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Clinical utility of urinary liver-type fatty acid binding protein measured by latex-enhanced turbidimetric immunoassay in chronic kidney disease

  • Atsuko Kamijo-Ikemori EMAIL logo , Takeshi Sugaya , Maki Yoshida , Seiko Hoshino , Satoshi Akatsu , Satoshi Yamazaki , Kenjiro Kimura and Yugo Shibagaki
Published/Copyright: March 4, 2016
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 10

Abstract

Background:

Urinary liver-type fatty acid binding protein (L-FABP) measured by enzyme-linked immunosorbent assay method (ELISA) was approved as a clinical biomarker of tubular damage by the Japanese Ministry of Health, Labor and Welfare (MHLW) in 2011. We evaluated a new latex-enhanced immunoturbidimetric assay (LTIA) to evaluate the clinical utility of urinary L-FABP measured by LTIA versus an ELISA assay.

Methods:

LTIA with anti-human L-FABP mouse monoclonal antibodies was performed using an automated clinical chemistry analyzer. Five positive samples with low, medium and high L-FABP concentrations were analyzed to determine the within-run precision. In patients with chronic kidney disease (CKD) (n=91), urinary L-FABP levels were measured by ELISA and LTIA.

Results:

Measurement of urinary L-FABP revealed urinary L-FABP levels within 30 min. The within-run coefficient of variation was 10.0% for 1.4 ng/mL, 4.4% for 2.5 ng/mL, 3.2% for 9.8 ng/mL, 1.5% for 50.1 ng/mL, and 1.2% for 102.7 ng/mL. Concentrations of urinary L-FABP measured by LTIA were significantly correlated with those measured by ELISA (ρ=0.932). Proportional systematic error was almost within limits of agreement (LOA). Urinary L-FABP levels measured by LTIA were significantly correlated with urinary albumin (ρ=0.634), urinary NAG (ρ=0.688) and eGFR (ρ=–0.561).

Conclusions:

Measurement of urinary L-FABP by LITA was simple, speedy, and similar in quality to ELISA results. Therefore, this method was approved as external body diagnosing medicines by the Japanese MHLW in 2014. Urinary L-FABP is expected to be widely used in various pathophysiological conditions by measuring urinary L-FABP using LTIA.

Keywords: biomarker; kidney disease; latex-enhanced immunoturbidimetric assay (LTIA); liver-type fatty acid binding protein (L-FABP); urinary L-FABP
Corresponding author: Atsuko Kamijo-Ikemori, MD, PhD, Departments of Nephrology and Hypertension, Internal Medicine, and Anatomy, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan, Phone: +81-44-977-8111 ext. 3629, Fax: +81-44-977-7083, E-mail:

Acknowledgments

We are grateful to Ms. Seiko Hoshino, Kimie Katayama and Jyunko Asano for assistance with the collection of urine and serum samples.

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

  2. Research funding: This work was supported by the consigned research fund from Sekisui Medical, Tokyo, Japan.

  3. Employment or leadership: T. Sugaya is the Director and a Senior scientist of CMIC HOLDINGS Co., Ltd., the company that produced the ELISA kits for L-FABP analysis. None of the other authors have conflicts of interest or financial disclosures of any relevance to the present study.

  4. Honorarium: None declared.

  5. 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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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2015-1084) offers supplementary material, available to authorized users.

Received: 2015-11-6
Accepted: 2016-1-2
Published Online: 2016-3-4
Published in Print: 2016-10-1

©2016 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2015-1084
Keywords for this article
biomarker; kidney disease; latex-enhanced immunoturbidimetric assay (LTIA); liver-type fatty acid binding protein (L-FABP); urinary L-FABP

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Serum myoglobin immunoassays: obsolete or still clinically useful?
  4. Reviews
  5. Kounis syndrome: an update on epidemiology, pathogenesis, diagnosis and therapeutic management
  6. What do we know about homocysteine and exercise? A review from the literature
  7. Mini Review
  8. Osteocalcin as a potential risk biomarker for cardiovascular and metabolic diseases
  9. Opinion Paper
  10. Statistical approach for optimization of external quality assurance (EQA) studies of molecular and serological viral diagnostics
  11. EFLM Article
  12. Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine
  13. General Clinical Chemistry and Laboratory Medicine
  14. Analyte stability during the total testing process: studies of vitamins A, D and E by LC-MS/MS
  15. Improvement in the predictive ability of the Intermountain Mortality Risk Score by adding routinely collected laboratory tests such as albumin, bilirubin, and white cell differential count
  16. Cystatin C provides a better estimate of the effect of glomerular filtration rate on serum human epididymis protein 4 concentrations
  17. Verification of the harmonization of human epididymis protein 4 assays
  18. Clinical utility of urinary liver-type fatty acid binding protein measured by latex-enhanced turbidimetric immunoassay in chronic kidney disease
  19. Comparison of three analytical platforms for quantification of the neurofilament light chain in blood samples: ELISA, electrochemiluminescence immunoassay and Simoa
  20. Reference Values and Biological Variations
  21. Distribution of antiphospholipid antibodies in a large population-based German cohort
  22. Cardiovascular Diseases
  23. Serum protein S100 as marker of postoperative delirium after off-pump coronary artery bypass surgery: secondary analysis of two prospective randomized controlled trials
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  26. Clinical and laboratory findings in the diagnosis of right lower quadrant abdominal pain: outcome analysis of the APPAC trial
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  31. Seasonal variations in plasma free metanephrine concentrations are not evident in the West of Ireland
  32. Potential errors in the determination of urinary ammonium by formol titration
  33. Interference by biological anti-cancer drugs in electrophoretic and immunofixation techniques
  34. A point mutation in the thiopurine S-methyltransferase gene that led to exon 5 deletion in the transcribed mRNA
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