Self-collected Samples Research Articles

Experiences of participating in cortisol awakening response research:“I was more consciousthan usual, I wanted to get it right”

Cortisol awakening response (CAR) research relies upon self-collected saliva sampling during the post-awakening period. It is unknown how the CAR protocol is perceived and how they may affect typical routines relevant to CAR methodology. CAR assessment is sensitive to state variables, suggesting that CAR measurement may be affected by research participation. This is the first qualitative study to explore motivation and experiences of participation in CAR research.Interviews were conducted with a sample of 20 participants (males/females: 4/16) aged 46-82 years following their participation in CAR research in the domestic setting. Responses were transcribed verbatim and thematically analysed.Participants were motivated to take part in CAR research for altruistic reasons and the apparent convenience of undertaking the study at home. Participants experienced the study as arduous describing apprehension and the cognitive burden it placed on them leading to disruptions to sleep and morning routines. Participants also struggled to identify the moment of awakening and there was uncertainty surrounding the timing of the first awakening sample. Disruptions were lessened with habituation to sampling on repeated study days.There was apprehension about taking part in CAR research, affecting mood, cognition, and sleep; state variables known to influence the CAR. Findings inform ways to optimise CAR ‘ecological validity’ and obtain typical CAR characteristics. The ‘moment of awakening’, was not universally understood, leading to hesitancy in deciding when to collect saliva samples. Researchers need to include a specific discussion of the commonly experienced ambiguity surrounding awakening to increase awareness, lessen anxiety and highlight its importance.

A cervical cancer control strategy for lower-resource settings: interventions to complement one-dose HPV vaccination.

One-dose prophylactic HPV vaccination of pre-adolescents may reduce cervical cancer deaths dramatically in lower-resource settings, but the benefits of achieving immediate high coverage among pre-adolescents would not be realized for 20 to 40 years. Prophylactic vaccine efficacy is reduced after sexual debut, and current therapeutic intervention candidates designed to treat existing HPV infections or precancerous lesions have yielded insufficient evidence to warrant widespread use. However, we are developing a feasible, scalable, high-quality cervical screening approach that could prevent hundreds of thousands of deaths, while we work to achieve high coverage of one-dose vaccination for adolescent cohorts. A time-limited "one screen" campaign approach for lower-resource settings could complement parallel efforts to achieve high coverage with one-dose vaccination. This screen-triage-treat strategy would target the highest risk groups of screening age (ie, 25 to 49 years) for once-in-a-lifetime HPV testing of self-collected samples using a low-cost accurate HPV test; subsequent triage relying on extended genotyping and a validated deep-learning algorithm for automated visual evaluation (AVE) would stratify management based on risk to provide treatment for those most likely to develop cancer without overburdening health care systems. Early efficacy of this approach has been demonstrated in 9 countries within the HPV-AVE (PAVE) Study Consortium. We estimate that the cost per death averted of a screen-triage-treat campaign is of similar magnitude to prophylactic vaccination. We do not envision perpetual investment in ubiquitous brick-and-mortar screening programs if "one dose, one screen" is implemented with high coverage and targets the highest-risk populations. In collaboration with in-country stakeholders, efforts to ensure acceptability, risk communication, and cost-effectiveness are underway.

High SARS-CoV-2 secondary infection rates in households with children in Georgia, United States, Fall 2020-Winter 2021.

A wide range of household secondary infection rates has been reported, and the role of children in population transmission dynamics for SARS-CoV-2 remains ill-defined. We sought to better understand household infection early in the pandemic. A cross-sectional study of 17 households in the Atlanta metropolitan area with at least one child and one case of COVID-19 in the prior 1-4 months were recruited between December 2020 and April 2021. Self-collected saliva samples were tested on a multiplexed platform to detect IgG antibodies that bind to SARS-CoV-2 antigens. Secondary infection rates (SIR) were calculated and compared. We report results on 17 families, including 66 individuals. We found an average SIR of 0.58; children and adults were similarly infected (62% children vs. 75% adults) (p = 0.2). Two out of 17 households had a pediatric index per our definition. Number of pediatric infections per household (p = 0.18), isolation (p = 0.34), and mask wearing (p = 0.80) did not differ significantly among households with an SIR above the mean vs. those with SIR below the mean. Households with higher SIR also had a higher number of symptomatic cases (p < 0.001). We demonstrated high household SIRs at the early stages of the pandemic in late 2020 to early 2021 with similar impact on children and adults. The ease of collecting saliva and the detection of asymptomatic infections highlight the advantages of this strategy and potential for scale-up.

Evidence from Europe on implementation, participation and performance of self-collection for cervical cancer screening.

Cervical cancer screening programs reduce the number of cervical cancer cases and deaths, but the success of any screening program is dependent on high participant uptake and coverage and many European countries are observing declining cervical cancer screening coverage to below national targets. Self-collection of vaginal samples for human papillomavirus testing, also termed self-sampling, is one strategy which is being introduced to try to increase screening coverage by removing barriers to participation and it has attracted growing interest and support globally. Informed by peer-reviewed and gray literature, this narrative review starts with a case study from the Netherlands and outlines the self-collection landscape in Europe within the themes of program implementation and relative test performance. It highlights some of the current evidence gaps needed to inform policy decisions on the use of self-collection within screening programs.

Acceptability and validity of HPV self-sampling for cervical cancer screening among women living in different ecological settings in India.

India records one fifth of global cervical cancer burden. Unlike human papillomavirus (HPV) self-sampling, other screening methods may cause discomfort and embarrassment. This study aimed to investigate attitudes, acceptability, barriers, predictors, effective modality of instructions, and validity of HPV self-sampling among Indian women residing in varied settings and different literacy levels. This is community-based interventional study among Indian women 30-55 years, residing in urban slums (500), urban non-slums (500), and rural (600) settings with varied washroom facilities and privacy, to collect self-samples. Each group was subdivided into two arms; in one women received education with pamphlets and other with health education program (HEP). Study involved enlisting eligibles, obtaining informed consents and conducting personal interviews to collect baseline data. Self-samplers were distributed with instructions (pictorial pamphlets in one group and HEP in other) regarding usage, storage and return. Willingness to use self-samplers, refusals, experiences, and so forth were captured. Post-intervention knowledge, attitudes, practices was recorded. HPV reports were distributed. Women with positive result on either test were offered further management. Acceptance rate of self-sampling was 99.2%, 97%, and 98.8% and HPV positivity was 7%, 7.8%, and 8.5%, respectively among urban non-slum, urban slum and rural women. Agreement rate between health personnel collected and self-collected samples was 96.5% in pamphlet and 93.2% in HEP arm. Major barriers of self-sampling were lack of confidence about performing self-test correctly, fear that test would be painful and anxiety about test results. HPV self-sampling has good acceptability among Indian women and good agreement with health personnel collected samples.

Effectiveness of bivalent HPV vaccination against genital HPV DNA-positivity of a catch-up campaign at age 13–16 years compared to routine vaccination at age 12 years: a biennial repeated cross-sectional study

BackgroundThe Netherlands is one of few countries worldwide which has used the bivalent HPV vaccine for girls-only for over a decade. This allows assessment of vaccine effectiveness (VE) against female genital HPV DNA-positivity of this vaccine in an observational post-licencing real-world setting. Additionally, it is unclear whether catch-up vaccination campaigns result in similar VE as routine vaccination. Therefore, type-specific and grouped VE were assessed and compared for women who had been eligible for catch-up vaccination at 13–16 years with those who had been eligible for routine vaccination at 12 years.MethodsPASSYON is a Dutch biennial repeated cross-sectional (2011–2021) study among sexual health clinic clients aged 16–24 years old. Women provided self-collected vaginal samples, questionnaires on demographics and sexual behaviour were administered, and women self-reported HPV vaccination status. Samples were analysed using a PCR-based assay (SPF10-LiPA25). Type-specific and grouped VE estimates, adjusted with propensity score stratification, were assessed against genital positivity for 14 HPV types. VE for targeted and non-targeted genotypes were compared between women who had been eligible for the catch-up and those who had been eligible for routine vaccination.ResultsThe study included 4488 female participants who had been eligible for HPV vaccination and provided genital swabs (1561 eligible for catch-up, 2927 for routine vaccination). Very high VE against genital HPV-16 and HPV-18 was observed (resp. 93.5% and 89.5%) and significant cross-protection against six other genotypes (HPV-31/33/35/45/52/58), varying from 18.0% (HPV-52) to 79.6% (HPV-45). VE estimates were comparable between women who had been eligible for the catch-up campaign and those eligible for routine vaccination: VE HPV-16/HPV-18: 92.2% (95%CI: 87.9–94.9) vs. 91.8% (95%CI: 86.0–95.2).ConclusionsIn real-world settings, the VE of bivalent vaccine is high against targeted genotypes, with cross-protection against 6 other genotypes. Catch-up campaigns up to age 16 years can be as effective as routine vaccination at age 12, although it is recommendable to provide HPV vaccination at an age at which most are likely not sexually active yet. This may inform countries considering catch-up campaigns when introducing or extending the use of HPV vaccination within their national immunisation programmes.

Extragenital self-collection testing for gonorrhea and chlamydia: A feasibility study for expanding STI screening in the Veterans Health Administration.

Rectal and pharyngeal infections with gonorrhea and chlamydia are of concern because they are associated with higher risk of HIV acquisition. Extragenital screening in asymptomatic persons at high risk may have the potential to reduce the incidence of these sexually transmitted infections (STIs). Several testing platforms are available for the testing of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests (NAATs). Self-collected extragenital samples are currently not approved by the US Food and Drug Administration in any NAAT platform. This study compares the analytical performance of self-collected extragenital specimens to that of clinician-collected specimens. We performed a multicenter/multiplatform validation study as a National Veterans Health Administration Pathology and Laboratory Medicine quality improvement project, with 9 different participating sites. Self-collected specimens were obtained at the same time as clinician-collected specimens. Clinician-collected specimens were used as the gold standard to evaluate the sensitivity and specificity of self-collection. A total of 2324 individual tests were analyzed (501 rectal and 661 oropharyngeal). The sensitivity was 94.44% for CT and 100% for NG for rectal specimens, whereas it was 100% for CT and 97.22% for NG for oral specimens. Specificity for oral specimens was 99.85% for CT and 99.36% for NG, whereas for rectal specimens, it was 99% for CT and NG. Self-collected specimens for extragenital CT/NG testing are highly sensitive and specific, with negative predictive values of 100%. Self-collection has the potential to overcome a major barrier for STI screening by providing an accessible, convenient, and patient-centered alternative.

A comparative study of self-collected versus clinician-collected specimens in detecting high-risk HPV infection: a prospective cross-sectional study.

The primary objective of this study was to compare the detection rate of high-risk human papillomavirus (HPV) infection between self-sampling to collect vaginal specimens and clinician sampling to collect cervical specimens, as well as the correlation between the two techniques. The secondary objective was to assess satisfaction with self-sampling for HPV testing. From October 2021 to September 2022, women positive for HPV 16/18 and other 12 high-risk HPV genotypes and cytological ASCUS were enrolled. All participants were instructed on the method for self-collection of HPV samples. Self-collected vaginal samples and clinician-collected cervical samples were subjected to HPV DNA typing. Paired self- and clinician-collected specimens were obtained from 104 women with positive HPV-positive results. The detection rate of high-risk HPV infection was comparable between the two techniques: 79/98 (80.6%) vs. 81/98 (82.7%) for the self-sampling and clinician-sampling techniques, respectively (McNemar's test; P=0.774). The agreement in detecting HPV infection was substantial, with a kappa coefficient of 0.75. More than 90% of the participants rated self-collection as satisfactory to very satisfactory because of its convenience and safety. Regarding methods of further follow-up, 51% of the participants chose self-sampling, whereas the remaining participants preferred collection by clinicians. No intervention-related complications were observed. The self-sampling technique for HPV testing was as effective as the clinician-sampling technique, and both techniques were substantially correlated in detecting high-risk HPV infection. The self-sampling method appears to be highly satisfactory and may provide better compliance for the detection of cervical HPV infection.

The Utility of an Human Papillomavirus Genotype Assay for Cancer Screening in Self-Collected Urine and Vaginal Samples from Japanese Women

Objectives: The high incidence of invasive cervical cancer among those who have not undergone cancer screening is a serious problem. This study aimed to investigate the utility of human papillomavirus (HPV) test results from self-collected urine and vaginal samples as screening tools. Design: The study was conducted in two steps. First, the appropriate storage container, temperature, and time until urine HPV assay performance were verified. Second, the results of spot urine testing under those conditions and of gynecologist-collected cervical and self-collected vaginal samples were compared to verify the feasibility of using the BD Onclarity® HPV assay for individuals with abnormal cervical cytology. Participants/Materials, Setting, Methods: The participants were 121 women with abnormal cervical cytology. Self-collected urine and vaginal samples, along with gynecologist-collected cervical samples, were tested for HPV using the BD Onclarity® HPV assay. The optimal conditions for urine sample storage were identified by comparing the HPV detection rates under various conditions. Results: Urine stored in a BD Probe Tec™ (QxUPT) for less than 72 h at room temperature was found to have the highest HPV positivity rate. Under these conditions, the detection rates of HPV in urine, cervical, and vaginal samples were examined. HPV type 16 was detected in 41.7% of the cervical samples, type 18 in 10%, and types 31 and 52 in 12.6% each. The concordance rate for HPV testing between clinician-collected cervical and urine samples was 63.9% (kappa: 0.34; 95% CI: 0.21–0.47), and that between clinician-collected cervical and self-collected vaginal samples was 77.8% (kappa: 0.68; 95% CI: 0.53–0.83), indicating good concordance. In a population with an HPV-related lesion/tumor prevalence of approximately 70%, the sensitivity of HPV testing was 82.7% for the cervix, 46.4% for urine, and 75.7% for vaginal samples. Limitations: The primary limitation is the lower detection rate of HPV in spot urine samples than in other sample types, indicating room for methodological improvement. The study’s findings are based on a specific population, which may limit generalizability. Conclusions: We investigated the optimal self-collected urine-to-testing time and temperature. Self-collected vaginal and urine HPV tests show moderate-high concordance with clinician-collected cervical HPV tests, suggesting their potential utility for women who do not undergo regular cancer screening. However, the sensitivity was not high in spot urine. Therefore, further large-scale studies are needed to verify these findings and optimize testing methods to encourage broader participation in cancer screening programs.

Ransomware Reloaded: Re-examining Its Trend, Research and Mitigation in the Era of Data Exfiltration

Ransomware has grown to be a dominant cybersecurity threat by exfiltrating, encrypting, or destroying valuable user data and causing numerous disruptions to victims. The severity of the ransomware endemic has generated research interest from both the academia and the industry. However, many studies held stereotypical assumptions about ransomware, used unverified, outdated, and limited self-collected ransomware samples, and did not consider government strategies, industry guidelines, or cyber intelligence. We observed that ransomware no longer exists simply as an executable file or limits to encrypting files (data loss); data exfiltration (data breach) is the new norm, espionage is an emerging theme, and the industry is shifting focus from technical advancements to cyber governance and resilience. We created a ransomware innovation adoption curve, critically evaluated 212 academic studies published during 2020 and 2023, and cross-verified them against various government strategies, industry reports, and cyber intelligence on ransomware. We concluded that many studies were becoming irrelevant to the contemporary ransomware reality and called for the redirection of ransomware research to align with the continuous ransomware evolution in the industry. We proposed to address data exfiltration as priority over data encryption, to consider ransomware in a business-practical manner, and recommended research collaboration with the industry.

A-240 Validation of the OSOM Flu SARS-CoV-2 Combo Home Test

Abstract Background COVID-19 and Influenza respiratory infections often cause similar symptoms, however, treatment is different for each infection. Delay in diagnosis can be fatal in some cases, therefore rapid detection and differentiation are critical for appropriate medical treatment. The OSOM Flu SARS-CoV-2 Combo Home Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2 and influenza A/B proteins using self-collected anterior nasal swab samples (self-collection is only recommended for those 14 years of age and older). An interpretation card, included with the test, is used to reliably distinguish among possible testing results. Methods A prospective study was conducted at multiple geographically distinct sites in the U.S during the 2023-2024 season for the validation of the OSOM Flu SARS-CoV-2 Combo Home Test to detect SARS-CoV-2/Flu A/Flu B in self-collected anterior nasal swab samples. The study evaluated the performance in symptomatic individuals only. A total of 703 prospective samples were evaluable for SARS. For Flu A/B, four additional subject samples were unevaluable due to comparator results not being available and a total of 699 samples were included in the data analysis. The comparator tests were FDA 510(k)-cleared molecular assays. Results Influenza A was detected with a sensitivity of 93.1% (95% CI: 84.8%-97.0%) and a specificity of 99.5% (95% CI: 98.6% - 99.8%). Influenza B was detected with a sensitivity of 89.1% (95% CI: 77.0% - 95.3%) and a specificity of 99.7% (95% CI: 98.9% - 99.9%). SARS CoV-2 was detected with a sensitivity of 87.0% (95% CI 78.6% - 92.4%) and a specificity of 99.1% (95% CI: 97.9% - 99.6%) when Ct values are standardized and 10% of samples are considered low positives, having a Ct value of ≥ 30. Conclusions With respiratory infections often showing indistinguishable symptoms and the possibility of co infection, lowering the testing hurdles for individuals to be able to perform a rapid differential test at home without the aid from a healthcare worker is the most effective way to mitigate spread and patient management from a public health perspective. Comparing the OSOM Flu SARS-CoV-2 Combo Home test to the FDA cleared comparators in a clinical setting, the OSOM Flu SARS-CoV-2 Combo Home test retains acceptable sensitivity and specificity. Using self-collected anterior nasal swabs which are minimally invasive alongside the low cost of a lateral flow immunochromatographic assay remains the most effective way to perform the serial screening testing recommended by the CDC in situations where transmission and severe outcome risk is high.

A-319 Capillary Blood Collection for Egg-cellent Reproductive Insights

Abstract Background In the United States, an estimated 13% of women between the ages of 15 and 49 years, experience impaired reproductive potential (fecundity). Assessment of fecundity typically requires an in-person physician visit and venous blood collection to evaluate hormone levels and identify potential reproductive health conditions. Exploring less invasive, at-home sampling options could offer couples insights into their personal reproductive abilities, providing peace of mind and aiding in family planning. Methods Capillary blood, obtained using the Tasso®+ capillary blood collection device coupled with a BD Microtainer® serum tube, was utilized for measurements of analytes associated with female fecundity (follicle stimulating hormone, luteinizing hormone, estradiol, progesterone, anti-Müllerian hormone, and prolactin). These are all FDA-approved assays measured on Roche cobas® e801, assay parameters remained unchanged. Professional and self-collected capillary serum samples were acquired in parallel with the standard venous serum samples, to compare clinical equivalency of the capillary sampling option. In addition to isothermal stability studies at room temperature (20-25°C) and refrigerated (2-8°C) conditions, shipping excursion studies based on ISTA 7D recommendations were performed using a novel packaging solution to control sample temperature and thus, specimen integrity. Studies to assess matrix equivalency, linearity, and imprecision of this alternate sample type were also performed to demonstrate analytical performance. Results Method comparison of venous and professional collection of capillary samples demonstrated correlations (R) ≥ 0.9720 with slopes ranging from 0.919 to 0.971 and mean biases within ±8.2% for all analytes (n = 19-79). Self-collected capillary serum samples demonstrated correlations (R) ≥ 0.9827 with slopes that ranged from 0.841 to 0.985 and mean biases within ±10.7% (n = 16-26). Isothermal stability was demonstrated for each analyte up to 7 days at room temperature and refrigerated conditions. Simulated shipping excursion results were found to be acceptable for both winter and summer conditions with mean biases for each analyte within ±10.2% and ±19.2%, respectively. Matrix equivalency, linearity, and imprecision results adhered to current CLIA acceptance limits for each respective measurement. Conclusions The analytical and stability results affirm the feasibility of collecting capillary serum in a patient-centric manner, providing women with relevant information about their reproductive health.

B-192 Covid on the PCR Pro: a consumer-friendly PCR test

Abstract Background The emergence of COVID-19 highlighted the need for rapid and accurate diagnostic solutions that can be deployed on a broad scale. The complexity and long turn-around-time of PCR testing typically performed in molecular laboratories is not compatible with community-wide screening. To overcome these challenges, we present the Co-Dx PCR Pro™, a rapid and simple test platform developed for self-collection and at-home use. The instrument is controlled from the user’s smartphone or tablet and performs sample treatment, RT-PCR, and DNA melting analysis. An automatic calling algorithm provides a simple, “Detected,” or, “Not detected,” result. We demonstrate the utility of this platform using a test for the detection of SARS-COV-2. Methods A self-collected anterior nasal swab sample and 2 mLs of water are added to the collection cup. Closing the lid of the cup initiates rehydrating a dried Proteinase K mixture to digest proteins in the sample. After a brief Proteinase K heat-kill step, the instrument mixes the sample with a dried PCR master mix. Primers target two SARS-COV-2 specific genes (RdRp and E gene) and the human RNase P gene as a control. The sample undergoes an RT step followed by 45 cycles of PCR and DNA melting analysis. Detection is by an automatic calling algorithm that identifies a SARS-COV-2 amplicon melting peak at 82°C and RNase P peak at 87°C. The total runtime is less than 30 minutes. The limit of detection for the assay was assessed by contriving intact virus in negative sample matrix, which was then applied to dry swabs. In addition, frozen and banked clinical samples were tested using the Logix Smart®™ Covid-19 test as a comparator assay. A third party performed a usability assessment by having (1) naïve users follow the instructions and self-administer the test (2) expert trained users perform an independent assessment of the assay. Participants were then asked to complete a usability assessment. Results The 95% limit of detection was 2,100 copies/swab using contrived nasal swabs. Clinical samples were blinded to the operator and run on the platform. All samples resulted in a diagnosis concordant with the comparator assay. The usability assessment was performed by six naïve users and resulted in a systems usability scale score of “Best” (84.2 ± 14.3, out of 100). The two expert users determined an 80% limit of detection of 700 genome equivalents and “ease of use,” and “satisfaction,” scores of 4.5/5.0 and 5.0/5.0, respectively. Conclusions Performance of the PCR Pro platform is on par with laboratory-based PCR testing. The benefits of our assay are its speed and the low complexity platform accessible to the lay. This platform could improve access to molecular diagnostic testing, including use at home. Future expansion to include common respiratory pathogens (Flu, RSV, Strep) will increase utility. Additionally, anonymized results can be aggregated and provide a wealth of epidemiological information at the community level to better inform public health initiatives and health outcomes.

Human papillomavirus self-sampling and urine-sampling tests and the management and short-term outcomes of cervical intraepithelial neoplasia: A prospective observational study.

The importance of human papillomavirus (HPV) co-testing using physician-, self-, and urine-collected samples to predict cervical intraepithelial neoplasia (CIN) grade 1-2 prognoses has not been previously reported. Therefore, this study aimed to investigate outcomes of patients with CIN 1-2 who simultaneously underwent physician-, self-, and urine-collection sampling tests. This study was conducted in Japan between October 2019 and November 2022 and examined the proportion of cases with CIN 1-2 progressions, the percentage of cases with persistent CIN 1-2, and the outcome differences according to the results of physician-, self-, and urine-sampling tests. There were 105 and 59 CIN 1 and 2 cases, respectively, with progression or persistence in 27 (29.3%) and 21 (50.0%) cases, respectively. The median follow-up was 20 and 12 months, respectively. Progression and persistence of CIN 1 were significantly associated with HPV-positive physician- and self-collected samples. No significant difference was observed between cases with CIN 2 who had HPV-positive and HPV-negative results using any sampling method. Physician- and self-testing for HPV are crucial for predicting disease progression risk in CIN 1 cases. Future research with an extended observation period and consideration of the progression risks is warranted.

Cohort profile: an observational population-based cohort study on COVID-19 vaccine effectiveness in the Netherlands – the VAccine Study COVID-19 (VASCO)

PurposeVAccine Study COVID-19 (VASCO) is a cohort study with a 5-year follow-up that was initiated when COVID-19 vaccination was introduced in the Netherlands. The primary objective is to estimate real-world...

Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples

BackgroundThe VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated. Methods490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5mL of eNAT medium, whilst cervical brushings were immediately transferred in 20mL ThinPrep. ResultsThe clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95% CI 0.94-1.05] and 1.00 [95% CI 0.96-1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for <CIN2 on both self-samples was lower than on cervical samples (urine/cervical ratio = 0.91 [95% CI 0.84-0.98]; vaginal/cervical ratio = 0.90 [95 % CI 0.84-0.98]). Cut-off optimisation improved specificity without compromising sensitivity. Median viral load values adjusted for cellularity were significantly higher in cervical samples compared to urine or vaginal self-samples, in general for all 12 high-risk HPV and in particular for HPV16, 18, 31, 33, 35, 45, 51, 58 (p<0.05). No difference was observed in median viral loads between urine and vaginal samples. ConclusionFollowing cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.

Comparative evaluation of swabbing sites for Omicron variant detection in PCR testing

PurposeThe Omicron variant of SARS-CoV-2 raised concerns about the best sampling sites for PCR testing, with early indications suggesting throat swab samples were better than nasal swab samples. Our study evaluated the sensitivity of detecting SARS-CoV-2 across different swabbing sites. MethodsParticipants undergoing testing at NHS Test and Trace sites in England provided self-collected samples using nose only, throat only, and combined nose and throat swabs, which were analysed by realtime PCR. ResultsAmong 815 participants, combined swabs had higher viral concentrations than nose or throat only swabs. Sensitivity was 91% for nose only and 97% for throat only, relative to the combined approach. VC remained stable in nose swabs but declined in throat swabs with time. ConclusionsCombined nose and throat swabs are the most effective for SARS-CoV-2 detection, including Omicron, though individual swabs are viable alternatives. VC variations highlight the importance of sampling sites for accurate diagnosis.

Comparative Analysis of HPV Detection Efficiency: Evaluating Cobas 8800 Performance in Vaginal Self-Sampling versus Clinician-Collected Samples at a Regional Thai Hospital

Background: This study, conducted at a regional Thai hospital, assesses the comparative efficacy of self-collected versus clinician-collected samples for HPV detection using the Cobas 8800 system among Thai women aged 30–60. Methods: Our methodology involved analyzing 1541 self-collected and 1398 clinician-collected samples. Results: The results show a statistically significant mean difference in cycle threshold (Ct) values favoring clinician-collected samples (1.53; 95% CI: 1.18–1.87, p &lt; 0.0001). This pattern was consistent across various age groups, with the most pronounced differences noted in the oldest cohort (50–59 years), suggesting higher detection efficiency in clinician-collected samples. The study further explored the correlation of Ct values with cytological and histological outcomes, where clinician-collected samples demonstrated superior diagnostic performance, particularly in identifying LSIL and HSIL conditions, evidenced by AUC values of 0.793 and 0.866, respectively. While self-sampling remains a viable method, with sensitivity reaching up to 48.84% for LSIL and 46.15% for HSIL, clinician collection proved more accurate, likely influencing future national screening policies. Conclusions: This work underscores the need for robust sample collection methods and the importance of ongoing enhancements to self-sampling assays and techniques to ensure their efficacy in cervical cancer screening programs.

Colonisation by multidrug-resistant organisms in health workers in primary care: narrow spectrum oral antimicrobials are a risk factor.

Limited information exists on carriage of multidrug-resistant organisms (MDRO) by health workers (HWs) in primary care settings. This study aims to determine the prevalence of MDRO carriage among HWs in primary care and to identify associated risk factors. A cross-sectional study was conducted across all 12 primary care units in São Caetano do Sul-SP, Brazil, from October to December 2023. Self-collected samples (nasal, oropharyngeal, and inguinal) were obtained. Environment cultures (potable water, sewage and stream water) were evaluated. Stenotrophomonas maltophilia isolates (human and environmental) were typed. The study included 265/288 (92%) of HWs in primary care teams, mostly women with a median age of 47years (IQR 38-57); 78% had no comorbidities. MDRO colonisation was found in 8.7% (23 HWs). The following bacteria were found: S. maltophilia (n = 9; 3.4%) in inguinal swabs; methicillin-resistant Staphylococcus aureus (n = 8; 3%) from all sites; extended-spectrum ß-lactamase-producing bacteria (n = 5; 2%) in inguinal swabs; and vancomycin-resistant enterococci in an inguinal swab (n = 1; 0.4%). Previous antibiotic use was significantly associated with MDRO colonisation (OR 2.91, 95% CI 1.19-7.09, p = 0.018), mainly narrow spectrum oral beta-lactams and macrolides. S. malthophilia was polyclonal and human and environmental isolates differed. Colonisation by MRSA, VRE, and ESBL-producing bacteria was low; however, 4% were surprisingly colonized by polyclonal S. maltophilia. This pathogen may also suggest using narrow-spectrum rather than the expected broad-spectrum antimicrobials. Antibiotic use was the only risk factor found, mainly with oral narrow-spectrum drugs.

Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial.

HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention. The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing. Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. DERR1-10.2196/56587.