Chromogenic In Situ Hybridization and p16/Ki67 Dual Staining on Formalin-Fixed Paraffin-Embedded Cervical Specimens: Correlation with HPV-DNA Test, E6/E7 mRNA Test, and Potential Clinical Applications

Table 1

Summary of results from histological diagnosis, HPV-DNA and mRNA tests, HPV viral load, CISH, and p16/Ki67 dual stain.

Case	Histological diagnosis	HR HPV-DNA; test result	HC2; viral load (RLU/CO)*	E6/E7 mRNA test result	Type specific mRNA test result**	HPV CISH^† signal	P16/Ki67; Dual stain result
1	CIN1	Positive	63.5	Negative	—	P	Negative
2	CIN1	Positive	516.61	Negative	—	D	Negative
3	CIN3	Positive	15.79	Negative	—	Negative	Positive
4	CIN2	Positive	146.77	Positive	16	D/P	Positive
5	CIN2	Positive	1283.97	Negative	—	D/P	Positive
6	CIN1	Positive	298.55	Negative	—	D	Negative
7	CIN3	Positive	1529.35	Positive	16, 31	D/P	Positive
8	CIN3	Positive	2207.8	Positive	31	D/P	Positive
9	CIN1	Positive	2.06	Negative	—	D	Negative
10	CIN2	Positive	216.93	Positive	31	D/P	Positive
11	CIN1	Positive	6.7	Negative	—	Negative	Negative
12	CIN2	Positive	84.32	Positive	31	Negative	Positive
13	CIN3	Positive	10.56	Positive	16	D/P	Positive
14	CIN3	Positive	338.02	Positive	16	D/P	Positive
15	CIN1	Positive	1211.84	Positive	33	D/P	Positive
16	CIN3	Positive	3.3	Positive	16	P	Positive
17	CIN1	Positive	155.79	Positive	16	D	Negative
18	CIN1	Positive	28.81	Negative	—	Negative	Positive
19	CIN2	Positive	34.82	Negative	—	D	Positive
20	CIN3	Positive	913.36	Negative	—	D	Positive
21	CIN2	Positive	1536.02	Positive	16	P	Negative
22	CIN2	Positive	107.22	Positive	18, 45	D/P	Positive
23	CIN1	Positive	75.86	Negative	—	D/P	Negative
24	CIN2	Positive	675.75	Positive	16	D/P	Positive
25	CIN2	Positive	596.84	Positive	16	D/P	Positive
26	CIN3	Positive	1914.17	Positive	16	D/P	Positive
27	CIN2	Positive	570.26	Positive	16, 45	D/P	Positive
28	CIN1	Positive	783.56	Negative	—	D	Negative
29	CIN1	Negative	—	Negative	—	Negative	Negative
30	CIN3	Positive	3.93	Positive	16	P	Positive
31	CIN3	Positive	968.56	Positive	31	D/P	Positive
32	CIN1	Positive	926.05	Positive	31	Invalid	Negative
33	CIN2	Negative	—	Positive	31	Invalid	Positive
34	CIN1	Positive	45	Negative	—	D	Negative
35	CIN3	Positive	117	Positive	16	D/P	Positive
36	CIN1	Positive	237.48	Positive	16	Invalid	Negative
37	CIN1	Positive	5.31	Positive	18, 31	Negative	Negative
38	CIN1	Positive	204.42	Positive	45	Negative	Negative
39	CIN3	Positive	663.26	Positive	33	Negative	Positive
40	CIN3	Positive	38.61	Positive	16	Negative	Positive
41	CIN1	Positive	10.11	Positive	33	D/P	Positive
42	CIN1	Positive	137.88	Negative	—	D	Negative
43	CIN3	Positive	6.21	Positive	16	Negative	Positive
44	CIN2	Positive	2663.26	Positive	31	D/P	Positive
45	SCC	Positive	1549.74	Positive	33	D/P	Positive
46	CIN2	Positive	894.17	Positive	16	P	Positive
47	CIN1	Positive	20.47	Negative	—	Negative	Negative
48	CIN1	Positive	26.23	Negative	—	Negative	Negative
49	CIN1	Positive	787.16	Positive	31	Negative	Negative
50	CIN1	Positive	676.46	Positive	16	D/P	Negative
51	CIN3	Positive	2.36	Positive	16	P	Positive
52	CIN3	Positive	1.45	Positive	18	P	Positive
53	CIN3	Positive	111.95	Positive	16, 18	D/P	Positive
54	CIN3	Positive	544.41	Positive	16	D/P	Positive
55	CIN2	Positive	663.21	Positive	16	D/P	Positive
56	CIN1	Negative	—	Negative	—	Negative	Negative
57	CIN2	Positive	1569.56	Positive	18	D/P	Positive
58	CIN3	Positive	758.66	Positive	16	D/P	Positive
59	CIN2	Positive	130.13	Positive	16	D/P	Positive
60	CIN3	Positive	87.01	Positive	16	P	Positive
61	CIN3	Positive	968.56	Positive	31	D/P	Positive
62	CIN2	Positive	6.21	Positive	16	P	Positive
63	CIN3	Positive	24.01	Positive	16	P	Positive

∗Relative light unit in relation to control (RLU/CO).
**HPV genotype(s) detected by Nuclisens EasyQ HPV mRNA test.
^†D: diffuse; P: punctated; D/P: mixed diffuse/punctated.