Original Title: Marcadores en orina para la predicción del rechazo del trasplante de rińón

Authors' objectives: To identify, evaluate and synthesize the available scientific knowledge on the effectiveness and cost-effectiveness of determining proteins (mRNA profile) in urine evaluated by the polymerase chain reaction (PCR) technique, as biomarkers for the prediction of kidney transplant rejection.

Authors' results and conclusions: RESULTS: A total of 1699 references were obtained, from which 136 abstracts were selected; a total of 15 studies were finally included: 2 SR with MA on the diagnostic performance of the granzyme B and perforin, respectively, and 13 primary studies. Two MA, each with six studies, were performed for these markers. For the granzyme B some cumulative sensitivity and specificity values of 80% and 78% respectively were obtained; the latter showed significant heterogeneity whilst in the case of perforin results were 80% and 72%, with significant heterogeneity in both cases. Other markers that showed good results were FOXP3, OX40, FasL, TIM-3 and PI-9, although they were only evaluated in one or two studies. Five studies analysed different multivariate models with sensitivity and specificity results of 71%-95% and 72%-94%, respectively. No costs studies or economic evaluations were found. CONCLUSIONS: The studies included reveal major variability in the markers evaluated and the comparison groups; their methodological quality shows limitations especially for the selection of patients and the use of diagnostic thresholds taken from the study sample itself. The multivariate models analysed do not coincide with the markers evaluated. The study with the highest methodological quality obtained some sensitivity and specificity values for the external validation sample that were marginally above 70%

Authors' recommendations: The current state of knowledge does not facilitate recommending urinary cell mRNA analysis by means of cPCR-TR to predict acute rejection after renal transplant. Further studies need to be performed to prospectively validate the diagnostic performance of the different models obtained from the studies with the highest methodological quality considered in this review.

Authors' methods: A systematic review (SR) was performed in the databases MEDLINE and PreMedline, EMBASE, CINAHL, Cochrane Library, and Centre for Reviews & Dissemination (CRD) up until March 2014. Two independent reviewers selected SR with meta-analysis (MA) and primary studies that offered data on the diagnostic performance of urinary cell mRNA to predict acute rejection after renal transplant diagnosed by means of biopsy. The methodological quality of the studies included was evaluated by means of the Oxman and QUADAS-2 scales for the SR and primary studies, respectively. A MA of the sensitivity and specificity of those markers, which were evaluated by three or more studies, was performed.

Project Status: Completed

Year Published: 2014

URL for published report: https://sescs.es/marcadores-en-orina-para-la-prediccion-del-rechazo-del-trasplante-de-rinon/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es