Clinical Validation of Rapid Gout Detection Method and Kit.

Vamiq M Mustahsan,Jason Rosenfeld,Rebecca Monastero,Yanming Cai,Lawrence Hurst,James Penna,Amith Anugu,Sahana Pentyala,David E Komatsu,Srinivas N Pentyala

doi:10.3390/mps4040069

Abstract

Gout is an inflammatory arthritis, which causes intense, acute pain due to the buildup of uric acid crystals in synovial fluid. The gold standard for gout diagnosis consists of synovial fluid analysis by polarized light microscopy, which is costly, time-intensive, and technique-dependent, therefore meriting a more efficient, inexpensive, and accessible method for diagnosis. We previously developed and validated a novel colorimetric gout detection method and device based on the reduction of silver nitrate by uric acid; here, we clinically validated our method and device using arthroscopically obtained synovial fluid samples from gout patients. We successfully identified uric acid crystals in clinical samples via our colorimetric method, visualized uric acid crystals in synovial fluid via handheld microscopy, and determined that silver nitrate stain did not interfere with the microscopic visualization of uric acid crystals necessary for diagnosis. We also developed and validated a method of processing turbid clinical samples for use in our device to prevent the obscuration of uric acid crystals by suspended material. Our method and device will clinically facilitate the immediate colorimetric diagnosis of gout and the subsequent bedside visualization of uric acid crystals in both ideal and turbid synovial fluid samples, allowing for a point-of-care diagnosis of gout.

Highlights

Gout is an inflammatory arthritis characterized by the buildup of uric acid crystals in synovial fluid, which can cause long-term destruction of joints if severe or recurrent
This clinical trial was designed as a prospective study with the objective of validating our bedside gout detection method
Clinical samples from 5 patients earlier diagnosed with gout by Stony Brook Orthopedic Practice were obtained via arthrocentesis in either an orthopedic clinic or hospital setting and were tested via both our rapid gout detection method and the standard-of-care of polarized light microscopy

Summary

Introduction

Gout is an inflammatory arthritis characterized by the buildup of uric acid crystals in synovial fluid, which can cause long-term destruction of joints if severe or recurrent. Gout affects approximately 8.3 million people each year, which in the United States presents as a prevalence of between 3–4 percent in the adult population [2,3]. Risk factors for gout include hyperlipidemia, diabetes, heavy alcohol consumption, frequent red meat consumption, and chronic kidney disease, each of which is highly prevalent in the United States population [4]. Gout causes marked levels of pain, swelling, and impaired mobility during a flare and contributes to 0.2% of ED visits per year in the United States [5]. Due to the functional impairment and severe pain associated with a gout flare, expedited diagnosis is critical for quickly and appropriately ameliorating patient symptoms

Methods

Results

Conclusion