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Sensitive albuminuria analysis using dye-binding based test strips.

Joris R Delanghe1, Jonas Himpe1, Naomi De Cock1

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Summary

Advanced urine strip readers using complementary metal oxide semiconductor (CMOS) technology can accurately quantify albuminuria and albumin:creatinine ratio for improved chronic kidney disease screening.

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Area of Science:

  • Biomedical Engineering
  • Clinical Chemistry
  • Medical Diagnostics

Background:

  • Screening for albuminuria is crucial for populations at high risk of chronic kidney disease (CKD).
  • Current methods may lack quantitative precision for albuminuria assessment.
  • Complementary metal oxide semiconductor (CMOS) sensor technology offers potential for advanced urine strip readers.

Purpose of the Study:

  • To investigate the capabilities of advanced urine strip readers utilizing CMOS sensor technology.
  • To assess the quantitative accuracy of albuminuria detection using these devices.
  • To evaluate the potential for determining the albumin:creatinine ratio.

Main Methods:

  • Reflectance data from Sysmex UFC 3500 reader with CMOS sensors were collected.
  • Test strip results were compared against established methods for albuminuria (BNII) and proteinuria (Cobas 8000).
  • Urinary creatinine was measured using a Jaffe-based assay (Cobas 8000).

Main Results:

  • A calibration curve for albumin was established (11.5–121.5mg/L) with a detection limit of 5.5mg/L.
  • High precision was observed with low within-run and between-run coefficients of variation (CV) for albumin and creatinine.
  • Strong correlations were found between test strip reflectance and established assays for albuminuria (r=0.92), creatinine (r=0.90), and albumin:creatinine ratio (r=0.59).
  • The system could detect various albumin isoforms.

Conclusions:

  • Dye-binding based albumin test strips coupled with CMOS readers enable quantitative albuminuria analysis.
  • This technology facilitates the determination of the albumin:creatinine ratio.
  • CMOS-based readers represent a promising advancement for CKD screening and monitoring.