Research Papers:

Efficacy of D5F3 IHC for detecting ALK gene rearrangement in NSCLC patients: a systematic review and meta-analysis

Hu Ma, Wen-Xiu Yao, Lang Huang, Su-Han Jin, Da-Hai Liu, Yuan Liu, Xu Tian, Jin-Hui Tian and Jian-Guo Zhou _

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Oncotarget. 2016; 7:70128-70142. https://doi.org/10.18632/oncotarget.11806

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Hu Ma1,*, Wen-Xiu Yao2,*, Lang Huang1,*, Su-Han Jin3, Da-Hai Liu1, Yuan Liu4, Xu Tian5, Jin-Hui Tian6, Jian-Guo Zhou1

1Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi 563000, China

2Department of Oncology, Affiliated Cancer Hospital of Medical School, University of Electronic Science and Technology of China, Sichuan Cancer Hospital and Institute & Cancer, The Second People’s Hospital of Sichuan Province, Chengdu, 610000, China

3Affiliated Stemmatological Hospital of Zunyi Medical University, Zunyi 563000, China

4Department of Pharmacology and Key Laboratory of Basic Pharmacology of Ministry of Education, Zunyi Medical University, Zunyi 563000, China

5Chongqing Cancer Hospital and Institute, Chongqing, 40030, China

6Evidence-Based Medicine Center of Lanzhou University, Lanzhou, 730000, China

*These authors have contributed equally to this work

Correspondence to:

Jian-Guo Zhou, email: [email protected]

Keywords: NSCLC, D5F3, ALK, diagnostic accuracy, meta-analysis

Received: June 06, 2016    Accepted: August 13, 2016    Published: September 01, 2016


We conducted a pooled analysis comparing the efficacy of an immunohistochemistry (IHC) assay using the D5F3 antibody with that of fluorescence in situ hybridization (FISH) for detecting ALK gene rearrangement in NSCLC patients. A total of 32 studies involving 5805 samples were included in this review. Pooled sensitivity for D5F3 IHC was 0.97 (95%CI: 0.93-0.98), specificity was 0.99 (95%CI: 0.98-1.00), PLR was 119.20 (95%CI: 57.79-245.89), NLR was 0.03 (95%CI: 0.02-0.07), DOR was 3526.66 (95%CI: 1344.71-9249.03), and AUROC was 1.00 (95%CI: 0.99-1.00). Meta-regression revealed that specimen type was a source of heterogeneity for specificity, and specimen type and FISH signal distance were sources of heterogeneity in the joint model. Subgroup analysis revealed that sensitivity and specificity were higher when the FISH signal distance standard was ≥ 2 than when it was ≥ 1. Sensitivity was higher for tumor specimens than for cell specimens; specificity was higher for cell specimens than for tumor specimens. In conclusion, the D5F3 IHC assay was nearly as effective as FISH for detection of ALK gene rearrangement in NSCLC patients.

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