Original Title: Avis - Détection de Chlamydia trachomatis, Neisseria gonorrhoeae et Trichomonas vaginalis par TAAN

Authors' objectives: A request to include a new test in the Répertoire québécois et système de mesure des procédures de biologie médicale (hereinafter the "Répertoire") was made by the Centre hospitalier régional de Lanaudière (CHRL) and sent to the Institut national d'excellence en santé en services sociaux (INESSS) via the mechanism for evaluating new clinical laboratory tests. The context of this mandate is the replacement of both T. vaginalis culture and the dual-target CT/NG NAAT with the CT/NG/TV triplex assay, in which case a T. vaginalis result could be sent to the clinician without this having been requested. The Ministère de la Santé et des Services sociaux (MSSS) therefore considers that the appropriate clinical steps need to be clarified for cases where an asymptomatic individual tests positive for T. vaginalis.

Authors' results and conclusions: RESULTS: The currently available prevalence data for T. vaginalis in Québec and Canada are fragmentary, the prevalence estimate for Québec being very low, possibly less than 1%. The Hologic AptimaMC TV, Cepheid XpertMC TV and BD MAXMC CT/GC/TV NAAT kits are superior to culture for detecting T. vaginalis in women. Of these kits, only Cepheid XpertMC TV can detect T. vaginalis in men. The literature search did not yield any studies showing an association between T. vaginalis infection and cervical cancer, prostate cancer or infertility. However, two systematic reviews indicate an association between T. vaginalis infection and HIV acquisition or shedding, while treating trichomoniasis reduces genital HIV shedding. The proposed triplex kit does not offer the option of not generating the T. vaginalis result in situations where it is not requested by the clinician. Although the laboratory computer system settings could enable one to withhold the T. vaginalis result from the clinician, there are some ethical issues, particularly with regard to the medical obligation to intentionally omit to provide a known positive result. A requisition form designed to limit triplex test ordering to individuals with trichomoniasis symptoms poses several operationalization issues for laboratory personnel.

Authors' recommendations: Based on the available information, INESSS recommends to the Minister that an NAAT approach for detecting T. vaginalis be included in the Répertoire to replace the conventional techniques (culture and antigen test) for individuals presenting with symptoms consistent with trichomoniasis, namely: a) Women, pregnant or not, with an abnormal vaginal discharge or signs or symptoms of cervicitis; b) Men with persistent symptoms of urethritis in whom C. trachomatis and N. gonorrhoeae have been ruled out. A multiplex approach for detecting other pathogens known to cause symptoms consistent with trichomoniasis could be used. However, laboratories using a multiplex approach combining T. vaginalis with the C. trachomatis/N. gonorrhoeae duplex (also used in asymptomatic populations) should include in the report a note for the clinician stating that treating asymptomatic trichomoniasis, including in pregnant women, is not recommended. The requesting clinician’s judgment should prevail at all times in the final decision to treat or reassess the symptoms and risk factors in an asymptomatic female patient after receiving an unsolicited positive result for T. vaginalis. The kits should be used in accordance with ISO standard 15189. Unless there is appropriate local verification, T. vaginalis should preferably not be routinely reported in men.

Authors' methods: The evaluation process included a rapid review of the scientific literature, a search of the grey literature and consultations with experts and other stakeholders. This methodology was used for five evaluation questions: • What is the prevalence of T. vaginalis infection in Québec and Canada? • What are the clinical situations in which a test for T. vaginalis is recommended? • What is the diagnostic performance of TV NAAT and multiplex CT/NG/TV NAAT in detecting T. vaginalis? • What is the clinical utility of T. vaginalis testing in the different clinical situations proposed? • What is the economic impact of NAAT testing for T. vaginalis alone or simultaneously with other pathogens compared to the current practice? A review of the scientific literature was carried out to assess the efficiency of T. vaginalis testing by NAAT compared to culture. Subsequently, we performed a budget impact analysis examining the costs associated with including simplex and triplex T. vaginalis NAAT testing in the Repertoire. The costs were projected over a three-year time horizon from a health-care system perspective. All the scientific, contextual and experiential data were interpreted and evaluated using a synthesis grid to guide the joint deliberation process of the Comité d’excellence clinique en dépistage des maladies chroniques and the Comité scientifique des analyses de biologie médicale (CSABM) for the purpose of developing recommendations.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/detection-de-chlamydia-trachomatis-neisseria-gonorrhoeae-et-trichomonas-vaginalis-par-taan.html

Year Published: 2022

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/detection-de-chlamydia-trachomatis-neisseria-gonorrhoeae-et-trichomonas-vaginalis-par-taan.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec