Efficacy of D5F3 IHC for detecting ALK gene rearrangement in NSCLC patients: a systematic review and meta-analysis.
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.
Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi 563000, China.
Hu
H
Ma
Department 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.
Wen-Xiu
WX
Yao
Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi 563000, China.
Lang
L
Huang
Affiliated Stemmatological Hospital of Zunyi Medical University, Zunyi 563000, China.
Su-Han
SH
Jin
Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi 563000, China.
Da-Hai
DH
Liu
Department of Pharmacology and Key Laboratory of Basic Pharmacology of Ministry of Education, Zunyi Medical University, Zunyi 563000, China.
Yuan
Y
Liu
Chongqing Cancer Hospital and Institute, Chongqing, 40030, China.
Xu
X
Tian
Evidence-Based Medicine Center of Lanzhou University, Lanzhou, 730000, China.
Jin-Hui
JH
Tian
Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi 563000, China.
Jian-Guo
JG
Zhou
D000077548:Anaplastic Lymphoma Kinase; D000906:Antibodies / Q000276:immunology*; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics*; D015321:Gene Rearrangement; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D008175:Lung Neoplasms / Q000235:genetics*; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics*
D000906:Antibodies; C000626173:ALK protein, human; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases
ALK; D5F3; NSCLC; diagnostic accuracy; meta-analysis