Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the international guidelines for human papillomavirus test requirements for cervical screening

Table 3 HPV Genotype distribution in 1265 SurePath screening samples and 1249 ThinPrep screening samples tested with Genomica CLART4S and MGP-PCR

HPV genotypes	Prevalence			Agreement (CLART4S/MGP-PCR)					Kappa	McNemar
HPV genotypes	CLART4S	MGP-PCR	Ratio	+/+	+/−	−/+	−/−	Agreement	Kappa	McNemar
SurePath^a
16	41	44	0.93	40	1	4	1220	99.6	0.94	0.38
18	10	11	0.91	9	1	2	1253	99.8	0.86	1.00
31	33	32	1.03	31	2	1	1231	99.8	0.95	1.00
33	11	7	1.57	7	4	0	1254	99.7	0.78	0.13
35	7	6	1.17	5	1	2	1257	99.8	0.77	1.00
39	20	13	1.54	10	10	3	1242	99.0	0.60	0.09
45	20	27	0.74	19	1	8	1237	99.3	0.81	0.04
51	10	7	1.43	6	4	1	1254	99.6	0.70	0.34
52	24	24	1.00	20	4	4	1237	99.4	0.83	1.00
56	12	11	1.09	10	1	2	1252	99.8	0.87	1.00
58	15	7	2.14	7	8	0	1250	99.4	0.63	0.01
59	10	11	0.91	8	2	3	1252	99.6	0.76	1.00
66	5	12	0.42	4	1	8	1252	99.3	0.47	0.04
68	14	8	1.75	3	11	5	1246	98.7	0.27	0.21
14 Hr-HPV	185	181	1.02	156	29	25	1055	95.7	0.83	0.68
ThinPrep^b
16	47	82	0.57	47	0	35	1167	96.0	0.72	0.00
18	9	12	0.75	9	0	3	1237	98.5	0.86	0.05
31	29	40	0.73	29	0	11	1209	97.9	0.84	0.00
33	20	18	1.11	17	3	1	1228	98.4	0.89	0.63
35	8	8	1.00	6	2	2	1239	98.4	0.75	1.00
39	3	9	0.33	3	0	6	1240	98,3	0.50	0.03
45	9	16	0.56	9	0	7	1233	98.2	0.69	0.02
51	14	23	0.61	13	1	10	1225	97.9	0.70	0.01
52	12	25	0.48	12	0	13	1224	97.7	0.64	0.00
56	4	8	0.50	4	0	4	1241	98.4	0.67	0.13
58	12	15	0.80	11	1	4	1233	98.3	0.81	0.38
59	2	10	0.20	2	0	8	1239	98.1	0.33	0.01
66	0	15	0.00	0	0	15	1234	97.5	0.00	0.00
68	9	10	0.90	4	5	6	1234	97.9	0.42	1.00
14 Hr-HPV	151	236	0.64	147	4	89	1009	91.4	0.72	0.00

^aData for both Control (1184) and Case (81) SurePath screening samples. In total 1265 SurePath samples
^bDato for both Control (1169) and Case (80) ThinPrep screening samples. In total 1249 ThinPrep samples

ISSN: 1471-2407