High genotyping concordance between the digene HPV Genotyping RH Test and the Reverse Line Blot genotyping assay on GP5+/6+-PCR products.
BACKGROUND
Based on epidemiologic studies, 18 mucosal human papillomavirus (HPV) types have been classified as (probably) high-risk (HR) (i.e., HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82). Recognition of HR HPV at the individual type level may be valuable in clinical management of HR HPV-positive women.


OBJECTIVE
The goal of this study was to evaluate the performance of the novel digene HPV Genotyping RH Test (digene RH Test), which uses type-specific probes for the 18 HR HPV genotypes, in comparison to the established in-house Reverse Line Blot (RLB) genotyping assay on PCR products generated with the clinically validated GP5+/6+-PCR method.


METHODS
GP5+/6+ amplimers, generated from 493 digene High Risk HPV HC2 DNA Test (HC2)-positive and 95 HC2-negative cervical smears, were genotyped by both the digene RH Test and the RLB assay.


RESULTS
Both genotyping assays demonstrated high concordance for overall HR HPV detection (ú = 0.886) and type-specific identification of the 18 HR types (overall ú = 0.951, individual ú range 0.777 to 1.000) in 493 HC2-positive samples. The digene RH Test revealed positivity for one or more HR HPV type(s) in 86.6% of the HC2-positive women, and negativity was confirmed in 97.9% of the HC2-negative women.


CONCLUSIONS
The digene HPV Genotyping RH Test revealed a high genotyping agreement with the established RLB assay on GP5+/6+ amplimers. Accordingly, this assay following GP5+/6+-PCR could serve as a follow-up test in a clinical setting for women who are HC2-positive to identify the respective HR HPV genotype(s).
Geraets
D T
DT
DDL Diagnostic Laboratory, Fonteynenburghlaan 7, 2275 CX Voorburg, The Netherlands.
Heideman
D A M
DA
de Koning
M N C
MN
Snijders
P J F
PJ
Meijer
C J L M
CJ
van Doorn
L J
LJ
Quint
W G V
WG
D000328:Adult; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification; D019411:Clinical Laboratory Techniques; D015342:DNA Probes; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D005260:Female; D005814:Genes, Viral; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013045:Species Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000209:etiology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000209:etiology
D015342:DNA Probes; D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic