Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
-
Li Wang
,
Guijian Liu
und
Wei Cui
Abstract
Background
Although laboratory information system (LIS) is widely used nowadays, the results of routine urinalysis still need 100% manual verification. We established intelligent verification criteria to perform the automated verification process and reduce manual labor.
Methods
A total of 4610 urine specimens were obtained from the patients of three hospitals in Beijing, China. Firstly, 895 specimens were measured to establish the reference intervals of formed-element parameters in UF5000. Secondly, 2803 specimens were analyzed for setting up the intelligent verification criteria (including the microscopic review rules and manual verification rules). Lastly, 912 specimens were used to verify the efficacy and accuracy of the intelligent verification criteria. Phase-contrast microscopes were used for the microscopic review.
Results
Employing a results level corresponding relationship in specific parameters including hemoglobin (red blood cell [RBC]), leukocyte esterase (white blood cell [WBC]) and protein (cast) between the dry-chemistry analysis and formed-element analysis, as well as instrument flags, we established seven WBC verification rules, eight RBC verification rules and four cast verification rules. Based on the microscopy results, through analyzing the pre-set rules mentioned earlier, we finally determined seven microscopic review rules, nine manual verification rules and three auto-verification rules. The microscopic review rate was 21.98% (616/2803), the false-negative rate was 4.32% (121/2803), the total manual verification rate was 35.71% (1001/2803) and the auto-verification rate was 64.29% (1802/2803). The validation results were consistent.
Conclusions
The intelligent verification criteria for urinary dry-chemistry and urinary formed-element analysis can improve the efficiency of the results verification process and ensure the reliability of the test results.
Funding source: CAMS Innovation Fund for Medical Sciences (CIFMS)
Award Identifier / Grant number: 2017-I2M-3-005
Funding statement: This work was supported by the CAMS Innovation Fund for Medical Sciences (CIFMS) (grant no. 2017-I2M-3-005).
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2019 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- The re-emergence of dried blood spot sampling – are we ready?
- Review
- The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
- Opinion Paper
- Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
- Guidelines and Recommendations from Scientific Societies
- A protocol for testing the stability of biochemical analytes. Technical document
- Genetics and Molecular Diagnostics
- Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
- General Clinical Chemistry and Laboratory Medicine
- Performance of a web-based application measuring spot quality in dried blood spot sampling
- Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients
- Plasma and dried blood spot lysosphingolipids for the diagnosis of different sphingolipidoses: a comparative study
- Liquid biopsy of cerebrospinal fluid identifies neuronal pentraxin receptor (NPTXR) as a biomarker of progression of Alzheimer’s disease
- Integrity of serum samples is changed by modified centrifugation conditions
- Heparin and citrate additive carryover during blood collection
- Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
- Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
- Measurement of α-dicarbonyl compounds in human saliva by pre-column derivatization HPLC
- Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
- Reference Values and Biological Variations
- A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach
- EGFR and EGFR ligands in serum in healthy women; reference intervals and age dependency
- Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
- Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
- Hematology and Coagulation
- Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
- Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
- Cardiovascular Diseases
- Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
- Infectious Diseases
- Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
- Letters to the Editor
- Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
- Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
- Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
- An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
- Utility of the icteric index for the management of bilirubin test requesting
- Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
- Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
- Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
- Appropriateness of repetitive therapeutic drug monitoring and laboratory turnaround time
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