MIC Distributions and Epidemiological Cut-off Values for Azithromycin in Neisseria gonorrhoeae as Determined by Agar Dilution

Background: Clinical breakpoints and epidemiological cut-off values for N. gonorrhoeae azithromycin antimicrobial susceptibility testing have not been established. This study utilized existing minimum inhibitory concentration (MIC) data from CDC’s Gonococcal Isolate Surveillance Project (GISP) to establish epidemiological cut-off values for azithromycin and N. gonorrhoeae as determined by agar dilution. Methods: MIC distributions for the pooled dataset and each data year (2005-2012) were constructed. Epidemiological cut-off values were calculated using two methods. Method 1 considers the wild-type MIC distribution, the modal MIC for the distribution, and the inherent variability of the test (±1 twofold-dilution). Method 2 defines the epidemiological cut-off value as two twofold-dilutions higher than the MIC50. Results: Taking into consideration the wild-type MIC distributions and the inherent variability of the test, the epidemiological cut-off value chosen for the pooled dataset and each data year using Method 1 was ≤1.0 µg/mL. The MIC50 for the pooled dataset and each data year was 0.25 µg/mL. Two twofold-dilutions higher than the MIC50 (0.25 µg/mL) for the pooled dataset and each data year was 1.0 µg/mL. Discussion: The epidemiological cut-off values chosen using Methods 1 and 2 (≤1.0 µg/mL) were identical for the pooled dataset and each data year, indicating the epidemiological cut-off value has not changed from 2005-2012. The epidemiological cut-off value for N. gonorrhoeae azithromycin agar dilution antimicrobial susceptibility testing established during this study can be used to help set clinical breakpoints and identify isolates with reduced susceptibility to azithromycin

Prevalence and correlates of active syphilis and HIV co-Infection among sexually active persons aged 15-59 years in Zambia: Results from the Zambia Population-based HIV Impact Assessment (ZAMPHIA) 2016.

ObjectivesThe main objectives of the study are to estimate HIV prevalence, active syphilis prevalence, and correlates of co-infection with HIV in Zambia, among recently sexually active individuals aged 15 to 59 years old.MethodsWe used data from the 2016 Zambia Population-based HIV Impact Assessment (ZAMPHIA), a national household survey that included biomarker testing for HIV and syphilis. Chembio DPP® Syphilis Screen and Confirm Assay was used to distinguish between active and older syphilis infections. This is the first time Chembio DPP® has been used in a national survey. Log-binominal modelling was utilized to understand the risk of acquiring HIV/active syphilis co-infection using select socio-demographic and sexual behavior variables. Multivariable analysis compared those with co-infection and those with no infection. All reported results account for the complex survey design and are weighted.ResultsA total of 19,114 individuals aged 15-59 years responded to the individual interview and had a valid syphilis and/or HIV test. The prevalence for those sexually active in the 12 months preceding ZAMPHIA 2016 was 3.5% and 13% for active syphilis and HIV, respectively. The prevalence of HIV/active syphilis co-infection was 1.5%. Factors associated with higher prevalence of co-infection versus no infection among females included, but were not limited to, those living in urban areas (adjusted prevalence ratio (aPR) = 3.0, 95% CI = 1.8, 4.8), those had sexual intercourse before age 15 years (aPR = 1.8, 95% CI = 1.1, 2.9), and those who had two or more sexual partners in the 12 months preceding the survey (aPR = 2.7, 95% CI = 1.6, 4.7).ConclusionThese findings show high prevalence for both mono-infection with HIV and syphilis, as well as co-infection with HIV/active syphilis in Zambia. There is a need for better screening and partner services, particularly among those engaging in high-risk sexual behaviors (e.g., engaging in transactional sex)

External quality assessment to support the WHO ProSPeRo study for the evaluation of two dual HIV/syphilis point-of-care tests in seven countries

Abstract Background Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries. Methods HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated. Results Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4–100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0–66.7% agreement for SD BIOLINE and 84.0–86.7% for DPP, respectively, for syphilis testing. Conclusions Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing

Development of minimum standards of care for juvenile localized scleroderma

Juvenile localized scleroderma (jLS), also known as morphea, is an orphan disease. Pediatric guidelines regarding diagnosis, assessment, and management are lacking. Our objective was to develop minimum standards of care for diagnosis, assessment, and management of jLS. A systematic review was undertaken to establish the pediatric evidence for assessment and monitoring of jLS. An expert panel, including members of the Pediatric Rheumatology European Society (PRES) Scleroderma Working Group, were invited to a consensus meeting where recommendations were developed based on evidence graded by the systematic review and, where evidence was lacking, consensus opinion. A nominal technique was used where 75% consensus was taken as agreement. Recommendations for diagnosis, assessment, and management were developed. Due to a lack of pediatric evidence, these were primarily consensus driven. Careful assessment for extra-cutaneous manifestations including synovitis, brain involvement, and uveitis were key features together with joint assessments between Dermatology and Rheumatology to improve and standardize care. Conclusion: Management of jLS is varied. These recommendations should help provide standardization of assessment and care for those with this rare and potentially debilitating condition. What is Known: _ Children with juvenile localized scleroderma (jLS) are managed by a number of specialties including pediatric rheumatologists and dermatologists, sometimes in shared clinics. Studies have shown that management varies considerably and that there are notable differences between specialties [1]. _ There is very little published guidance on management of jLS. What is new: _ These recommendations aim to standardize diagnosis, assessment, and management through review of pediatric evidence and consensus agreement. Joint review of patients by both pediatric rheumatologists and dermatologists is recommended