Effect of estradiol vaginal gel on vaginal atrophy in postmenopausal women: A randomized double-blind controlled trial.

AIM: To evaluate the efficacy and safety of 25 µg of estradiol gel on postmenopausal vaginal tissue. METHODS: This randomized double-blind controlled trial included postmenopausal women with vaginal atrophy who attended our menopause clinic during July 2017-January 2018. Women were randomly assigned to the estradiol gel group or control group (K-Y® Jelly). Treatment consisted of 2 mL of product applied intravaginally daily for 2 weeks, and two doses per week for the next 6 weeks. The most bothersome symptom (MBS), vaginal health index (VHI), vaginal pH, vaginal maturation index, vaginal maturation value (VMV), female sexual function index (FSFI), serum estradiol level and endometrial thickness were evaluated at baseline, 4 and 8 weeks. RESULTS: Seventy-five of 80 women completed the trial. After 8 weeks of treatment, VMV, VHI, vaginal pH and FSFI improved significantly in the estradiol group, with no observed change in the control group. The MBS was decreased in both groups with no significant difference between groups. Serum estradiol level and endometrial thickness were not significantly different between groups at baseline or at week 8. CONCLUSION: Estradiol vaginal gel demonstrated an ability to reverse vaginal atrophy with a high safety profile and low systemic absorption of estradiol.

Comparison of Siriraj liquid-based solution and standard transport media for the detection of high-risk human papillomavirus in cervical specimens.

PURPOSE: To evaluate the performance of Siriraj liquid-based solution for human papillomavirus (HPV) DNA testing compared with standard transport media. METHODS: This cross-sectional study enrolled 217 women aged 30 years or older who attended for cervical cancer screening or had abnormal cervical cytology, or were diagnosed with cervical cancer at the Department of Obstetrics-Gynecology, Siriraj Hospital from March 2015 to January 2016. We excluded patients with a history of any cervical procedures, hysterectomy, or previous treatment with pelvic irradiation or chemotherapy. Two cervical specimens were collected from each participant. The standard Cervi-Collect Specimen Collection Kit was used to preserve the first sample, and Siriraj liquid-based solution was used for the second one. All samples were sent for HPV DNA testing using the same standard high-risk HPV assay. HPV test results were recorded and statistically analyzed. RESULTS: The results showed agreement between standard transport media and Siriraj liquid-based solution for HPV DNA testing, at a kappa value of 0.935 (P < 0.001). We found no discorrelation for the detection of HPV 16, which accounts for approximately 50% of cervical cancers. The relative sensitivity of Siriraj liquid-based solution and standard transport media in patients with high-grade cervical intraepithelial neoplasia or worse (CIN2+) is 98% (50/51). The relative specificity of Siriraj liquid-based solution and standard transport media in patients with non-CIN2+ is 98.1% (102/104). CONCLUSION: Siriraj liquid-based solution showed almost perfect agreement with the standard transport media for HPV DNA testing. This solution, costing 2 to 3 times less than the commercially available standard media, may be an alternative option for HPV DNA testing.

Paper-based immunosensor with signal amplification by enzyme-labeled anti-p16INK4a multifunctionalized gold nanoparticles for cervical cancer screening.

The aim of this study was to develop a paper-based immunosensor for cervical cancer screening, with signal amplification by multifunctionalized gold nanoparticles (AuNPs). The AuNPs were functionalized with a highly specific antibody to the p16INK4a cancer biomarker. The signal was amplified using a combination of the peroxidase activity of horseradish peroxidase (HRP) enzyme-antibody conjugate and the peroxidase-like activity of the AuNPs. The immune complex of p16INK4a protein and multifunctionalized AuNPs was deposited on the nitrocellulose membrane, and a positive result was generated by catalytic oxidation of peroxidase enzyme substrate 3,3',5,5'-Tetramethylbenzidine (TMB). The entire reaction occurred on the membrane within 30 min. Evaluation in clinical samples revealed 85.2% accuracy with a kappa coefficient of 0.69. This proof of concept study demonstrates the successful development of a highly accurate, paper-based immunosensor that is easy to interpret using the naked eye and that is suitable for cervical cancer screening in low-resource settings.

Prevalence of Abnormal Anal Cytology in Women with Abnormal Cervical Cytology.

OBJECTIVE: The aim of this study was to evaluate the prevalence of abnormal anal cytology in women presenting with abnormal cervical cytology (intraepithelial lesion or cervical cancer) at the largest tertiary university hospital in Thailand. METHODS: A cross-sectional prospective study design was used. Anal cytology was performed on 145 women with abnormal cervical cytology between June 2014-Octoble 2014. If abnormal anal cytology was detected, anoscopy was performed with biopsy in any suspicious area of precancerous change. RESULTS: Prevalence of abnormal anal cytology was 5.5% (8 patients). Of 8 patients, six patients presented with low-grade squamous intraepithelial lesion, one patient with high-grade squamous intraepithelial lesion, and one with atypical squamous cell cannot exclude high-grade squamous intraepithelial lesion. Abnormal anoscopic impression was found in 3 cases, as follow: The first case showed faint acetowhite lesion and anoscopic impression was low grade squamous intraepithelial lesion; the second case was reported as human papillomavirus (HPV) change by anoscopic impression; and the third case showed dense acetowhite lesion with multiple punctation and pathologic examination showed anal intraepithelial neoplasm III (AIN3). The last patient underwent wide local excision of AIN3 with split-thickness skin graft reconstruction. Final pathology confirmed AIN3 with free resection margin. CONCLUSION: Prevalence of abnormal anal cytology was 5.5%  in patients with abnormal cervical cytology. The prevalence might be support anal cytology screening in this group of patients.

Vaginal atrophy and sexual dysfunction in current users of systemic postmenopausal hormone therapy.

OBJECTIVE: To determine the prevalence of vaginal atrophy and sexual dysfunction in current users of systemic postmenopausal hormone therapy (pHT). MATERIAL AND METHOD: A cross-sectional study was conducted in 97 current users of pHT at Siriraj Menopause Clinic from 2005 to 2007. Subjective symptoms of vaginal atrophy and sexual dysfunction were assessed by interviewing. Objective signs of vaginal atrophy were assessed using pelvic examination, vaginal pH, and maturation value (MV). RESULTS: The prevalence of vaginal atrophy in current users of systemic pHT determining from patient's symptoms, pelvic examination, vaginal pH, and MV were 44.3%, 15.5%, 21.6% and 8.8%, respectively. The prevalence of sexual dysfunction varied from 48.7% to 71.6% depending on types of dysfunction. There was poor association between the subjective symptoms and signs, and the objective indicators of vaginal atrophy. Among various regimens of pHT, tibolone had the lowest prevalence of subjective atrophic symptoms; estrogen-only pHT had the lowest prevalence of objective atrophic signs; and raloxifene had the highest prevalence of atrophic symptoms and signs, and sexual dysfunction. There was statistically significant association between regimens of pHT and objective indicators for vaginal atrophy (p = 0.004 for pH, and 0.000 for MV). CONCLUSION: Current users of systemic pHT still have vaginal atrophy and sexual dysfunction which relates to regimens of pHT. The prevalence of vaginal atrophy varies depending on the assessment methods. The subjective method gives higher prevalence than the objective one does. Since the subjective symptoms of vaginal atrophy would have more adverse effect on quality of life than the objective signs do, the authors suggest that patients' complaints be used to assess factors affecting vaginal atrophy in further research.

Digital Cervicography by Simply Portable Device as an Alternative Test for Cervical Cancer Screening in Rural Area of Thailand

Objective: Various screening methods for cervical cancer are proved to be effective in reducing such type of cancer. We aims to introduce a new portable device as an alternative method for cervical cancer screening. The performance of device was tested on the assessment of cervical lesions using cervicograph score with the cervical cytology. Methods: 325 non-pregnant women were tested from March 2013 to August 2015. The cervical and vaginal cells from the sample were collected for cytology, then all of them received the digital cervicography conducted with our new device and scored using cervicograph score. Small pieces of cervical tissues were also collected for histologic examination. SPSS software version 18.0 was used for the statistical analysis. Results: We grouped cytology results and cervicograph scores to 2 subgroups, ≤ ASC-US and ≥ LSIL, and 0-3 points and 4-6 points, respectively. The data then correlated with histology results which sub-grouped to ≤ CIN 1 and ≥ CIN 2. The accuracy, sensitivity, specificity, and positive predictive value (PPV) of cervicograph scores 4-6 points to detect CIN 2+ were 92%, 72.41%, 97%, and 84%, respectively which were not inferior to Pap smear did. Conclusion: The digital cervicography device provides similar accuracy to Pap cytology screening and is suitable to use in the area that lacks cytoscreeners. Large scale use and generalization are required for this new device

Identification of reference genes for circulating long noncoding RNA analysis in serum of cervical cancer patients.

Circulating lncRNAs have attracted considerable attention as potential noninvasive biomarkers for diagnosing cancers. RT-qPCR is the canonical technique for detecting circulating RNA and depends largely on stable reference genes for data normalization. However, no systematic evaluation of reference genes for serum lncRNA has been reported for cervical cancer. Here, we profiled and validated lncRNA expression from serum of cervical cancer patients and controls using microarrays and RT-qPCR. We identified lncRNA RP11-204K16.1, XLOC_012542, and U6 small nuclear RNA as the most stable reference genes based on geNorm, NormFinder, BestKeeper, delta Ct, and RefFinder. These genes were suitable also for samples from different age groups or with hemolysis. Additionally, we discovered lncRNA AC017078.1 and XLOC_011152 as candidate biomarkers, whose expression was down-regulated in cervical cancer. Our findings could aid research on circulating lncRNA and the discovery of blood-based biomarkers for cervical cancer diagnosis.

Benefits of Cervical Cancer Screening by Liquid-Based Cytology as Part of Routine Antenatal Assessment.

PURPOSE: To determine the prevalence of abnormal cervical cytology, as diagnosed using a liquid-based cytology technique, in pregnant women attending the Antenatal Care (ANC) clinic at Siriraj Hospital. MATERIALS AND METHODS: This cross-sectional study included 655 first-visit pregnant women who attended ANC clinic at Siriraj Hospital during June to November 2015 study period. After receiving routine antenatal care, cervical cytology screening was performed with the Siriraj liquid-based cytology technique. All specimens were reviewed by a certi ed cytopathologist using Bethesda System 2001 criteria. Patients with abnormal PAP results characterized as epithelial cell abnormalities were referred to a gynecologic oncologist for further management according to ASCCP Guidelines 2012. RESULTS: Mean age of participants was 28.9±6.2 years. Prevalence of abnormal cervical cytology was 3.4% (95% CI: 2.0-4.7). Among this group, there were ASC-US, ASC-H, LSIL, HSIL for 12(1.8%), 2(0.3%), 7(1.1%) and 1(0.2%), respectively. In 633 specimens of the normal group, infection was identified in 158 specimens (24.1%) which were caused by Candida spp. and Trichomonas vaginalis. Regarding patient perception about the importance of cervical cancer screening, although most women perceived screening to be important, 54% of participants had never been screened for cervical cancer. Rate of loss to follow-up in the postpartum period was as high as 41.8%. CONCLUSIONS: Prevalence of abnormal cervical cytology in pregnant women attending the ANC clinic at Siriraj Hospital was 3.4%. Inclusion of cervical cancer screening as part of antenatal assessment can help to identify precancerous lesions or cervical cancers in patients who might otherwise not be screened, thereby facilitating early treatment and improved patient outcomes.

Ultrasensitive electrochemical immunosensor based on dual signal amplification process for p16(INK4a) cervical cancer detection in clinical samples.

The p16(INK4a) (p16) is a cyclin-dependent kinase inhibitor, which has been evaluated in several studies as a diagnostic marker of cervical cancer. Immunostaining using p16 specific antibody has confirmed an over-expression of p16 protein in cervical cancer cells and its association with disease progression. This article reports an ultrasensitive electrochemical immunosensor for specific detection of p16 and demonstrates its performance for detection of solubilized p16 protein in cell lysates obtained from patients. Sandwich-based immunoreaction couple with double signal amplification strategy based on catalytic enlargement of particle tag was used for high sensitivity and specificity. The conditions were optimized to create an immunoassay protocol. Disposable screen-printed electrode modified with capture antibodies (Ab1) was selected for further implementation towards point-of-care diagnostics. Small gold nanoparticles (15 nm diameter) conjugated with detection antibodies (Ab2) were found to better serve as a detection label due to limited interference with antigen-antibody interaction. Double signal enhancement was performed by sequential depositions of gold and silver layers. This gave the sensitivity of 1.78 µA mL(ng GST-p16)(-1) cm(-2) and detection limit of 1.3 ng mL(-1) for GST-p16 protein which is equivalent to 0.49 ng mL(-1) for p16 protein and 28 cells for HeLa cervical cancer cells. In addition to purified protein, the proposed immunosensor effectively detected elevated p16 level in cervical swab samples obtained from 10 patients with positive result from standard Pap smear test, indicating that an electrochemical immunosensors hold an excellent promise for detection of cervical cancer in clinical setting.

Long term outcomes of laser conization for high grade cervical intraepithelial neoplasia in Thai women.

AIM: To report long term outcomes of laser conization for high grade cervical intraepithelial neoplasia (CIN) in Thai women. MATERIALS AND METHODS: A retrospective cohort study was conducted in patients undergoing laser conization due to abnormal cervical cytology suggesting neoplasia during 1989 to 1994 and having follow-up data until December 2010. Conization was performed under colposcopy using a 0.5-mm CO2 laser beam with power density of 18,000-20,000 watts/cm2, and the surgical base was vaporized using a low power defocused beam. The follow-up protocol included cervical cytology and colposcopy. Long term outcome measures were failure rate (persistence and recurrence), post-conization status of transformation zone, and obstetric outcomes. RESULTS: Of 104 patients undergoing conization, 71 had therapeutic conization for high grade CIN and were followed up for a median time of 115 (range 12-260) months. There was one case of persistent and one of recurrent disease comprising a failure rate of 2.8%. The post treatment transformation zone was well visualized in 68.3% of 63 patients with an intact uterus. Sixteen patients achieved 25 pregnancies; none had second trimester miscarriage. The obstetric outcomes were unremarkable. CONCLUSIONS: Laser conization under colposcopic visualization for the treatment of high grade CIN in Thai women has a low failure rate of 2.8%. The post-conization transformation zone could not be evaluated completely in approximately 30% of cases; therefore the follow-up protocol should include both cytology and colposcopy. Obstetric outcomes are not adversely affected by this therapeutic procedure.

Agreement between colposcopic diagnosis and cervical pathology: Siriraj hospital experience.

AIM: To evaluate the agreement between colposcopic diagnosis and cervical pathology a retrospective chart review was performed. MATERIALS AND METHODS: This study included 437 patients who underwent colposcopy and cervical biopsy or conization at Siriraj Hospital from October 2010 - December 2012. The patient clinical characteristics, cervical cytology results, colposcopic diagnoses, cervical pathology results were recorded and correlations between variables were analyzed. RESULTS: Agreement of colposcopic diagnosis and cervical pathology was matched in 253 patients (57.9%). The strength of agreement with weighted Kappa statistic was 0.494 (p<0.001). Colposcopic diagnoses more often overestimated (31.1%) than underestimated (11%) the cervical pathology. Agreement of colposcopic diagnosis and cervical pathology within 1 grade was found in 411 patients (94.1%). Positive predictive value (PPV) of high grade colposcopy or more was 75.5%, whereas the negative predictive value (NPV) of insignificant and low grade colposcopy was 83.8%. False positives of high grade colposcopy or more were 21%. False negatives of insignificant or low grade colposcopy were 19.1%. CONCLUSIONS: Strength of agreement between colposcopic diagnosis and cervical pathology was found to be only moderate. A biopsy at colposcopy should be performed at a gold standard level to detect high grade lesions.

Long-term outcomes of a loop electrosurgical excision procedure for cervical intraepithelial neoplasia in a high incidence country.

AIM: To evaluate the operative, oncologic and obstetric outcomes of the loop electrosurgical excision procedure (LEEP) in cases with cervical neoplasia. MATERIALS AND METHODS: A retrospective cohort study was conducted on patients who were suspected of cervical neoplasia and therefore undergoing LEEP at Siriraj Hospital, Mahidol University, Thailand, during 1995-2000. Outcome measures included operative complications in 407 LEEP patients and long-term outcomes in the 248 patients with cervical intraepithelial neoplasia (CIN) who were treated with only LEEP. RESULTS: There were 407 patients undergoing LEEP; their mean age was 39.7±10.5 years. The histopathology of LEEP specimens revealed that 89 patients (21.9%) had lesions ≤CIN I, 295 patients (72.5%) had CIN II or III, and 23 patients (5.6%) had invasive lesions. Operative complications were found in 15 patients and included bleeding (n=9), and infection (n=7). After diagnostic LEEP, 133 patients underwent hysterectomy as the definite treatment for cervical neoplasia. Of 248 CIN patients who had LEEP only, seven (2.8%) had suffered recurrence after a median of 16 (range 6-93) months; one had CIN I, one had CIN II, and five had CIN III. All of these recurrent patients achieved remission on surgical treatment with re-LEEP (n=6) or simple hysterectomy (n=1). A significant factor affecting recurrent disease was the LEEP margin involved with the lesion (p=0.05). Kaplan-Meier analysis showed 5-year and 10-year disease-free survival (DFS) estimates of 99.9%. Twelve patients became pregnant a total of 14 times, resulting in 12 term deliveries and two miscarriages - one of which was due to an incompetent cervix. CONCLUSIONS: LEEP for patients with cervical neoplasia delivers favorable surgical, oncologic and obstetric outcomes.

Performance of Siriraj liquid-based cytology: a single center report concerning over 100,000 samples.

BACKGROUND: To evaluate the performance of Siriraj liquid-based cytology (LBC) for cervical neoplasia screening after increasing use of this technology. MATERIALS AND METHODS: Cytological reports of 103,057 Siriraj-LBC specimens obtained in 2007-2009 were compared with those of 23,676 specimens obtained in 2006. RESULTS: Comparing with the year 2006, the 2007-2009 patients were slightly older (43.4 ± 12.yr vs 42.7 ± 12.2 yr, p <0.001), and their specimens had much lower proportion of unsatisfactory slides (OR=0.06, 95%CI 0.04-0.09) with comparable detection rates (3.96% vs 3.70%, p=0.052) but different proportions of various cytological abnormalities (p<0.001). The 2007-2009 Siriraj-LBC had a negative predictive value (NPV) for cervical intraepithelial neoplasia 2+ (CIN2+) of 97.6% and an overall positive predictive value (PPV) of 43.9%. The PPV for CIN2+ varied with types of abnormal cytology, from 13.7% to 93.8% in atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), atypical squamous cells cannot exclude HSIL (ASC-H), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), to squamous cell carcinoma (SCC), respectively. The PPVs for CIN2+ in ASCUS and LSIL were comparable, but the PPV for CIN1 was higher for LSIL than for ASCUS (41.63% vs 16.32%). CONCLUSIONS: Siriraj-LBC has demonstrated a stable detection rate and NPV for CIN2+ of >95% since the first year of use. The comparable PPVs for CIN2+ of ASCUS and LSIL suggests that these two conditions may undergo similar management; other cytological abnormalities need immediate evaluation.

Factors predicting pathologic significance among women with atypical glandular cells on liquid-based cytology.

OBJECTIVE: To determine incidence, originating organ, and factors predicting significant histopathology (premalignant and malignant lesions) among women with atypical glandular cells (AGCs) on liquid-based cytology (LBC). METHODS: In a retrospective study at Siriraj Hospital, Bangkok, Thailand, clinical and histologic data were reviewed for women with AGCs who underwent appropriate examinations from January 2007 to December 2010. RESULTS: There were 284 women with AGC cytology (mean age, 51.2 years). The incidence of significant pathology and invasive cancer was 43.3% and 34.5%, respectively. The most common malignant organ was the uterus (64/123, 52%). Predictors of serious pathology were AGC favor neoplasia (AGC-FN) endocervical (odds ratio [OR], 5.64; 95% confidence interval [CI], 1.62-19.57), AGC-FN endometrial (OR, 4.11; 95% CI, 1.27-13.32), AGC-FN glandular (OR, 8.23; 95% CI, 2.02-33.49) subtypes, and bleeding (OR, 2.88; 95% CI, 1.47-5.65). Combining patient age and AGC subtype, there were no serious cervical lesions among women aged 50 years or younger with AGC-FN glandular subtype, or serious non-cervical neoplasia among women aged 50 years or younger with AGC not otherwise specified (AGC-NOS) or AGC-FN endocervical subtypes. CONCLUSION: AGC subcategories defined from LBC, alone or combined with patient age, might be predictors of significant histopathology, cancer incidence, and originating organ.

Clinicopathologic importance of women with squamous cell carcinoma cytology on Siriraj liquid-based cervical cytology.

OBJECTIVES: The purposes of this study were to determine the prevalence and predictive value to detect significant neoplasia and invasive lesions, and to evaluate the correlation between clinical and histopathology of women with squamous cell carcinoma (SCCA) on Siriraj liquid-based cervical cytology (Siriraj-LBC). METHODS: The computerized database of women who underwent Siriraj-LBC at Siriraj Hospital, Mahidol University from January 2007 to December 2010 were retrieved. The hospital records of women with SCCA cytology were reviewed. RESULTS: The prevalence of SCCA cytology was 0.07%. A total of 86 women, mean age was 58.1 years. Sixty-one women (70.9%) were post-menopausal. Overall significant pathology and invasive gynecologic cancer were detected in 84 women (97.7%) and 71 women (82.5%), respectively. The positive predictive values for detection of significant neoplasia and invasive lesion were 97.7% and 82.6%, respectively. The cervical cancer was diagnosed in 69 women and among these 58 women were SCCA. Thirteen women (15.1%) had cervical intraepithelial neoplasia (CIN) 3 and two women (2.3%) had cervicitis. The sensitivity and specificity of colposcopy for cervical cancer detection in SCCA cytology were 83.3% and 75%, respectively. Median follow up period was 17.6 months and 64 patients were alive without cytologic abnormality. CONCLUSIONS: The final histopathology of SCCA cytology in our populations demonstrated a wide variety, from cervicitis to invasive cancer and the most common diagnosis was invasive cervical cancer. Colposcopy with biopsy and/or endocervical curettage and loop electrosurgical excision procedure should be undertaken to achieve histologic diagnosis.

Performance and cost analysis of Siriraj liquid-based cytology: a direct-to-vial study.

OBJECTIVE: To compare the cytological diagnoses, specimen adequacy, and cost of the Siriraj liquid-based cytology (LBC) with those of the conventional smear technique. STUDY DESIGN: An observational study with historical comparison was conducted in a tertiary university hospital. Cytological reports of 23,676 Siriraj-LBC specimens obtained in 2006 were compared with those of 25,510 conventional smears obtained in 2004. RESULTS: Overall prevalence of abnormal cervical cytology detected by conventional smear was 1.76% and by Siriraj-LBC was 3.70%. Compared with the conventional method, the Siriraj-LBC yielded a significantly higher overall detection rate of abnormal cervical cytology, with a 110.23% increase in the detection rate (P<0.001), mainly due to the increase in diagnosis of squamous intraepithelial lesions (SIL), both low and high grade, together with atypical squamous cells of undetermined significance, "atypical squamous cells cannot exclude HSIL", and malignancies, but not atypical glandular cells. The Siriraj-LBC had a smaller proportion of unsatisfactory slides (4.94% vs. 18.60%, P<0.001) and a higher negative predictive value (96.33% vs. 92.74%, P=0.001), but no difference in positive predictive value (83.03% vs. 86.83%, P=0.285). The cost of Siriraj-LBC was approximately 67% higher than that of the conventional cytology used in Siriraj Hospital and 50-70% lower than that of the commercially available LBC techniques in Thailand. CONCLUSION: The Siriraj-LBC increases the detection rate of abnormal cytology, improves specimen adequacy, and enhances the negative predictive value without compromising the positive predictive value. For centers where conventional Pap smear does not perform well, the introduction of a low cost Siriraj-LBC might help to improve performance and it may be an economical alternative to the commercially available liquid-based cytology.

Meigs' Syndrome with Elevated Serum CA125: Case Report and Review of the Literature.

An elevated serum CA125 level in association with a pelvic mass, pleural effusion, and massive ascites usually signifies a dismal prognosis in a postmenopausal woman. However, surgery and histopathological examination are required for the correct diagnosis and treatment, since an elevated CA125 level can be falsely positive for ovarian malignancy. We present a case of Meigs' syndrome due to right ovarian fibroma with elevated CA125 level in a postmenopausal woman.

Comparison between Siriraj liquid-based and conventional cytology for detection of abnormal cervicovaginal smears: a split-sample study.

This study aimed to evaluate the correlation and agreement between Siriraj liquid-based cervical cytology (Siriraj -LBC) and conventional cytology. A total of 479 women who attended the Department of Obstetric and Gynaecology Siriraj Hospital for cervical cancer screening were enrolled. For each woman collection of cervical cells was performed using VCE technique. After smearing cells on a glass slide for conventional cytology, both broken ends of wooden spatula and cotton swabs were then placed into a plastic vial containing a specific preservative solution for Siriraj-LBC. All specimens were prepared and interpreted by experienced cytotechnologists at the Gynecologic Cytology Unit. Interpretations of the results from one technique were made without knowledge of those from the other technique. The results from both techniques were compared for agreement and correlation. Colposcopy or histology was used as the gold standard. The overall detection rate of abnormal cervicovaginal cells was higher by Siriraj-LBC than by conventional cytology (11.1% vs. 1.67%, P <0.001). These two techniques had high diagnostic agreement of 89.77%, and minimal to fair correlation with a Kappa of 0.128 (P<0.001) and a Spearman rho correlation coefficient of 0.394 (P <0.001). There were 49 cases whose Siriraj-LBC revealed higher cytologic grading than did the conventional cytology; there were no cases of the opposite result. The gold standard was available in 45 cases with abnormal cytology by Siriraj-LBC, revealing a positive predictive value (PPV) of 71.1% for Siriraj-LBC and 97.8% for conventional cytology, and a negative predictive value (NPV) of 42.2% for the conventional cytology. In conclusion, The results from Siriraj-LBC and conventional cytology have high diagnostic agreement and minimal to fair correlation. The Siriraj-LBC increases detection rate of abnormal cervicovaginal cells with probable decrease in false negatives but increase in false positives from the baseline values by conventional cytology. Therefore the screening performance of Siriraj-LBC is not inferior to the conventional cytology and this approach may be used as an alternative screening method for cervical cancer.