High-risk human papillomavirus (hrHPV) testing is now being introduced as a potential primary screening test for improved detection of cervical precancer and cancer. Current U.S. Food and Drug Administration-approved tests are batch tests that take several hours to complete. A rapid, non-batch test might permit point-of-care (POC) testing, which can facilitate same-day screen and management strategies. For a non-batch, random-access platform (GeneXpert; Cepheid, Sunnyvale, CA), a prototype hrHPV assay (Xpert) has been developed where testing for 14 hrHPV types can be completed in 1 h. In the first clinical evaluation, Xpert was compared to two validated hrHPV tests, the cobas HPV test (cobas, Roche Molecular Systems) and Hybrid Capture 2 (hc2, Qiagen), and to histologic outcomes using specimens from colposcopy referral populations at 7 clinical sites in the United States (n ‫؍‬ 697). The sensitivity of Xpert for cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2؉) (n ‫؍‬ 141) was equal to that of cobas (90.8% versus 90.8%, P ‫؍‬ 1) and greater than that of hc2 (90.8% versus 81.6%, P ‫؍‬ 0.004). Xpert was more specific than cobas (42.6% versus 39.6%, P ‫؍‬ 0.02) and less specific than hc2 (42.6% versus 47.7%, P < 0.001). Similar results were observed for cervical intraepithelial neoplasia grade 3 or higher (CIN3؉) (n ‫؍‬ 91). HPV16 detection by Xpert identified 41.8% of the CIN2؉ specimens with a positive predictive value (PPV) of 54.6%. By comparison, HPV16 detection by cobas identified 42.6% of the CIN2؉ specimens with a PPV of 55.0%. hrHPV detection by the Xpert demonstrated excellent clinical performance for identifying women with CIN2؉ and CIN3؉ that was comparable to that of currently available clinically validated tests.

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The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.

Background Reported US cases of chlamydia and gonorrhea have increased since 2000, whereas studies in select populations suggest that the prevalence of these diseases has decreased. We sought to determine if these diagnoses are increasing among pregnant women delivering at our center. Methods This is a retrospective study of women delivering at least 1 infant >18 weeks of gestation at the Medical University of South Carolina for 11 years (2008–2018). Using the perinatal information system, we collected maternal race, age, insurer, and chlamydia and gonorrhea screening results during the pregnancy of record. Cochran-Armitage trend analyses were performed to evaluate trends in these diagnoses by delivery year for all women and for age/race subgroups. Results During the study period, there were 24,807 deliveries. The median age of women was 28 years (interquartile range, 23–32 years). Five percent (5.0%) of women were diagnosed with chlamydia and 1.2% with gonorrhea. The percent of women diagnosed decreased for both chlamydia (9.6%–3.4%) and gonorrhea (2.5%–1.1%; P < 0.001, trend analyses for both). A higher percentage of Black women had chlamydia and gonorrhea, and both diagnoses declined over time: 17.4% to 6.9% (P < 0.0001) for chlamydia and 5.8% to 2.1% (P < 0.0001) for gonorrhea. In a subanalysis of race and age, Black women younger than 25 years experienced the most significant decline in chlamydia diagnoses (P < 0.0001). Conclusions We observed declining diagnoses of chlamydia and gonorrhea among pregnant women in our center. Although Black women delivering were more likely to have either diagnoses, they experienced a significant decline in both chlamydia and gonorrhea over time.

The purpose of this study was to describe the fetal and newborn safety profile of prolonged indomethacin treatment during pregnancy. A retrospective cohort of 124 pregnant women treated with indomethacin was used to assess the outcomes of oligohydramnios, constriction of the ductus arteriosus, and composite neonatal morbidity. Eight patients (6.5%) developed ductal constriction and nine patients (7.3%) developed oligohydramnios. Composite morbidity occurred in 36 neonates (29%). Ductal constriction, oligohydramnios, and composite morbidity were not associated with duration of therapy, gestational age at start or stop of therapy, time between dosing and delivery, or dose regimen. Prolonged indomethacin therapy rarely is associated with ductal constriction and oligohydramnios.