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Purpose The Cytobacteriological Examination of Urine (CBEU) is one of the most requested microbiological analyses in the medical bacteriology laboratory. According to the ISO 15189 standard, Medical Biology Laboratory (MBL) must validate the techniques before their use. It is in this perspective that, within the Medical Bacteriology Laboratory of the INH of Lome, we have carried out the on-site verification of the CBEU method using UriSelect4 chromogenic medium at the INH of Lomé. Material and methods The biological material was composed of reference bacterial strains and clinical bacterial strains isolated at INH. Failure Modes Effects and Criticality Analysis (FMECA) with 5 M model was used to perform risk analysis and performances as repeatability, intermediate fidelity/reproducibility, sensitivity and inter-operator variability were evaluated using references strains and different operators. “Comité Français d’Accréditation” (COFRAC) SH GTA 04 was used as reference. Single-factor ANOVA was used to analyze the data. Results Operating procedures, Patients preparation, Samples and Preparation of culture media were identified as main critical points with a criticality index of 8, 9, 9 and 12 respectively. The use of uriselect4 to perform ECBU was shown to be repeatable and reproducible. The sensibility of Uriselect4 to detect urinary infection was 100% with negligible inter-operator variability. Conclusion This study performed on-site verification of Uriselect4 at the bacteriology lab of INH of Lome and identified some critical points to master. The overall performance criteria from COFRAC SH GTA 04 were conform. Introduction Urinary Tract Infections (UTI) are defined as the colonization of the urinary tract by bacteria [1] . They are more common in pregnant women [2,3]. There are two main types of urinary tract infections: cystitis (bladder infection) and pyelonephritis (kidney infection) [1]. They can be treated very well with antibiotics. The most frequently implicated germs are Escherichia coli , Proteus mirabilis , Klebsiella Spp , Staphylococcus saprophyticus , Enterococcus faecalis and Staphylococcus aureus [4]. The confirmation of the diagnosis of UTI requires the performance of CBEU. This examination allows the detection of signs of UTI (reflected by leukocyturia) and the identification and enumeration of the pathogen(s) involved [5]. Indeed, the classical method of identification of uropathogens usually requires 48 h, which considerably lengthens the time for reporting results and hinders optimal therapeutic management of the patient [6]. In order to allow an easy, fast and accurate presumptive identification of uropathogens chromogenic agars such as CPSE, CPSO, CPS ID3, CPS ID4 and UriSelect4 media; have been proposed by some culture media manufacturers [[7], [8], [9]]. Thus, the medical bacteriology laboratory of the National Institute of Hygiene (INH) of Lomé has chosen the UriSelect4 medium for the identification of uropathogens. In order to confirm to the clinician the existence or not of a urinary tract infection, the biologist relies on recommendations from learned societies [10]; in this case, the ISO 15189 standard which stipulates in its chapter 5 section 5.5.1 that the Medical Biology Laboratory (MBL) must conduct the verification of the methods before their use [11]. Thus, the INH of Lomé, being in a quality management process and not having yet carried out the verification of certain methods in bacteriology lab, this study aimed to perform an on-site verification of the CBEU method using UriSelect4 chromogenic medium. The outcomes of this study will help to improve the diagnosis of UTIs in at the INH of Lomé. Section snippets Material and methods This was a prospective study conducted at the laboratory of medical bacteriology of the INH of Lomé from November 2017 to February 2018. The biological material was composed of reference bacterial strains ( E. coli ATCC 25922, P. aeruginosa ATCC 27853, S. aureus ATCC 29213 and E. faecalis strain ATCC 29212) and clinical bacterial strains isolated in the said laboratory. Risk management was carried out before the evaluation of the technical performance. The performances evaluated during the study Risk management Table 1 presents the headings of the 5 M salient method, the critical points, their frequencies, their severity, detectability and criticality indices. Of the 5 M method headings, only the Method, Matter and Material headings had activities with a Criticality Index (CI) greater than 6. In the Method, only the operating procedures had a CI of 8 with a frequency of 2–3 times every 2 months and a probability of detectability and severity; then comes the Matter, where the preparation of the Discussion Urinary tract infections, characterized by microbial multiplication within the urinary tract associated with a local inflammatory reaction [15,16], are one of the most frequent bacterial infections [17,18]. According to the WHO, they are a real public health problem. In France, it is estimated that 70,000 cases per year are resistant to conventional antibiotics [19]. Since these infections represent a significant proportion of bacterial infections, it is important to have an efficient and Conclusion This on site-verification of CBEU method using UriSelect4 at INH of Lomé demonstrated a good sensitivity, repeatability, reproductibility and was comparable to the CBEU methods using standard media. The caracterized risk of this method will be controlled in order to improve the diagnosis of UTIs using UriSelect4 media. It would also be advisable to carry out on-site verification of other microbiological techniques for the biological diagnosis of microbial infections, which would be a step Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Ethical statement This study received the approval of the scientific and educational committee of the ESTBA opinion N°0023/2017. Authors’ contributions Gnatoulma Katawa : Conceptualization, Methodology, Formal analysis, Writing - Review & Editing, Visualization. Akpanto Tchalon : Conceptualization, Methodology, Formal analysis, Writing - Original Draft, Visualization. Adodo Sadji : Conceptualization, Methodology, Resources, Visualization. Wemboo Halatoko : Conceptualization, Methodology, Resources, Visualization. Essoham Ataba : Investigation, Formal analysis, Visualization. Christèle Nguepou Tchopba : Formal analysis, Writing - Original Acknowledgements We thank the team of the “Institut National d’Hygiène” (INH) for its great collaboration. References (30) M.T.G. Dowzicky et al. Characterization of isolates associated with emerging resistance to quinupristin/dalfopristin (Synercid®) during a worldwide clinical program Diagn Microbiol Infect Dis (2000) A.L. Flores-Mireles et al. Urinary tract infections: epidemiology, mechanisms of infection and treatment options Nat Rev Microbiol (2015) J. Matuszkiewicz-Rowińska et al. Urinary tract infections in pregnancy: old and new unresolved diagnostic and therapeutic problems Arch Med Sci (2015) N. Gilbert et al. Urinary tract infection as a preventable cause of pregnancy complications: opportunities, challenges, and a global call to action Global Adv Health Med (2013) P. Mariani-Kurkdjian Physiopathologie des infections urinaires Méd Thérapeutique/Pédiatrie (2004) J.P.R.P. Lavigne Place de la spectrométrie de masse en bactériologie Ann Biol Clin (2015) M.M. Asma Ferjani et al. Evaluation du milieu chromogène uriselect4 au cours des urocultures Ann Biol Clin (2011) M.M. Mariam Medded et al. Comparaison de l'utilisation en routine de deux milieux chromogènes ChromID CPS® (bioMérieux) et Uriselect4®(Bio-Rad) pour la détection d' Escherichia coli et des principaux uropathogènes dans les urines John Libbey EUROTEXT Ann Biol Clin (2014) J.V.P. Rigaill et al. Evaluation of new bioMérieux chromogenic CPS media for detection of urinary tract pathogens J Clin Microbiol (2015) 5ème édition (2015) Laboratoires De biologie médicale - exigences concernant la qualité et la compétence (2012) P. Di Maiolo Cc et al. Dégradation des digues due à la présence d’infrastructures: recensement et classification des causes par la méthode des 5 M (2017) F. Hurtrel Lb et al. Analyse des risques liés au circuit de gestion et de dispensation des produits en expérimentation clinique par AMDeC » Research gate (2012) COFRAC. Guide technique D'accreditation De verification (Portee A)/validation (Portee B) Des methodes en biologie... Navigate Down View more references Cited by (0) Recommended articles (6) View full text © 2023 Indian Association of Medical Microbiologists. Published by Elsevier B.V. All rights reserved. About ScienceDirect Remote access Shopping cart Advertise Contact and support Terms and conditions Privacy policy We use cookies to help provide and enhance our service and tailor content and ads. By continuing you agree to the use of cookies . Copyright © 2023 Elsevier B.V. or its licensors or contributors. ScienceDirect® is a registered trademark of Elsevier B.V. ScienceDirect® is a registered trademark of Elsevier B.V.
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