Implementation and evaluation of the Presto combined qualitative real-time assay for <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> in Rwanda.



Cuylaerts, Vicky ORCID: 0000-0003-0183-0033, De Baetselier, Irith ORCID: 0000-0002-1804-252X, Muvunyi, Claude M ORCID: 0000-0003-4180-442X, Mwambarange, Lambert ORCID: 0000-0002-1393-4545, Smet, Hilde ORCID: 0000-0002-9374-2710, Rusine, John ORCID: 0000-0001-8519-0840, Musengamana, Viateur ORCID: 0000-0002-6512-5467, van de Wijgert, Janneke ORCID: 0000-0003-2728-4560 and Crucitti, Tania ORCID: 0000-0002-2235-6038
(2019) Implementation and evaluation of the Presto combined qualitative real-time assay for <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> in Rwanda. African journal of laboratory medicine, 8 (1). 739-.

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Abstract

<h4>Background</h4>The Presto combined qualitative real-time assay for <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> (Presto CT/NG PCR assay) is appealing for developing countries, because it can be used with multiple DNA extraction methods and polymerase chain reaction (PCR) platforms.<h4>Objectives</h4>The objective of the study was to implement and evaluate the Presto CT/NG PCR assay at the National Reference Laboratory (NRL) in Kigali, Rwanda, where no real-time PCR assays for the detection of <i>C. trachomatis</i> or <i>N. gonorrhoeae</i> were available.<h4>Methods</h4>The Presto CT/NG PCR assay was first evaluated at the Institute of Tropical Medicine (ITM) in Antwerp, Belgium. Next, NRL laboratory technicians were trained to use the assay on their ABI PRISM 7500 real-time PCR instrument and their competencies were assessed prior to trial initiation. During the trial, endocervical swabs were tested at the NRL, with bi-monthly external quality control testing monitored by the ITM. The final NRL results were evaluated against extended gold standard testing at the ITM, consisting of the Abbott <i>m</i>2000 RealTi<i>m</i>e System with confirmation of positive results by an in-house real-time PCR assay for <i>C. trachomatis</i> or <i>N. gonorrhoeae</i>.<h4>Results</h4>Of the 192 samples analysed using the Presto assay at the NRL, 16 samples tested positive for <i>C. trachomatis</i> and 17 tested positive for <i>N. gonorrhoeae</i>; four of these were infected with both. The sensitivity and specificity of the Presto assay were 93.3% (95% confidence interval [CI]: 68.1% - 99.8%) and 99.4% (95% CI: 96.8% - 100%) for <i>C. trachomatis</i> and 100% (95% CI: 76.8% - 100%) and 98.8% (95% CI: 95.8% - 99.9%) for <i>N. gonorrhoeae</i>.<h4>Conclusion</h4><i>C. trachomatis</i> and <i>N. gonorrhoeae</i> testing with the Presto assay was feasible in Kigali, Rwanda, and good performance was achieved.<h4>Keywords</h4>qPCR; <i>Chlamydia trachomatis</i>; <i>Neisseria gonorrhoeae</i>.

Item Type: Article
Uncontrolled Keywords: Sexually Transmitted Infections, Infection, 3 Good Health and Well Being
Depositing User: Symplectic Admin
Date Deposited: 15 May 2019 09:23
Last Modified: 17 Mar 2024 03:43
DOI: 10.4102/ajlm.v8i1.739
Open Access URL: http://doi.org/10.4102/ajlm.v8i1.739
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3041415