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Objective: This study evaluated the usefulness of p16^INK4a/Ki-67 as a new biomarker in the diagnosis of human papillomavirus (HPV)-related cervical lesions. Study Design: From 69 women with previous positive cytology, clinician-collected (CC) samples were obtained using a Cervex-Brush®. One month later, self-collected (SC) material was acquired using a Rovers® Viba-Brush. Liquid-based cytology specimens were prepared from both samples, and then the grades of squamous intraepithelial lesions (SIL) were determined; following immunostaining with CINtec® PLUS, HPV status was analyzed using a linear array. Results: The mean double-positive cell scores (SCORE) in the CC samples were 3.2 in samples negative for intraepithelial lesions or malignancy, 1.3 in atypical squamous cells of undetermined significance, 87.1 in low-grade SIL, and 367 in high-grade SIL. According to HPV risk type, the mean SCORE was 16 in samples negative for HPV, 8.4 in low-risk HPV, 143 in high-risk HPV other than type 16, and 420 in HPV16 – with a statistical significance between high-risk HPV and type 16 (p < 0.05). The SCORE of the SC group was lower than that of the CC group because of the limited number of cells collected. Conclusions: The SCORE showed a significant correlation with HPV16 compared with lesser-degree lesions. CINtec PLUS is useful as a diagnostic marker of progression of lesions and a surrogate marker of an elevated risk of high-grade lesions with HPV16.

Objective: This study compared the usefulness of self-collected (SC) and clinician-collected (CC) materials for cervical cytology and human papillomavirus (HPV) genotyping. Study Design: Fifty women with previous positive cytology and who were undergoing regular checkups were included in the study. CC samples were collected using a Cervex-Brush Combi with liquid-based cytology. One month later, SC material was acquired using the Rovers Viba-brush vaginal sampler, and fixed at home. Thin-layer specimens were prepared from both samples and HPV status was analyzed using a linear array. Results: A total of 37/50 CC (74%) and 41/50 SC (82%) cases were positive for HPV. Pap tests identified high-grade squamous intraepithelial lesions in 11 (22%) and seven (14%) patients, low-grade squamous intraepithelial lesions in 19 (38%) and 16 (32%), atypical squamous cells of undetermined significance in 2 (4%) and 0 patients, and NILM (negative for intraepithelial lesion or malignancy) in 18 (36%) and 27 (54%) patients in the CC and SC groups, respectively. Conclusions: SC material had a lower positive cytology rate, but a higher HPV-positive rate than CC material. These results suggest that a combination of Pap and HPV tests on SC material may provide a diagnostic strategy with high sensitivity and specificity.

Abstract. To evaluate the physiological significance of inhibin in various types of amenorrhea, serum immunoreactive (IR)-inhibin levels were measured and compared with those in normal cycling women. Amenorrheic women were as follows: (1) 23 women with PCOD, 11 women with hypogonadotropic amenorrhea (HA, n=23) and 11 women with regular menstrual cycles. Women with HA were further divided into 2 groups according to the presence or absence of withdrawal bleeding (WDB) after progesterone administration.HA with WDB was categorized as HA1, while HA without as HA 2. Serum IRinhibin levels in women with PCOD were significantly higher than those in HA 2 and normal women at days 2 to 5 from the onset of menstruation and significantly lower than those in normal women in the mid-luteal phase. A significant positive correlation was obtained between IR-inhibin and FSH in HA 2 (r=0.681) and HA 1 (r=0.658), but no significant correlation between these two hormones in PCOD and normal women. These results indicated that basal IR-inhibin levels vary with types of amenorrhea. High IR-inhibin levels in PCOD patients suggest that inhibin plays a part in the discordant gonadotropin secretion in these patients.

Abstract. Changes in serum immunoreactive (IR)-inhibin were measured by RIA in two studies, in order to elucidate, firstly whether the pattern of IR-inhibin secretion is similar to that of estradiol (E2), and secondly, whether inhibin suppresses endogenous FSH release. Study 1: Purified urinary FSH (pFSH) or human menopausal gonadotropin (hMG) were daily injected intramuscularly into women with hypogonadotropic amenorrhea at 12 to 14 week intervals. PFSH and hMG stimulated IR-inhibin release in a similar fashion in the ovulatory cycles, but the increase in estradiol (E2) during pFSH administration was delayed and lower than that during the hMG cycles. This suggests that E2 and IRinhibin are secreted independently from the granulosa cells. Study 2: Ovulation induction was performed in 18 cycles of 9 women with polycystic ovarian disease (PCOD) by the step-down administration of pFSH. The serum FSH concentration in cycles with premature LH release increased even after the dose of pFSH was reduced, and were significantly higher than those of cycles without premature LH release. It was also found that the serum IR-inhibin concentration in cycles with the premature LH release was 2 to 4 times as high as in cycles without premature LH release. This suggests that IR-inhibin does not suppress endogenous FSH release associated with premature LH release.