. 2018 Sep 17;11:147–155. doi: 10.2147/PGPM.S156672

Table 1.

Performance of D5F3 immunohistochemistry in detecting ALK rearrangements in lung cancer

Study	N	Country	Histologic types	Scoring system	Sensitivity	Specificity	Note for positivity
Mino-Kenudson 2010³⁸	153	USA	Adenocarcinoma	Binary	100	99.0
Martinez 2013⁴⁷	79	Spain	NSCLC	Binary (cutoff 10%)	83.3	100
Minca 2013⁴⁸	249	USA	NSCLC	Binary	100	100	Corrected in accordance with the results of the second FISH and clinicopathologic data
Ying 2013⁴⁹	196	China	Adenocarcinoma	0–3+	100	95.0	>1+
Zhou 2014⁵⁸	368	China	Adenocarcinoma	0–3+	100	98.8	>2+, corrected in accordance with the results of RT-PCR
Shan 2014⁵⁴	286	China	Adenocarcinoma	0–2+ based on intensity (0–3+) and extent (0–5+)	100	98.8	>1+, corrected in accordance with the results of RT-PCR
Le Quesne 2014⁵³	15	UK	Adenocarcinoma	Intensity (0–3+) and extent (0–5+)	100	86	Only FISH-positive cases, intensity ≥1 and extent ≥4
Tantraworasin 2014⁵⁵	267	Thailand	NSCLC	Binary	80	94.9	Only strongly positive staining
Demidova 2014⁵²	36	Russia	NSCLC	0–3+	100	100	>1+
Ali 2014^*⁵⁰	523	Italy	NSCLC	Binary	90	100	RT-PCR for EML4–ALK variants 1–3 was negative in the two FISH+/IHC− cases
Conde 2014⁵¹	103	Spain	NSCLC	0–3+	98	100	>2+
Wang 2014^*⁵⁶	430	China	Adenocarcinoma	Binary	100	98.2
Wynes 2015⁵⁷	103	USA	NSCLC	Binary	90	95
Pekar-Zlotin 2015⁶⁰	51	Israel	Adenocarcinoma	0–3+	100	97.7	H score ≥40, corrected in accordance with the results of NGS
Rogers 2015⁶¹	362	Australia	NSCLC	Intensity (0–3+) and extent (0–3+)	100	99.7
Lantuejoul 2015⁵⁹	547	France	Adenocarcinoma	0–3+	89	76	≥10% of the cells with a 1–3+ intensity, corrected in accordance with the results of RT-PCR
Savic 2015⁶²	72	Switzerland	NSCLC	0–3+	96	100	>3+
Ilie 2015^*²⁶	176	France	Adenocarcinoma	Binary	81	99	The five FISH+/IHC− cases were FISH borderline positive (15%–20%); three overexpressed c-MET and responded to crizotinib, and two without c-MET expression progressed on crizotinib
Wang 2016³⁹	595	China	Adenocarcinoma	0–3+	75.9	99.8	>1+
Thorne-Nuzzo 2017^*⁶⁴	933	Global (clinical trial)	NSCLC	Binary	86.0	96.3	Overall response rate to crizotinib: 86.7% for FISH+/IHC+ and 33.3% for FISH+/IHC− cases (P=0.0083)
Wagle 2017^*⁶⁵	200	India	Adenocarcinoma	Binary	100	90.5
Murthy 2017^*⁶³	341	India	Adenocarcinoma	Binary	100	94.4
Kheng 2018⁶⁶	304	UK	NSCLC	Binary	100	96.6

Note:

Studies in which the ALK (D5F3) CDx immunohistochemistry assay or an equivalent assay was used in conjunction with a binary scoring algorithm.

Abbreviations: ALK, anaplastic lymphoma kinase; FISH, fluorescent in situ hybridization; IHC, immunohistochemistry; NSCLC, non-small-cell lung cancer; RT-PCR, real-time polymerase chain reaction.