Overcoming analytical and preanalytical challenges associated with extragenital home collected STI specimens.

Home sample collection for sexually transmitted infection (STI) screening options can improve access to sexual healthcare across communities. For Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), genital infections have classically been the focus for remote collection options. However, infections may go undiagnosed if sampling is limited to urogenital sites because some individuals only participate in oral and/or anal intercourse. Here we evaluated samples for CT/NG detection after several pre-analytical collection challenges. A paired provider to self-collection validation was performed on rectal [n = 162; 22 + for CT and 9 + for NG by provider-collected (PC)] and throat (N = 158; 2 + for CT and 11 + for NG by provider-collected) swabs. The positive percent agreement for CT and NG ranged from 90.9% to 100%. The discrepancies were more often positive on self-collected (SC) (n = 9 SC+/PC-; n = 1 PC+/SC-; n = 1 PC+/SC Equiv.; n = 2 PC-/SC Equiv.). An empirical limit of detection (LoD) lower than the manufacturer's claim (0.031 vs 2.5 IFU/mL for CT and 0.063 vs 124.8 CFU/ml for NG, respectively) was used to challenge additional variables. Common hand contaminants, including soap, hand sanitizer, lotion, and sunscreen were added to known positive (3× empirical LoD) or negative samples and did not influence detection. Samples at 2× and 10× the empirical LoD were challenged with extreme temperature cycling and extended room temperature storage. Detection was not affected by these conditions. These results indicate that remote self-collection is an appropriate method of sample acquisition for detecting extragenital CT/NG infections. Additionally, they provide a foundation towards meeting the regulatory standards for commercial testing of home collected extragenital samples. IMPORTANCE: There is a clinical need for expanded extragenital bacterial sexually transmitted infection (STI) testing options, but the current regulatory landscape limits the wide-spread promotion and adoption of such services. Improved access, particularly for the LGBTQ+ community, can be achieved by validating testing for specimens that are self-collected at a remote location and arrive at the laboratory via a postal carrier or other intermediary route. Here we provide valuable data showing that self-collected samples for anal and oropharyngeal STI testing are equally or increasingly sensitive compared with those collected by a provider. We systematically consider the effects of storage time, exposure to temperature extremes, and the addition of common toiletries on results.

Diagnostic performance, stability, and acceptability of self-collected saliva without additives for SARS-CoV-2 molecular diagnosis.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused the coronavirus disease 2019 (COVID-19), leading to a global pandemic. The molecular diagnosis of this virus is mostly performed by collecting upper respiratory samples, which has many disadvantages, including patient discomfort and the need for trained healthcare professionals. Although saliva has emerged as a more comfortable sample, the use of additives to preserve viral RNA is expensive and, in some cases, difficult for self-collection. METHOD: This study evaluated the diagnostic performance by RT-PCR and stability of self-collected saliva using wide-mouth specimen collection cups without stabilization and/or inactivation buffers for SARS-CoV-2 detection, compared to nasopharyngeal samples and saliva collected with additives. Additionally, the study assessed the acceptability of this sample collection method among participants and healthcare personnel. RESULTS: The study included 1281 volunteers with a 24.6% positive infection rate. Saliva demonstrated comparable diagnostic performance to nasopharyngeal samples, with a sensitivity of 87.6% and specificity of 99.6%, for a total percent agreement of 96.4%. The study also showed that viral RNA in saliva remained stable for at least 72 h at different temperatures. Notably, saliva samples without additives exhibited a lower RdRp Ct compared to samples with additives, suggesting that the absence of stabilization and/or inactivation buffers does not significantly affect its performance. The study highlighted the acceptability of saliva among patients and healthcare personnel due to its noninvasive nature and ease of collection. CONCLUSIONS: This research supports the implementation of self-collected saliva as a comfortable and user-friendly alternative sample for SARS-CoV-2 diagnosis.

Sexual behavior stigma and HIV/STI biospecimen self-collection among cisgender gay, bisexual, and other sexually minoritized men in the United States.

INTRODUCTION: Disparities in HIV and other sexually transmitted infections (STIs) persist among cisgender sexually minoritized men in the United States, driven in part by sexual behavior stigma, which is a barrier to clinic-based HIV/STI testing. HIV/STI biospecimen self-collection (HSBS) is a novel testing approach that mitigates stigma by allowing for some testing-related procedures to be conducted by oneself in one's home or any private location rather than a facility that requires interpersonal interactions and exposure to other members of the public. HSBS has demonstrated acceptability, feasibility, and effectiveness in testing uptake, but the extent to which stigma persists in HSBS and the quantification of stigma's role in HSBS is limited. METHODS: From 2019-2020, a nationwide sample of sexually minoritized men completed an online biobehavioral survey. Those who agreed to be recontacted (N = 4147) were invited to participate in HSBS; consented participants received self-collection kits that were laboratory-tested if completed. Sexual behavior stigma and HSBS associations were assessed with logistic regression. RESULTS: Mean age of participants was 35 years, 58% (2421/4147) were non-Hispanic white, 82% (3391/4147) were gay-identifying, 47% (1967/4147) had at least a college degree, and 56% (2342/4147) earned ≥ $40,000 annually; 27% (1112/4147) expressed HSBS interest, and 67% (689/1034) completed HSBS. HSBS interest and completion were less common among non-Hispanic Black sexually minoritized men and sexually minoritized men of lower socioeconomic status. Stigma from family and friends was significantly, negatively associated with HSBS interest (aOR = 0.72, 95% CI = 0.56, 0.93). Among those who had not tested for HIV/STIs in the past year, anticipated healthcare stigma was marginally, negatively associated with HSBS completion (aOR = 0.40, 95% CI = 0.15, 1.07). Among those who had never previously tested for HIV/STIs, anticipated healthcare stigma was significantly, negatively associated with HSBS interest (aOR = 0.32, 95% CI = 0.14, 0.72). CONCLUSIONS: Sexual behavior stigma persists as an HIV/STI testing barrier, even in the case of HSBS, limiting its utilization. Increasing HSBS among sexually minoritized men in the US necessitates stigma mitigation efforts that directly address equity in implementation.

HPV self-collection for cervical cancer screening among survivors of sexual trauma: a qualitative study.

Intimate partner violence affects 20-30% of women in the United States. Disparities in routine cervical cancer surveillance have been demonstrated in certain populations, including victims of intimate partner violence (IPV). This study examined and assessed the acceptability of high-risk HPV (hrHPV) self-collection among individuals who have experienced IPV. We conducted an observational study using qualitative data collection and analysis. We interviewed individuals with a history of IPV and who currently reside in Oregon. This study identified key themes describing knowledge and attitudes towards cervical cancer screening for individuals who have experienced IPV. They include: guideline knowledge, prior office-based cervical cancer screening experience, barriers to cervical cancer screening, at-home hrHPV self-collection experience, and testing confidence. Participants experienced fewer barriers and expressed increased comfort and control with hrHPV self-collection process. Individuals with a history of IPV have lower rates of cervical cancer screening adherence and higher rates of cervical dysplasia and cancer than other populations. The patient-centered approach of hrHPV self-collection for cervical cancer screening can reduce barriers related to the pelvic exam and empower patients to reduce their risks of developing cervical cancer by enabling greater control of the testing process.

The acceptability of, and informational needs related to, self-collection cervical screening among women of Indian descent living in Victoria, Australia: A qualitative study.

BACKGROUND: In July 2022, self-collection became universally available as part of Australia's National Cervical Screening Program. This change aims to address screening inequities experienced among underscreened populations, including women of Indian descent. This study explored experiences of cervical screening, alongside the acceptability of self-collection, among women of Indian descent living in Victoria, Australia. We also aimed to articulate the informational needs to promote self-collection among this population. METHODS: Five focus group discussions with 39 women living in Victoria were conducted in English (n = 3) and Punjabi (n = 2). Transcripts were thematically analysed, as informed by the Theoretical Framework of Acceptability. RESULTS: Women were motivated by the choice to self-collect, perceiving the ability to maintain modesty and greater autonomy as key enablers. Healthcare practitioners were seen as central in supporting patient-centred models of care. Perceived barriers to self-collection included concerns around its accuracy and women's confidence in collecting their own sample. Widespread dissemination of culturally tailored promotion strategies communicating concepts such as 'privacy' and 'accuracy' were suggested by women to promote self-collection. CONCLUSION: Self-collection was highly acceptable among women of Indian descent, particularly when assured of its accuracy, and sociocultural norms and previous screening experiences are considered. This study highlights the huge potential that self-collection can play in increasing equity in Australia's cervical screening programme. PATIENT OR PUBLIC CONTRIBUTION: Members of the public were involved in focus group discussions. Findings were summarised and disseminated via a poster. A bicultural worker was involved in all stages of the research.

Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial.

Cervical cancer remains a significant public health burden in low-resourced countries. Thus, the WHO prioritized cervix screening, and recently recommended thermal ablation treatment for cervical precancer. However, there is limited information on side effects during treatment and recovery, and acceptability among those treated. The ASPIRE Mayuge trial recruited women to participate in self-collection cervix screening between 2019 and 2020 (N = 2019). Screen-positive women (N = 531, 26.3%) were referred for visual inspection with acetic acid and thermal ablation treatment, per Uganda Ministry of Health recommendations; 71.2% of those referred attended follow-up. Six months post-screening, a subset of trial participants were recontacted. Those who received thermal ablation completed a survey assessing side effects during and after the procedure, and willingness to recommend the treatment to others. We summarized the results to describe the side effects and acceptability of thermal ablation treatment. Of 2019 participants, 349 (17%) received thermal ablation. A subset of 135 completed the follow-up survey, where 90% reported pain during treatment; however, intensity and duration were low. Over a third of women reported problems with recovery for reasons including pain, discharge and bleeding. Regardless, 98% reported they would recommend the treatment to others. The use of thermal ablation to treat cervical precancer appears to be highly acceptable in this population. While many women reported side effects during the procedure and recovery, the majority said they would recommend the treatment to others. However, given the substantial proportion who reported problems with recovery, efforts should be made to provide additional resources to women after receiving thermal ablation treatment for cervical precancer.

Widening the offer of human papillomavirus self-sampling to all women eligible for cervical screening: Make haste slowly.

Self-collection of samples for human papillomavirus (HPV) testing has the potential to increase the uptake of cervical screening among underscreened women and will likely form a crucial part of the WHO's strategy to eliminate cervical cancer by 2030. In high-income countries with long-standing, organised cervical screening programmes, self-collection is increasingly becoming available as a routine offer for women regardless of their screening histories, including under- and well-screened women. For these contexts, a validated microsimulation model determined that adding self-collection to clinician collection is likely to be cost-effective on the condition that it meets specific thresholds relating to (1) uptake and (2) sensitivity for the detection of high-grade cervical intraepithelial neoplasia (CIN2+). We used these thresholds to review the 'early-adopter' programme-level evidence with a mind to determine how well and how consistently they were being met. The available evidence suggested some risk to overall programme performance in the situation where low uptake among underscreened women was accompanied by a high rate of substituting clinician sampling with self-collection among well-screened women. Risk was further compounded in a situation where the slightly reduced sensitivity of self-sampling vs clinician sampling for the detection of CIN2+ was accompanied with lack of adherence to a follow-up triage test that required a clinician sample. To support real-world programmes on their pathways toward implementation and to avoid HPV self-collection being introduced as a screening measure in good faith but with counterproductive consequences, we conclude by identifying a range of mitigations and areas worthy of research prioritisation.

Self-sampling of blood using a topper and pediatric tubes; a prospective feasibility study for PSA analysis using 120 prostate cancer patients.

OBJECTIVES: Self-collection of blood for diagnostic purposes by blood collection assist devices (BCAD) has gained a lot of momentum. Nonetheless, there are a lack of studies demonstrating the feasibility and reliability of self-collecting capillary blood for routine (immuno)chemistry testing. In this study we describe the topper technology together with pediatric tubes to enable self-collection of blood and investigated its feasibility for PSA testing by prostate cancer patients. METHODS: A total of 120 prostate cancer patients for which a routine follow-up PSA test was requested, were included in this study. Patients received instruction materials and the blood-collection device consisting of a topper, pediatric tube and base-part, and performed the blood collection procedure themselves. Afterwards a questionnaire was filled-in. Finally, PSA was measured on a Roche Cobas Pro. RESULTS: The overall self-sampling success rate was 86.7 %. Furthermore, when specified per age category, a 94.7 % success rate for patients under 70 years and a 25 % success rate for patients of 80 years and older was observed. Venous and self-collected PSA were highly comparable when analyzed by Passing-Bablok regression with a slope of 0.99 and intercept of 0.00011, Spearmans correlation coefficient (0.998) and average self-collected PSA recovery of 99.8 %. CONCLUSIONS: Evidence is presented that self-collected capillary blood by topper and pediatric tube from the finger is feasible, particularly for patients under 70 years. Furthermore, capillary blood self-sampling did not compromise any of the PSA test results. Future validation in a real-world setting, without supervision and including sample stability and logistics, is required.

Application an internet facilitation in a community-based cervical cancer screening project.

OBJECTIVE: To evaluate the feasibility of an internet-facilitated community model for cervical cancer screening using self-collected HPV testing as primary screening. METHOD: A population-based cervical cancer screening program was conducted in the suburb of Shenzhen, China, from September 2014 to July 2017. Women with 25-60 years of age and no pregnancy were eligible for participation. Participants could register for screening by logging in a website by themselves or with the aids of local community workers. A unique barcode was issued to each applicant upon successful registration. After registration, women could get sampling kits from community screening site/study clinic, collect vaginal samples privately or in group, and provide their sample for Hr-HPV tests on Cobas4800 and SeqHPV assays. Testing reports were checkable through personal account for all participant and phone calls were given to all women positive of Hr-HPV. Participants positive of both or either the 2 assays were identified as the positives. The positives could return the study clinic for triage or search medical care in other clinics. Colposcopy directed or ramdom biopsies were performed on all positives who returned to the study clinics. RESULTS: A total of 10,792 community women registered for screening, among whom, 10,010 provided their vaginal samples for tests. 99.5% of the participants were confirmed to have correct personal identifiable information and samples, and 98.9% of them got HPV testing results from both or either assays. No adverse event was reported. CONCLUSION: When self-collected HPV testing is used as the primary testing, the internet-based data platform facilitates the screening in registration, data collection, and data tracking, and increases the screening coverage. Internet-facilitated community model is promising to cervical cancer control and applicable in regions with variety of resources.

Implementation of an mHealth intervention to increase adherence to triage among HPV positive women with HPV-self-collection (ATICA study): post-implementation evaluation from the women's perspective.

BACKGROUND: Low adherence to triage after positive screening is a widespread problem for cervical cancer screening programs in Low- and Middle-income Countries. Adherence to cytology-based triage can be challenging, especially among women with self-collected tests. SMS-based interventions are accepted by women and can increase screening uptake. The ATICA study was an effectiveness-implementation hybrid type I trial, combining a cluster randomized controlled trial (RCT) with a mixed-methods implementation evaluation involving quantitative and qualitative methods. Although the RCT provided evidence regarding the effectiveness of the SMS-based intervention, less is known about its acceptability, relevance, and usefulness from the women´s perspective. METHODS: We carried out a cross-sectional study based on a structured questionnaire among HPV-positive women who were enrolled in ATICA's intervention group. We measured acceptability, appropriateness, and message content comprehension. Also, we evaluated if the SMS message was considered a cue to encourage women to pick up their HPV test results and promote the triage. RESULTS: We interviewed 370 HPV-positive women. Acceptability of SMS messages among women who had received at least one message was high (97%). We found high levels of agreement in all appropriateness dimensions. More than 77% of women showed high comprehension of the content. Among women who received at least one SMS message, 76% went to the health center to pick up their results. Among those who got their results, 90% reported that the SMS message had influenced them to go. We found no significant differences in acceptability, appropriateness or message comprehension between women who adhered to triage and those who did not adhere after receiving the SMS messages. CONCLUSION: The intervention was highly acceptable, and women reported SMS was an appropriate channel to be informed about HPV test results availability. SMS was also a useful cue to go to the health center to pick up results. The implementation did not encounter barriers associated with the SMS message itself, suggesting the existence of other obstacles to triage adherence. Our results support the RCT findings that scaling up SMS is a highly acceptable intervention to promote cervical screening triage adherence.

Implementation and scaling-up of an effective mHealth intervention to increase adherence to triage of HPV-positive women (ATICA study): perceptions of health decision-makers and health-care providers.

BACKGROUND: The ATICA study was a Hybrid I type randomized effectiveness-implementation trial that demonstrated effectiveness of a multicomponent mHealth intervention (Up to four SMS messages sent to HPV-positive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive-test), to increase adherence to triage of HPV positive women (ATICA Study). We report data on perceptions of health decision-makers and health-care providers regarding the intervention implementation and scaling-up. METHODS: A qualitative study was carried out based on individual, semi-structured interviews with health decision-makers (n = 10) and health-care providers (n = 10). The themes explored were selected and analyzed using domains and constructs of the Consolidated Framework for Implementation Research (CFIR) and the maintenance dimension of the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. RESULTS: Both health-care providers and decision-makers had a positive assessment of the intervention through most included constructs: knowledge of the intervention, intervention source, design quality, adaptability, compatibility, access to knowledge and information, relative advantage, women's needs, and relative priority. However, some potential barriers were also identified including: complexity, leadership engagement, external policies, economic cost, women needs and maintenance. Stakeholders conditioned the strategy's sustainability to the political commitment of national and provincial health authorities to prioritize cervical cancer prevention, and to the establishment of the ATICA strategy as a programmatic line of work by health authorities. They also highlighted the need to ensure, above all, that there was staff to take Pap tests and carry out the HPV-lab work, and to guarantee a constant provision of HPV-tests. CONCLUSION: Health decision-makers and health-care providers had a positive perception regarding implementation of the multicomponent mHealth intervention designed to increase adherence to triage among women with HPV self-collected tests. This increases the potential for a successful scaling-up of the intervention, with great implications not only for Argentina but also for middle and low-income countries considering using mHealth interventions to enhance the cervical screening/follow-up/treatment process.

The early impacts of primary HPV cervical screening implementation in Australia on the pathology sector: a qualitative study.

BACKGROUND: The transition of Australia's National Cervical Screening Program from cytology to a molecular test for human papillomavirus (HPV) (locally referred to as the 'Renewal'), including a longer five-year interval and older age at commencement, significantly impacted all sectors of program delivery. The Renewal had major implications for the roles and requirements of pathology laboratories providing services for the Program. This study aimed to understand the early impacts of the Renewal and its implementation on the pathology sector. METHODS: Semi-structured qualitative interviews were conducted with key stakeholders (N = 49) involved in the STakeholder Opinions of Renewal Implementation and Experiences Study (STORIES), 11-20 months after the program transition. A subset of interviews (N = 24) that discussed the pathology sector were analysed using inductive thematic analysis. RESULTS: Four overarching themes were identified: implementation enablers, challenges, missed opportunities, and possible improvements. Participants believed that the decision to transition to primary HPV screening was highly acceptable and evidence-based, but faced challenges due to impacts on laboratory infrastructure, resources, staffing, and finances. These challenges were compounded by unfamiliarity with new information technology (IT) systems and the new National Cancer Screening Register ('Register') not being fully functional by the date of the program transition. The limited availability of self-collection and lack of standardised fields in pathology forms were identified as missed opportunities to improve equity in the Program. To improve implementation processes, participants suggested increased pathology sector involvement in planning was needed, along with more timely and transparent communication from the Government, and clearer clinical management guidelines. CONCLUSION: The transition to primary HPV screening had a significant and multifaceted impact on the Australian pathology sector reflecting the magnitude and complexity of the Renewal. Strategies to support the pathology sector through effective change management, clear, timely, and transparent communication, as well as adequate funding sources will be critical for other countries planning to transition cervical screening programs.

Perceptions and implications for cervical screening and self-collection: A qualitative exploration of never and under-screened Queensland women.

BACKGROUND: Over 70% of cervical cancers are detected in women not currently screening. Queensland Health wanted to better understand the drivers of screening to inform our planning and capitalise on self-collection as an option to reach under-screened women. In 2020 Queensland Health commissioned qualitative research to explore barriers and enablers to cervical screening with never-screened and under-screened women in Queensland (with under-screeners defined as having last screened more than 4 years ago and being more than 2 years overdue). Additionally, the research explored the acceptability of self-collection amongst this cohort. METHODS: A mixed methods qualitative approach of online focus groups and in-depth interviews was employed. Online focus groups were conducted with under-screeners. In-depth telephone interviews were conducted with never-screeners due to the anticipated personal nature of their reasons for not screening. RESULTS: A total of 51 Queensland women aged 30 to 50 years participated in the research. CONCLUSIONS: Queensland women cited several negative experiences and aspects of the current program, as well as barriers in their social and personal lives that limited screening intention and behaviour. Barriers and enablers to cervical screening identified in this research have been classified into four categories: structural, knowledge and attitudinal, social, and personal. The research identified more factors associated with nonparticipation than participation. However, the research did uncover a range of potential enablers to encourage screening, some of which related to the program design. SO WHAT?: The concept of self-collection was broadly well accepted by research participants, particularly by never-screeners. Recommendations resulting from this research include communications, systems, and eligibility changes, particularly regarding the availability and benefits of self-collection.

Meta-analysis of agreement/concordance statistics in studies comparing self- vs clinician-collected samples for HPV testing in cervical cancer screening.

We conducted a meta-analysis of test agreement/concordance between human papillomavirus (HPV) testing in self-collected vs clinician-collected samples in 26 studies (10 071 participants) updating a previous meta-analysis on accuracy for cervical precancer. Pooled overall agreement was 88.7% (95% CI: 86.3%-90.9%), positive agreement was 84.6% (95% CI: 79.9%-88.7%), negative agreement was 91.7% (95% CI: 89.1%-94.0%) and kappa was 0.72 (95% CI: 0.66-0.78). Subgroup meta-analyses suggested higher overall agreement for target amplification-based DNA assays (90.4%) compared to signal amplification-based DNA assays (86.7%; P = .175) or RNA assays (82.3%; P < .001). HPV test agreement/concordance targets may provide criteria to extend existing validations toward alternative sampling approaches and devices/storage media.

Feasibility of a novel self-collection method for blood samples and its acceptability for future home-based PrEP monitoring.

BACKGROUND: Most non-clinic based HIV pre-exposure prophylaxis (PrEP) programs require fingersticks to self-collect blood specimens for laboratory monitoring, a technique that often results in inadequate blood volume for quantitative syphilis and HIV serological testing. We evaluated the acceptability and feasibility of using the Tasso OnDemand™ device as a self-sampling method for PrEP monitoring tests and compared results from samples obtained using the Tasso device to clinician-collected blood samples. METHODS: We enrolled study subjects online and in a sexual health clinic and HIV clinic in Seattle, WA, USA to assess the acceptability of blood self-sampling and preferences for home-based PrEP monitoring. We compared HIV antigen/antibody, quantitative rapid plasma reagin and creatinine results in paired self-collected and clinical specimens collected from a subset of participants. RESULTS: Of 141 participants, 124 (88%) were interested in collecting samples for PrEP monitoring at home. Among 48 who completed blood collections, 94% found the Tasso device easy to use and 95% felt they could perform self-sampling at home. Of 27 participants who used two devices, 100% collected sufficient blood to perform up to two tests while 33% collected sufficient serum for three tests. Agreement in test results between paired samples was high. CONCLUSIONS: These pilot data suggest that using the Tasso self-collection device is acceptable and could feasibly be used to obtain serum specimens sufficient for guideline-recommended PrEP monitoring, though use of a larger volume device may be preferable.

Pandemic driven innovation: A pilot evaluation of an alternative respiratory pathogen collection device.

BACKGROUND: The nasopharyngeal swab is the gold standard collection method for COVID-19, but is invasive and painful, subsequently resulting in poor patient acceptance. This investigation explores the process of developing and validating an alternative respiratory pathogen collection device that relies on a nasopharyngeal irrigation mechanic. The primary objective was to determine if sufficient pathological sampling can be achieved by mechanism of nasopharyngeal irrigation that is proportionate to the nasopharyngeal swab method. METHODS: The study device was designed using Shapr3D modeling software and fabricated on a fused deposition modeling printer. Fifteen participants were enrolled with each receiving a saline nasopharyngeal washing using the study device. Specimen adequacy was evaluated by two real-time reverse transcriptase polymerase chain reaction (PCR) testing methods to identify the presence of the human RNase P gene. Results were evaluated quantitatively through interpretation of the PCR cycle threshold (Ct). RESULTS: All 15 specimens tested positive for the presence of RNaseP, demonstrating specimen cellularity, adequate extraction of nucleic acids, and the absence of inhibitors to amplification. The mean Ct value was 29.5 (Applied Biosystems TaqPath RT-qPCR) and 30.7 (NECoV19). All participants felt the study device irrigation procedure was faster than the nasopharyngeal swab, with none experiencing any discomfort from the irrigation mechanism. CONCLUSION: The importance of early diagnostic testing and its role in countermeasures for communicable diseases such as COVID-19 is well established in the literature. Innovation to bolster our testing infrastructure is more important now than ever. This study was successful in developing and validating an alternative nasopharyngeal respiratory pathogen collection device that utilizes fluid debridement as its core mechanic. Data from this pilot study demonstrated the study device was successful in producing high-quality specimens for PCR testing. Feedback from the study participants was also in favor of the study device when compared to the nasopharyngeal swab.

[Comparison of doctor sampling and self-collection of specimens in the same examinee for cervical cytopathology and human papillomavirus testing].

Objectives　The purpose of the study is to compare the results of doctor sampling and self-collection of specimens in the same examinee for cervical cytopathology and human papillomavirus (HPV) testing.Methods　Patients who have undergone cervical cancer screening at the four clinics affiliated with the Association for Preventive Medicine of Japan and who consented to participate were included in the study. Approximately one month after undergoing cervical cancer screening at the clinic, we tested a method of self-collection by mailing a Kato-type self-collection container to the participants. We evaluated the results of cytopathology and HPV testing obtained by self-collection and doctor sampling in the same patients. We used the χ2 test and κ analysis for the evaluation of the results.Results　A total of 134 health checkup participants each underwent both doctor sampling and self-collection. The positive rate of cytology was 6.0% in doctor sampling and 2.2% for self-collection, but there was no evidence in statistical significance (P>0.05). However, cervical duct lining membrane cells could not be detected by self-collection. The positive rate of HPV testing in both doctor sampling and self-collection was the same at 14.2%. However, HPV18 type was positive only in one case by self-collection.Conclusion　The results of this study suggest that it is necessary to proceed with studies by self-collection, and introduce the applications of liquid cytopathology and its combined uses with HPV testing.

Feasibility and Performance of Self-Collected Nasal Swabs for Detection of Influenza Virus, Respiratory Syncytial Virus, and Human Metapneumovirus.

BACKGROUND: We assessed performance of participant-collected midturbinate nasal swabs compared to study staff-collected midturbinate nasal swabs for the detection of respiratory viruses among pregnant women in Bangkok, Thailand. METHODS: We enrolled pregnant women aged ≥18 years and followed them throughout the 2018 influenza season. Women with acute respiratory illness self-collected midturbinate nasal swabs at home for influenza viruses, respiratory syncytial viruses (RSV), and human metapneumoviruses (hMPV) real-time RT-PCR testing and the study nurse collected a second midturbinate nasal swab during home visits. Paired specimens were processed and tested on the same day. RESULTS: The majority (109, 60%) of 182 participants were 20-30 years old. All 200 paired swabs had optimal specimen quality. The median time from symptom onsets to participant-collected swabs was 2 days and to staff-collected swabs was also 2 days. The median time interval between the 2 swabs was 2 hours. Compared to staff-collected swabs, the participant-collected swabs were 93% sensitive and 99% specific for influenza virus detection, 94% sensitive and 99% specific for RSV detection, and 100% sensitive and 100% specific for hMPV detection. CONCLUSIONS: Participant-collected midturbinate nasal swabs were a valid alternative approach for laboratory confirmation of influenza-, RSV-, and hMPV-associated illnesses among pregnant women in a community setting.

The road to cervical cancer elimination in Malaysia: Evaluation of the impact and cost-effectiveness of human papillomavirus screening with self-collection and digital registry support.

The WHO has launched a global strategy to eliminate cervical cancer through the scale-up of human papillomavirus (HPV) vaccination, cervical screening, and cervical cancer treatment. Malaysia has achieved high-coverage HPV vaccination since 2010, but coverage of the existing cytology-based program remains low. Pilot studies found HPV self-sampling was acceptable and effective, with high follow-up rates when a digital registry was used, and recently the Malaysian Government announced plans for a national HPV-based screening program. We therefore evaluated the impact of primary HPV screening with self-collection in Malaysia in the context of Malaysia's existing vaccination program. We used the "Policy1-Cervix" modeling platform to assess health outcomes, cost-effectiveness, resource use and cervical cancer elimination timing (the year when cervical cancer rates reach four cases per 100 000 women) of implementing primary HPV testing with self-collection, assuming 70% routine-screening coverage could be achieved. Based on available data, we assumed that compliance with follow-up was 90% when a digital registry was used, but that compliance with follow-up would be 50-75% without the use of a digital registry. We found that the current vaccination program would prevent 27 000 to 32 200 cervical cancer cases and 11 700 to 14 000 deaths by 2070. HPV testing with a digital registry was cost-effective (CER = $US 6953-7549 < $US 11 373[<1×GDP per capita]) and could prevent an additional 15 900 to 17 800 cases and 9700 to 10 600 deaths by 2070, expediting national elimination by 11 to 20 years, to 2055 to 2059. If HPV screening were implemented without a digital registry, there would be 1800 to 4900 fewer deaths averted by 2070 and the program would be less cost-effective. These results underline the importance of HPV testing as a key elimination pillar in Malaysia.

At-Home Specimen Self-Collection and Self-Testing for Sexually Transmitted Infection Screening Demand Accelerated by the COVID-19 Pandemic: a Review of Laboratory Implementation Issues.

The coronavirus disease 2019 (COVID-19) pandemic reduced the sexually transmitted infection (STI) testing volume due to social-distancing and stay-at-home orders, among other reasons. These events highlighted previously known benefits of at-home STI self-testing or specimen self-collection and accelerated testing demand via telemedicine. We review testing outside traditional clinical settings. We focus on three curable bacterial STIs among the top 10 U.S. nationally notifiable conditions with screening recommendations: syphilis, gonorrhea (Neisseria gonorrhoeae, also known as the gonococcus [GC]), and chlamydia (Chlamydia trachomatis). At least 19 million GC/C. trachomatis (GC/CT) screening or diagnostic tests are performed annually, presenting a considerable challenge during the pandemic. Unlike for HIV, STI at-home tests are currently not commercially available. However, innovative telemedicine providers currently offer services where specimen self-collection kits are mailed to patients at home who then ship them to laboratories for processing. We discuss technical and regulatory aspects of modifications for home-based specimen self-collection. The telemedicine provider typically manages and communicates results, provides linkage to care, and is responsible for billing and case reporting. We also describe rapid testing devices in development that may present an opportunity for future self-testing. In summary, COVID-19 has accelerated the evaluation and development of STI self-tests and specimen self-collection. The remaining obstacles are high price, regulatory approval, support for laboratories offering the service, and uncertainty regarding whether target populations with the greatest need are reached effectively. However, increased testing, convenience, and privacy are potential benefits that may enhance uptake and outlast the pandemic.