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European Urinalysis Guidelines SUMMARY

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European Urinalysis Guidelines SUMMARY Scand J Clin Lab Invest 2000; 60: 1 ± 96 European Urinalysis Guidelines SUMMARY These European Urinalysis Guidelines are given Classi®cation of examiniations under the auspices of the European Confedera- Examinations have been re-classi®ed into four tion of Laboratory Medicine (ECLM). hierarchical levels based on accuracy of mea- surements (chemistry on Page 12, particle Medical needs for urinalysis analysis on Page 23, microbiology on Page Urinalysis should always be performed on the 31). In addition, the previous literature on the basis of medical need, and appropriate exam- visual appearance and odour of urine is inations for various clinical populations and presented (Page 13). presentations should be determined by cost/ bene®t analysis. On this basis, selection indica- Chemical methods of examination tions for urinalysis are suggested for detecting Principles and performance criteria of multiple diseases of the kidneys or urinary tract (Page 6). test strips are reviewed (Page 13). A nitrite test The referral for detailed urine examinations should not be used alone in detecting urinary should include an adequate description of the tract infections because of its low sensitivity. specimen type, and should inform the labora- Quali®ed procedures for measurement are tory of the clinical need in order to facilitate recommended (Page 56). Pregnancy examina- correct selection of examination procedures and tions are reviewed brie¯y (Page 18). interpretation of results (Page 6). This medical Quantitative chemical measurements are dis- information is mandatory when the choice is cussed in detail, mainly with respect to protein being made between minimum and optimum measurements (Page 18). Measurements asses- procedures for different specimens. The mini- sing volume rate (diuresis) are also summarized mum information needed is outlined (Page 48). (Page 19). Reference intervals, existing reference Requirements for computerized information materials (calibrators) and measurement proce- systems are discussed (Page 49). dures are quoted (Page 57). Automation can be applied in centralized Patient preparation laboratories after appropriate evaluation of analytical equipment (and pre-analytical proce- Preparation for a high-quality urine specimen dures). Local diagnostic requirements guide the should start on the previous evening and should manner of implementation of point-of-care be as uniform as possible to allow standard methods, as well as manual or automated interpretation of results (Page 7). Details of procedures in different laboratories. patient preparation before specimen collection is given, ending with quali®ed specimens when- Particle analysis ever possible (Page 8). First and second morning urine specimens are de®ned (Page 7). Clinically signi®cant particles in urine are reviewed and classi®cation is divided into basic and advanced levels (Page 20), one of Collection of specimens, preservation and which should be selected by each laboratory (or transport by its subunit, such as emergency services versus Recommended methods of urine collection are regular-hour working personnel). listed (Page 9), including detailed illustrations For routine particle identi®cation, a standar- for the collection of mid-stream specimens dized procedure with phase-contrast microscopy (Page 50, 91 ± 96). Speci®cations for collection or supravitally stained urine sediment is recom- and transport containers are given (Page 10), mended (Pages 23, 62). Morphological criteria of and preservation procedures for chemical mea- particles are given as investigated under a cover- surements, particle analysis and microbiological slip with a known volume of urine (Page 64). examinations are listed (Page 51). Urine cytology for investigation of cancer cells is 1 2 ECLM ± European Urinalysis Group considered to require special expertise. For Automation of bacterial cultures may be microbiology, different procedures apply because considered in large microbiological laboratories bacterial infection usually needs to be detected in based on evaluation of instrument performance ordinal scale. That is why the slide-centrifugation against an appropriate comparison method. technique and Gram staining are recommended as the comparison method (Page 23). Stepwise strategies in urinalysis Instruments supplement clinical particle ana- Cost-bene®t analyses should guide screening lysis by reducing manual work (Page 25). policies. Multiple examinations recommended Evaluations against an appropriate comparison for sieving of general patient populations method are recommended. should include measurements of leukocytes, Microbiology methods bacteria, erythrocytes, albumin (protein), and of quantity for volume rate (~ diuresis; such as It is not necessary to request microbiological creatinine or other) (Page 34). In acute cases, examination of urine in all clinical situations. measurements of glucose, ketone bodies and pH Low-risk symptomatic patients consist of adult can be of additional value. A ¯ow-chart is given females with recurrent dysuria/urgency symp- for additional investigations in the case of toms without fever, and without known diseases positive ®ndings (Page 36). It includes questions predisposing to urinary tract infection (Page of clinical need. 26). Urine cultures from these cystitis patients Use of a ¯ow-chart is suggested to reduce the are discouraged for routine purposes ± they are number of less important urine cultures (Page necessary, however, for epidemiological pur- 38). After clinical evaluation, a highly speci®c poses. Rapid methods for detecting bacteriuria laboratory examination should be undertaken can be used in acute treatment decisions (Page as a ®rst step. Remaining negative specimens 26) after appreciating the possibility of false- shall then be examined with a sensitive pro- negative ®ndings. All other symptomatic cedure to exclude true negative cases. The patients belong in the high-risk group, whose development of new examinations with high specimens should be sent for bacterial culture, sensitivity (and speci®city) for rapid bacterial including identi®cation of species and anti- detection is encouraged to reduce the number of microbial susceptibility testing. routine cultures (Page 34). Asymptomatic We provide a new classi®cation of bacteria individuals should not be screened for bacter- based on the uropathogenicity and frequency of iuria, with the exception of pregnant women bacteria in the aetiology of urinary tract and some other speci®ed patient groups (Page infection (Page 26, Table IX). Limits of 38). Increased local co-operation with clinical signi®cant bacteriuria are de®ned more precisely units and detailed information from individual than previously depending on the type of specimens is needed to ®rst de®ne and then specimen, clinical presentation and organism select the minimum operating procedures or the (Page 30, Table XIII). For selected patient enhanced procedures for each specimen in groups, large 10 mL or 100 mL inocula are routine work-¯ow. needed to reach the required sensitivity. A new Increased detection sensitivity for early renal standardized unit for reporting quantitative damage is recommended because of the prog- cultures is recommended based on the develop- nostic signi®cance in diabetes mellitus, probably ing particle identi®cation techniques, adapting also in hypertension, and in monitoring patients international standardization of nomenclature receiving nephrotoxic drugs (Page 39). New and volume: colony forming bacteria/litre patient groups should be incorporated into (CFB/L) (Page 28). strategies using these sensitive measurements Details of different culture procedures are when prevention of long-term deterioration of given (Page 68). Procedures for species identi- renal function is anticipated. ®cation are quoted for routine microbiology laboratories (Page 72). Antimicrobial suscepti- Quality assurance, including analytical quality bility testing is reviewed, with acceptance of speci®cations direct susceptibility testing for rapid test positive cases (clear positives) in experienced Procedures for quality assurance and new hands (Page 32). analytical quality speci®cations are suggested European Urinalysis Guidelines 3 for rapid (ordinal scale) examinations (Page 42), document is limited to the most commonly particle analysis (Page 44) and microbiological requested examinations. Some analytes are examinations (Page 45). For ordinal-scale discussed in terms of specimen collection only, examinations they are based on detection and since the precise medical needs and actual con®rmation limits, as compared with a quan- analytical methods concerned would have titative reference procedure (Page 53), or made this document too large for everyday calculation of agreement based on k statistics use. The present recommendations have made (Page 55). Analytical quality speci®cations for use of some of the existing national guidelines protein and other quantitative chemical mea- [2 ± 7] as appropriate. Certain recent analytical surements are summarized based on earlier techniques, such as ¯ow cytometry and nucleic literature (Page 44). Implementation of elements acid ampli®cation, have widened the perspec- of a structured quality system (good laboratory tives of information obtainable from urine. The practice (GLP) with standard operating proce- latest technology is referred to but not described dures (SOP) as documented in a quality in detail. manual) is encouraged even in small labora- Target audiences: These guidelines
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