[Testing of a new probe 16/18/45 Hybrid Capture (Digene) in women with high risk HPV infection].
BACKGROUND
HPV HR detection test are needed when ASCUS is diagnosed on Pap test. The risk of progression to cervical cancer is dependant on the HPV genotype and three types (HPV 16, 18 and 45) are found in 77.4% of the cervical cancer. Here we have tested a new probe 16/18/45 (Digene) that is able to detect specifically these three types.


METHODS
Thirty-seven women with a Hybrid Capture 2 High Risk test (Digene) positive were selected to test the new probe 16/18/45. Samples were typed using sequencing reaction after GP5+/GP6+ PCR. Types were given after comparison with the GenBank. Discordant results were controlled with Inno-Lipa HPV genotyping v2 test (Innogenetics).


RESULTS
Among the 37 women with HR HPV result, 48.6% were positive with the probe 16/18/45 (18 patients). After genotyping, 12 results were concordant and six discordant (three HPV 31, two HPV 58 et one HPV 59). For the other 19 patients with negative result, 18 are concordant and one discordant (HPV 18). Global concordance for typing between this probe and sequencing was 81% with a kappa test of 0.62 that means a good concordance. Positive predictive value is 66.6% and negative predictive value is 94.7%.


CONCLUSIONS
This study shows a good efficiency of the 16/18/45 probe to detect the genotypes that have the higher risk of progression to cervical cancer. This probe could also allow to follow the epidemiology of HR HPV infection after a large use of HPV vaccines.
Hantz
S
S
Laboratoire de bactériologie-virologie, EA3175, CHU de Limoges, 2, avenue Martin-Luther-King, 87000 Limoges, France. shantz@wanadoo.fr
Decroisette
E
E
Caly
H
H
Renaudie
J
J
Dussartre
C
C
Bakeland
D
D
Denis
F
F
Alain
S
S
D052685:Alphapapillomavirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D015344:DNA Probes, HPV; D005260:Female; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology*; D010802:Phylogeny; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012306:Risk; D013045:Species Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology*; D014626:Vaginal Smears
D015344:DNA Probes, HPV; D011933:Reagent Kits, Diagnostic