Authors' objectives: The Allomap™ test is a panel of genes faced with a blood sample which tries to distinguish between acute rejection moderate / severe and the absence of rejection, and thus be an alternative to endomyocardial biopsy. The aim of the systematic review was to assess the efficacy, effectiveness, and safety of the Allomap™ test for the diagnosis of acute cellular rejection in heart transplant recipients.

Authors' recommendations: A systematic review was performed and 2 evidence reports, 4 diagnostic test studies, 1 clinical trial and 1 description of costs study were selected. Methodological quality of the studies was adequate or high for the most of them. Diagnostic test studies reported the accuracy of the Allomap™ test showing low capacity in detecting the moderato/sever acute cellular rejection. Global accuracy outcomes were: sensitivity between 71% and 100%, specificity values between 42% and 79%, which makes it more suitable to rule out the disease. The positive likelihood ratios ranged between 1.3 and 3.6, while the negative likelihood ratios ranged from 0 to 0.58. The clinical trial evaluated the clinical utility (effectiveness) of the Allomap™ test. During a median follow-up period of 19 months, patients who were monitored with the Allomap™ test and those who underwent biopsies had similar risk of rejection (HR 1.04; 95% CI, 0.67-1.68) or death (HR 1.10; 95%CI: 0.50–2.40). Safety of the Allomap™ test has been demonstrated because of it is required for its implementation only a peripheral blood sample, as opposed to endomyocardial biopsy, which is an invasive test. Although the cost of the tests was similar, a description of cost study indicated an annual savings of $ 12 million in the U.S.A. to be needed a greater number of biopsies Allomap™ test.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/allomap-prueba-genetica-para-el-rechazo-de-trasplante-cardiaco/

Year Published: 2012

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2010_2-1_Allomap.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)