[Show abstract][Hide abstract] ABSTRACT: High-risk human papillomavirus (HR-HPV) DNA detection in cervical cytology samples is useful for primary screening of cervical cancer and for triage of patients with equivocal cytological findings. The GenoFlow HPV array test (GF assay; Diagcor Bioscience Inc., Hong Kong) was recently developed to detect 33 HPV genotypes by a "flowthrough" hybridization technology. In this study, we assessed the analytical sensitivity and reproducibility of the GF assay and compared its genotyping results with those of the Linear Array (LA) assay (Roche Molecular Diagnostics, Indianapolis, IN), using 400 archived liquid-based cytology samples representing the full range of cytology findings. Genotyping findings of the GF and LA assays were concordant or compatible for 93.44% of tested samples, with a good (κ = 0.797) to very good (κ = 0.812) strength of agreement for assay-common and oncogenic HPV types, respectively. The two assays showed good (κ = 0.635) agreement in detecting infections with multiple HPV genotypes. The lowest detection limits of the GF assay for HPV16 and HPV18 were 25 copies and 20 copies, respectively. Repeat testing of 60 samples by use of two different lots of the GF assay revealed no discordant results, suggesting good reproducibility of the assay. Both assays achieved approximately 80% and 100% sensitivity for identifying cases of atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) with subsequent detection of LSIL+ and high-grade squamous intraepithelial lesions or higher (HSIL+) in 2 years, respectively. Among ASC-US samples, the GF assay achieved the highest specificity (23.08%) for indicating subsequent identification of HSIL compared with the LA (19.23%) and Hybrid Capture 2 (HC2) (8.97%) assays. The GF and LA assays showed significant discrepancy in detecting HPV genotypes 11, 26, 39, 52, and 66. More sensitive detection of HPV52 by GF assay offers an advantage in regions where HPV52 is more prevalent. The sensitivity of the GF assay for detecting patients with HSIL+ was noninferior to that of the LA assay.
Journal of clinical microbiology 02/2012; 50(5):1691-7. · 4.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Abbott RealTime High Risk HPV test is a new qualitative real-time PCR assay for the detection of 14 high risk HPV (HR-HPV) types and specific identification of HPV16 and HPV18. For each new HPV DNA test, it is important to validate its clinical performance using established tests as benchmarks. Hybrid Capture 2 (HC2) is the first USA FDA-approved HR-HPV DNA test.
To compare the performance of Abbott RealTime High Risk HPV test with that of Hybrid Capture 2 in detecting cytology samples with varying prognosis.
250 liquid-based cervical cytology samples diagnosed of Atypical Squamous cells of Undetermined Significance (ASC-US) collected from an Asian Screening Population were independently tested with both Abbott RealTime High Risk HPV test and HC2. Their utility in predicting disease progression was evaluated in 82 of the samples for which follow up cytology or colposcropic histology data was available.
Good to excellent agreement between the two tests was demonstrated (Kappa=0.800, 95% CI: 0.726-0.874). The sensitivity, specificity, positive (PPV) and negative predictive values (NPV) of the two tests in detecting cases with underlying HSIL/CIN2+ were evaluated (Abbott: 100%, 20.83%, 14.93% and 100% respectively; HC2: 100%, 12.50%, 13.70% and 100% respectively). HPV16/18 genotyping provided by the Abbott test enhanced specific identification of cases with LSIL/CIN1+ (specificity 91.30%, PPV 84.62%) and HSIL/CIN2+ (specificity 86.11%, PPV 23.08%) at follow-up.
The Abbott test performed similarly to HC2 and is unlikely to be affected by ethnicity. Abbott combined HPV detection and HPV 16/18 genotyping is found to provide enhanced sensitivity and specificity for triage of ASC-US.
Journal of clinical virology: the official publication of the Pan American Society for Clinical Virology 06/2011; 51(2):136-8. · 3.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The objective of the study was to determine the prevalence and clinical significance of atypical glandular cells (AGC) or atypical glandular cells of undetermined significance (AGUS) diagnosed in pregnant and postpartum women.
Smears having a diagnosis of AGC or AGUS, taken from pregnant and postpartum (within six weeks after delivery) women between 1995 and 2008 were reviewed and subclassified according to the Bethesda 2001 classification. Case records were then reviewed and a second cytology review was performed after disclosure of the follow-up data.
Among 91,133 smears taken from pregnant and postpartum women, 70 had AGC or AGUS (0.07%) diagnosed. Follow-up data were available in 40 cases, with mean duration of follow-up being 43 months. Among the 40 patients with follow-up data, nineteen had smears with coexisting squamous abnormalities. Thirty patients had positive pathology, including 18 (45%) cervical intraepithelial neoplasia III (CIN III), four (10%) cervical adenocarcinoma-in situ, three (7.5%) squamous cell carcinoma of cervix, four (10%) condylomas and one (2.5%) hydatidiform mole. On review, 24 out of 32 smears with AGC 'not otherwise specified' ('NOS') had significant pathology.
AGC found on cervical smears during pregnancy and the postpartum period is uncommon. The chance of having significant cervical pathology, however, is high and colposcopy should be performed.
European journal of obstetrics, gynecology, and reproductive biology 01/2011; 155(2):213-6. · 1.97 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: P63 and p73 are two homologues of the important tumor suppressor gene p53. In this study, we investigated p63 and p73 expression by immunocytochemistry using antibodies for TAp73 and p634A4 isoforms in 91 high-grade and 107 low-grade squamous intraepithelial lesions, 212 atypical squamous cells of undetermined significance, 9 squamous cell carcinomas and 63 normal samples from an Asian screening population together with 47 hospital samples of carcinomas. There was significant correlation between the TAp73 and p634A4 indices (P<0.0001). Significantly, higher TAp73 and p634A4 indices were found in high-grade lesions or carcinoma when compared with atypical squamous cells and low-grade lesions (P<0.0001). Among atypical squamous cells, p634A4 indices of cases that subsequently progressed to low-grade (P=0.031) or high-grade lesions (P=0.006) were significantly higher than those that did not. For atypical squamous cells positive for high-risk human papillomavirus (HPV) as detected by Digene (61%), cases with high p634A4 index were still more likely to have subsequent high-grade lesions detected (P=0.016). Among low-grade lesions, significantly higher TAp73 (P=0.038) was found in cases that subsequently progressed to high-grade lesions. There was significant correlation between presence of high-risk HPV and p634A4 index (P=0.01). In summary, p63 and p73 immunocytochemistry are potential good markers for detection of carcinoma and high-grade lesions in cervical cytology samples and for triage management of women with atypical squamous cells and low-grade lesions.
Modern Pathology 04/2010; 23(4):559-66. · 5.25 Impact Factor