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1.
MMWR Recomm Rep ; 73(1): 1-32, 2024 02 08.
Article in English | MEDLINE | ID: mdl-38319847

ABSTRACT

This report provides new CDC recommendations for tests that can support a diagnosis of syphilis, including serologic testing and methods for the identification of the causative agent Treponema pallidum. These comprehensive recommendations are the first published by CDC on laboratory testing for syphilis, which has traditionally been based on serologic algorithms to detect a humoral immune response to T. pallidum. These tests can be divided into nontreponemal and treponemal tests depending on whether they detect antibodies that are broadly reactive to lipoidal antigens shared by both host and T. pallidum or antibodies specific to T. pallidum, respectively. Both types of tests must be used in conjunction to help distinguish between an untreated infection or a past infection that has been successfully treated. Newer serologic tests allow for laboratory automation but must be used in an algorithm, which also can involve older manual serologic tests. Direct detection of T. pallidum continues to evolve from microscopic examination of material from lesions for visualization of T. pallidum to molecular detection of the organism. Limited point-of-care tests for syphilis are available in the United States; increased availability of point-of-care tests that are sensitive and specific could facilitate expansion of screening programs and reduce the time from test result to treatment. These recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. Future revisions to these recommendations will be based on new research or technologic advancements for syphilis clinical laboratory science.


Subject(s)
Syphilis , Humans , United States , Syphilis/diagnosis , Syphilis Serodiagnosis/methods , Treponema pallidum , Serologic Tests , Centers for Disease Control and Prevention, U.S.
2.
Int J Cancer ; 152(2): 137-150, 2023 01 15.
Article in English | MEDLINE | ID: mdl-35904861

ABSTRACT

Declines in cervical intraepithelial neoplasia grades 2 to 3 and adenocarcinoma in situ (CIN2+) observed among young women suggest impact from human papillomavirus (HPV) vaccination. To further evaluate vaccine impact including cross-protection and type replacement, we described high-risk (HR)-HPV type-specific cervical precancer incidence rates among women aged 20 to 39 years, 2008 to 2016. We analyzed cross-sectional population-based data on 18 344 cases of CIN2+ from a 5-site surveillance system. Diagnostic specimens were tested for individual HPV types, including 14 HR-HPV types (HPV16/18/31/33/35/39/45/51/52/56/58/59/66/68). We estimated age-specific annual HR-HPV type-specific CIN2+ incidence per 100 000 screened women for individual types, vaccine HR-HPV types (HPV16/18) and nonvaccine HR-HPV types (non-HPV16/18). We evaluated trends using average annual percent changes (AAPC) and 95% confidence intervals (CI), and estimated total declines by comparing 2015-2016 to 2008-2009 using incidence rate ratios. Among 20-24-year-olds, HPV16/18-CIN2+ declined from 2008 through 2016 (AAPC: -21.3%, 95% CI: -28.1%, -13.8%), whereas no trend was observed for non-HPV16/18-CIN2+ (AAPC: -1.8%, 95% CI: -8.1%, 4.9%). After 2010, CIN2+ among 20-24-year-olds was more often caused by nonvaccine vs vaccine HR-HPV types. No significant declining trends were observed in older age groups. In 2015-2016 compared with 2008-2009, HPV16-CIN2+ declined 78%, HPV18-CIN2+ 72% and HPV31-CIN2+ 51% among 20-24-year-olds; no increases were observed in type-specific CIN2+ incidence. Among 25-29-year-olds, HPV16-CIN2+ declined 18%; CIN2+ attributed to seven nonvaccine types increased significantly. No significant declines were observed in older groups. Significant declines in HPV16/18-CIN2+ in 20-24-year-olds and HPV16-CIN2+ in 25-29-year-olds corroborate impact of HPV vaccination. A declining trend in HPV31-CIN2+ is consistent with cross-protection from vaccination.


Subject(s)
Papillomavirus Vaccines , Uterine Cervical Dysplasia , Uterine Cervical Neoplasms , Humans , Female , United States/epidemiology , Aged , Uterine Cervical Neoplasms/pathology , Cross-Sectional Studies , Papillomavirus Vaccines/therapeutic use , Human papillomavirus 16 , Human papillomavirus 31
3.
J Clin Microbiol ; 61(6): e0016823, 2023 06 20.
Article in English | MEDLINE | ID: mdl-37219422

ABSTRACT

Automated nontreponemal rapid plasma reagin (RPR) tests were recently introduced in the United States for syphilis testing and limited performance data are available. In collaboration with the Association of Public Health Laboratories, three public health laboratories (PHL) were chosen through a competitive selection process to evaluate the performance of three FDA-cleared automated RPR test systems: BioPlex 2200 Syphilis Total & RPR assay (Bio-Rad Laboratories), AIX 1000 (Gold Standard Diagnostics), and ASI Evolution (Arlington Scientific). Panels prepared at the CDC included: a qualitative panel comprised of 734 syphilis reactive/nonreactive sera; a quantitative panel of 50 syphilis reactive sera (RPR titer 1:64 to 1:1,024); and a reproducibility panel of 15 nonreactive and reactive sera (RPR titer 1:1 to 1:64). Panels were shipped frozen to the PHL and tested on the automated RPR systems following manufacturers' instructions. Prior test results were blinded to all laboratories. When compared to manual RPR (Arlington Scientific) performed at the CDC as a reference test, the qualitative panel results demonstrated an overall concordance of 95.9% for AIX 1000, 94.6% for ASI Evolution, and 92.6% for Bioplex RPR; quantitative panel showed within range titer of 2-fold for 94% of specimens for AIX 1000, 68% for ASI Evolution, and 64% for BioPlex RPR, and the reproducibility testing panel demonstrated point estimates ranging from 69 to 95%. Automated RPR instruments could reduce turnaround time and minimize interpretation errors. However, additional evaluations with more specimens could assist laboratories with implementing automated RPR tests and understanding their limitations.


Subject(s)
Syphilis , Humans , Syphilis/diagnosis , Reagins , Reproducibility of Results , Antibodies, Bacterial , Syphilis Serodiagnosis/methods , Treponema pallidum
4.
AIDS Behav ; 27(1): 96-105, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35916949

ABSTRACT

Annual screening for bacterial sexually transmitted infections (STI), including gonorrhea/chlamydia (GC/CT) and syphilis, is recommended for persons with HIV (PWH). We used the prevention index to quantify the extent to which STI screening was completed at guideline-recommended frequency in African American and Latinx persons, women, persons with alcohol (AUD) and substance (SUD) use disorders. Data from PWH at Kaiser Permanente Northern California were collected from electronic health records. We defined receipt of GC/CT and syphilis screening consistent with recommendations as a prevention index score ≥ 75%. Among 9655 PWH (17.7% Latinx; 16.2% African American; 9.6% female; 12.4% AUD; 22.1% SUD), prevention index scores for GC/CT and syphilis increased from 2015 to 2019. African American PWH had lower odds of receiving an annual syphilis screen (aOR 0.87 [95% CI 0.79-0.97]). Female sex was associated with lower odds of GC/CT (aOR 0.30 [95% CI 0.27-0.34]) and syphilis (aOR 0.27 [95% CI 0.24-0.310) screening. AUD and SUD were not associated with differences in annual GC/CT or syphilis screening. Key PWH subgroups experience ongoing challenges to annual STI screening despite comparable healthcare access.


Subject(s)
Chlamydia Infections , Gonorrhea , HIV Infections , Sexually Transmitted Diseases , Syphilis , Female , Humans , Male , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Syphilis/complications , Syphilis/diagnosis , Syphilis/epidemiology , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/complications , Gonorrhea/diagnosis , Gonorrhea/epidemiology , Mass Screening , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Prevalence
5.
Sex Transm Dis ; 49(4): 313-317, 2022 04 01.
Article in English | MEDLINE | ID: mdl-35312669

ABSTRACT

BACKGROUND: The National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (NNPTC) trains clinical providers to diagnose and treat sexually transmitted infections (STIs) in the United States. The purpose of this study was to examine the demographics of clinical providers and to correlate the number of training episodes with STI rates at the county level. METHODS: Registration data were collected between April 1, 2015, and March 31, 2020, in a custom Learning Management System from clinical providers taking NNPTC training. Using the 2018 STI surveillance data, counties were divided into quartiles based on reportable STI case rates and the number of county-level training events was compared per quartile. Univariate and multivariate analyses were conducted in IBM SPSS Statistics 23 (Armonk, NY) and SAS Enterprise Guide 7.1 (Cary, NC). RESULTS: From 2015 to 2020, the NNPTC trained 21,327 individuals, predominantly in the nursing professions and working in a public health environment. In multivariate analysis, the number of training events was significantly associated with higher STI rates at the county level (P < 0.0001) and the state where a prevention training center is located (P < 0001). CONCLUSIONS: The analysis suggests that NNPTC trainings are reaching the clinical providers working in geographic areas with higher STI rates.


Subject(s)
Sexually Transmitted Diseases , Humans , Public Health , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Sexually Transmitted Diseases/prevention & control , United States/epidemiology
6.
Sex Transm Dis ; 48(1): e1-e4, 2021 01.
Article in English | MEDLINE | ID: mdl-32649580

ABSTRACT

The national Sexually Transmitted Diseases (STD) Clinical Consultation Network receives requests regarding complex STD cases. A total of 927 requests from Western states, 2017 to 2019, were analyzed for STD of inquiry and syphilis-specific subtopics. Syphilis requests accounted for most queries, and the number and proportion of syphilis-related requests increased significantly over time.


Subject(s)
Sexually Transmitted Diseases , Syphilis , Humans , Referral and Consultation , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Syphilis/diagnosis , Syphilis/epidemiology
7.
Sex Transm Dis ; 48(9): e124-e125, 2021 09 01.
Article in English | MEDLINE | ID: mdl-34110747

ABSTRACT

ABSTRACT: A case of congenital syphilis due to multiple missed opportunities, highlights the challenges of treating syphilis during pregnancy. Although cases are increasing in the United States, congenital syphilis, a disease with devastating consequences, is preventable.


Subject(s)
Pregnancy Complications, Infectious , Syphilis, Congenital , Syphilis , Delivery of Health Care , Female , Humans , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/drug therapy , Prenatal Care , Syphilis/diagnosis , Syphilis/drug therapy , Syphilis, Congenital/diagnosis , Syphilis, Congenital/drug therapy , United States
8.
Sex Transm Dis ; 48(11): e165-e167, 2021 11 01.
Article in English | MEDLINE | ID: mdl-34110752

ABSTRACT

ABSTRACT: We implemented self-collected gonorrhea/chlamydia testing in 17 medical centers in California serving men who have sex with men living with HIV. From 2012 to 2018, gonorrhea/chlamydia testing increased from 45.2% to 63.4%. Among those tested, rectal testing increased from 42.0% to 77.3%; pharyngeal testing increased from 31.0% to 79.9% (all, Ptrend < 0.0001).


Subject(s)
Chlamydia Infections , Chlamydia , Gonorrhea , HIV Infections , Sexual and Gender Minorities , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Gonorrhea/diagnosis , Gonorrhea/epidemiology , HIV Infections/diagnosis , HIV Infections/epidemiology , Homosexuality, Male , Humans , Male
9.
J Low Genit Tract Dis ; 25(3): 192-198, 2021 Jul 01.
Article in English | MEDLINE | ID: mdl-33797511

ABSTRACT

OBJECTIVE: The aim of the study was to describe trends in human papillomavirus (HPV) testing preceding diagnosis of cervical precancer during a time of changing screening recommendations. MATERIALS AND METHODS: We conducted a cross-sectional analysis of data from active, population-based, laboratory surveillance among 1.5 million residents of 5 areas in the United States. We included women aged 21-39 years diagnosed with cervical intraepithelial neoplasia grades 2, 2/3, or 3 or adenocarcinoma in situ (collectively, CIN2+) during 2008-2016, who had a cytology and/or HPV test before diagnosis (n = 16,359). RESULTS: The proportion of women with an HPV test preceding CIN2+ increased from 42.9% in 2008 to 73.3% in 2016 (p < .01); testing increased in all age groups (21-24 y: 35.3% to 47.6%, 25-29 y: 40.9% to 64.1%, 30-39 y: 51.7% to 85.9%, all p < .01). The HPV testing varied by cytology result and was highest among women with atypical squamous cells of unknown significance (n = 4,310/4,629, 93.1%), negative for intraepithelial lesion or malignancy (n = 446/517, 86.3%), and atypical glandular cells (n = 145/257, 56.4%). By 2016, at least half of all cases in every surveillance area had an HPV test before diagnosis. CONCLUSIONS: During 2008-2016, the proportion of women with an HPV test preceding CIN2+ increased significantly for all age groups, cytology results, and surveillance areas. By 2016, most (85.9%) women aged 30-39 years had an HPV test, consistent with recommendations. Increasing utilization of HPV tests, which have demonstrated improved sensitivity for detecting cervical disease, may in part explain increasing rates of cervical precancer among women 30 years and older.


Subject(s)
Papillomavirus Infections/diagnosis , Papillomavirus Infections/epidemiology , Uterine Cervical Dysplasia/epidemiology , Uterine Cervical Dysplasia/pathology , Uterine Cervical Neoplasms , Adenocarcinoma/pathology , Adult , Alphapapillomavirus/isolation & purification , Cross-Sectional Studies , Early Detection of Cancer , Female , Humans , Neoplasm Staging , Precancerous Conditions/pathology , United States/epidemiology , Uterine Cervical Neoplasms/epidemiology , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/virology , Young Adult
10.
Clin Infect Dis ; 71(Suppl 1): S13-S20, 2020 06 24.
Article in English | MEDLINE | ID: mdl-32578866

ABSTRACT

We conducted a systematic review of relevant syphilis diagnostic literature to address the question, "What is the sensitivity and specificity of the treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis (by stage)?" There were 16 treponemal assays evaluated: 13 immunoassays and 3 manual assays (fluorescent treponemal antibody absorbed test [FTA-ABS], microhemagglutination assay for Treponema pallidum antibodies [MHA-TP], Treponema pallidum particle agglutination assay [TP-PA]). MHA-TP and FTA-ABS were less sensitive in primary and secondary syphilis than TP-PA; TP-PA is the most specific manual treponemal assay. There is insufficient evidence to recommend one particular treponemal immunoassay (eg, enzyme immunoassays, chemiluminescence immunoassays, microbead immunoassays) over another based on published performance data. For diagnosis of neurosyphilis, cerebrospinal fluid (CSF) TP-PA has similar performance to CSF FTA-ABS in studies with patients with definitive or presumptive neurosyphilis. However, CSF treponemal testing has limitations in its sensitivity and specificity and should be interpreted within the context of the clinical scenario, additional CSF test results and syphilis prevalence.


Subject(s)
Neurosyphilis , Syphilis , Antibodies, Bacterial , Humans , Sensitivity and Specificity , Syphilis/diagnosis , Syphilis Serodiagnosis , Treponema pallidum
11.
Int J Cancer ; 146(3): 810-818, 2020 02 01.
Article in English | MEDLINE | ID: mdl-30980692

ABSTRACT

Primary prevention through the use of human papillomavirus (HPV) vaccination is expected to impact both cervical intraepithelial neoplasia (CIN) and adenocarcinoma in situ (AIS). While CIN is well described, less is known about the epidemiology of AIS, a rare cervical precancer. We identified AIS and CIN grade 3 (CIN3) cases through population-based surveillance, and analyzed data on HPV types and incidence trends overall, and among women screened for cervical cancer. From 2008 to 2015, 470 AIS and 6,587 CIN3 cases were identified. The median age of women with AIS was older than those with CIN3 (35 vs. 31 years; p < 0.01). HPV16 was the most frequently detected type in both AIS and CIN3 (57% in AIS; 58% in CIN3), whereas HPV18 was the second most common type in AIS and less common in CIN3 (38% vs. 5%; p < 0.01). AIS lesions were more likely than CIN3 lesions to be positive for high-risk types targeted by the bivalent and quadrivalent vaccines (HPV16/18, 92% vs. 63%; p < 0.01), and 9-valent vaccine (HPV16/18/31/33/45/52/58, 95% vs. 87%; p < 0.01). AIS incidence rates decreased significantly in the 21-24 year age group (annual percent change [APC] overall: -22.1%, 95% CI: -33.9 to -8.2; APC among screened: -16.1%, 95% CI: -28.8 to -1.2), but did not decrease significantly in any older age group. This report on the largest number of genotyped AIS cases to date suggests an important opportunity for vaccine prevention of AIS, and is the first to document a decline in AIS incidence rates among young women during the vaccine era.


Subject(s)
Adenocarcinoma in Situ/epidemiology , Human papillomavirus 16/isolation & purification , Human papillomavirus 18/isolation & purification , Papillomavirus Infections/epidemiology , Precancerous Conditions/epidemiology , Uterine Cervical Dysplasia/epidemiology , Adenocarcinoma in Situ/prevention & control , Adenocarcinoma in Situ/virology , Adolescent , Adult , Age Factors , DNA, Viral/isolation & purification , Female , Human papillomavirus 16/genetics , Human papillomavirus 18/genetics , Humans , Incidence , Mass Screening/statistics & numerical data , Papillomavirus Infections/prevention & control , Papillomavirus Infections/virology , Papillomavirus Vaccines/therapeutic use , Precancerous Conditions/prevention & control , Precancerous Conditions/virology , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control , Uterine Cervical Neoplasms/virology , Young Adult , Uterine Cervical Dysplasia/prevention & control , Uterine Cervical Dysplasia/virology
12.
Am J Epidemiol ; 189(4): 265-276, 2020 04 02.
Article in English | MEDLINE | ID: mdl-31680146

ABSTRACT

Before 2016, human papillomavirus (HPV) vaccination was recommended on a 3-dose schedule. However, many vaccine-eligible US females received fewer than 3 doses, which provided an opportunity to evaluate the real-world vaccine effectiveness (VE) of 1, 2, and 3 doses. We analyzed data on cervical intraepithelial neoplasia (CIN) grades 2-3 and adenocarcinoma in situ (designated CIN2+) from the HPV Vaccine Impact Monitoring Project (HPV-IMPACT; 2008-2014). Archived tissue from CIN2+ lesions was tested for 37 types of HPV. Women were classified by number of doses received ≥24 months before CIN2+ detection. Using a test-negative design, VE was estimated as 1 minus the adjusted odds ratio from a logistic regression model that compared vaccination history for women whose lesions tested positive for HPV-16/18 (vaccine-type cases) with that for women who had all other CIN2+ lesions (controls). Among 3,300 women with available data on CIN2+, typing results, and vaccine history, 1,561 (47%) were HPV-16/18-positive, 136 (4%) received 1 dose of HPV vaccine, 108 (3%) received 2 doses, and 325 (10%) received 3 doses. Adjusted odds ratios for vaccination with 1, 2, and 3 doses were 0.53 (95% confidence interval (CI): 0.37, 0.76; VE = 47%), 0.45 (95% CI: 0.30, 0.69; VE = 55%), and 0.26 (95% CI: 0.20, 0.35; VE = 74%), respectively. We found significant VE against vaccine-type CIN2+ after 3 doses of HPV vaccine and lower but significant VE with 1 or 2 doses.


Subject(s)
Adenocarcinoma in Situ/prevention & control , Papillomavirus Vaccines/administration & dosage , Uterine Cervical Dysplasia/prevention & control , Uterine Cervical Neoplasms/prevention & control , Adenocarcinoma in Situ/virology , Adolescent , Adult , Female , Human papillomavirus 16/isolation & purification , Human papillomavirus 18/isolation & purification , Humans , Population Surveillance , Uterine Cervical Neoplasms/virology , Young Adult , Uterine Cervical Dysplasia/virology
13.
Clin Infect Dis ; 68(6): 913-918, 2019 03 05.
Article in English | MEDLINE | ID: mdl-29986091

ABSTRACT

BACKGROUND: Treponemal immunoassays are increasingly used for syphilis screening with the reverse sequence algorithm. There are few data describing performance of treponemal immunoassays compared to traditional treponemal tests in patients with and without syphilis. METHODS: We calculated sensitivity and specificity of 7 treponemal assays: (1) ADVIA Centaur (chemiluminescence immunoassay [CIA]); (2) Bioplex 2200 (microbead immunoassay); (3) fluorescent treponemal antibody absorption test (FTA-ABS); (4) INNO-LIA (line immunoassay); (5) LIAISON CIA; (6) Treponema pallidum particle agglutination assay (TPPA); and (7) Trep-Sure (enzyme immunoassay [EIA]), using a reference standard combining clinical diagnosis and serology results. Sera were collected between May 2012-January 2013. Cases were characterized as: (1) current clinical diagnosis of syphilis: primary, secondary, early latent, late latent; (2) prior treated syphilis only; (3) no evidence of current syphilis, no prior history of syphilis, and at least 4 of 7 treponemal tests negative. RESULTS: Among 959 participants, 262 had current syphilis, 294 had prior syphilis, and 403 did not have syphilis. FTA-ABS was less sensitive for primary syphilis (78.2%) than the immunoassays or TPPA (94.5%-96.4%) (all P ≤ .01). All immunoassays were 100% sensitive for secondary syphilis, 95.2%-100% sensitive for early latent disease, and 86.8%-98.5% sensitive in late latent disease. TPPA had 100% specificity. CONCLUSIONS: Treponemal immunoassays demonstrated excellent sensitivity for secondary, early latent, and seropositive primary syphilis. Sensitivity of FTA-ABS in primary syphilis was poor. Given its high specificity and superior sensitivity, TPPA is preferred to adjudicate discordant results with the reverse sequence algorithm over the FTA-ABS.


Subject(s)
Immunoassay , Syphilis Serodiagnosis , Syphilis/diagnosis , Syphilis/microbiology , Treponema pallidum , Adult , Algorithms , Coinfection , Female , Humans , Immunoassay/methods , Immunoassay/standards , Male , Mass Screening/methods , Middle Aged , Reproducibility of Results , Sensitivity and Specificity , Syphilis/epidemiology , Syphilis Serodiagnosis/methods , Syphilis Serodiagnosis/standards , Treponema pallidum/immunology
14.
Clin Infect Dis ; 68(8): 1282-1291, 2019 04 08.
Article in English | MEDLINE | ID: mdl-30137283

ABSTRACT

BACKGROUND: We describe changes in rates of cervical intraepithelial neoplasia grades 2, 3 and adenocarcinoma in situ (CIN2+) during a period of human papillomavirus (HPV) vaccine uptake and changing cervical cancer screening recommendations. METHODS: We conducted population-based laboratory surveillance for CIN2+ in catchment areas in 5 states, 2008-2015. We calculated age-specific CIN2+ rates per 100000 women by age groups. We estimated incidence rate ratios (IRR) of CIN2+ for 2-year periods among all women and among screened women to evaluate changes over time. RESULTS: A total of 16572 CIN2+ cases were reported. Among women aged 18-20 and 21-24 years, CIN2+ rates declined in all sites, whereas in women aged 25-29, 30-34, and 35-39 years, trends differed across sites. The percent of women screened annually declined in all sites and age groups. Compared to 2008-2009, rates among screened women were significantly lower for all 3 periods in women aged 18-20 years (2010-2011: IRR 0.82, 95% confidence interval [CI] 0.67-0.99; 2012-2013: IRR 0.63, 95% CI 0.47-0.85; 2014-2015: IRR 0.44, 95% CI 0.28-0.68) and lower for the latter 2 time periods in women aged 21-24 years (2012-2013: IRR 0.86, 95% CI 0.79-0.94; 2014-2015: IRR 0.61, 95% CI 0.55-0.67). CONCLUSIONS: From 2008-2015, both CIN2+ rates and cervical cancer screening declined in women aged 18-24 years. The significant decreases in CIN2+ rates among screened women aged 18-24 years are consistent with a population-level impact of HPV vaccination.


Subject(s)
Adenocarcinoma in Situ/epidemiology , Early Detection of Cancer/trends , Papillomavirus Vaccines/administration & dosage , Uterine Cervical Dysplasia/epidemiology , Uterine Cervical Neoplasms/epidemiology , Adolescent , Adult , Female , Humans , United States/epidemiology , Young Adult
15.
Sex Transm Dis ; 46(4): 250-253, 2019 04.
Article in English | MEDLINE | ID: mdl-30628945

ABSTRACT

BACKGROUND: In this study, we evaluate the performance of the Syphilis Health Check (SHC) in clinical and laboratory settings using fingerstick whole blood and serum. METHODS: Fingerstick whole blood and serum specimens from adult patients (n = 562) without prior syphilis history presenting at 2 county health department STD clinics in North Carolina were tested. Fingerstick specimens were tested with the SHC in clinic, and serum specimens were tested at the North Carolina State Laboratory of Public Health with: (1) qualitative rapid plasma reagin, (2) treponemal EIA, and (3) SHC. Sensitivity and specificity were calculated with 95% confidence intervals. RESULTS: The fingerstick whole blood had a sensitivity of 100% (7 of 7) and specificity of 95.7% (531 of 555), compared with consensus reference testing (CRT) (rapid plasma reagin and EIA reactive), but a sensitivity of 50% (8 of 16), and specificity of 95.9% (523 of 546), when compared with the treponemal EIA. Both laboratory-based SHC on serum and whole-blood SHC performed similarly, compared with CRT, and the treponemal EIA alone. Twenty-four specimens SHC reactive on whole blood were nonreactive by CRT. In 8 of these 24 cases, STD clinic staff reported difficulty reading the test line for the SHC. Of the fingerstick whole-blood SHC reactive specimens, only 14 of 31 were also serum SHC reactive. CONCLUSIONS: The SHC on whole blood appears to be sensitive at detecting patients likely to have syphilis and could be an option for testing among high-risk populations. However, given challenges in interpreting SHC test results, adequate training of persons performing testing and ongoing quality assurance measures are key.


Subject(s)
Antibodies, Bacterial/blood , Syphilis Serodiagnosis/standards , Syphilis/diagnosis , Adult , Algorithms , Ambulatory Care Facilities/statistics & numerical data , Female , Humans , Male , North Carolina , Sensitivity and Specificity , Syphilis/blood , Syphilis Serodiagnosis/methods , Treponema pallidum , Young Adult
16.
MMWR Morb Mortal Wkly Rep ; 68(15): 337-343, 2019 Apr 19.
Article in English | MEDLINE | ID: mdl-30998672

ABSTRACT

Human papillomavirus (HPV) causes approximately 30,000 cancers in the United States annually (1). HPV vaccination was introduced in 2006 to prevent HPV-associated cancers and diseases (1). Cervical cancer is the most common HPV-associated cancer in women (1). Whereas HPV-associated cancers typically take decades to develop, screen-detected high-grade cervical lesions (cervical intraepithelial neoplasia grades 2 [CIN2], 3 [CIN3], and adenocarcinoma in situ, collectively CIN2+) develop within a few years after infection and have been used to monitor HPV vaccine impact (1-3). CDC analyzed data from the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT), a population-based CIN2+ surveillance system, to describe rates of CIN2+ among women aged ≥18 years during 2008-2016. Age-specific rates were applied to U.S. population data to estimate the total number of CIN2+ cases diagnosed in the United States in 2008* and in 2016. From 2008 to 2016, the rate of CIN2+ per 100,000 women declined significantly in women aged 18-19 years and 20-24 years and increased significantly in women aged 40-64 years. In the United States in 2008, an estimated 216,000 (95% confidence interval [CI] = 194,000-241,000) CIN2+ cases were diagnosed, 55% of which were in women aged 18-29 years; in 2016, an estimated 196,000 (95% CI = 176,000-221,000) CIN2+ cases were diagnosed, 36% of which were in women aged 18-29 years. During 2008 and 2016, an estimated 76% of CIN2+ cases were attributable to HPV types targeted by the vaccine currently used in the United States. These estimates of CIN2+ cases likely reflect changes in CIN2+ detection resulting from updated cervical cancer screening and management recommendations, as well as primary prevention through HPV vaccination. Increasing coverage of HPV vaccination in females at the routine age of 11 or 12 years and catch-up vaccination through age 26 years will contribute to further reduction in cervical precancers.


Subject(s)
Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/epidemiology , Adolescent , Adult , Aged , Female , Humans , Middle Aged , Neoplasm Grading , Papillomavirus Vaccines/administration & dosage , United States/epidemiology , Young Adult
17.
J Clin Microbiol ; 56(1)2018 01.
Article in English | MEDLINE | ID: mdl-29046410

ABSTRACT

Automated treponemal immunoassays are used for syphilis screening with the reverse-sequence algorithm; discordant results (e.g., enzyme immunoassay [EIA] reactive and reactive plasma reagin [RPR] nonreactive) are resolved with a second treponemal test. We conducted a study to determine automated immunoassay signal strength values consistently correlating with reactive confirmatory treponemal testing. We conducted a cross-sectional analysis of four automated immunoassays (BioPlex 2200 microbead immunoassay [MBIA], Liaison chemiluminescence immunoassay [CIA], Advia-Centaur CIA, and Trep-Sure EIA) and three manual assays (Treponema pallidum particle agglutination [TP-PA], fluorescent treponemal antibody absorption [FTA-ABS] test, and Inno-LIA line immunoassay). We compared signal strength values of automated immunoassays and positive and negative agreement. Among 1,995 specimens, 908 (45.5%) were true positives (≥4/7 tests reactive) and 1,087 (54.5%) were true negatives (≥4/7 tests nonreactive). Positive agreement ranged from 86.1% (83.7 to 88.2%) for FTA-ABS to 99.7% (99.0 to 99.9%) for Advia-Centaur CIA; negative agreement ranged from 86.3% (84.1 to 88.2%) for Trep-Sure EIA to 100% for TP-PA (99.6 to 100%). Increasing signal strength values correlated with increasing reactivity of confirmatory testing (P < 0.0001 for all automated immunoassays by Cochran-Armitage test for trend). All automated immunoassays had signal strength cutoffs corresponding to ≥4/7 reactive treponemal tests. BioPlex MBIA and Liaison CIA had signal strength cutoffs correlating with ≥99% and 100% TP-PA reactivity, respectively. The Advia-Centaur CIA and Trep-Sure EIA had signal strength cutoffs correlating with at least 95% TP-PA reactivity. All automated immunoassays had signal strength cutoffs correlating with at least 95% FTA-ABS reactivity. Assuming that a 95% level of confirmation is adequate, these signal strength values can be used in lieu of confirmatory testing with TP-PA and FTA-ABS.


Subject(s)
Immunoassay , Mass Screening/methods , Syphilis Serodiagnosis/methods , Syphilis/diagnosis , Algorithms , Antibodies, Bacterial/blood , Cross-Sectional Studies , Humans , Predictive Value of Tests , Reproducibility of Results , Syphilis/blood , Syphilis/immunology , Treponema pallidum/immunology
18.
Sex Transm Dis ; 43(2 Suppl 1): S28-41, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26779685

ABSTRACT

BACKGROUND: The asymptomatic nature and suboptimal screening rates of sexually transmitted diseases (STD) call for implementation of successful interventions to improve screening in community-based clinic settings with attention to cost and resources. METHODS: We used MEDLINE to systematically review comparative analyses of interventions to improve STD (chlamydia, gonorrhea, or syphilis) screening or rescreening in clinic-based settings that were published between January 2000 and January 2014. Absolute differences in the percent of the target population screened between comparison groups or relative percent increase in the number of tests or patients tested were used to score the interventions as highly effective (>20% increase) or moderately effective (5%-19% increase) in improving screening. Published cost of the interventions was described where available and, when not available, was estimated. RESULTS: Of the 4566 citations reviewed, 38 articles describing 42 interventions met the inclusion criteria. Of the 42 interventions, 16 (38.1%) were categorized as highly effective and 14 (33.3%) as moderately effective. Effective low-cost interventions (<$1000) included the strategic placement of specimen collection materials or automatic collection of STD specimens as part of a routine visit (7 highly effective and 1 moderately effective) and the use of electronic health records (EHRs; 3 highly effective and 4 moderately effective). Patient reminders for screening or rescreening (via text, telephone, and postcards) were highly effective (3) or moderately effective (2) and low or moderate cost (<$1001-10,000). Interventions with dedicated clinic staff to improve STD screening were highly effective (2) or moderately effective in improving STD screening (1) but high-cost ($10,001-$100,000). CONCLUSIONS: Successful interventions include changing clinic flow to routinely collect specimens for testing, using EHR screening reminders, and reminding patients to get screened or rescreened. These strategies can be tailored to different clinic settings to improve screening at a low cost.


Subject(s)
Ambulatory Care Facilities/statistics & numerical data , Health Promotion , Mass Screening , Patient Acceptance of Health Care/statistics & numerical data , Quality Improvement/organization & administration , Referral and Consultation/organization & administration , Sexually Transmitted Diseases/prevention & control , Cost-Benefit Analysis , Humans , Mass Screening/standards , Mass Screening/statistics & numerical data , Mass Screening/trends , Prevalence , Program Evaluation , Sexually Transmitted Diseases/diagnosis
19.
Sex Transm Dis ; 43(4): 258-9, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26967304

ABSTRACT

An HIV-negative man with pharyngeal gonorrhea had a positive test-of-cure (nucleic acid amplification test) result 7 days after treatment with ceftriaxone/azithromycin. Neisseria gonorrhoeae Multi-Antigen Sequencing Type 1407 and mosaic pen A (XXXIV) gene were identified in the test-of-cure specimen, and culture was negative. Retreatment with ceftriaxone 500 mg intramuscularly plus azithromycin 2 g orally yielded a negative test-of-cure result.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , Ceftriaxone/therapeutic use , Gonorrhea/drug therapy , Neisseria gonorrhoeae/immunology , Sexually Transmitted Diseases/drug therapy , Asymptomatic Diseases , Humans , Injections, Intramuscular , Male , Neisseria gonorrhoeae/genetics , Nucleic Acid Amplification Techniques , Pharynx/microbiology , Treatment Outcome , Young Adult
20.
Clin Infect Dis ; 61 Suppl 8: S849-55, 2015 Dec 15.
Article in English | MEDLINE | ID: mdl-26602622

ABSTRACT

To provide updates for the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines on human papillomavirus (HPV) and anogenital warts (AGWs), a review of the literature was conducted in key topic areas: (1) epidemiology and burden of disease; (2) transmission and natural history; (3) diagnosis and management of AGWs; (4) occupational exposure of healthcare workers; (5) anal cancer screening among men who have sex with men (MSM); and (6) HPV vaccine recommendations. Most sexually active persons will have detectable HPV at least once in their lifetime; 14 million persons are infected annually, and 79 million persons have prevalent infection. HPV is transmitted frequently between partners; more frequent transmission has been reported from females to males than from males to females. A new formulation of imiquimod (3.75% cream) is recommended for AGW treatment. Appropriate infection control, including performing laser or electrocautery in ventilated rooms using standard precautions, is recommended to prevent possible transmission to healthcare workers who treat anogenital warts, oral warts, and anogenital intraepithelial neoplasias (eg, cervical intraepithelial neoplasia). Data are insufficient to recommend routine anal cancer screening with anal cytology in persons living with human immunodeficiency virus (HIV)/AIDS or HIV-negative MSM. An annual digital anorectal examination may be useful for early detection of anal cancer in these populations. HPV vaccine is recommended routinely for 11- or 12-year-olds, as well as for young men through age 21 years and young women through age 26 years who have not previously been vaccinated. HPV vaccine is also recommended for MSM, people living with HIV/AIDS, and immunocompromised persons through age 26 years.


Subject(s)
Condylomata Acuminata/epidemiology , Papillomavirus Infections/epidemiology , Adolescent , Aminoquinolines/therapeutic use , Antiviral Agents/therapeutic use , Anus Neoplasms/drug therapy , Anus Neoplasms/virology , Centers for Disease Control and Prevention, U.S. , Condylomata Acuminata/diagnosis , Condylomata Acuminata/drug therapy , Condylomata Acuminata/virology , Female , HIV Infections/complications , HIV Infections/virology , Humans , Imiquimod , Male , Papillomavirus Infections/drug therapy , Papillomavirus Infections/transmission , Papillomavirus Infections/virology , Papillomavirus Vaccines/administration & dosage , Practice Guidelines as Topic , Prevalence , United States/epidemiology , Young Adult
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