Comparison of the PANArray HPV Genotyping Chip Test with the Cobas 4800 HPV and Hybrid Capture 2 Tests for Detection of HPV in ASCUS Women

PURPOSE: This study aimed to evaluate the performance of the PANArray human papilloma virus (HPV) test, a PCR-based DNA microarray assay, in detecting HPV from patient samples and its concordance with the cobas 4800 HPV and Hybrid Capture 2 (HC2) tests. MATERIALS AND METHODS: The PANArray HPV, cobas 4800 HPV, and HC2 tests were performed on 504 cervical swab samples from patients with atypical cells of undetermined significance at five hospitals. The samples that were interpreted as ‘HPV-other’ type positive in the PANArray HPV test were confirmed by direct sequencing. RESULTS: The concordance rates were 80.8% between the cobas 4800 HPV and PANArray HPV tests [κ=0.59, 95% confidence interval (CI) 0.52–0.66] and 80.2% (κ=0.6, 95% CI 0.55–0.68) between the HC2 and PANArray HPV tests. Among the 62 patients negative on PANArray HPV (defined as the absence of high risk HPV), but positive on both cobas 4800 HPV and HC2 tests, 42 (67.7%) tested positive for ‘HPV-other’ types on the PANArray HPV test, and 31 (50.0%) had gray zone results [relative light unit/control (RLU/CO), 1.4–9.25] in the HC2 test. Of the patients deemed positive by the PANArray HPV test, 43 tested positive for high-risk (HR) HPV in cobas 4800 HPV and HC 2 tests. Among them, 58.2% showed HR HPV, including HPV 16, by direct sequencing, of which 25% had gray results. CONCLUSION: Results classified as ‘HPV-other’ type by the PANArray HPV test, or gray zone results by HC2 (RLU/CO ratio level 1–10) should be carefully interpreted using comprehensive clinical information.

The efficacy of HPV DNA chip test in the atypical squamous cell of undetermined significance / 부인종양

OBJECTIVE: This study was performed to investigate the efficacy of DNA chip method for detecting and genotyping of human papillomavirus (HPV) and screening of high-grade CIN (cervical intraepithelial neoplasia) or invasive cancer in the patients with atypical squamous cells of undetermined significance (ASC-US). METHODS: This study was based on 131 cases to be revealed ASC-US by Pap smear for the cervical cancer screening from July 2004 to Octorber 2004. They were evaluated by HPV DNA chip test, Cervical colposcopy and directed biopsy, and cone biopsy. The results of type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 54, 56, 58, 59, 66 and 68 in HPV DNA chip test were categorized as high risk HPV. We evaluate the detection rate of the high-grade CIN and invasive cancer by HPV DNA chip test. RESULTS: The incidence of high risk HPV DNA was 51.1% (67/131). Twelve of 131 (9.2%) were diagnosed as high-grade CIN or CIS on histology. The detection rate of high risk HPV DNA in high-grade CIN and invasive cancer was 83.3% (10/12). The detection rate of high risk HPV DNA was 36.0% (31/86) in normal or reactive, and 83.3% (10/12) in CIN II or above on histology. Higher the grade of biopsy, more the detection rate of high risk HPV DNA by HPV DNA chip test. CONCLUSION: The use of HPV DNA chip test in patients with ASC-US may be useful in detection of high-grade CIN or invasive cancer.

Chromosomal Abnormality of Spontaneous Abortus in Relation to Transvaginal Ultrasonographic Finding / 대한산부인과학회잡지

OBJECTIVE: To determine the clinical value of human papillomavirus deoxyribonucleic acid(HPV DNA) testing by polymerase chain reaction(PCR), specifically to examine whether HPV testing could identify the women with Pap smears read as mostly atypical squamous cells of undetermined significance(ASCUS) or more. METHODS: HPV DNA testing by PCR for 3 high-risk cancer associated genotypes(HPV 16, 18, 33), repeat Pap smears and colposcopically directed punch biopsies were performed concurrently on 169 women referred for cervical cancer screening test with a previous Pap smear read as ASCUS or more. RESULTS: HPV DNA testing positivity was significantly associated with abnormal cytology and high-grade squamous intraepithelial lesion(HSIL) and squamous cell carcinoma(SCC) in histology(P=0.034). The sensitivity, specificity, positive predictive value(PPV), negative predictive value(NPV) of Pap smear and HPV testing for identifying 38 cases of histologically confirmed HSIL and carcinoma by different triage protocols(HPV positive or HSIL or SCC) among 169 women were 65.8%(25/38), 85.5%(112/131), 56.8%(25/44) and 89.6%(112/125), respectively. Also sensitivity, specificity, PPV and NPV were varied by ages and more higher in older. CONCLUSION: HPV DNA testing by PCR appears to offer an effective means by which women whose cervical Pap smears have been read as ASCUS or more could be triaged for colposcopically directed biopsy. The sensitivity for HSIL could be maintained in high and specificity markedly improved by HPV genotypes 16, 18, 33.

Comparison of Qualified Diagnosis of "Atypical Squamous Cells of Undetermined Significance" with Subsequent Biopsy / 대한세포병리학회지

To evaluate whether different qualifications of a cytologic diagnosis of "atypical squamous cells of undetermined significance(ASCUS)" predict a greater or lesser likelihood of tissue diagnosis of uterine cervix, we compared different cytologic qualifications of ASCUS with the tissue diagnosis. One hundred twenty-two con secutive Papanicolaou smears showing ASCUS in women who had undergone cervical biopsy within nearest 30 days were collected. The 122 smears were qualified as "favor reactive"(25%), "favor low grade squamous intraepithelial lesion (LSIL)"(24%), "favor squamous intraepithelial lesion(SIL)"(16%), "favor high grade squa mous intraepithelial lesion(HSIL)"(16%), and "not otherwise specified"(19%). Squamous intraepithelial or invasive lesion was pathologically confirmed by cervical biopsy in 13% of the "favor reactive", 27% in "favor LSIL", 70% in "favor SIL", 75% in "favor HSIL", and 35% in "not otherwise specified" smears. There were significant asso ciations between the favor reactive smear and the benign biopsy finding and between the favor SIL smear and the biopsy showing a squamous intraepithelial or more severe lesion. Nevertheless, most of favor LSIL smears exhibit reactive process in tissue biopsy. Conclusively, qualified ASCUS stratifies women into different risk groups for SIL. The cytopathologist should make the cytologic diagnosis of "ASCUS, favor LSIL" circumspectly.

Histologic and Cytologic Follow-up in Atypical Squamous Cells of Undetermined Significance(ASCUS) on Cervical Smears / 대한세포병리학회지

In 1988, The Bethesda System for reporting cervical and vaginal cytologic diagnoses was introduced and this was revised in 1991. The new diagnostic category "atypical squamous cells of undetermined significance(ASCUS)" introduced by The Bethesda System is an area of controversy about the diagnostic category, clinical significance and appropriate treatment. A retrospective 2 years and 9 months study(April,1994-December,1996) was performed to evaluate the significance of reporting ASCUS on cervical smears. Sixtyseven(1.17%) of 5,730 smears were diagnosed as ASCUS and 21 cases were followed by cervical biopsies and/or endocervical curettages in 4 cases(19%), and repeat cervical smears in 17 cases (81%). Tissue diagnoses were benign in 2 cases and squamous cell carcinoma in situ in 2 cases. Cytologic diagnosis of follow up smear were negative in 14 cases (82.4%) and persistent ASCUS in 3 cases(17.6%).

Two Cases of Neonaal Renal Venous Thrombosis

"To evaluate whether different qualifications of a cytologic diagnosis of atypical squamous cells of undetermined significance (ASCUS) predict a greater or lesser likelihood of tissue diagnosis of uterine cervix, we compared different cytologic qualifications of ASCUS with the tissue diagnosis. One hundred twenty-two con- secutive Papanicolaou smears showing ASCUS in women who had undergone cervical biopsy within nearest 30 days were collected. The 122 smears were qualified as ""favor reactive (25%), favor low grade squamous intraepithelial lesion (LSIL) (24%), favor squamous intraepithelial lesion (SIL) (16%), favor high grade squa- mous intraepithelial lesion (HSIL) (16%), and not otherwise specified (19%). Squamous intraepithelial or invasive lesion was pathologically confirmed by cervical biopsy in 13% of the favor reactive, 27% in favor LSIL, 70% in ""favor SIL, 75% in favor HSIL, and 35% in not otherwise specified smears. There were significant associations between the favor reactive smear and the benign biopsy finding and between the favor SIL smear and the biopsy showing a squamous intraepithelial or more severe lesion. Nevertheless, rnost of favor LSIL smears exhibit reactive process in tissue biopsy. Conclusively, qualified ASCUS stratifies women into different risk groups for SIL. The cytopathologist should make the cytologic diagnosis of ASCUS, favor LSIL circumspectly."