Implementation and evaluation of the presto combined qualitative real-time assay for Chlamydia trachomatis and Neisseria gonorrhoeae in Rwanda

Background: The Presto combined qualitative real-time assay for Chlamydia trachomatis and Neisseria gonorrhoeae (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.Objectives: 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 C. trachomatis or N. gonorrhoeae were available.Methods: 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 m2000 RealTime System with confirmation of positive results by an in-house real-time PCR assay for C. trachomatis or N. gonorrhoeae.Results: Of the 192 samples analysed using the Presto assay at the NRL, 16 samples tested positive for C. trachomatis and 17 tested positive for N. gonorrhoeae; 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 C. trachomatis and 100% (95% CI: 76.8% ­ 100%) and 98.8% (95% CI: 95.8% ­ 99.9%) for N. gonorrhoeae.Conclusion: C. trachomatis and N. gonorrhoeae testing with the Presto assay was feasible in Kigali, Rwanda, and good performance was achieved

Innovative strategies for a successful SLMTA country programme: the Rwanda story

Background: In 2009; to improve the performance of laboratories and strengthen healthcare systems; the World Health Organization Regional Office for Africa (WHO AFRO) and partners launched two initiatives: a laboratory quality improvement programme called Strengthening Laboratory Management Toward Accreditation (SLMTA); and what is now called the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA). Objectives: This study describes the achievements of Rwandan laboratories four years after the introduction of SLMTA in the country; using the SLIPTA scoring system to measure laboratory progress.Methods: Three cohorts of five laboratories each were enrolled in the SLMTA programme in 2010; 2011 and 2013. The cohorts used SLMTA workshops; improvement projects; mentorship and quarterly performance-based financing incentives to accelerate laboratory quality improvement. Baseline; exit and follow-up audits were conducted over a two-year period from the time of enrolment. Audit scores were used to categorise laboratory quality on a scale of zero ( 55%) to five (95% - 100%) stars. Results: At baseline; 14 of the 15 laboratories received zero stars with the remaining laboratory receiving a two-star rating. At exit; five laboratories received one star; six received two stars and four received three stars. At the follow-up audit conducted in the first two cohorts approximately one year after exit; one laboratory scored two stars; five laboratories earned three stars and four laboratories; including the National Reference Laboratory; achieved four stars.Conclusion: Rwandan laboratories enrolled in SLMTA showed improvement in quality management systems. Sustaining the gains and further expansion of the SLMTA programme to meet country targets will require continued programme strengthening