Evaluation of Presto(plus) assay and LightMix kit Trichomonas vaginalis assay for detection of Trichomonas vaginalis in dry vaginal swabs

This is an evaluation study of the Prestoplus Assay for T. vaginalis by comparing to the TIB MOLBIOL LightMix Kit Trichomonas vaginalis Assay using 615 dry collected vaginal and rectal swabs. Discordant samples were analyzed by the Qiagen® Microbial DNA qPCR for TV Assay. Both assays showed comparable performances (McNemar p > 0.05).http://www.elsevier.com/ locate/jmicmeth2017-08-31hb2016Microbiology and Plant Patholog

Quantitative modeling of tumor dynamics and development of drug resistance in non-small cell lung cancer patients treated with erlotinib

Insight into the development of treatment resistance can support the optimization of anticancer treatments. This study aims to characterize the tumor dynamics and development of drug resistance in patients with non-small cell lung cancer treated with erlotinib, and investigate the relationship between baseline circulating tumor DNA (ctDNA) data and tumor dynamics. Data obtained for the analysis included (1) intensively sampled erlotinib concentrations from 29 patients from two previous pharmacokinetic (PK) studies, and (2) tumor sizes, ctDNA measurements, and sparsely sampled erlotinib concentrations from 18 patients from the START-TKI study. A two-compartment population PK model was first developed which well-described the PK data. The PK model was subsequently applied to investigate the exposure-tumor dynamics relationship. To characterize the tumor dynamics, models accounting for intra-tumor heterogeneity and acquired resistance with or without primary resistance were investigated. Eventually, the model assumed acquired resistance only resulted in an adequate fit. Additionally, models with or without exposure-dependent treatment effect were explored, and no significant exposure-response relationship for erlotinib was identified within the observed exposure range. Subsequently, the correlation of baseline ctDNA data on EGFR and TP53 variants with tumor dynamics’ parameters was explored. The analysis indicated that higher baseline plasma EGFR mutation levels correlated with increased tumor growth rates, and the inclusion of ctDNA measurements improved model fit. This result suggests that quantitative ctDNA measurements at baseline have the potential to be a predictor of anticancer treatment response. The developed model can potentially be applied to design optimal treatment regimens that better overcome resistance.</p

Complicated Odontogenic Infections at 2 District Hospitals in Tonkolili District, Sierra Leone:Protocol for a Prospective Observational Cohort Study (DELAY)

BACKGROUND: Deficits in global oral health care are paramount, and complications of odontogenic infections constitute a considerable global health problem, particularly in low-income countries. A high mortality rate has been observed for patients who have been admitted with complicated odontogenic infections to our facilities in Tonkolili District, Sierra Leone, although exact data have not been published yet. Data regarding who in this region is at risk and why are lacking. OBJECTIVE: The Dental Abscess Study (DELAY) aims to prospectively investigate morbidity and mortality from complicated dental abscesses and to analyze patients’ characteristics and microbial findings to examine predisposing factors for poor outcomes. In particular, the incidence and the clinical and microbial characteristics of complicated odontogenic infections, as well as the sociodemographic data and comorbidities of affected patients, will be studied to develop improved management algorithms based on circumstance-specific factors. METHODS: Patients who present with complicated dental infections requiring hospital admission in Masanga Hospital or Lion Heart Medical Centre will be consecutively selected for possible inclusion in the study (starting on September 4, 2021) over a study period of 1 year, and individual routine follow-ups will be conducted at least 3 months after discharge. The results of standardized questionnaires will be obtained, and clinical measurements as well as medical photos will be taken. Standard laboratory tests (eg, full blood count and HIV status tests) will be performed, and pus specimens will be examined. Local treatment guidelines will be adhered to, and data on medical and surgical treatment as well as data on outcomes will be collected. The study results will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria. Routine follow-ups will take place at 1 and 3 months postdischarge. RESULTS: The DELAY protocol was endorsed by the Masanga Medical Research Unit’s Scientific Review Committee on June 16, 2021, and ethical approval was granted on July 5, 2021, by the Sierra Leone National Ethics Committee. The funding of the budgeted study costs was approved by Dental Health International Netherlands in August 2021. The projected start date of data collection was September 4, 2021, and the study period will most likely last for 1 year. As such, data collection is expected to be complete in November 2022. CONCLUSIONS: The aim of our prospective observational cohort study is to gain more knowledge about complicated odontogenic infections in Tonkolili District, Sierra Leone, to further improve treatment strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/3367

Comparison of GMT presto assay and Roche cobase (R) 4800 CT/NG assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in dry swabs

Urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most prevalent bacterial STIs worldwide. Molecular tests are the standard for the detection of CT and NG, as these are difficult to culture. The recently introduced CE-IVD marked GMT Presto assay promises to be a valuable addition in CT and NC diagnostics. The advantage of the Presto assay is that it works on many PCR systems and the DNA can be isolated by any system. We compared the Presto assay to the widely used Roche cobas (R) 4800 CT/NC test for the detection of CT and NC in 612 vaginal and rectal dry collected swabs. Discrepant samples were tested by the TIB MOLBIOL Lightmix Kit 480 HT CT/NC assay. The alloyed gold standard was defined as two concurring Presto and cobas (R) 4800 results, or, with discrepant Presto and cobas (R) results, two concurring results of either test together with the Lightmix Kit 480 HT CT/NC assay. For the Presto assay, we observed 77 CT positive (13%) and 22 NC positive (3,6%) vaginal samples, and 41 CT positive (6,7%) and 11 NC positive (1,8%) rectal samples. For the cobas (R) 4800 assay, we observed 77 CT positive (13%) and 21 NC positive (3,4%) vaginal samples, and 39 CT positive (6,4%) and 11 NC positive (1,8%) rectal samples. Ten CT samples were discrepant between Presto and cobas (R) 4800 CT/NC assays, while two NC samples were discrepant. CT sensitivity in both assays was 100% compared to the alloyed gold standard. The sensitivity was 100% for both vaginal and rectal dry swabs, underlining the suitability of these sample types for detection of CT and NC. The Presto assay is therefore valuable for molecular detection of CT and NC in dry vaginal and rectal swabs

So, what's best? Accuracy and acceptance of thermometers in triage and inpatients in a low-resource tropical setting – The MaTe study

Objectives: We searched for the most-suitable thermometry method in the low-resource, tropical setting of Sierra Leone, both in terms of accuracy and also patient and user acceptance. Methods: We conducted a prospective comparative study of different methods of body temperature measurement. Each participant had their temperature taken by four different methods: non-contact infrared temperature (NCIT), axillary, tympanic membrane and rectal measurements. Rectal temperature was considered clinical gold standard. Primary outcome was predicted sensitivity and specificity of thermometry methods in detecting fever (rectal temperature ≥38.0 °C). Questionnaires were used to explore patient and healthcare worker attitudes towards different methods of temperature-taking. Results: 824 rectal body temperature readings were taken from 562 participants. The mean rectal temperature was 37.4 °C (IQR 37 °C to 37.7 °C), with a minimum reading of 35.2 °C and maximum of 41.0 °C. Tympanic membrane thermometry showed the highest sensitivity of fever detection using the Genius3 TM thermometer (sensitivity 70.8 %, 95 % CI 60.2%–79.9 %; specificity 97.2 %, 95 % CI 95.5–98.4 %); and Braun TM (sensitivity 51.5 %, 95 % CI 42.6%–62.0 %; specificity 98.8 %, 95 % CI 97.7–99.5). NCIT thermometry sensitivity was low (36.8 %–41.4 % for the two devices used). Axillary thermometry sensitivity was 40.6 %. Participants ranked NCIT as the most and rectal as the least preferred method. Questionnaires from 32 participating nurses showed agreeability to using NCIT, TM and axillary methods routinely, but less so for rectal thermometry. Conclusions: When combining the accuracy of different thermometry methods in detecting fever with user and patient acceptability, tympanic membrane thermometry appears most suitable but also has limitations

Prevalence of Trichomonas vaginalis infection and protozoan load in South African women:a cross-sectional study

Objectives Trichomonas vaginalis is thought to be the most common non-viral sexually transmitted infection worldwide. We investigated the prevalence, risk factors and protozoan load of T. vaginalis infection in South African women. Methods A cross-sectional study of 604 women was conducted at 25 primary healthcare facilities in rural South Africa (Mopani district). T. vaginalis DNA was detected in vaginal and rectal swabs. In univariate and multivariate analyses, the T. vaginalis infection was investigated in relation to demographic characteristics, medical history and behavioural factors. The T. vaginalis load was determined as the logarithm of DNA copies per microlitre sample solution. Results Collected vaginal and rectal swabs were tested for T. vaginalis DNA. Prevalence of vaginal T. vaginalis was 20% (95% CI 17.0% to 23.4%) and rectal 1.2% (95% CI 0.6% to 2.4%). Most women (66%) with a vaginal infection were asymptomatic. Factors associated with T. vaginalis infection were a relationship status of single (OR 2.4; 95% CI 1.5 to 4.0; p<0.001) and HIV positive infection (OR 1.6; 95% CI 1.0 to 2.6; p=0.041). Women with vaginal T. vaginalis infection were more likely to have concurrent Chlamydia trachomatis rectal infection than those without vaginal infection (12%vs3%; p<0.001; OR 4.1). A higher median T. vaginalis load was observed among women with observed vaginal discharge compared with those without vaginal discharge (p=0.025). Conclusions Vaginal trichomoniasis is highly prevalent in rural South Africa, especially among single women and those with HIV infection, and often presents without symptoms

Quantitative modeling of tumor dynamics and development of drug resistance in non-small cell lung cancer patients treated with erlotinib

Insight into the development of treatment resistance can support the optimization of anticancer treatments. This study aims to characterize the tumor dynamics and development of drug resistance in patients with non-small cell lung cancer treated with erlotinib, and investigate the relationship between baseline circulating tumor DNA (ctDNA) data and tumor dynamics. Data obtained for the analysis included (1) intensively sampled erlotinib concentrations from 29 patients from two previous pharmacokinetic (PK) studies, and (2) tumor sizes, ctDNA measurements, and sparsely sampled erlotinib concentrations from 18 patients from the START-TKI study. A two-compartment population PK model was first developed which well-described the PK data. The PK model was subsequently applied to investigate the exposure-tumor dynamics relationship. To characterize the tumor dynamics, models accounting for intra-tumor heterogeneity and acquired resistance with or without primary resistance were investigated. Eventually, the model assumed acquired resistance only resulted in an adequate fit. Additionally, models with or without exposure-dependent treatment effect were explored, and no significant exposure-response relationship for erlotinib was identified within the observed exposure range. Subsequently, the correlation of baseline ctDNA data on EGFR and TP53 variants with tumor dynamics’ parameters was explored. The analysis indicated that higher baseline plasma EGFR mutation levels correlated with increased tumor growth rates, and the inclusion of ctDNA measurements improved model fit. This result suggests that quantitative ctDNA measurements at baseline have the potential to be a predictor of anticancer treatment response. The developed model can potentially be applied to design optimal treatment regimens that better overcome resistance.</p

High-resolution multilocus sequence typing reveals novel urogenital Chlamydia trachomatis strains in women in Mopani district, South Africa

Recently, we reported a high prevalence (16%) of urogenital Chlamydia trachomatis infections among women in a rural setting in South Africa. Molecular epidemiological studies on C. trachomatis infections could provide insights into the characteristics of this epidemic, yet such data are not available. The objective of this study was therefore to assess the distribution of C. trachomatis strains among women from a South African rural community, the Mopani district, and to compare it with strains from Amsterdam, the Netherlands. High-resolution multilocus sequence typing (hr-MLST) was used to study urogenital C. trachomatis infections in women visiting primary healthcare facilities across rural Mopani District in Limpopo Province, South Africa. Sequence types (STs) were compared with 100 strains from women visiting the sexually transmitted infection clinic in Amsterdam, the Netherlands. Full hr-MLST data were obtained for C. trachomatis infection in 43 women from Mopani district. Using the complete hr-MLST profile of all 43 women from Mopani district, 26 STs could be identified, of which 18 (69%) were novel to the hr-MLST database. The remaining STs clustered together with strains from Amsterdam. Hr-MLST data revealed a diverse molecular epidemiology with novel STs and a specific cluster for the Mopani district. Also C. trachomatis types that occur worldwide were detecte

Sexual behaviour of women in rural South Africa: a descriptive study

Abstract Background Sexual behaviour is a core determinant of the HIV and sexually transmitted infection (STI) epidemics in women living in rural South Africa. Knowledge of sexual behaviour in these areas is limited, but constitutes essential information for a combination prevention approach of behavioural change and biomedical interventions. Methods This descriptive study was conducted in rural Mopani District, South Africa, as part of a larger study on STI. Women of reproductive age (18–49 years) who reported sexual activity were included regardless of the reason for visiting the facility. Questionnaires were administered to 570 women. We report sexual behaviour by age group, ethnic group and self-reported HIV status. Results Young women (34 years); there was no difference for condom use during last sex act (36 % overall). Sotho women were more likely to report concurrent sexual partners whereas Shangaan women reported more frequent intravaginal cleansing and vaginal scarring practice in our analysis. HIV-infected women were older, had a higher number of lifetime sexual partners, reported more frequent condom use during the last sex act and were more likely to have a known HIV-infected partner than women without HIV infection; hormonal contraceptive use, fellatio, and a circumcised partner were less often reported. Conclusions This study provides insight into women’s sexual behaviour in a rural South African region. There are important differences in sexual behaviour by age group and ethnicity and HIV status; these should be taken into account when designing tailor-made prevention packages