Objective: To assess the value of galactomannan (GM) double-direct sandwich enzyme-linked immunosorbent assay (ELISA) in the diagnosis of invasive aspergillosis (IA).
Methods: A search in MEDLINE, EMbase, OVID, CBMdisc and CHKD from Jan. 1991 to Dec. 2008 was conducted to collect all articles about diagnostic tests of serum GM detection. Then the methodological quality was assessed by QUADAS-items, sources of heterogeneity investigated, pooled effect quantities evaluated, and meta-analysis studies, SROC curves, and subgroup analysis performed.
Results: Thirty-six articles with a population of 4959 patients were included. The average prevalence of IA was 10%(532/4959). Our meta-analysis reported a median heterogeneity (I(2) = 48.6%, P < 0.05), with a pooled DOR value of 19.10 (95%CI 12.67 - 28.79), a pooled sensitivity of 0.66 (95%CI 0.61 - 0.70), a pooled specificity of 0.90 (95%CI 0.89 - 0.90), a pooled positive likelihood ratio of 5.48 (95%CI 4.27 - 7.02), a pooled negative likelihood ratio of 0.38 (95%CI 0.29 - 0.50), and an area under curve of SROC 0.88. The rate of underdiagnosis of serum GM detection was 34% (168/490) and the rate of misdiagnosis was 10% (466/4469). With a rise in the cut-off value the sensitivity of GM test decreased and specificity increased. Two consecutive positive tests decreased the sensitivity but increased the specificity. Age had no significant effect on the diagnosis by GM test. Both antifungal prophylaxis and antifungal therapy had no significant effect on sensitivity and specificity of GM test for IA diagnosis.
Conclusion: Serum GM detection is an effective diagnostic tool for invasive aspergillosis in high-risk populations.