QUALITATIVE MOLECULAR TESTS FOR CONFIRMATION OF THE DIAGNOSIS OF HEPATITIS C IN SEROPOSITIVE PATIENTS- A SYSTEMATIC REVIEW

Author(s)

Oliveira IG, Pereira C, Portela MOswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil

OBJECTIVES: Hepatitis C represents a serious Public Health problem. In approximately 80% of cases, the disease becomes chronic and the diagnosis can sometimes be made before the disease becomes severe. In 1993, the Brazilian government adopted a screening system with serological kits for hepatitis C diagnosis in blood donors. A positive screening, however, should be confirmed with another type of test since they do not distinguish active infection from past infection. So, molecular tests are very important to establish actual viremia and the hepatitis c diagnosis. Many guidelines throughout the world recommend the molecular test in various settings, including the confirmation of HCV in seropositive people. There are different qualitative molecular tests available for detecting HCV. The aim of this study was to conduct a systematic review of the accuracy of these different tests for confirmation of the diagnosis of HCV in seropositive people. METHODS: We searched MEDLINE, SCOPUS and the Cochrane Library. QUADAS was the tool used for quality assessment of the studies. RESULTS: The search resulted in 1222 articles for evaluation. Only 2 studies were included in the systematic review, according to the established inclusion and exclusion criteria. Both COBAS AMPLICOR and AMPLICOR tests had high sensitivity and specificity in one of the studies. The second study, presented accuracy data regarding an “in house” PCR test, which presented overall accuracy of 75%. CONCLUSIONS: Although we identified many articles in our search, the vast majority addressed analytical sensitivity, therefore not meeting our criteria, especially because they did not present accuracy data according to an established a gold standard. Furthermore, the 2 studies included did not present a good methodological quality according to QUADAS. These findings show the urgent need of studies with appropriate design for extraction of accuracy data of molecular tests.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

PMD4

Topic

Epidemiology & Public Health

Topic Subcategory

Disease Classification & Coding

Disease

Gastrointestinal Disorders

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