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Meta-Analysis
. 2015 Dec 30;2015(12):CD007394.
doi: 10.1002/14651858.CD007394.pub2.

Galactomannan detection for invasive aspergillosis in immunocompromised patients

Mariska M G Leeflang  1 , Yvette J Debets-Ossenkopp, Junfeng Wang, Caroline E Visser, Rob J P M Scholten, Lotty Hooft, Henk A Bijlmer, Johannes B Reitsma, Mingming Zhang, Patrick M M Bossuyt, Christina M Vandenbroucke-Grauls
Affiliations
Meta-Analysis

Galactomannan detection for invasive aspergillosis in immunocompromised patients

Mariska M G Leeflang et al. Cochrane Database Syst Rev. .

Abstract

Background: Invasive aspergillosis is the most common life-threatening opportunistic invasive mycosis in immunocompromised patients. A test for invasive aspergillosis should neither be too invasive nor too great a burden for the already weakened patient. The serum galactomannan enzyme-linked immunosorbent assay (ELISA) seems to have the potential to meet both requirements.

Objectives: To obtain summary estimates of the diagnostic accuracy of galactomannan detection in serum for the diagnosis of invasive aspergillosis.

Search methods: We searched MEDLINE, EMBASE and Web of Science with both MeSH terms and text words for both aspergillosis and the sandwich ELISA. We checked the reference lists of included studies and review articles for additional studies. We conducted the searches in February 2014.

Selection criteria: We included cross-sectional studies, case-control designs and consecutive series of patients assessing the diagnostic accuracy of galactomannan detection for the diagnosis of invasive aspergillosis in patients with neutropenia or patients whose neutrophils are functionally compromised. The reference standard was composed of the criteria given by the European Organization for Research and Treatment of Cancer (EORTC) and the Mycoses Study Group (MSG).

Data collection and analysis: Two review authors independently assessed quality and extracted data. We carried out meta-analysis using the bivariate method. We investigated sources of heterogeneity by adding potential sources of heterogeneity to the model as covariates.

Main results: We included 54 studies in the review (50 in the meta-analyses), containing 5660 patients, of whom 586 had proven or probable invasive aspergillosis. When using an optical density index (ODI) of 0.5 as a cut-off value, the sensitivity of the test was 82% (73% to 90%) and the specificity was 81% (72% to 90%). At a cut-off value of 1.0 ODI, the sensitivity was 72% (65% to 80%) and the specificity was 88% (84% to 92%). At a cut-off value of 1.5 ODI, the sensitivity was 61% (47% to 75%) and the specificity was 93% (89% to 97%). None of the potential sources of heterogeneity had a statistically significant effect on either sensitivity or specificity.

Authors' conclusions: If we used the test at a cut-off value of 0.5 ODI in a population of 100 patients with a disease prevalence of 9% (overall median prevalence), two patients who have invasive aspergillosis would be missed (sensitivity 82%, 18% false negatives), and 17 patients would be treated unnecessarily or referred unnecessarily for further testing (specificity 81%, 19% false negatives). If we used the test at a cut-off value of 1.5 in the same population, that would mean that four invasive aspergillosis patients would be missed (sensitivity 61%, 39% false negatives), and six patients would be treated or referred for further testing unnecessarily (specificity 93%, 7% false negatives). These numbers should, however, be interpreted with caution because the results were very heterogeneous.

PubMed Disclaimer

Conflict of interest statement

Authors ML, YD, JW, CV, HB, LH, RS, JBR, MZ, PMB, CVG state no conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
Methodological quality graph: Review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Methodological quality summary: Review authors' judgements about each methodological quality item for each included study.
4
4
Forest plots of sensitivity and specificity. The squares represent the sensitivity and specificity of one study, the black line its confidence interval. Studies are grouped by reported cut‐off value. If a study reported accuracy data for more than one cut‐off, its results are included in more than one subgroup. TP = True Positive; FP = False Positive; FN = False Negative; TN = True Negative. Forest plot of the included studies. TP = True Positive; FP = False Positive; FN = False Negative; TN = True Negative. Between brackets the 95% confidence intervals (CI) of sensitivity and specificity. The figure shows the estimated sensitivity and specificity of the study (blue square) and its 95% confidence interval (black horizontal line).
5
5
Plot of sensitivity versus specificity for all 54 studies, with different symbols for the different cut‐off values. The width of the symbols is proportional to the inverse standard error of the specificity in every study and the height of the symbols is proportional to the inverse standard error of the sensitivity.
6
6
Summary ROC plots for galactomannan test at three different cut‐off values. The graph shows the point estimates of sensitivity and specificity (solid dots) and the 95% confidence regions (dotted lines) around it. Data for individual studies are not shown in this plot.
7
7
Sensitivity analyses
1
1. Test
Platelia ‐ all cut‐offs.
2
2. Test
Platelia in children.
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References

References to studies included in this review

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References to studies excluded from this review

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He 2011 {published data only}
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    1. Hu H, Yang Y, Teng GL, Ju YF, Zhang LL, Wei M. Application of detecting bronchoalveolar lavage fluid Aspergillus galactomannan antigen in the diagnosis of pulmonary aspergillosis [支气管肺泡灌洗液半乳甘露聚糖抗原检测在肺曲霉病诊断中的价值]. Chung‐Hua i Hsueh Tsa Chih [Chinese Medical Journal] 2012;92(32):2268‐70. - PubMed
Husain 2004 {published data only}
    1. Husain S, Kwak EJ, Obman A, Wagener MM, Kusne S, Stout JE, et al. Prospective assessment of Platelia Aspergillus galactomannan antigen for the diagnosis of invasive aspergillosis in lung transplant recipients. American Journal of Transplantation 2004;4(5):796‐802. - PubMed
Jarque 2003 {published data only}
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Jathavedam 2009 {published data only}
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Ji 2007 {published data only}
    1. Ji Y, Liu DH, Xu LP, Liu KY, Huang XJ. The value of serum galactomannan detection for diagnosis of invasive aspergillosis in hematopoietic stem cell transplant recipients. Zhonghua Xue Ye Xue Za Zhi 2007;28(2):83‐6. - PubMed
Ji 2011 {published data only}
    1. Ji Y, Xu LP, Liu DH, Chen YH, Han W, Zhang XH, et al. Positive results of serum galactomannan assays and pulmonary computed tomography predict the higher response rate of empirical antifungal therapy in patients undergoing allogeneic hematopoietic stem cell transplantation. Biology of Blood and Marrow Transplantation 2011;17(5):759‐64. - PubMed
Jin_J 2010 {published data only}
    1. Jin, J.Sun, T.Y.Hu, Y.J.Li, Y.M. Multiple serum antigenic assays for diagnosis of invasive fungal infections in non‐neutropenic adult patients. Chinese journal of tuberculosis and respiratory diseases 2010;33(9):not reported. - PubMed
Khanna 2013 {published data only}
    1. Khanna S, Oberoi JK, Datta S, Aggarwal S, Wattal C. Variables affecting the performance of galactomannan assay in high‐risk patients at a tertiary care centre in India. Indian Journal of Medical Microbiology 2013;31(1):34‐9. - PubMed
Kimura 2009 {published data only}
    1. Kimura S, Odawara J, Aoki T, Yamakura M, Takeuchi M, Matsue K. Detection of sputum Aspergillus galactomannan for diagnosis of invasive pulmonary aspergillosis in haematological patients. International Journal of Hematology 2009;90(4):463‐70. - PubMed
Kitasato 2009 {published data only}
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Leng_Y 2010 {published data only}
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Li_L 2011 {published data only}
    1. Li LL, Wang JM, Zhang WP, Hou J, Cheng H, Yang JM, et al. Value of circulating galactomannan screening for early diagnosis of invasive aspergillosis in hematological patients. Journal of Leukemia and Lymphoma 2011;20(7):418‐21.
Lim 2004 {published data only}
    1. Lim ZY, Pagliuca A, Wade J, Ho A, Devereux S, Mufti GJ. Use of the galactomannan ELISA in the detection of invasive aspergillosis: a retrospective review and potential pitfalls in application. British Journal of Haematology 2004;125:59‐60.
Lopes 2010 {published data only}
    1. Lopes da Silva R, Ribeiro P, Abreu N, Ferreira T, Fernandes T, Monteiro A, et al. Early diagnosis of invasive aspergillosis in neutropenic patients. Comparison between serum galactomannan and polymerase chain reaction. Clinical Medicine Insights. Oncology 2010;4:81‐8. - PMC - PubMed
Maertens 2004 {published data only}
    1. Maertens J, Theunissen K, Verbeken E, Lagrou K, Verhaegen J, Boogaerts M, et al. Prospective clinical evaluation of lower cut‐offs for galactomannan detection in adult neutropenic cancer patients and haematological stem cell transplant recipients. British Journal of Haematology 2004;126(6):852‐60. - PubMed
Maertens 2007 {published data only}
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Maertens 2007a {published data only}
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Marr 2005 {published data only}
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Pazos 2005 {published data only}
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Pereira 2005 {published data only}
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Rogers 2013 {published data only}
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Sarrafzadeh 2010 {published data only}
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    1. Tabone MD, Vu‐Thien H, Latge JP, Landman‐Parker J, Perez‐Castiglioni P, Moissenet D, et al. Value of galactomannan detection by sandwich enzyme‐linked immunosorbent assay in the early diagnosis and follow‐up of invasive aspergillosis. Opportunistic Pathogens 1997;9(1):5‐15.
Uryu 2006 {published data only}
    1. Uryu H, Kozeki M, Asada N, Takeuchi M, Suenaga T. Analysis of serum Aspergillus galactomannan contents conducted at our hospital during the past 2 years. Japanese Journal of Antibiotics 2006;59(5):413‐4. - PubMed
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    1. Verweij PE, Latge JP, Rijs AJ, Melchers WJ, Pauw BE, Hoogkamp‐Korstanje JA, et al. Comparison of antigen detection and PCR assay using bronchoalveolar lavage fluid for diagnosing invasive pulmonary aspergillosis in patients receiving treatment for hematological malignancies. Journal of Clinical Microbiology 1995;33(12):3150‐3. - PMC - PubMed
Wang_Y 2013 {published data only}
    1. Wang Y Y, Xiao CL, Li JM, Zhao WL, Mi JQ, Hu J, Ni YX, Shen ZX. The retrospective study of serum aspergillus galactomannan (GM) antigen assay in invasive aspergillosis on hematological diseases. Chung‐Hua Hsueh Yeh Hsueh Tsa Chih [Chinese Journal of Hematology] 2013;34(6):498‐501. - PubMed
Xiang_J 2010 {published data only}
    1. Xiang J, Sun Z, Xu Z, Xia J, Huan J. Contribution of galactomannan antigen assay to early diagnosis of aspergillosis in patients with extensive burns [血清半乳甘露聚糖抗原动态检测对烧伤伴曲霉感染早期诊断的意义]. Chinese Journal of Infection and Chemotherapy 2010;10(4):304‐7.
Yao 2009 {published data only}
    1. Yao JF, Su D, Huang Y, Zhang P, Lin QS, Wang ZY, et al. A preliminary investigation on early diagnosis of invasive aspergillusis in patients with blood diseases by using circulating galactomannan test. Zhongguo Shi Yan.Xue Ye Xue Za Zhi 2009;17(3):765‐9. - PubMed
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    1. Yu J, Li RY, Gao LJ, Lu QY, Wang XH. Utility of galactomannan enzyme immunoassay and (1,3)beta‐D‐glucan assay in invasive fungal infection. Zhonghua Yi Xue Za Zhi 2010;90(6):371‐4. - PubMed
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