators related to urinary tract infection)
8.1.1 Leukocyte esterase
The normal value is negative, and the urinary tract infection is positive.
8.1.2 Nitrite
The normal value is negative. Positive is common in urinary tract infections caused by gram-negative bacilli such as Escherichia coli, and the degree of positive reaction is similar to that in urine
The number of bacteria is directly proportional.
8.1.3 Urine protein
Normally, it is qualitatively negative, and the quantitative value is < 100mg/24h. Urinary tract infections may have proteinuria.
8.2 Urine sediment examination (indicators related to urinary tract infection)
8.2.1 Manual inspection
Inflammation, its number is often closely related to its severity.
8.2.2 Instrument inspection
There are two main categories of urine analyzers. image-based urine formed element analyzers, fully automated combined flow cytometry and electrical impedance detection
Urine formed element analyzer. The white blood cell count is greater than the normal reference interval of the instrument, and the increase in epithelial cells indicates urinary tract infection. But should
Manual inspection to eliminate interference factors.
8.3 Microscopic examination of gram stain
Observe for bacteria, polymorphonuclear leukocytes and squamous epithelial cells. If there are many squamous epithelial cells in a female urine sample, it indicates
The specimen is likely to be contaminated by vaginal secretions and should be resubmitted for examination. This method is suitable for screening patients with high colony counts, most of which are asymptomatic
Symptoms and patients with pyelonephritis. In order to improve the sensitivity at the 104CFU/mL level, it is recommended that the cytocentrifuge smear is followed by leather
Blue staining microscopic examination. When Gram staining is positive, it is related to bacteriuria, and it can help clinical experience to treat according to the morphology and staining characteristics of bacteria
Choose antibacterial drugs for treatment.
8.4 Urine culture
8.4.1 Selection of culture type. How to inoculate and culture urine specimens depends on the method of specimen collection, the patient's symptoms and clinical indications. Urine
Specimen inoculation requires the laboratory to collect necessary information, including urine collection method, type of patient (for example. urology or geriatrics), clinical
Symptoms, urine routine microscopic examination and analysis results and previous culture results to select the corresponding culture type, see Table 1.
8.5 Inoculation method
8.5.1 Shake gently to mix the urine, immerse the quantitative inoculation loop vertically 3mm to 5mm below the surface of the urine specimen, and suck the specimen into the loop.
8.5.2 Draw a cross on the blood agar plate, and then apply dense and uniform coating.
8.5.3 In addition to inoculation to the blood plate for quantification, it is also necessary to inoculate to MacConkey or China Blue Agar plate for strain screening.
8.6 Homology detection of pathogenic bacteria
Pathogen homology testing can help diagnose patients with multiple urinary tract infections as recurrent infections or recurring infections (such as repeated urine
Tract infections), it can also be used to detect different patients infected with the same bacterial clone (such as suspected hospital infections or outbreaks in the community
Row). Commonly used genotyping methods include pulsed field gel electrophoresis, nucleic acid typing, multi-site enzyme electrophoresis, ordinary PCR or multiple PCR typing
method.
9 Antimicrobial sensitivity test
9.1 Antibacterial drug sensitivity test
The clinically isolated strains that are meaningful to the colony count result are identified to the species level and subjected to standard antimicrobial drug sensitivity tests.
Broth dilution method, paper diffusion method, Etest method or automated drug sensitivity analyzer, etc.
9.2 Direct antibacterial drug sensitivity test
The direct antimicrobial sensitivity test is only applicable to pure culture bacteria with a bacterial count ≥105CFU/mL. The purpose is to shorten the reporting time and reduce
Reduce patient medical expenses. However, it should be noted that this method lacks standardized procedures and is not recommended as a routine drug susceptibility test method; it cannot be used for mixed fine
Specimen with bacterial growth; not applicable to specimens with a bacterial count of < 105CFU/mL; the microbiology laboratory shall explain the results of the drug sensitivity test by itself.
10 Interpretation of results
10.1 Overview
Using 1μL inoculation volume, the counting result is the number of plate colonies×103CFU/mL; when using 10μL inoculation volume, the counting result is the number of plate colonies×102CFU/mL. It is recommended that clinicians analyze the clinical significance of urine culture results based on urine routine results.
10.2 General explanation
After the urine quantitative culture in the clean middle section, the number of single bacterial colonies> 105CFU/mL may be infection; < 104CFU/mL may be pollution
Infection, 104CFU/mL～105CFU/mL need to be evaluated based on the patient’s clinical manifestations. Most pyelonephritis and cystitis can be evaluated based on this
These parameters are correctly judged. For complicated urinary tract infections, multiple inspections can be performed. Clean the mid-stage morning urine culture for 3 consecutive times > 105 CFU/mL
High suspicion of urinary tract infection.
10.3 Explanation of different types of urine culture
The corresponding explanations of the results of the clean mid-stage urine quantitative culture of different infection types are shown in Table 2 and Table 3; the results of invasive collection of specimen culture
The results are explained in Table 4.
10.4 Explanation of special bacterial infections
10.4.1 When using a special medium and prolonging the culture time to isolate a large number of normal urethral or vaginal flora, including Corynebacterium, negative
Gardnerella dau, Haemophilus influenzae, and Haemophilus parainfluenzae may be related to urinary tract infections.
Elderly patients with severe immunodeficiency, invasive urinary tract operations or long-term hospitalization, and are related to pyelonephritis, and in the absence of antimicrobial treatment
It can disappear automatically under conditions.
10.4.5 Bacteria that rarely cause urinary tract infections. anaerobic bacteria, Actinobacteria, Lactobacillus, α-hemolytic streptococcus, coagulase-negative staphylococci
(Except for staphylococcus saprophytic bacteria isolated from urine specimens of young women), Corynebacterium and some unusual gram-negative bacilli.
11 Report results
11.1 Negative result
For 48-hour aseptic growth, report “inoculation of 1μL urine and 48-hour aseptic growth (< 103CFU/mL, no clinical significance)” or “inoculation of 10μL urine and 48-hour aseptic growth (< 102CFU/mL, no clinical significance). Clinical significance)". Strict aseptic operations, such as urine collected by suprapubic bladder puncture, can directly report "aseptic growth of 48 hours in culture".
11.2 Positive result
11.2.1 There is a clear clinical significance. report the colony count, bacterial species name and antimicrobial drug sensitivity test results.
11.2.2 No clear clinical significance. report the colony count, Gram staining morphological characteristics, and indicate the growth of pure or mixed bacteria.
12 Operation process
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