Viral and Cellular Biomarkers in the Diagnosis of Cervical Intraepithelial Neoplasia and Cancer

Table 1

Commercial available assays targeting viral as well as cellular biomarkers.

Available assays	Manufacturer	Target	HPV genotypes	Genotyping	FDA; approved
Viral Assay HPV DNA
COBAS 4800	Roche	L1 DNA	13 HR HPV and HPV66	16 and 18	Yes
Cervista	Hologic	L1 DNA	13 HR HPV and HPV66	16 and 18	Yes
Hybrid Capture 2	QIAGEN	Full Genome	13 HR HPV and HPV66	No	Yes
Amplicor	Roche	L1 DNA	13 HR HPV	No	No
CareHPV	QIAGEN	L1 DNA	13 HR HPV and HPV66	No	No
Digene HPV eHC	QIAGEN	Full Genome	13 HR HPV, HPV66 and 82	No	No
EIA kit HPV GP HR	Diassay	L1 DNA	13 HR HPV and HPV66	No	No
INFINITI HPV-HR QUAD	AutoGenomics	E1 DNA	13 HR HPV and HPV66	No	No
RT HPV	Abbott	L1 DNA	13 HR HPV and HPV66	16 and 18	No
Digene HPV eHC 16 18/45	QIAGEN	Full Genome	13 HR HPV, HPV66 and 82	16, 18, and 45	No
Clart	Genomica	L1 DNA	13 HR HPV and 22 no HR	Yes	No
INFINITITM	Genomica	L1 DNA	13 HR HPV and 12 no HR	Yes	No
InnoLiPA	Innogenetics	L1 DNA	13 HR HPV and 15 no HR	Yes	No
Linear Array	Roche	L1 DNA	13 HR HPV and 24 no HR	Yes	No
Multiplex HPV genotyping	Multimetrix	L1 DNA	13 HR HPV and 11 no HR	Yes	No
PapilloCheck	Greiner Bio-One	E1 DNA	13 HR HPV and 11 no HR	Yes	No
HPV RNA
APTIMA	GenProbe	E6/E7 mRNA	13 HR HPV and HPV66	No	Yes
NucliSens EasyQ	Biomerieux	E6/E7 mRNA	5 HR HPV	16, 18, 31, 33, and 45	No
OncoTect	IncellDx	E6/E7 mRNA	13 HR HPV	Yes	No
PreTect Proofer	Norchip	E6/E7 mRNA	5 HR HPV	16, 18, 31, 33, and 45	No
HPV Proteins
Cytoactiv	Cytoimmun Diagnostics	L1	All known HPVs	No	No
OncoE6	Arbor Vita	E6	3 HR HPV	16, 18, and 45	No
Cellular Assay
CINtec	mtm Laboratories	p16ink4a			No
CINtec Plus	mtm Laboratories	p16ink4a/K1-67			No
Ki-67 (MIB1)	DakoCytomation	Ki-67			No
ProEx C	Becton Dickinson	TOP2A/MCM2			No