Sampling Kit Research Articles

P-2179. Nirsevimab in Patient Samples Does Not Interfere with Respiratory Syncytial Virus (RSV) Detection by Commercially Available Rapid Antigen Tests

Abstract Background Nirsevimab is an extended half-life monoclonal antibody (mAb) that binds to the prefusion conformation of the respiratory syncytial virus (RSV) fusion (F) protein, and is approved for the prevention of RSV-associated lower respiratory tract infection in neonates and infants. Rapid antigen testing is routinely used for the clinical diagnosis of RSV, and primarily relies on direct interaction with the RSV F protein in patient nasal samples. While expected mAb levels in nasal samples are low (< 1 μg/mL), some mAbs targeting the RSV F protein, such as palivizumab, have been shown to interfere with RSV rapid antigen test results. We assessed whether the presence of nirsevimab in samples may interfere with RSV detection by rapid antigen tests, leading to false-negative or equivocal results.Figure 1.Evaluation of nirsevimab- and palivizumab-associated interference with RSV detection by rapid antigen tests Methods We evaluated six waived RSV rapid antigen tests (simple tests with a low risk of erroneous results), representative of those in the US Food and Drug Administration Clinical Laboratory Improvement Amendments database. To assess mAb interference with RSV detection, each test kit was performed according to the manufacture’s procedures (Figure 1). Test samples contained phosphate-buffered saline spiked with RSV subtype A or B at 5 × 105 plaque forming units/mL, and nirsevimab or palivizumab at two concentrations (1 or 10 µg/mL). For RSV-positive results, the intensity of the line on the test device was graded by observers as a ‘weak’ or ‘strong’ RSV detection signal.Table 1.Effects of nirsevimab and palivizumab on RSV detection by a panel of rapid antigen test kits Results RSV was detected by all rapid antigen tests in the presence of nirsevimab at both concentrations, with only a slight decrease in the RSV A detection signal observed for the Remel X/pect RSV kit at concentrations of 10 µg/mL (Table 1). RSV was not detected by the Remel X/pect RSV and Binax NOW RSV kits in samples with 10 µg/mL of palivizumab, and decreases in RSV detection signals were observed for the Quidel QuickVue RSV, Meridian TRU RSV, and BD Directigen EZ RSV kits (Table 1). Funding statement Conclusion Nirsevimab did not interfere with RSV detection for the six RSV rapid antigen tests assessed, even at a high concentration of 10 µg/mL. In contrast, 10 µg/mL of palivizumab did interfere with RSV detection for two test kits. Our findings suggest that patients who have received nirsevimab are unlikely to require alternative assays for clinical RSV diagnosis. Disclosures Sarah R. Sincero, BSc, AstraZeneca: Employee of AstraZeneca and may own AstraZeneca stock or stock options. Katie Streicher, PhD, AstraZeneca: Employee of AstraZeneca and may own AstraZeneca stock or stock options. Elizabeth J Kelly, PhD, AstraZeneca: Former employee of AstraZeneca.|AstraZeneca: Stocks/Bonds (Public Company)|PLP: Stocks/Bonds (Public Company)|Sanofi: Current employee of Sanofi.|Sanofi: Stocks/Bonds (Public Company) Kevin M. Tuffy, MS, AstraZeneca: Employee of AstraZeneca and may own AstraZeneca stock or stock options. Deidre Wilkins, BSC, AstraZeneca: Employee of AstraZeneca and may own AstraZeneca stock or stock options.

P-284. Effect of Different Disinfection Methods on Hospital Sink Drain Disinfection

Abstract Background A commercially available foaming disinfectant containing hydrogen peroxide, peracetic acid, and octanoic acid is EPA-registered for biofilm disinfection in sink drains, but recolonization occurs quickly. We evaluated the impact of adding physical removal of bioburden to foaming disinfectant use on bacterial colonization in sink drains. Methods We conducted a longitudinal study in a level-IV neonatal intensive care unit (NICU) at an academic medical center in Baltimore, MD. The NICU has 52 single-patient rooms with sinks with removable drain plug covers. We included 20 unique rooms to investigate the effect of foaming disinfectant alone and coupled with physical removal of biofilm through (1) mechanical cleaning with a brush, and (2) replacement of drain cover (Figure 1). In addition, we sampled 10 room sinks as control (no intervention). Samples were collected from 2 inches below the sink drain and underside of the drain cover using a polyester tripped swab (Puritan ESK environmental sampling kit with neutralizing buffer) at baseline (day 0) and days 1, 3, 5, and 7 post-intervention. Samples were serially diluted, plated on MacConkey II agar (Becton Dickinson), and incubated for 24 hours at 35+2°C. Colony-forming units (CFU) of total gram-negative bacilli (GNB) were calculated. The primary outcome was the difference in GNB burden (mean log CFUs) from baseline at each time point, for each intervention strategy, compared using paired t-test. Results Baseline counts for all groups including control were similar. On day 1, we found significant reductions from baseline for each intervention strategy, with differences from baseline becoming smaller over time. There was no significant change in GNB counts for the control group at any time point (Figure 2, Table 1). Strategies with mechanical cleaning (vs without) performed better for sinks, whereas sink cover change (vs without) resulted in greater log reductions in the cover bioburden through day 7 (Figure 2, Table 1). Conclusion Physical bioburden removal improved the effect of a foaming disinfectant on GNB counts in hospital sink drains. The impact of this strategy on hospital-acquired infections needs to be studied. Disclosures J Kristie Johnson, PhD, D (ABMM), biomerieux: has given presentations/speeches for the company listed above

Development of a Paper-Based Disposal Thin-Film Solid-Phase Microextraction Tool for the Quantification of Environmentally Hazardous 4-Chlorophenol in Water.

The presence of chlorinated compounds in water resources presents various environmental and health risks. Therefore, there is a precise need to develop a potential technique for fast and efficient monitoring of chlorinated contaminants in water due to environmental protection and regulation compliance. Here, we designed a paper-based thin-film solid-phase microextraction (TF-SPME) patch to estimate 4-chlorophenol (4-CRP), a widely known environmentally hazardous pollutant in water samples. We fabricated the microextraction patch on the paper support utilizing the thin film applicator for uniform coating using divinylbenzene, polydimethylsiloxane, and a multiwalled carbon nanotube (MW-CNT) composite recipe. To check the performance of our fabricated tool, we directly exposed the TF-SPME patches to standard solutions with various concentrations of 4-CRP in water and finally quantified the analyte by exploiting the gas chromatography-mass spectrometer. Our experiments demonstrated the high extraction efficiency of the paper-based TF-SPME analytical tool for the estimation of 4-CRP in water with a limit of detection of ∼10 ng/mL, suggesting the practical applicability of the technique to monitor the analyte within the recommended range. To check the feasibility of the proposed technique for rapid determination, we performed the calibration curve of the analyte in the concentration range of 100-10,000 ng/mL and finally derived the curve fitting equation for the estimation of an unknown amount of 4-CRP. This study demonstrated the feasibility of using a simple paper-based thin-film solid-phase microextraction patch as a sampling kit for monitoring the environmentally hazardous 4-CRP pollutant from water. In the future, the proposed analytical method may be useful for the rapid quantification of chlorinated compounds from the water matrix.

Novel sequence types and low levels of antimicrobial resistance associated with clinical mastitis in sheep flocks across Scotland.

This research paper aimed to demonstrate that mammary secretions provided by sheep farmers across Scotland from cases of clinical mastitis are free from environmental contamination, as well as to provide information on the major bacterial causes of disease and levels of antimicrobial resistance. Mastitis represents one of most significant diseases of small ruminant production worldwide. Staphylococcus aureus, Mannheimia haemolytica, Streptococcus uberis and coagulase-negative Staphylococcal species are common pathogens isolated from cases of sheep mastitis. Sampling kits supplied to 23 farms provided 33 samples for bacteriology, antimicrobial susceptibility testing and genetic analysis. Of the bacterial isolates identified, 60% were S. aureus, 23% M. haemolytica and 7% coagulase-negative staphylococci. Low levels of antimicrobial resistance were identified in the S. aureus isolates which provided novel multi-locus sequence types. In conclusion, this proof-of-concept survey demonstrated that mammary secretions free from environmental contamination may be provided by sheep farmers. It also provided data on the prevalence of antimicrobial resistance associated with clinical mastitis in sheep and will inform on the scale required for larger surveys aiming to improve current strategies for mastitis control in sheep flocks across the UK.

Validation of an LC-MS-MS method for analysis of 58 drugs of abuse in oral fluid and method comparison with an established LC-HRMS method.

Liquid chromatography-mass spectrometry (LC-MS) methods for detection of multiple drugs of abuse (DoA) in oral fluid (OF) samples are being implemented in many clinical routine laboratories. Therefore, there is a need to develop new multianalyte methods with simple sample pretreatment and short analysis times. The purpose of this work was to validate a method detecting 58 DoA to be used with two different OF sampling kits, the saliva collection system (SCS) from Greiner Bio-One and Quantisal from Immunalysis, using the same sample pretreatment and analytical method. A set of 110 samples collected with the SCS kit was further compared to an high-resolution mass spectrometry (LC-HRMS) method in another laboratory. The method was successfully validated, with precision and accuracy of ≤15% and z-scores of <2 for external controls. Using a sensitive LC-MS-MS instrument, the detection limits were <1 µg/l in neat oral fluid. In the comparative study between the LC-MS-MS and LC-HRMS methods using SCS samples, a good agreement was observed. Discrepancies were limited to lower concentration ranges, attributable to differences in cut-off thresholds between the methods. This work contributes to the development of LC-MS multianalyte methods for OF samples, which are suitable for clinical routine laboratories.

Factors Associated With Missing Biological Samples in the Dog Ageing Project.

The Dog Aging Project (DAP) is a longitudinal study examining aging in US companion dogs, where missing data pose a challenge to result validity and statistical power. Early recognition and procedural adjustments are vital to address missing samples. This research assesses missing biospecimen samples within the PRECISION cohort of the DAP, aiming to identify contributing factors and propose mitigation strategies. Ninety sample kits collected between August 2021 and October 2021 were evaluated for the missingness of individual kit components. A primary assessment reviewed the missingness of each sample type with hypothesized associated factors. A secondary assessment addressed the missingness of plasma and serum aliquots made after check-in. EDTA samples for flow cytometry, peripheral blood mononuclear cells (PBMCs), DNA and biobanking were missing at rates of 18.9%, 13.3%, 6.7% and 5.6%, respectively. Faecal samples were missing at 5.6%. Urine and plasma were each missing at 2.2%. Serum, hair and dried blood spot cards were each missing at 1.1%. No statistically significant difference in missingness was seen across regions, ease of blood collection, or cooperativeness of dog during sample collection. Higher time-to-receipt was associated with a higher missingness proportion. Increasing missingness proportions were seen across plasma and serum aliquots that were created in sequential order. The study suggests reevaluating sample collection instructions to address frequently missing sample types and prevent further loss. Investigation into collection procedures for these types is recommended to identify potential causes of sample yield loss.

High-risk HPV mRNA testing on self-samples offered to those who do not attend for organised cervical screening – real world data from the Dumfries and Galloway region in Scotland

BackgroundHPV self sampling can act as a tool to engage women in cervical screening and population based studies can inform optimal implementation of this approach. MethodsSelf sampling kits were mailed to women who had defaulted from routine screening resident in an entire territorial health board in Scotland. Kit return rates and compliance to colposcopy follow up in those who were HPV mRNA positive were assessed. Concordance of the self-sample with samples taken later at colposcopy was measured alongside PPV of an mRNA positive result for CIN2+. ResultsOf 4173 women invited to participate, 20.5 %, returned their kit and a greater return rate with increasing age was observed. HPV mRNA positivity was 12.0 %, and invalidity rate was approximately 3 %. Compliance to colposcopy follow up was 88.3 % and the PPV for an mRNA test for CIN2+ on a self sample was 25.6 %. hr-HPV concordance on the initial swab and the follow up swab and liquid based cytology (LBC) sample taken at colposcopy was 67.1 % and 30 % respectively. ConclusionsHPV self sampling using a “mail to all” approach is feasible in Scotland although only 1 in 5 actively responded to the offer. Future work to monitor screening behaviours in those who were invited but did not engage initially will help quantify any additional benefit(s) incurred.

First Report of Beet Western Yellows Virus Infecting Vasconcellea x heilbornii (Caricaceae) in Ecuador.

Vasconcellea x heilbornii, known as babaco, is a hybrid native to Ecuador grown in small orchards in sub-tropical highland regions. Over the last decade, several viruses have been identified in babaco using high-throughput sequencing (HTS) (Cornejo-Franco et al. 2020, (Reyes-Proaño et al. 2023). In 2021, total RNA from a babaco plant showing distinctive leaf yellowing was extracted using the PureLink RNA Mini Kit (Thermo Fischer Scientific, USA) and subjected to HTS on an Illumina NovaSeq6000 system as 150 paired-end reads (Macrogen Inc., South Korea). Library construction was done using the TruSeq Stranded Total RNA Sample kit with Plant Ribo-Zero, as described (Villamor et al. 2022). Reads were processed using BBDuk and de novo assembled using SPAdes 3.15. both implemented in Geneious 2022. Contig analysis was done by BLASTx using the NCBI viral sequence database (as of November 2022). HTS generated 54 million reads, of which 12% assembled into contigs corresponding to genomes of previously reported babaco viruses including babaco virus Q (BabVQ), babaco nucleorhabdovirus 1 (BabRV1) and babaco ilarvirus 1 (BabIV1). Interestingly, 144 reads (0.0003%) assembled into seven contigs ranging from 100 to 480 nucleotides (nt) in length. These contigs showed homology, with 97% amino acid (aa) identity (100% query coverage), to regions of the RNA-dependent-RNA-polymerase (RdRp) of beet western yellows virus (BWYV, Acc. No. NC_004756), a member of the Polerovirus genus. To confirm the occurrence of BWYV in babaco, double-stranded RNA (dsRNA) was extracted from 15 g of leaf tissue from the original sample as described (Dodds et al. 1984) and used as template for reverse-transcription (RT)-PCR using overlapping primers designed to span all short contigs. RT-PCR amplified fragments were cloned into a pGEM®T-easy vector (Promega, USA) and sequenced by the Sanger method (Macrogen Inc., South Korea). The sequences were assembled into a single 2.7 kbp BWYV genome fragment comprising the complete protein 1 (P1) and partial RdRp gene (GenBank Acc. No. PP480670). Sequence alignments between the partially sequenced genome of the babaco isolate and its corresponding fragment from the closest BWYV isolate (NC_004756) revealed 94% and 97% identities at the nt and aa levels, respectively. To assess the prevalence of BWYV in babaco, 30 leaf samples showing yellowing symptoms from Pichincha (n=15) and Azuay (n=15) provinces were tested by RT-PCR using total RNA. Total RNA extraction and reverse transcription were done using the methodology described by Halgren et al. (2007). For RT-PCR, the primer set BWYV_Bab_F: 5'-CAGTGTCCTCCAAGTGCAACAT-3' / BWYV_Bab_R: 5'GGTTCCTTCCCAGTTTGGTGGT-3', which amplifies a 235 nt-long P1 region, was used. Three RT-PCR products from each positive sample were purified using the GeneJET PCR clean-up kit (Thermo Scientific, USA) and sequenced. BWYV was confirmed in 9 out of 15 samples (60%) from Pichincha, and in 10 out of 15 samples (64%) from Azuay. Samples were also tested for additional babaco viruses as described (Reyes-Proaño et al. 2023). All BWYV-infected plants turned out positive for papaya ringspot virus (PRSV), babaco mosaic virus (BabMV), BabVQ, and BabIV1. Hence, the impact of BWYV infection on babaco plants in single and mixed infections warrants further investigation. To the best of our knowledge, this is the first report of BWYV in a crop in Ecuador, and the first time it has been found in a Caricaceae species.

Single-test syphilis serology: A case of not seeing the forest for the trees

Introduction There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening. Methods Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma. Results Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants. Conclusion Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost.

An integrated uncrewed aerial vehicle platform with sensing and sampling systems for the measurement of air pollutant concentrations

Abstract. In this study, an uncrewed aerial vehicle (UAV) platform with sensing and sampling systems was developed for three-dimensional (3D) measurements of air pollutant concentrations. The sensing system of this platform contains multiple microsensors and Internet of Things devices for determining the 3D distributions of four critical air pollutants and two meteorological parameters in real time. Moreover, the sampling system comprises remote-controllable gas sampling kits, each of which contains a 1 L Tedlar bag for the 3D measurement of volatile organic compound (VOC) concentrations according to the Toxic Organics-15 (TO-15) method of the US Environmental Protection Agency. The performance of the developed UAV platform was verified in experiments where it was used to detect air pollutant emissions from a large industrial zone in Taiwan that included a traditional industrial park, a precision machinery park, and a municipal waste incineration plant. Three locations were selected as field measurement sites according to the prevailing local wind direction. The vertical distributions of four critical air pollutants, the ambient temperature, and the relative humidity were determined from data gathered at the aforementioned sites in March and May 2023. A total of 56 and 72 chemical species were qualitatively and quantitatively analyzed in these two periods, respectively. The experimental results verified the feasibility of using the proposed UAV platform for accurately evaluating the air pollutant concentration distribution and transport in an industrial zone. The sampling system can be used as the sampling part of the TO-15 method, thus extending the method to measure the 3D distribution of VOCs in an area. The UAV platform can serve as a useful tool in the management of and decision-making process for air pollution in industrial areas.

Feasibility and applicability of self-sampling based online cervical cancer screening: findings from the China online cervical cancer screening trial

ObjectiveThis study aims to evaluate the feasibility and applicability of an online cervical cancer screening program using a website as the public platform and self-collected HPV testing as the primary screening method.MethodsA website (mcareu.com) was developed to facilitate the online cervical cancer screening program by Peking University Shenzhen Hospital (PUSH). Women in Shenzhen could register for participation on the website by providing essential demographic data. Sampling kits and specimens were delivered through regular logistics. Eligible women collected vaginal samples by themselves using the provided kits and in referring of the graphic guidance. The specimens were tested for HPV at PUSH or a reference lab, and the results were accessible on the website through participants' personal accounts. Participants who tested positive for high-risk HPV were scheduled for colposcopy and biopsies. The demographic and social background data of the eligible participants were analyzed to evaluate the feasibility and applicability of the online screening approach.ResultsA total of 1712 applicants registered for participation, with 99.9% (1710/1712) completing registration with full data. The analysis included 1560 applicants aged 30–59, with an average age of 41.1 (± 7.6) years. Among them, 83.3% (1299/1560) provided self-collected samples for testing. Age-group analysis revealed an overall sample provision rate (SPR) exceeded 80% in all age groups. A significant difference in SPR was observed only between the 30–34 and 45–49 age groups (p < 0.05), while no significant differences were found among other age groups. 99.7% of the samples were tested qualified, and there was no significant difference in sampling failure rate among age groups. Analysis of demographic and social elements showed no significant impact on the rates of sample provision among groups in most of the social elements but the medical insurance and the monthly family-incomes.ConclusionThe findings demonstrate that online cervical cancer screening is reliable for self-registration, self-sampling, and self-ordering for specimen transportation. It is suitable for women of all ages needing to be screened, irrespective of social elements, and effectively facilitates screening for women with limited access to medical resources. Therefore, online screening holds promise as an effective approach to increase screening coverage.

Abstract 7288: Evaluation of silica spin-column and bead formats for rapid promoter DNA methylation analysis by qMSP in clinical and point-of-care settings

Abstract Late-stage cancers often lack effective management and treatment options, emphasizing the importance of early diagnosis for better prognosis and lower mortality rates. Molecular markers, such as DNA methylation tests, have shown promise in predicting and detecting cancer at its earliest stages. The COVID-19 post-pandemic scenario is providing a one in one-hundred-year opportunity of utilizing the excess installed PCR capacity world-wide to develop novel Quantitative Methylation Specific PCR (qMSP) screening strategies for cervical cancer screening in low-resource settings. This study aimed to compare the use of commercial bisulfite conversion kits in cervical epithelium liquid cytology samples (liquid cytology) from cancer screening clinics in the United States. Commercially available rapid bisulfite conversion protocols using silica spin column and magnetic beads were compared with conventional DNA extraction followed by bisulfite conversion protocols to profile DNA methylation by qMSP in a panel of methylated genes we previously developed to distinguish normal and cervical cancer patient samples. The results revealed that small sample volumes are suitable for methylation studies. Comparisons among four spin-column kits showed no significant differences in β-actin Cycle Threshold (Cts) values between Abcam, Epigentek, QIAGEN and Zymo D5021 kits. Zymo The best performing spin-column kit was compared with manual and automated versions of magnetic bead kits using a 96-well plate format for higher throughput. Methylation profiling of three genes (β-actin ZNF516, and FKBP6) with manual and automated magnetic bead kits revealed that automation increases throughput without a reduction in amplification efficiency in open PCR systems. Cost analysis showed that the direct kits 96-well plate format were more affordable compared to the Gold Standard manual protocol that uses spin-columns. An optimized version of Zymo D5046 magnetic bead kit provides the fastest turnaround time with similar amplification efficiency, when compared to spin-column or other magnetic bead kits. The test cost per sample is $5.41 dollars to process 83 samples in a 96 well-plate format in less than 2 hours. Another significant finding was showing the feasibility of using as low as 12µL of liquid cytology samples for DNA methylation testing, proving that bodily fluids are a liquid biopsy alternative to plasma. Overall, this comprehensive comparison is useful in determining optimal options for efficient and cost-effective cancer DNA methylation diagnostic tests, particularly in low-resource settings. Citation Format: Fernando Zamuner, Ashley Ramos-Lopez, Amanda Garcia-Negron, Ana Purcell-Wiltz, Andrea Cortes-Ortiz, Aniris Roman, Keerthana Gosala, Eli Winkler, David Sidransky, Mariana Brait, Rafael E. Guerrero-Preston. Evaluation of silica spin-column and bead formats for rapid promoter DNA methylation analysis by qMSP in clinical and point-of-care settings [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 7288.

Evaluation of a novel vaginal cells self-sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability.

Cervical cancer is a significant public health concern, particularly in low- and middle-income countries where resources for prevention and treatment are limited. Routine screening, such as the Papanicolaou test (Pap smears) and human papillomavirus (HPV) testing, plays a crucial role in the early detection and prevention of cervical cancer. However, the participation rate in cervical cancer screening programs remains below optimal levels due to various factors. This study aimed to evaluate the reliability and acceptability of the HygeiaTouch Self Sampling Kit for Women in collecting vaginal samples for HPV typing, comparing the results with samples collected by physicians. The study included 1210 women aged 21-65 from three medical centers in Taiwan. The findings indicated that the self-sampling kit was as effective as physician-collected specimens in terms of obtaining valid samples and identifying HPV. The agreement between the two methods was 88%, with a κ value of 0.75. Furthermore, the study assessed the mechanical characteristics of the self-sampling applicator through tensile, bending, and torque tests, and determined that it was safe for intravaginal use. Additionally, the study evaluated the safety and satisfaction of self-sampling and found a low rate of adverse events (0.7%) and high levels of satisfaction (over 90%) among participants. Overall, we demonstrated that the HygeiaTouch Self Sampling Kit for Women is a reliable and acceptable device for HPV testing and cervical screening, providing a convenient, safe, and effective alternative for women.

Pre-admission virus detection during the COVID-19 pandemic in children with and without symptoms of infection.

Pre-admission viral screening is used only in exceptional situations such as pandemics. We therefore evaluated pre-admission screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), respiratory syncytial virus (RSV) and influenza during the COVID-19 pandemic, comparing epidemiology and clinical features of admitted children. Children were screened at a paediatric emergency department from 1 March 2020 to 30 June 2022 by nasopharyngeal sampling and polymerase chain reaction kit. We retrospectively retrieved positive results from the laboratory and scrutinised charts of admitted children. Out of 15 927 screened children, 522, 127 and 572 were positive and admitted with RSV, influenza A or SARS-CoV-2, respectively. Of these, 29 (5.6%), 26 (24.1%) and 245 (44.8%) were incidental findings, lacking symptoms of infection. RSV and influenza A were initially absent but re-emerged in the autumn of 2021. The rate of COVID-19 rose when the Omicron variant emerged in December 2021. The median age of children with RSV was 0.3 years, of those with influenza A 6.7 years and of those with COVID-19 1.6 years. Major complications were rare. Frequent incidental detections of SARS-CoV-2 likely reflected widespread presence of a mild infection. Clinically, COVID-19 was like other viral respiratory infections in children.

Consistency in human papillomavirus type detection between self-collected vaginal specimens and physician-sampled cervical specimens.

With the rising need for accessible cervical cancer screening, self-sampling methods offer a promising alternative to traditional physician-led sampling. This study aims to evaluate the efficacy of the HygeiaTouch Self Sampling Kit for Women in detecting human papillomavirus (HPV) types and predicting cervical lesions. We studied the concordance in identifying high-risk HPV (hrHPV) types between samples collected by physicians and those self-collected by women using a self-sampling kit for validation. Women aged 21-65, fitting into specific categories based on their cervical health history were eligible. Cohen's kappa coefficient to gauge concordance between the two specimen types and relative accuracy metrics in identifying cervical intraepithelial neoplasia (CIN) were also calculated, with physician-sampled specimens serving as a reference. A total of 1210 participants from three institutes were involved. The self-sampling kit closely matched the physician-led method in terms of collecting valid specimens (100% vs. 100%), identifying hrHPV types (kappa: 0.75, 95% confidence interval [95% CI]: 0.72-0.79; agreement: 87.7%, 95% CI: 85.8-89.6) and predicting CIN grade 2 or worse (CIN2+) (relative sensitivity: 0.949, relative accuracy: 0.959). Kappa values varied between 0.71 and 0.83 for different hrHPV types and combinations, with an overall value 0.75 (95% CI: 0.72-0.79) signifying robust compatibility between the two methods. Our study underscores the potential of the HygeiaTouch Self Sampling Kit as a reliable, efficient, and user-friendly alternative to traditional sampling methods. This suggests that self-sampling could be pivotal in expanding cervical cancer screening accessibility and enhancing detection rates.

Observation of Automated Management Use of Self-Sampling Kits

Abstract In the current times of ever-growing prevalence of infectious diseases, it is requisite to explore ways to provide the safest and most effective medical care for our patients. The aim of this study is to explain how the issues raised by the SARS-CoV-2 pandemic were addressed by the E. Gulbis Laboratory in Latvia. The study looks back on the goal to introduce an automated and effective solution for the management of self-collected samples. The study is primarily aimed to formulate the conclusions about the data and use of automation in the self-sample kit collection. Results were collected from 18 automated (contactless) sample collection devices used by E. Gulbis Laboratory. Sixty-four thousand two hundred fifty-seven (64,257) saliva kits for SARSCoV-2 PCR testing were employed. It was found that 3.92% of them were positive (SARS-CoV-2 virus RNA found in saliva sample). The average processing time in automated devices located in the capital city was 11.13 hours, in the suburbs — 15.52 hours, rest of the country — 17.60 hours. The average age of patients that choose an automatic device to hand in their saliva sample kits was 33.94 years. These results suggest that by using the automated device, patient contacts are decreased, and direct communication with medical staff is excluded, which reduces the risk of infection during processing. Automated devices make sample kit distribution available 24 hours. They save workforce resources in the laboratory that are already very limited, especially during a pandemic period.

P1046 Home calprotectin testing: An east London experience

Abstract Background Monitoring of inflammatory bowel disease (IBD) using home faecal calprotectin (FCP) testing kits was adopted widely during the Sars-Cov-2 pandemic. CalproSmart is a kit which allows patients to measure FCP at home and upload the results to a smart phone application allowing remote monitoring. Recent NHS long term recovery plan has highlighted the importance of ensuring equity of access with service development1. Following the British Society of Gastroenterology guidance during the pandemic we introduced the system to our hospital in Newham, one of the most ethnically diverse regions of the UK2. The aim of this pilot study was to evaluate the uptake of the kits, patient acceptability and how they impacted on IBD care. Methods 62 patients with stable IBD were invited to take part in the study over a 12 month period. They were sent four FCP tests and instructions on how to enrol onto the CalproSmart portal. The participants who enrolled on the portal were then sent a post-study questionnaire. Results 28 of the 62 patients invited (45%) enrolled onto the CalproSmart portal. 14 of these 28 patients (50%) completed the post-study questionnaire. The patients invited to take part were from a variety of ethnic backgrounds, the average age was 36 and there were a mix of Ulcerative Colitis (60%) and Crohn’s (40%) diagnoses. When comparing those invited and those who used the home kit, uptake varied according to gender and ethnicity. 57% of women invited used the home kit compared to 34% of males. Additionally, despite 69% of the borough’s population being non-white, 50% of those using the home tests were white (see table 1). The post –study questionnaire showed that both the sample kit and the application were found easy to use by 12 (86%) and 13 (93%) of the patients, respectively. 11 patients (79%) reported they found the results of the FCP home kit helpful and 6 patients (50%) felt the FCP home kit improved the treatment of their disease (see figure 1).10 patients (71%) reported they preferred a home test to dropping stool samples at the hospital. The reasons for this were the convenience of not having to visit the hospital (90%) and the speed in which they got the results (80%). Conclusion This study demonstrates that home FCP tests are an easy-to-use tool and patients prefer them to attending the hospital. The home kit was well received in a diverse area of London with a mix of ethnic groups and socio-economic backgrounds. However, the ethnicity of patients using the home tests did not reflect the diversity of the invited participants or the borough. This suggests there needs to be additional exploration into their barriers to access and consider any extra support needed to improve uptake of patient initiated monitoring.

Development of a disposable paper-based thin film solid-phase microextraction sampling kit to quantify ketone body.

Diabetes ketoacidosis (DKA) is a life-threatening complication and requires immediate medical attention in the case of diabetes subjects, especially in the case of type 1 diabetes mellitus. In the condition of DKA, the body produces an excess amount of ketone bodies after unregulated fat degradation, causing blood to become acidic and hampering the regular metabolic activities of the body. The current diagnostic technique for DKA condition is based on monitoring ketone bodies, especially β-hydroxybutyric acid, from human urine and blood samples. The detection of serum ketone bodies in pathology is sometimes limited due to false positive results and the lack of standardization for precise quantification of analytes. In this study, a paper-based patch operating on the thin film solid-phase microextraction (TF-SPME) principle was developed and it was coupled with gas chromatography-mass spectrometry for simple quantification of β-hydroxybutyric acid (BHB) ketone body from a phosphate-buffered saline matrix. To fabricate the paper-based TF-SPME patches, a regular A4 sheet paper sheet was utilized as the substrate and uniform coating by multiwalled carbon nanotubes (MWCNT), polydimethylsiloxane (PDMS) and divinyl benzene (DVB) compounds was performed with an automatic film applicator. The 70 μm paper-based coated sheet was trimmed into 4 cm × 1 cm dimension pieces to obtain multiple patches from a single sheet. Extraction of the BHB ketone body into the closed vials was performed by exploiting the individual DVB/PDMS and DVB/CNT/PDMS paper patches followed by desorption with acetonitrile before quantification by gas chromatography-mass spectrometry analysis. Our study showed that the BHB extraction efficiency of DVB/PDMS-coated patches was higher than that of DVB/CNT/PDMS. The outcome showed a good linearity (R 2 = 0.99) within the 500-20 000 ng mL-1 concentration range of BHB by paper-based DVB/PDMS patches. This study demonstrated the feasibility of utilizing simple, cost-effective paper-based disposable TF-SPME patches as a sampling kit for future screening of diabetes ketoacidosis without the need for prolonged traditional sample preparation in pathology.

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

ObjectiveTo evaluate the feasibility of an internet-facilitated community model for cervical cancer screening using self-collected HPV testing as primary screening.MethodA 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.ResultsA 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.ConclusionWhen 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.

EE83 Cost-Utility and Budget Impact Analyses of Cervical Cancer Screening Using Self-Collected Sample Kit for HPV DNA Testing in Thailand

EE83 Cost-Utility and Budget Impact Analyses of Cervical Cancer Screening Using Self-Collected Sample Kit for HPV DNA Testing in Thailand