P38.01
Background: Studies have demonstrated the association between BV and HIV acquisition in woman. The prevalence of BV reported in clinical trials conducted by the Medical Research Council HIV Prevention Research Unit (MRC HPRU) is between 5–9%. In an attempt to reduce turnaround time for results, enable direct contact with research clinics, facilitate staff capacitation and reduce costs, the HPRU was selected by the Protocol Reference Laboratory to perform in-house testing for diagnosing BV. We report here on the operational challenges associated with the set-up of the laboratory to perform the analysis.
Methods: To perform the testing, the laboratory underwent infrastructural changes in order to implement a staining workbench. Correct waste management disposal was also part of the set-up process as well as procurement for staining reagents, consumables and internal quality control (IQC) slides. Staff that were involved in the testing had to undergo rigorous training.
Results: Operational challenges included: training and evaluating only staff who specialize in clinical pathology and microbiology, quality of gram stain reagents, QC processes, waste management and manual IQC slides which were compared to commercially available ones. Commercial gram stain reagents and IQC slides were preferred as less labour intensive with enhanced staining results. Waste receptacles proved futile and a local municipal waste discharge permit was obtained instead. To date, 1605 slides have been analyzed. The following errors were noted during the QC process: incorrect slide preparation (47%) and inadequate sample material for diagnosis (0.3%), however, retraining of clinical staff resulted in a significant reduction (50%) of errors.
Conclusions: Despite operational challenges HPRU has been successful in the set-up of gram stain analysis for BV diagnosis as a Protocol Reference Laboratory. This enables BV to be diagnosed in real-time rather than shipping to an international laboratory where slides are analyzed at study end.
