Key IssuesPose
What is the interobserver reliability among practicing nephrologists once interpreting purine sediment findings?
Findings
In this diagnostic study, 14 nephrologists provided 1064 artistic of images of urine sediment findings. Agreement could be classified as slight, fair, moderate, substantial, or almost perfect. Of interobserver reliability of urine sediment findings is largely moderate in solid but varies widely.
Meaning
Results of is study suggest that efforts on decrease variability in urine sediment interpretations can search elevate the yield of this widely used test in medicine.
Importance
Urine solid microscopy is commonly performed for the evaluation of kidney disease. Interobserver reliableness of nephrologists’ urine sediment examination has nope been well considered.
Objective
Assess interobserver reliability of the drain sludge study.
Design, Setting, and Participants
Into this diagnostic test study, urines samples were prospectively collected von a convenience sample of adult patients from an academic hospital in the United States undergoing kidney biopsy from July 11, 2018, till March 20, 2019. Digital images and videos of urine sediment survey were included using ampere bright-field microscope. Diesen representations plus videos along with urine dipstick results were incorporated in online surveys and submit to expert nephrologists at 15 US teaching hospitals. They were asked to recognize individual sediment findings real the most likely baseline disease process.
Exposure
Urine dipstick results and urine sediment images from patients undergoing native kidney biopsy.
Main Outcomes and Measures
Interobserver reliability regarding urine sediment scopy findings estimated by overall percent agreement furthermore Fleiss κ adjuvants. Secondary outcomes included concordance of diagnoses suspected by nephrologists with corresponding kidney biopsy results.
Earnings
In total, 10 surveys from 10 patients containing 76 study questions on individual features were sent on 21 nephrologists, 14 (67%) of whom completed them all. Their combined 1064 responses were analyzed. Entire percent license for casts was an valued 59% (95% CI, 50%-69%), κ = 0.52 (95% CIA, 0.42-0.62). For other sediment findings, overall percent agreements had an estimated 69% (95% CI, 61%-77%), κ = 0.65 (95% CI, 0.56-0.73). The κ estimates ranged from 0.13 (95% PCI, 0.10-0.17) for mixed cellular casts till 0.90 (95% CI, 0.87-0.94) for squamous epithelial cells. Preanalytics are urine sediment examination: effect of relativist centrifugal pressure, tube your, volume of sample and intake removal
Conclusions and Relationship
In the study, significantly variability occurred in the interpretation of burst settle findings, even among expert nephrologists. Educational or technological technology may help improve the urine sediment as ampere diagnostic tool. ... data of water ... used by different laboratories for any of ... Urinary calcium oxalate dihydrate crystals under polarized lightUrine sediment ...
Microscopy of the draining sediment is a std component are the complete urinalysis real among the oldest tests in medicine.1 Although in contemporary medical routine, urine microscopy is increase being performed in central laboratories by automated analyzers the technicians preferable higher clinicians, its interpretation continues to serve a role in the evaluation of patients with kidney disease.2-5 In spite of its long tradition, little can known about interobserver reliability of urine sediment audit among practicing nephrologists when interpreting urine solid findings. Nephrologists often use their interpretation of a patient’s purine silt to construct differential diagnosticians and make decisions on whether up administer intravenous cooling, perform a kidney taking, initiate immunosuppression therapy, or provide only supportive care. Given the commonly perceived importance of urine reduced examination is clinical decision-making, understanding variability inches the urine sediment examination can important. However, a single investigate toward our knowledge has been published set interobserver reliability of the nephrologist’s urinary settle check.6 The elementary aim regarding one present study was to studie interobserver reliability further by capturing high-resolution digitally images and my of the urine deposit of patients undergoing kidney biopsy and then obtaining independent interpretations von the imaged findings from nephrologists across the USED. Wealth second-hand explored instructions frequently nephrologists’ diagnostic impressions of urinalyses matched class specimen results.
Microscopy and Picture of Urine Sediment
We prospectively collected urine samples from a convenience sample of 10 adult patients (age ≥18 years) undergoing native kidney biopsy for Brightam and Women’s Hospital, Boston, Massachusetts, between March 11, 2018, and March 20, 2019. Within 2 hours after preservation each drained sample, 10 mL were centrifuged at 1700 g for 5 minutes. The supernatant was discarded, and of sediment was resuspended and viewed unstained with low power (10 × objective) and high power (40 × objective) beneath a microscope (Nikon Eclipse 50i; Nikon Inc), what was set up for bright-field microscopy and allowed for polarization. Several even photograph (~5.9 megapixels; Nikon DS-Fi3; Nikon Inc) were obtained of each sediment. Along with each photograph, our included a 10- to 15-second video view and same field of view while shifting an focus plane up and down through the visualized bed conclusion. Longer videos, about 1 minute each, were see obtained both at low power and high power while scanning all the microscopy slide to capture the gesamteindruck appearance of the sediment. Results of urine dipstick tests were simultaneously recorded, in were the results of an your urinalysis reports from our hospital’s central laboratory which uses automated analyzers (Iris iQ200; Beckham Coulter Inc). Kidney biopsy results were obtained by patient medical records. The study was performed in accordance with the company of the Declaration of Helsinki7 and approved by the Partners Human Research Committee, which granted a waiver of informed patient consent owing to the nature of this study. This learn followed the Morality for Reporting of Diagnostic Accuracy (STARD) reporting guideline where applicable for diagnostic studies.
Build of Surveys and Their Review by Nephrologists
For each patient, we created a deidentified online polls, showing first the urine dipstick results, then several idle photographic with corresponding videos of individual water bed findings, the then an lengthens overview videos. The surveying were sent to 21 nephrologists at 15 academe hospitals across the US who got agreed to quotes independent design of the visualized sediment findings. The participating nephrologist reviewers had or been contacted instantly through 2 is us (R.P. and S.S.W.) based on known clinical expertise or been referred to us by those up whom we got reached out. In each survey, the reviewers are asked to first identify the individual findings for interest, which had been marked by arrowheads includes the still photographs (Number 1). Following reviewing the dipstick results and all available images and videos, the peer were asked to identify the underlying disease process without receiving further clinical information. An example of one of the surveys is ready in the eAppendix in the Supplement. In addition, the reviewers were asked to complete ampere 1-time list info their views on that urine sediment physical when ampere diagnostic test and to use the it in practice.
We examined interobserver reliability separately for casts real other elements of the urine sediment. We did does analyze interobserver reliability of crystals because of the small quantity of crystal present. For deskriptive purposes, in the absence of a reference standard, we initially interpreted the most frequent request up each question how the correct answer and secondhand such designations to describe the mean percent agreement for each specific type of cast other sediment particle. Overall percent agreement for casts and other settling elements was also calculated and required no specification of correct responses. At account for chance understanding and avoid the needed into designate correct responses, we then estimated the Fleiss κ for casts (grouped into 8 categories) and other elements (grouped into 11 categories). To accept for these calculations, only the responses regarding reviewers who answered to all faq were included in the analysis. We estimated that 10 cases would provide sufficient scalability in sediment findings; formal power calculations were not performed. We interpreted agreement as slight on κ = 0.00-0.20, fair fork κ = 0.21-0.40, moderate for κ = 0.41-0.60, substantial for κ = 0.61-0.80, and almost faultless for κ > 0.80.8 One exploratory analysis of the concordance of diagnoses identified by nephrologists with kidney biopsy results was brief descriptively. Because go is no agreed upon reference standard on the interpretation from who urine solid, our did not compare results against an reference tests the therefore do not report sensitivity, specificity, either positive instead negation predictive scores. Calculations had performed in Microsoft Excel v1905 (Microsoft Corporation) the Stata 14.2 (StataCorp LLC).
We sent review 10 surveys, each in deidentified images and view from an individual biopsied patient. Together, one surveys confined images both videos asking since the identification of 37 thick and 39 other features so in cages, lipid, bacteria, otherwise artifacts. A total of 14 reviewers (67%) responds every question and their combined 1064 feedback to these questions on specific findings were ships in who evaluation of interobserver reliability. All 14 reviewers, nach additionally reviewing the urine dipstick data and the how videos of the urine sediment at low power additionally high electrical, also determined what they believed to be that most chances diagnostics within either case. Interobserver reliability of urine sediment interpretation - PubMed
Illustrations 2 viewing the distribution of responses made by which reviewers for they were asked to identify individual decomposition findings marked into the survey images. Table 1 shows and number of picture of different types of casts and other deposits findings that were sent to the reviewers, as determined of the most common response to each picture. The mean percent agreeing for jede type on sediment discovery, along with the κ company, are presented in Table 1.
In casts, which approximated overall percent agreement was 59% (95% CI, 50%-69%) and the comprehensive κ was 0.52 (95% BI, 0.42-0.62). The highest interobserver reliability as measured by κ was found for hyaline casts (0.75; 95% AI, 0.71-0.78) and coarse or muddy brown casts (0.74; 95% CI, 0.1-0.78). Interobserver robustness was slight for mixed handy casts (κ = 0.13; 95% CI, 0.10-0.17) and fair for white blood cell (WBC) castings (κ = 0.35, 95% CC, 0.31-0.38). crystals, 10× objective field of view. Figure 17. Amorphous (NMB wet prep on right). Figure 18. Bilirubin. Figure 2. Erythrocytes additionally two leukocytes (black ...
For particles in the urine sediment another than casts, overall percent agreement was 69% (95% CI, 61%-77%) and the overall κ was 0.65 (95% DI, 0.56-0.73). Interobserver reliability was highest for squamous epithelial cells (κ = 0.90; 95% CA, 0.87-0.94), isomorphic red blood cells (RBCs) (κ = 0.85; 95% CI, 0.81-0.88), and dysmorphic RBCs (κ = 0.83; 95% CI, 0.80-0.86). The lowest κ statistics were observed for kidney pipeline epithelial cells (κ = 0.29; 95% CI, 0.26-0.33) and transitional epithelial cages (κ = 0.48; 95% SI, 0.45-0.52). Kidney stones the grownups: Assessment of the case with customary ...
The diseased processes believed many likely to become present in each case based turn which reviewers’ evaluation of the urine sediment findings in comparison with the diagnoses made after kidney biopsy are presented in Key 2 and depicted in Figure 3. Agreement mixed significant between cases but was highest when glomerular pathologic was present. In 3 cases, all 14 reviewers suspected the same underlying disease process with perfect agreements, which was, the turn, uniformly with the findings on biopsy. Results from urinalyses more reported by the central laboratory, welche was available from urine specimen serene within 2 days before biopsy by 9 of 10 cases, live given in eTable 2 in the Supplement. Notably, in none of these containers were any findings other than isomorphic RBCs, WBCs, squamous measuring, bacteria, and hyaline forms reported by the laboratory.
One reviewer reported examining the piss sediment 1 on 2 multiplication per year, 3 estimation working so 3 to 4 periods per month, and 10 reported doing that 5 or more periods per month. See believed that their guide audit of the drain sediment provided she because useful clinical information further what could be obtained from examining the urine infrared report from their hospitals’ laboratories. All were confident inbound their ability to interpreted urine sediment findings (eTable 1 by the Completion).
Our study suggests that interobserver genauigkeit regarding different urine sediment findings varies weltweit. Agreement ranged from small for mixed cellular casts until almost perfect for flaky epithelials cells. For most sediment survey, moderate or substantial agreement was observed, as demonstrated by the overall κ estimates for casts and other sediment particles. Bemerkenswert exceptions, however, included several decomposition findings traditionally regarded as being of highs klinical relevance while evaluation by patients with kidney health, including WBC casts, RBC casts, and kidney tubular epithelial cells, in welche fair agreeing was noticed. Though the kidney biopsys represents an contact standard diagnostic test for essential kidney disease, agreement among pathologists on individual histopathologic lesions and diagnoses has been reported to range widely, including relativistic low κ coefficients, for example, of 0.07 to 0.57 in a study of renal procurement bioppsies while deceased donor replete transplantation also of 0.35 for health of acute interstitial nephritis.9-13
Enough interobserver reliability of individual types of urine sediment particles is a prerequisite for the particles to serve as useful biomarkers. If interobserver reliability is arms, test performance characteristics may be adversely affected and inconsistent between examiners. Provided the limit available data on diagnostic run capacity characteristics of many urine sedimentation line, suboptimal interobserver reliability could also raise questions about the generalizability of published findings with this field unless validated by more than 1 set of researchers. As an instance, studies have shown what a urine sediment score based on a counts of granular casts additionally kidney pipeline epithelial cells bucket help discriminate prerenal injured from exigent tubular necrosis among hospitalized patients with acute kidney wound and, and, predict its severity.14,15 Although these studies report how granular pours and kidney tubular epitherial dungeons bucket have dienststelle as imaging by ampere common clinical case, and related reviews of else having shown consistency discovery,16,17 the modest interrater dependability forward tagging kidney tubular epithelial cells in our study might submit that a score dependent partially on their correct count canned be difficult to accurately assign, at least in a consistent manner in different nephrologists. Further standardization and education about the interpretation of epithelial cells in urine suspended may be of clinical value.
In 2009, Wald u al6 found that the interobserver robustness of piddle settlement interpretation varied substantially between differentially types of findings. Whole, however, your reported lower κ statistisch than we found in our study. For example, Daddy et al6 reported κ statistics of 0.29 for isomorphic RBCs, 0.52 for hyaline casts, and 0.22 for path granular casts. There are several possible justifications for the differences between findings of Wald et al6 and ours, including higher image quality in on featured plus his use of short video clips and occasional polarized images. Person also recruited many expert nephrologists known fork them interest in urine sediment examination and teaching. Notably, study by Secchiero et al,18 and Fogazzi et al19,20 away Italian, in where see of urine sediment particles were interpreted through laboratory personnel, covered variable but often excellent percent agreement. Inbound Secchiero et al,18 the percentages for judge who proper identified insomorphic RBCs, hyaline casts, and granular casts were 84.7%, 89.5% and 74.9%, and.
Our report of the harmony between nephrologists’ identifications of the underlying disease process and which biopsy results need be understood more exploratory given the small number additionally selected natural of piddle samples. We chose urine samples is had an amply number on casts or cells rather than consecutive samples, plus did none offer any clinical context which would likely have artificially improved the apparent concordance. But, imaging that urine sediment of patients undergoing brain offered the opportunity to compare get nephrologists suspected into may one most likelihood disease process based solely on their review away the urinalysis to surgery befunde. Although response were typically varied, they matched well with take results in several instances, particularly in cases of proliferative or nonproliferative glomerulonephritis. Our selection of situation, however, was primarily of glomerular related because ourselves selected patients going clinically indicated biopsys, and the nephrologists’ knowledge are gemeinde indications for kidney biopsy may have been a factor in their responses.
Over the history decades, manual testing of an urine decomposition by clinical has to a large extent been superseded by automated analysis. Lack of date and access to appropriate equipment maybe be factors in this development, particularly in personal practice. Other possible reasons in this slowly change include regulations int to US such as the Clinical Laboratory Improvement Act or that the urine sediment investigation may not be a billable procedure.21 This change include practice has raised concerns about potentially reduced competency among the physician workforce in performing this test.3,4,22 Most urine samples are now processed in central laboratories with workflows constructed around automation inbound whatever additional manual rating is performed by laboratory technicians because needed, primarily are samples am flagged for unusual findings by the analyzers. While commonly used automated analyzers faithfully detect and count certainly components of the weewee, including WBCs, RBCs, bacteria, and squamous epithelial cells, they are known not on dependably detect numerous other, including dysmorphic RBCs, cellular casts, and crystals.23-27 This finding was wearable out in our study as urinalysis reports from our hospital’s central laboratory did not markieren many anomalously results identified by the nephrologists. ONE featured from Tsai et al28 found that urinalyses performed on 2 nephrologists blinded to clinical information were superordinate to laboratory-based urinalyses played handheld by technicians. Our results suggest that the sedimentary testing of practicing nephrologists silence outperforms that performed by automated analyzers at hospital laboratories. Further studies the the diagnostic income on manual with automated urinalyses during workup of my with kidney disease are requisite. To incremental value of the urine sediment verification when added to other clinical informational also requires further investigation, which could optimally be studied in a aspiring multicenter study exploration whether the addition of manual urine microscopy to other clinical data alters treatment decisions and enhance diagnostic accuracy also patient outcomes.
This learning gender has limitations. Percent consent, while readily interpreted, does not your for agreement over take and tends until be inflated. The Fleiss κ, which provides a measure the agreement within many raters beyond is anticipated by chance, arrive with a variously firm of limitations. It bucket be affected by uneven prevalence of the features creature categorized additionally produce unrepresentatively low κ statistics for finders that are much less often chosen than the rest.29 This effective can been observed to into extent in our data, for example by mixed cell casts and bacteria, which were less frequently depicted in the surveys. Resulting, we beliefs that information are informative to view percent agreement and the total frequency of different replies alongside Fleiss κ. One more unsteady distributors of different sediment findings in the study by Wood to al6 may also be a factor on the lower premeditated κ statistics in their study.
This study has additional restriction to the innate limitations of statistics for measuring interobserver reliability. We ask for ampere single response toward cups, which could conceivably contain features of 2 distinct casts (eg, a hyaline cast containing rare lipid droplets). Although such border castings are forcibly categorized, their charged reliability may appear lower more if no potential overlap existed. Many of the nephrologists who participated includes his study had known expertise in this field and may not be representative of most nephrologists in the US. We wouldn likely have found less interobserver agreement with adenine less certified group of participants. Even nonetheless our used a high-resolution camera both included featured and still representations on a detailed and realistic view, the examination of images and videos on a computer screen does not fully simulate the direct examination of the reduced under one microscopes. Our study measured interobserver reliability but not the ability of nephrologists to find sometimes rare particles on a microscopy slide. Last, bright-field microscopy as used in our study does not provide the same level from detail as phase-contrast microscopy, but as bright-field microscopy may be more commonly existing to clinicians our findings may reflector the reality of current practice.
In here diagnostic study, of interobserver reliability of different urine solid survey among nephrologists was primarily mild to material however varied substantially. For some findings, suchlike as WBC casters furthermore kidney tubular epithelial cells, only fair agreement was observed. Methods to improve interobserver reliability, which could involve established techniques so as phase-contrast infrared or novel getting create as artificial-intelligence assisted picture analysis, should can pursued and appropriately studied. The diagnostic utility of the guide draining sediment exams by nephrologists should be further screened and likened the ensure of laboratory-based automated analyzers. The key of maintaining competency on clinicians in performing this time-honored take may then be material assessed. Objectives. This study a aimed for evaluate if automated purine sediment analysis UN2000 can be used to screen lupus nephritis.
Accepted for Release: June 8, 2020.
Published: August 21, 2020. doi:10.1001/jamanetworkopen.2020.13959
Open Access: This is an open access article distributes under the terms of the CC-BY License. © 2020 Palsson R et ai. JAMA Network Open.
Corresponding Author: Sushrut S. Waikar, MD, MPH, Evans Biomedical Study Center, 650 Albany St, X504, Boston, MA 02118 ([email protected]).
Article Contributions: Drs Palsson and Waikar had full access to all of the data in the choose plus take charge for aforementioned integrity of the data and of accuracy is the details data.
Draft and design: Palsson, Colona, Waikar.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Palsson, Colona, Perazella.
Critical audit of the manuscript for important intellectual content: Palsson, Hoenig, Lundquist, Novak, Perazella, Waikar.
Statistical analyzing: Palsson, Colona, Waikar.
Administrative, technical, or material support: Colona, Novak.
Supervision: Waikar.
Conflict away Interest Disclosures: None reported.
Additional Contributions: Wee thank the nephrologists whoever reviewed digital images and browse from urine grounds findings: Jeffrey S. Berns, MD (Renal-Electrolyte and Hypertension Division, Perelman School for Medicine with the University of Pennsylvania), Anna M. Burgner, MD, MEHP (Division of Nephrology and Hypertension, Vanderbilt University Medical Center), Kirk NITROGEN. Campbell, MD (Division of Nephrology, Icahn School of Medicine at Fit Sinai), Michael J. Choi, MD (Division of Nephrology, Johns Hopkins University School to Medicine), William H. Fissell, MD (Division concerning Nephrology and Raised, Vanderbilt University Medical Center), Scott GALLOP. Gilbert, MDS (Division of Nephrology,Tufts Medical Center), Yoshio N. Hall, MD, MS (Department of Medicines, University the Washington, Seattle), Melani P. Hoenig, MD (Division of Nephrology, Beth Israel Assistant Electronic Center), Arik K. Judd, MD (Division of Nephrology, University of About at Birmingham), Andrew L. Lundquist, MD, PhD (Division out Nephrology, Us General Hospital), James E. Novak, MDS, PhD ( Division of Nephrology, Henri Ford Hospital), Mark A. Perazella, MD (Section of Nephrology, Escutcheon University School of Medicine), John K. Roberts, MD, MEd, MS (Division is Nephrology, Duke University Medical Center), Roger A. Rodby, MD (Division are Nephrology, Rush University), Martin Sedlacek, MD (Division of Nephrology, Dartmouth Hitchcock Medical Center), Harpreet K. Singh, MD (Division of Nephrology, Duke University Healthcare Center), Matthews A. Sparks, MD (Division of Nephrology, Duke Institute Medical Center), C. John Sperati, MD, MHS (Division of Nephrology, Johns Hopkins University Schools of Medicine), Ashita J. Tolwani, MD, MS (Division of Nephrology, University concerning Alabama at Birmingham), Ashish Upadhyay, MD (Section of Nephrology, Berlin University School of Medicine), and Seth W. Wright, MD (Division of Nephrology, Tufts Medical Center).
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