Objectives: The aim of this study was to develop a novel urine transport method to be used in self-collection-based screening for Chlamydia trachomatis. The method needed to be suitable for C trachomatis PCR detection, be economical and suitable for transport by standard envelope mailing.
Methods: An anhydrous gel composed of super-absorbent polymer and buffering agent was used to desiccate urine into a dry granulous state, which could subsequently be reconstituted upon arrival at a laboratory. DNA was then extracted from the reconstituted solution using the Roche MagNA Pure protocol for the detection of C trachomatis by PCR. Collections of urine specimens from three populations with widely differing chlamydia prevalence (100%,n = 56; 47%, n = 70; 3%, n = 97) were used. We determined the gel method’s impact on C trachomatis PCR sensitivity and specificity using neat and gel-processed urine specimens. An equine herpes virus PCR was used to test for assay inhibition.
Results: Overall, the sensitivity of the gel-based method ranged from 94.6–100% compared with neat urine, with a specificity of 100%. No PCR inhibition or decrease in analytical sensitivity was observed using the gel-processed extracts.
Conclusions: The gel-based method was found to be suitable for the detection of C trachomatis by PCR. In addition, its ease of use, effectiveness at ambient temperature and low cost makes it well-suited for self-collection kits used in population-based C trachomatis screening, particularly for geographically and socially isolated individuals.
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Funding: This project was funded by the Australian Commonwealth Government as part of a National Chlamydia Pilot Program that is currently running to test the effectiveness of a number of models for chlamydia testing in Australia. This project will assist in developing possible recommendations for a National Chlamydia Program.
Competing interests: None.
Ethics approval: Approved by the Human Research Ethics Committee for the Townsville Health Service District and James Cook University.
Contributors: SB: conceptualisation, study design, sample processing, data collection and analyses, and drafting of manuscript; DMW: conceptualisation, study design and drafting of manuscript; MBS: study design, sample collection, data analyses and drafting of manuscript; CB: sample processing and testing and drafting of manuscript; KB: sample collection and drafting of manuscript; SA: sample collection and drafting of manuscript; RG: study design, sample collection and data analyses; RM: data analyses and drafting of manuscript; SBL: study design, data analyses and drafting of manuscript; JD: study design and drafting of manuscript; MDN: study design and drafting of manuscript; TPS: conceptualisation, study design and drafting of manuscript.