Article Text

Original article
Performance evaluation of automated urine microscopy as a rapid, non-invasive approach for the diagnosis of non-gonococcal urethritis
  1. Marcus J Pond1,
  2. Achyuta V Nori1,2,
  3. Sheel Patel2,
  4. Ken Laing1,
  5. Margarita Ajayi1,
  6. Andrew J Copas3,
  7. Philip D Butcher1,
  8. Phillip Hay1,2,
  9. Syed Tariq Sadiq1,2
  1. 1Institute for Infection and Immunity, St George's University of London, London, UK
  2. 2Department of Genitourinary & HIV Medicine, St George's Healthcare NHS Trust, London, UK
  3. 3Research Department of Infection and Population Health, University College London, Mortimer Market Centre, London, UK
  1. Correspondence to Dr Tariq Sadiq, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; ssadiq{at}sgul.ac.uk

Abstract

Objectives Gram-stained urethral smear (GSUS), the standard point-of-care test for non-gonococcal urethritis (NGU) is operator dependent and poorly specific. The performance of rapid automated urine flow cytometry (AUFC) of first void urine (FVU) white cell counts (UWCC) for predicting Mycoplasma genitalium and Chlamydia trachomatis urethral infections was assessed and its application to asymptomatic infection was evaluated.

Methods Receiver operating characteristic curve analysis, determining FVU-UWCC threshold for predicting M. genitalium or C. trachomatis infection was performed on 208 ‘training’ samples from symptomatic patients and subsequently validated using 228 additional FVUs obtained from prospective unselected patients.

Results An optimal diagnostic threshold of >29 UWC/µL gave sensitivities and specificities for either infection of 81.5% (95% CI 65.1% to 91.6%) and 85.8% (79.5% to 90.4%), respectively, compared with 86.8% (71.1% to 95%) and 64.7% (56.9% to 71.7%), respectively, for GSUS, using the training set samples. FVU-UWCC demonstrated sensitivities and specificities of 69.2% (95% CI 48.1% to 84.9%) and 92% (87.2% to 95.2%), respectively, when using validation samples. In asymptomatic patients where GSUS was not used, AUFC would have enabled more infections to be detected compared with clinical considerations only (71.4% vs 28.6%; p=0.03). The correlation between UWCC and bacterial load was stronger for M. genitalium compared with C. trachomatis (τ=0.426, p≤0.001 vs τ=0.295, p=0.022, respectively).

Conclusions AUFC offers improved specificity over microscopy for predicting C. trachomatis or M. genitalium infection. Universal AUFC may enable non-invasive diagnosis of asymptomatic NGU at the PoC. The degree of urethral inflammation exhibits a stronger association with pathogen load for M. genitalium compared with C. trachomatis.

  • URETHRITIS
  • DIAGNOSIS
  • M GENITALIUM
  • CHLAMYDIA TRACHOMATIS
  • MOLECULAR TECHNIQUES

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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