Age-stratified performance of the Cervista HPV 16/18 genotyping test in women with ASC-US cytology.

BACKGROUND: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age. METHODS: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined. RESULTS: The prevalence of cervical intraepithelial neoplasia (CIN) 2(+) in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women ≥30 years. CONCLUSIONS: The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata. IMPACT: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.

Clinical validation of the Cervista HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology.

OBJECTIVE: High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens. METHODS: The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel. RESULTS: There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8% (95% confidence interval [CI]: 84.1-96.9) and the negative predictive value (NPV) was 99.1% (95% CI: 98.1-99.6). Sensitivity for detection of > or =CIN 3 in women with ASC-US was 100% (95% CI: 85.1-100) and the NPV was 100% (95% CI: 99.4-100). The specificity of the test for detection of > or =CIN 2 and > or =CIN 3 was 44.2% (95% CI: 41.5-46.9) and 43% (95% CI: 40.3-45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV. CONCLUSION: The Cervista HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.

A cross-sectional study of a prototype carcinogenic human papillomavirus E6/E7 messenger RNA assay for detection of cervical precancer and cancer.

PURPOSE: To evaluate carcinogenic human papillomavirus (HPV) mRNA for E6 and E7 mRNA detection on clinical specimens to identify women with cervical precancer and cancer. EXPERIMENTAL DESIGN: We evaluated a prototype assay that collectively detects oncogenes E6/E7 mRNA for 14 carcinogenic HPV genotypes on a sample of liquid cytology specimens (n=531), masked to clinical data and to the presence of HPV genotypes detected by PGMY09/11 L1 consensus primer PCR assay. RESULTS: We found an increasing likelihood of testing positive for carcinogenic HPV E6/E7 mRNA with increasing severity of cytology (P(Trend) < 0.0001) and histology (P(Trend) < 0.0001), with 94% of cervical intraepithelial neoplasia grade 3 (CIN3) histology cases (46 of 49) and all five cancer cases testing positive for carcinogenic HPV E6/E7 mRNA. Overall, fewer specimens tested positive for carcinogenic HPV E6/E7 mRNA than for carcinogenic HPV DNA (P<0.0001, McNemar's chi(2) test), especially in women with

Mouthwash as a low-cost and safe specimen transport medium for human papillomavirus DNA testing of cervicovaginal specimens.

The usefulness of mouthwash as a transport medium for cervical specimens for carcinogenic human papillomavirus (HPV) DNA testing has not been evaluated. Two cervical specimens were collected from each of 34 patients, with one placed in mouthwash (Scope, Proctor and Gamble, Inc.) and the other in a liquid cytology medium commonly used for HPV DNA testing in alternating order. Paired specimens were tested by a PCR assay for carcinogenic HPV and a PCR HPV genotyping assay for 37 HPV types at 0, 3, and 6 weeks after collection; the results of the HPV genotyping assay were categorized into HPV risk groups according to cancer risk (HPV-16 > HPV-18 > other carcinogenic HPV types > noncarcinogenic HPV types > negative). After 4 months of storage, specimens were tested using a second, non-PCR test for carcinogenic HPV. We observed a >or=94% total agreement and kappa values of >or=0.88 between media at each time point for PCR-detected carcinogenic HPV. We observed a >or=74% total agreement, >or=0.62 unweighted kappa, and >or=0.75 linearly weighted kappa between media at each time point for PCR-detected HPV cancer risk category. Finally, we observed an 88% total agreement and kappa of 0.77 between media for carcinogenic HPV detection using a second test after 4 months of storage. We suggest that mouthwash might be used as a low-cost, safe, nonflammable storage and transport medium for cervical specimens for HPV DNA testing in cervical cancer screening programs.

Conceptualizing the Influence of Social Agents of Behavior Change: A Meta-Analysis of the Effectiveness of HIV-Prevention Interventionists for Different Groups.

A meta-analysis of 166 HIV-prevention interventions tested theoretical predictions about the effects of experts, lay community members, and similar and dissimilar others, as agents of change. In general, expert interventionists produced greater behavior change than lay community members, and the demographic and behavioral similarity between the interventionist and the recipients facilitated behavioral change. Equally importantly, there were differences across groups in the efficacy of various sources, especially among populations of low status and/or power. These findings support the hypothesis that unempowered populations are more sensitive to characteristics of the interventionists who can facilitate access to various resources. In addition, they suggest the need to ensure the availability of health professionals from diverse demographic and behavioral backgrounds.

The role of defensive confidence in preference for proattitudinal information: how believing that one is strong can sometimes be a defensive weakness.

This series of studies identified individuals who chronically believe that they can successfully defend their attitudes from external attack and investigated the consequences of this individual difference for selective exposure to attitude-incongruent information and, ultimately, attitude change. Studies 1 and 2 validated a measure of defensive confidence as an individual difference that is unidimensional, distinct from other personality measures, reliable over a 2-week interval, and organized as a trait that generalizes across various personal and social issues. Studies 3 and 4 provided evidence that defensive confidence decreases preference for proattitudinal information, therefore inducing greater reception of counterattitudinal materials. Study 5 demonstrated that people who are high in defensive confidence are more likely to change their attitudes as a result of exposure to counterattitudinal information and examined the perceptions that mediate this important phenomenon.

Development of gastrointestinal function: risk factors for necrotizing enterocolitis.

The intestinal tract of the fetus matures rapidly in the third trimester of the pregnancy. The premature infant has decreased intestinal motility, limited digestion, absorption and excretion, and poor intestinal barrier defense. These limitations place the infant at high risk for acute intestinal injury, necrotizing enterocolitis. This article reviews the development of the gastrointestinal tract in the fetus, the barriers to feeding the high risk, premature infant, and the most serious intestinal disease, necrotizing enterocolitis.

Persuasive communications to change actions: an analysis of behavioral and cognitive impact in HIV prevention.

This meta-analysis examined the validity of various theoretical assumptions about cognitive and behavioral change following a communication recommending condom use. The synthesis comprised 82 treatment and 29 control groups included in 46 longitudinal reports with measures of perceived severity and susceptibility, attitudes and expectancies, norms, perceptions of control, intentions, knowledge, behavioral skills, or condom use. Results indicated that across the sample of studies, communications taught recipients about facts related to HIV and also induced favorable attitudes and expectancies, greater control perceptions, and stronger intentions to use condoms in the future. Moreover, messages that presented attitudinal information and modeled behavioral skills led to increased condom use. Results are discussed in the context of theories of human behavior and change and in reference to HIV-prevention interventions.

Systematic steps to diminish multi-fold medication errors in neonates.

Tenfold and other multiple-of-dose errors are particularly common in the neonatal intensive care unit (NICU), where the fragility of the patients increases the potential for significant adverse outcomes. Such errors can originate at any of the sequential phases of the process, from medication ordering to administration. Each step of calculation, prescription writing, transcription, dose preparation, and administration is an opportunity for generating and preventing medication errors. A few simple principles and practical tips aimed at avoiding decimal and other multiple-dosing errors can be systematically implemented through the various steps of the process. The authors describe their experience with the implementation of techniques for error reduction in a NICU setting. The techniques described herein rely on simple, inexpensive technologies for information and automation, and on standardization and simplification of processes. They can be immediately adapted and applied in virtually any NICU and could be integrated into the development of computerized order entry systems appropriate to NICU settings. Either way, they should decrease the likelihood of undetected human error.