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Evaluation of pre-analytical factors impacting urine test strip and chemistry results

  • Mary Kathryn Bohn , Anselmo Fabros and Ashley Di Meo EMAIL logo
Published/Copyright: January 10, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 6

Abstract

Objectives

Careful consideration of the pre-analytical process for urine examination is essential to avoid errors and support accurate results and decision-making. Our objective was to assess the impact of various pre-analytical factors on urine test strip and quantitative chemistry results, including stability, tube type, fill volume, and centrifugation.

Methods

Residual random urine specimens were identified. Stability of 10 urine test strips and 13 quantitative chemistry parameters were assessed at eight time points (2, 4, 6, 8, 24, 48, 72, and 96 h) at room temperature (RT) and 2–8 °C (n=10–20 samples). The effect of additional pre-analytical variables was assessed, including using preservative tubes for urine chemistry as well as preservative tube underfilling and centrifugation on urine test strip results (n=10 samples).

Results

Seven of the ten urine tests strips evaluated met the minimal agreement criteria for stability (Cohen’s kappa >0.70) across all conditions. A Cohen’s kappa value of <0.70 was observed for pH (48 h), glucose (72 h), and protein (96 h) at RT. All 13 urine chemistry analytes remained stable at defined time points and conditions. Underfilling preservative tubes for urine test strips and centrifugation demonstrated no significant effect. The impact of using preservative tubes for urine chemistry was negligible with the exception of sodium and osmolality.

Conclusions

These findings highlight the pre-analytical factors that impact urine specimen evaluation and may be useful in informing clinical laboratory practices. Acceptable stability window for urine test strips should be considered in the context of the proportion of pathological samples evaluated.

Keywords: test strip; urine chemistry; quality; stability; pre-analytical
Corresponding author: Ashley Di Meo, PhD, FCACB, Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; and Division of Clinical Biochemistry, Laboratory Medicine Program, Toronto General Hospital, University Health Network, 200 Elizabeth Street, Toronto, ON M5G 2C4, Canada, E-mail:

Acknowledgments

We would like to acknowledge the staff at Toronto General Hospital for their help with sample procurement and instrument time.

  1. Research ethics: The University Health Network’s Quality Improvement Review Committee determined this study as exempt from further review by the Research Ethics Board.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: The author states no conflict of interest.

  7. Data availability: Not applicable.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-1233).

Received: 2024-10-22
Accepted: 2024-12-26
Published Online: 2025-01-10
Published in Print: 2025-05-26

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-1233
Keywords for this article
test strip; urine chemistry; quality; stability; pre-analytical

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. The Friedewald formula strikes back
  4. Liquid biopsy in oncology: navigating technical hurdles and future transition for precision medicine
  5. The neglected issue of pyridoxal- 5′ phosphate
  6. Reviews
  7. Health literacy: a new challenge for laboratory medicine
  8. Clinical applications of circulating tumor cell detection: challenges and strategies
  9. Opinion Papers
  10. Pleural effusion as a sample matrix for laboratory analyses in cancer management: a perspective
  11. Interest of hair tests to discriminate a tail end of a doping regimen from a possible unpredictable source of a prohibited substance in case of challenging an anti-doping rule violation
  12. Perspectives
  13. Sigma Metrics misconceptions and limitations
  14. EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes
  15. General Clinical Chemistry and Laboratory Medicine
  16. Evaluation of current indirect methods for measuring LDL-cholesterol
  17. Verification of automated review, release and reporting of results with assessment of the risk of harm for patients: the procedure algorithm proposal for clinical laboratories
  18. Progranulin measurement with a new automated method: a step forward in the diagnostic approach to neurodegenerative disorders
  19. A comparative analysis of current С-peptide assays compared to a reference method: can we overcome inertia to standardization?
  20. Blood samples for ammonia analysis do not require transport to the laboratory on ice: a study of ammonia stability and cause of in vitro ammonia increase in samples from patients with hyperammonaemia
  21. A physio-chemical mathematical model of the effects of blood analysis delay on acid-base, metabolite and electrolyte status: evaluation in blood from critical care patients
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  23. Comparison between monotest and traditional batch-based ELISA assays for therapeutic drug monitoring of infliximab and adalimumab levels and anti-drug antibodies
  24. Evaluation of pre-analytical factors impacting urine test strip and chemistry results
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