9. Development and Validation of a Novel Gel-Based Urine Transport System for Use in Chlamydia Trachomatis PCR Based Diagnosis

Abstract

Background: Chlamydia trachomatis infection rates have increased within Australia over the past several years, including persistently high incidences in known risk groups. The development of novel C. trachomatis detection methods which can be self-collected and mailed in a plain envelope presents significant opportunities for increasing access to urine testing across Australia, particularly those who are geographically or socially isolated and have limited or impeded access to mainstream health services. Aim: The purpose of the study was to develop a urine transportation system which retains comparable sensitivity to standard sampling methods, is easy and safe to use by the average person within a home setting, and which complies with regulations concerning the transport of biological specimen through regular mail. Results/Discussion: An expanding-matrix based method was developed in which a small amount of urine is applied to a dry mixture of a super absorbent polymer and nucleic acid stabiliser, yielding a dry gel. The gel can then be subsequently treated in the diagnostic laboratory to release the reconstituted urine, from which nucleic acid can be extracted using standard methods. Once extracted, the sample can be utilised in a nucleic acid amplification based C. trachomatis diagnostic assay. The clinical sensitivity of the gel-matrix was found to be comparable to that of standard urine transport methods. The applicability of the gel for use by the public in a home collection setting was deemed appropriate due to the non-toxic nature of the matrix materials, ease of use, and the basic packing and postage requirements. The dry gel form of the urine and packaging complied with Australia Post standard postage requirements. Results of the initial development and validation of the gel matrix will be presented.