Performance verification and clinical evaluation of the NAP-Fluo Cycler system for detecting five genital tract pathogens based on microfluidic technology.

Introduction: Sexually transmitted infections (STIs) are among the most common infectious diseases worldwide, often leading to coinfections. Timely detection of genital tract pathogens in at-risk populations is crucial for preventing STIs. We evaluated the NAP-Fluo Cycler System, an innovative microfluidic nucleic acid detection platform, for its ability to simultaneously identify Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Ureaplasma urealyticum (UU), Mycoplasma genitalium (MG), and Mycoplasma hominis (MH) in urethral or cervical secretions. Materials and methods: The limits of detection (LODs), repeatability, specificity, and interference resistance of the system were evaluated using standard strains, a panel of 24 pathogens, and seven interferents. We used the system to analyze 302 clinical samples and compared the results with those of five approved commercial reference kits. Results: The system achieved LODs of 500 IFU/mL, 500 CFU/mL, and 500 CCU/mL for CT, NG, and UU/MG/MH, respectively, demonstrating high stability (coefficient of variation <1.1 %), specificity, and resistance to interference. Among 302 clinical samples, 237 tested positive with single, dual, and triple infection rates of 35.6 %, 16.2 %, and 3.0 %, respectively. The reference kits detected 138 positive samples. The concordance rates with commercial reference kits were 100 % for UU, NG, and MH; 94.85 % for CT; and 80.00 % for MG. Conclusions: This system offers a streamlined, rapid, and multiplex detection method that reduces testing time and complexity. Although it performs well with pure strains, it has limitations when using clinical samples of CT and MG, suggesting the need for further refinement before its widespread use in the clinic.

Improving assay feasibility and biocompatibility of 3D cyclic olefin copolymer microwells by superhydrophilic modification via ultrasonic spray deposition of polyvinyl alcohol.

Sample partitioning is a crucial step towards digitization of biological assays on polymer microfluidic platforms. However, effective liquid filling into microwells and long-term hydrophilicity remain a challenge in polymeric microfluidic devices, impeding the applicability in diagnostic and cell culture studies. To overcome this, a method to produce permanent superhydrophilic 3-dimensional microwells using cyclic olefin copolymer (COC) microfluidic chips is presented. The COC substrate is oxidized using UV treatment followed by ultrasonic spray coating of polyvinyl alcohol solution, offering uniform and long-term coating of high-aspect ratio microfeatures. The coated COC surfaces are UV-cured before bonding with a hydrophobic pressure-sensitive adhesive to drive selective filling into the wells. The surface hydrophilicity achieved using this method remains unchanged (water contact angle of 9°) for up to 6 months and the modified surface is characterized for physical (contact angle & surface energy, morphology, integrity of microfeatures and roughness), chemical composition (FTIR, Raman spectroscopy) and coating stability (pH, temperature, time). To establish the feasibility of the modified surface in biological applications, PVA-coated COC microfluidic chips are tested for DNA sensing (digital LAMP detection of CMV), and biocompatibility through protein adsorption and cell culture studies (cell adhesion, viability, and metabolic activity). Kidney and breast cells remained viable for the duration of testing (7 days) on this modified surface, and the coating did not affect the protein content, morphology or quality of the cultured cells. The ultrasonic spray coated system, coating with 0.25 % PVA for 15 cycles with 0.12 A current after UV oxidation, increased the surface energy of the COC (naturally hydrophobic) from 22.04 to 112.89 mJ/m2 and improved the filling efficiency from 40 % (native untreated COC) to 94 % in the microwells without interfering with the biocompatibility of the surface, proving to be an efficient, high-throughput and scalable method of microfluidic surface treatment for diagnostic and cell growth applications.

The use of point of care gastric ultrasound and anesthesia management in pediatric patients with preoperative fasting non-adherence scheduled for elective surgical procedures: a retrospective study.

BACKGROUND: Failure to adhere to perioperative fasting requirements increases aspiration risk and can lead to delay or cancellation of surgery. Point of care gastric ultrasound may guide decision-making to delay, cancel or proceed with surgery. METHODS: This study aimed to describe gastric contents using point of care gastric ultrasound in pediatric patients with known fasting guideline violations presenting for elective surgery. This was a single-center retrospectivechart review of gastric ultrasound scans in patients presenting for elective surgeries with "nothing by mouth" violation (per fasting guidelines) or unclear fasting status. The primary outcome is description of gastric contents using point of care ultrasound. The ultrasound findings were classified as low-risk for aspiration (empty, clear fluid < 1.5 ml/kg), high-risk (solids, clear fluid > 1.5 ml/kg), or inconclusive study. Gastric ultrasound findings were communicated to the attending anesthesiologist. For patients proceeding without delay the estimated time saved was defined as the difference between ultrasound scan time and presumed case start time based on American Society of Anesthesiologists fasting guidelines. RESULTS: We identified 106 patients with a median age of 4.8 years. There were 31 patients (29.2%) that had ultrasound finding of high-risk gastric contents. These patients had cases that were delayed, cancelled or proceeded with rapid sequence intubation. Sixty-six patients (62.3%) were determined to be low-risk gastric contents and proceeded with surgery without delay. For these patients, a median of 2.6 h was saved. No aspiration events were recorded for any patients. CONCLUSIONS: It is feasible to use preoperative point of care gastric ultrasound to determine stomach contents and risk-stratify pediatric patients presenting for elective surgical procedures with fasting non-adherence. Preoperative gastric ultrasound may have a role in determining changes in anesthetic management in this patient population.

Qualitative evaluation of a molecular point-of-care testing study for influenza in UK primary care.

BACKGROUND: Influenza contributes to the surge in winter infections and the consequent winter pressures on the health service. Molecular point-of-care testing(POCT) for influenza might improve patient management by providing rapid and accurate clinical diagnosis to inform the timely initiation of antiviral therapy and reduce unnecessary admissions and antibiotics use. AIM: To explore factors that influence the adoption or non-adoption of POCT in English general practices and provide insights to enable its integration into routine practice workflows. DESIGN & SETTING: A qualitative implementation evaluation was conducted in ten general practices within the English national sentinel network (Oxford-RCGP Research and Surveillance Centre), from April to July 2023. METHOD: Using the nonadoption, abandonment, scale-up, spread, and sustainability framework, data collection and analysis were conducted across ten practices. We made ethnographic observations of the POCT workflow and surveyed the practice staff for their perspectives on POCT implementation. Data were analysed using a mix of descriptive statistics, graphical modelling techniques and framework approach. RESULTS: Ethnographic observations identified two modes of POCT integration into practice workflow: 1) clinician POCT workflow - typically involving batch testing due to time constraints, 2) research nurse/healthcare assistant POCT workflow - characterised by immediate testing of individual patients. Survey indicated that most primary care staff considered the POCT training offered was sufficient, and these practices were ready for change and had the capacity and resources to integrate POCT in workflows. CONCLUSION: General practices should demonstrate flexibility in the workflow and workforce they deploy to integrate POCT into routine clinical workflow.

The cost-effectiveness of integrating simplified HCV testing into HIV pre-exposure prophylaxis (PrEP) and treatment services among men who have sex with men in Taiwan.

Background: Simplified hepatitis C virus (HCV) testing integrated into existing HIV services has the potential to improve HCV diagnoses and treatment. We evaluated the cost-effectiveness of integrating different simplified HCV testing strategies into existing HIV pre-exposure prophylaxis (PrEP) and treatment services among men who have sex with men (MSM) in Taiwan. Methods: Mathematical modeling was used to assess the cost-effectiveness of integrating simplified HCV tests (point-of-care antibody, reflex RNA, or immediate point-of-care RNA) with HCV treatment into existing HIV prevention and care for MSM from a healthcare perspective. The impact of increasing PrEP and HIV treatment coverage among MSM in combination with these HCV testing strategies was also considered. We reported lifetime costs (2022 US dollars) and quality-adjusted life years (QALYs) and calculated incremental cost-effectiveness ratios (ICERs) with a 3% annual discounting rate. Findings: Point-of-care HCV antibody and reflex RNA testing are cost-effective compared to current HCV testing in all PrEP and HIV treatment coverage scenarios (ICERs <$32,811/QALY gained). Immediate point-of-care RNA testing would be only cost-effective compared to the current HCV testing if coverage of HIV services remained unchanged. Point-of-care antibody testing in an unchanged HIV services coverage scenario and all simplified HCV testing strategies in scenarios that increased both HIV PrEP and treatment coverage form an efficient frontier, indicating best value for money strategies. Interpretation: Our findings support the integration of simplified HCV testing and people-centered services for MSM and highlight the economic benefits of integrating simplified HCV testing into existing services for MSM alongside HIV PrEP and treatment. Funding: This study was made possible as part of a research-funded PhD being undertaken by HJW under the UNSW Sydney Scientia scholarship and was associated with the Rapid Point of Care Research Consortium for infectious disease in the Asia Pacific (RAPID), which is funded by an NHMRC Centre for Research Excellence. JG is supported by a National Health and Medical Research Council Investigator Grant (1176131).

Development of two novel on-site detection visualization methods for murine hepatitis virus based on the multienzyme isothermal rapid amplification.

Murine hepatitis virus (MHV) infection is one of the most prevalent types of mice infection in laboratory. MHV could cause death in mice and even interfere with the results in animal experiments. Herein, we developed two isothermal approaches based on the Multienzyme Isothermal Rapid Amplification (MIRA), for rapid detection of MHV in conserved M gene. We designed and screened several pairs of primers and probes and the isothermal fluorescence detector was applied for the exonuclease Ⅲ reverse transcription MIRA (exo-RT-MIRA) assay. To further simplify the workflow, the portable fluorescence visualization instrument, also as a palm-sized handheld system, was used for the naked-eye exo-RT-MIRA assay. The amplification temperature and time were optimized. The assay could be processed well at 42 °C 20 min for the exo-RT-MIRA and the naked-eye exo-RT-MIRA assay. The limit of detection (LoD) of the exo-RT-MIRA assay was 43.4 copies/µL. The LoD of the naked-eye exo-RT-MIRA assay was 68.2 copies/µL. No nonspecific amplifications were observed in the two assays. A total of 107 specimens were examined by qPCR and two assays developed. The experimental results statistical analysis demonstrated that the exo-RT-MIRA assay with the qPCR yielded sufficient agreement with a kappa value of 1.000 (p < 0.0001). The results also exhibited a good agreement (kappa value, 0.961) (p < 0.0001) between the naked-eye exo-RT-MIRA assay and the qPCR assay. In our study, the exo-RT-MIRA assay and the naked-eye exo-RT-MIRA assay presented the possibility of new methods in MHV point-of-testing diagnosis.

Diagnostic accuracy of Savanna RVP4 (QuidelOrtho) for the detection of Influenza A virus, RSV, and SARS-CoV-2.

Seasonal increase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus A/B (Flu A/B), and respiratory syncytial virus (RSV) require rapid diagnostic test methods for the management of respiratory tract infections. In this study, we compared the diagnostic accuracy of Savanna RVP4 (RVP4, QuidelOrtho) with Xpert Xpress Plus SARS-CoV-2/Flu/RSV (Xpert, Cepheid). Nasopharyngeal swabs from patients treated at a tertiary care hospital (Germany) were tested for SARS-CoV-2, Flu A/B, and RSV by RVP4 to assess diagnostic accuracy (reference standard: Xpert). The intra and inter assay precision of Ct-values was assessed by repeated test in triplicates (on day 1) and duplicates (days 2-3). All patients with a physician's order for a multiplex test for SARS-CoV-2, Flu, and RSV test were included. Duplicate swabs from the same patient, samples with a total volume ≤1 mL, or inappropriate shipment/storage were excluded. In total, 229 swabs were included between September 2023 and February 2024. The concordance between both tests was 96.5% (SARS-CoV-2), 98.7% (Flu A), and 99.6% (RSV). Flu B was not detected by both tests. The RVP4 test had a sensitivity of 85%-95% and a specificity of 100% for the detection of SARS-CoV-2, Flu A, and RSV. The intra and inter assay precision of Ct-values from RVP4 was 3% and 2% (SARS-CoV-2), 5% and 4% (Flu A), and 0% and 3% (RSV), respectively. The Savanna RVP4 has a favorable diagnostic accuracy for the detection of SARS-CoV-2, Flu A, and RSV. IMPORTANCE: We assessed the diagnostic accuracy of a new point-of-care test for the rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus A/B (Flu A/B), and respiratory syncytial virus (RSV). The new test has a concordance with the reference standard of 96.5% (SARS-CoV-2), 98.7% (Flu A), and 99.1% (RSV). The sensitivity of 85%-95% and specificity of 100% for the detection of SARS-CoV-2, Flu A, and RSV is comparable with similar nucleic acid amplification-based point of care tests but at lower costs.

An Ultrasensitive Biosensor for Probing Subcellular Distribution and Mitochondrial Transport of l-2-Hydroxyglutarate.

l-2-Hydroxyglutarate (l-2-HG) is a functionally compartmentalized metabolite involved in various physiological processes. However, its subcellular distribution and mitochondrial transport remain unclear owing to technical limitations. In the present study, an ultrasensitive l-2-HG biosensor, sfLHGFRH, composed of circularly permuted yellow fluorescent protein and l-2-HG-specific transcriptional regulator, is developed. The ability of sfLHGFRH to be used for analyzing l-2-HG metabolism is first determined in human embryonic kidney cells (HEK293FT) and macrophages. Then, the subcellular distribution of l-2-HG in HEK293FT cells and the lower abundance of mitochondrial l-2-HG are identified by the sfLHGFRH-supported spatiotemporal l-2-HG monitoring. Finally, the role of the l-glutamate transporter SLC1A1 in mitochondrial l-2-HG uptake is elucidated using sfLHGFRH. Based on the design of sfLHGFRH, another highly sensitive biosensor with a low limit of detection, sfLHGFRL, is developed for the point-of-care diagnosis of l-2-HG-related diseases. The accumulation of l-2-HG in the urine of patients with kidney cancer is determined using the sfLHGFRL biosensor.

A Portable Automated Microfluidic Platform for Point-of-Care Testing for Multiple Mycotoxins in Wine.

Food safety requires point-of-care testing (POCT) for mycotoxins, since their presence in wine significantly impacts the wine industry and poses a severe threat to human life. Traditional detection methods are usually limited to detecting one mycotoxin and cannot achieve high-throughput, automated, and rapid quantitative analysis of multiple mycotoxins in real samples. Here, we propose a portable automated microfluidic platform (PAMP) integrating a chemiluminescence (CL) imaging system and a microfluidic chip to realize POCT for multiple mycotoxins in real samples, simplifying complex manual operations, shortening the detection time, and improving the detection sensitivity. Specially, silicone films were used as substrates on microfluidic chips to incubate mycotoxin conjugations, and the streptavidin-biotin (SA-B) system and an indirect immunoassay were implemented on silicone films to improve the sensitivity of reaction results. Interestingly, these methods significantly improved detection results, resulting in sensitive detection of mycotoxins, including zearalenone (ZEA) ranging from 1 to 32 ng/mL, aflatoxin B1 (AFB1) ranging from 0.2 to 6.4 ng/mL, and ochratoxin A (OTA) ranging from 2 to 64 ng/mL. The recovery of samples reached 91.39-109.14%, which verified the reliability and practicability of the PAMP. This PAMP enables sensitive and rapid detection of multiple mycotoxins in markets or wineries that lack advanced laboratory facilities. Therefore, it is essential to develop a portable microfluidic platform for POCT to detect mycotoxins in real samples.

Nanozyme-Catalyzed Colorimetric Detection of the Total Antioxidant Capacity in Body Fluids by Paper-Based Microfluidic Chips.

Total antioxidants play a crucial role in human health, and detection of the total antioxidant capacity (TAC) has broad application prospects in fields such as food safety, environmental assessment, and disease diagnosis. However, a long detection time, cumbersome steps, high cost, reliance on professional equipment, and nonportability still remain significant challenges. In this work, an efficient strategy of point-of-care testing (POCT) of the TAC in body fluids by nanozyme-catalyzed colorimetric paper-based microfluidic sensors is proposed. The paper-based microfluidic sensors coupled with a smartphone can reduce testing costs and provide portability. The nanozyme prepared by the solvothermal method presents Michaelis constants of 0.11 and 0.129 mM for H2O2 and TMB, respectively. A method for immobilizing nanozymes and chromogenic agents on a paper-based microfluidic chip is established. Based on smartphone photography and image grayscale extraction, the TAC can be qualitatively detected with a detection limit and linear range of 33.4 and 50-700 µM, respectively. Furthermore, the proposed sensor can realize the one-step quantitative analysis of the TAC in body fluids (blood, saliva, and sweat) within 15 min. The proposed nanozyme-catalyzed colorimetric paper-based microfluidic sensors presented in this study exhibit promising application prospects in the fields of biochemical analysis and POCT.

Kiwi-Inspired Rational Nanoarchitecture with Intensified and Discrete Magneto-Fluorescent Functionalities for Ultrasensitive Point-of-Care Immunoassay.

Fluorescent lateral flow immunoassays (FLFIA) is a well-established rapid detection technique for quantitative analysis. However, achieving accurate analysis of biomarkers at the pg mL-1 level using FLFIA still poses challenges. Herein, an ultrasensitive FLFIA platform is reported utilizing a kiwi-type magneto-fluorescent silica nanohybrid (designated as MFS) that serves as both a target-enrichment substrate and an optical signal enhancement label. The spatially-layered architecture comprises a Fe3O4 core, an endocarp-fibers like dendritic mesoporous silica, seed-like quantum dots, and a kiwi-flesh like silica matrix. The MFS demonstrates heightened fluorescence brightness, swift magnetic response, excellent size uniformity, and dispersibility in water. Through liquid-phase capturing and fluorescence-enhanced signal amplification, as well as magnetic-enrichment sample amplification and magnetic-separation noise reduction, the MFS-based FLFIA is successfully applied to the detection of cardiac troponin I that achieved a limit of detection at 8.4 pg mL-1, tens of times lower than those of previously published fluorescent and colorimetric lateral flow immunoassays. This work offers insights into the strategic design of magneto-fluorescent synergetic signal amplification on LFIA platform and underscores their prospects in high-sensitive rapid and on-site diagnosis of biomarkers.

Point of care testing for the diagnosis of periprosthetic joint infections: a review.

BACKGROUND: Periprosthetic joint infection (PJI) remains a major complication following total joint arthroplasties (TJA), significantly affecting patient outcomes and healthcare costs. Despite advances in diagnostic techniques, challenges persist in accurately diagnosing PJI, underscoring the need for effective point-of-care testing (POCT). METHODS: This review examines the current literature and latest developments in POCT for diagnosing PJI, focusing on biomarkers such as alpha-defensin, leukocyte esterase, calprotectin, and C-reactive protein (CRP). Criteria from various societies like the Musculoskeletal Infection Society, Infectious Diseases Society of America, and the International Consensus Meeting were compared to evaluate the effectiveness of these biomarkers in a point-of-care setting. RESULTS: POCT provides rapid results essential for the timely management of PJI, with alpha-defensin and leukocyte esterase showing high specificity and sensitivity. Recent advancements have introduced novel biomarkers like calprotectin, which demonstrate high diagnostic accuracy. However, challenges such as the variability in test performance and the need for validation under different clinical scenarios remain. DISCUSSION: While POCT for PJI shows promising results, their integration into clinical practice requires standardized protocols and further validation. The evolution of these diagnostic tools offers a potential shift toward more personalized and immediate care, potentially improving outcomes for patients undergoing TJA.

A SERS-based point-of-care testing approach for efficient determination of diquat and paraquat residues using a flexible silver flower-coated melamine sponge.

Diquat (DQ) and paraquat (PQ) residues in food are potential hazards to consumers' health. Point-of-care testing (POCT) of them remains challenging. Based on surface-enhanced Raman spectroscopy (SERS) technology, we developed a POCT strategy for DQ and PQ on apple surface and in apple juice. A point-of-use composite was fabricated using a piece of porous melamine sponge (MS) modified with silver nanoflowers (AgNFs), combining the specificity of the SERS fingerprint and the excellent adsorption capacity of MS. Using this dual-functional AgNFs@MS, the on-site determination of the DQ and PQ residues was completed within 3 min without pretreatment. Clear trends were observed between SERS intensity and logarithmic concentrations, with r values from 0.962 to 0.984. The limit of detection of DQ and PQ were 0.14-0.70 ppb in apple juice and on apple surface. This study provides a new point-of-use alternative for rapidly detecting DQ and PQ residues in nonlaboratory settings.

Unnecessary antibiotic use in men who have sex with men (MSM) with anogenital symptoms attending a sexual health clinic: a retrospective analysis.

OBJECTIVES: To quantify the amount of unnecessary antibiotics, in particular ceftriaxone, given to men who have sex with men (MSM) with anogenital symptoms as part of presumptive management in an urban sexual health clinic and examine factors associated with unnecessary ceftriaxone. METHODS: This is a retrospective cross-sectional analysis of electronic records from all visits involving MSM reporting symptoms of bacterial sexually transmitted infection (STI) and who received presumptive antibiotics at Sydney Sexual Health Centre. The following variables were extracted: demographic and sexual behaviour data, presenting symptoms, prior STI diagnoses, use of anoscopy, use of point-of-care microscopy, prescriptions of antibiotics and subsequent nucleic acid amplification testing (NAAT) results for chlamydia and gonorrhoea in all anatomical sites (urethra, pharynx and rectum). We defined unnecessary antibiotic as an agent prescribed to treat an STI organism that was subsequently not detected. RESULTS: Among 1061 visits in this analysis, 41.8% yielded negative NAAT results for both chlamydia and gonorrhoea in all anatomical sites. There were 44.3% of visits which had positive gonorrhoea NAAT result in at least one anatomical site. There were 187 courses of ceftriaxone prescribed in patients who tested negative for gonorrhoea in all anatomical sites and therefore were unnecessary. Unnecessary ceftriaxone prescribing occurred in 50.2% of visits with anorectal symptoms, 19.6% of scrotal symptoms and 7.3% of urethral symptoms. Microscopy was associated with significantly less unnecessary ceftriaxone in urethral but not anorectal or scrotal presentations. In multivariable analysis, the following factors were associated with a higher likelihood of unnecessary ceftriaxone use: anorectal symptoms, scrotal symptoms, gonorrhoea in the preceding year, contact of a bacterial STI and living with HIV. CONCLUSIONS: This study highlights the significant amount of unnecessary ceftriaxone used for STI symptoms in MSM. A new pathway incorporating rapid point-of-care molecular testing in symptomatic patients may improve the precision of antibiotic prescribing and reduce unnecessary use.

Development and Clinical Evaluation of a CRISPR/Cas12a-Based Nucleic Acid Detection Platform for the Diagnosis of Keratomycoses.

Objective: The objective of this study was to develop a rapid and accurate clustered regularly interspaced short palindromic repeats (CRISPR)/Cas12a-based molecular diagnostic assay (Rapid Identification of Mycoses using CRISPR, RID-MyC assay) to detect fungal nucleic acids and to compare it with existing conventional mycologic methods for the diagnosis of fungal keratitis (FK). Design: This study was structured as a development and validation study focusing on the creation and assessment of the RID-MyC assay as a novel diagnostic modality for FK. Subjects: Participants comprised 142 individuals presenting with suspected microbial keratitis at 3 tertiary care institutions in South India. Methods: The RID-MyC assay utilized recombinase polymerase amplification targeting the 18S ribosomal RNA gene for isothermal amplification, followed by a CRISPR/Cas12a reaction. This was benchmarked against microscopy, culture, and polymerase chain reaction for the diagnosis of FK. Main Outcome Measures: The primary outcome measures focused on the analytical sensitivity and specificity of the RID-MyC assay in detecting fungal nucleic acids. Secondary outcomes measured the assay's diagnostic sensitivity and specificity for FK, including its concordance with conventional diagnostic methods. Results: The RID-MyC assay exhibited a detection limit ranging from 13.3 to 16.6 genomic copies across 4 common fungal species. In patients with microbial keratitis, the RID-MyC assay showed substantial agreement with microscopy (kappa = 0.714) and fair agreement with culture (kappa = 0.399). The assay demonstrated a sensitivity of 93.27% (95% confidence interval [CI], 86.62%-97.25%) and a specificity of 89.47% (95% CI, 66.86%-98.70%) for FK diagnosis, with a median diagnostic time of 50 minutes (range, 35-124 minutes). Conclusions: The RID-MyC assay, utilizing CRISPR-Cas12a technology, offers high diagnostic accuracy for FK. Its potential for point-of-care use could expedite and enhance the precision of fungal diagnostics, presenting a promising solution to current diagnostic challenges. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Using an intersectionality lens to explore barriers and enablers to hepatitis C point-of-care testing: a qualitative study among people who inject drugs and service providers.

BACKGROUND: Hepatitis C virus (HCV) infection is a significant global health burden, particularly among people who inject drugs. Rapid point-of-care HCV testing has emerged as a promising approach to improve HCV detection and linkage to care in harm reduction organizations such as needle and syringe programs. The objective of this study was to use an intersectionality lens to explore the barriers and enablers to point-of-care HCV testing in a needle and syringe program. METHODS: A qualitative study was conducted using semi-structured interviews with clients (people who inject drugs) and service providers in a large community organization focused on the prevention of sexually transmitted and blood borne infections and harm reduction in Montreal, Canada. An intersectionality lens was used alongside the Theoretical Domains Framework to guide the formulation of research questions as well as data collection, analysis, and interpretation. RESULTS: We interviewed 27 participants (15 clients, 12 providers). For clients, four themes emerged: (1) understanding and perceptions of HCV testing, (2) the role of an accessible and inclusive environment, (3) the interplay of emotions and motivations in decision-making, and (4) the impact of intersectional stigma related to HCV, behaviors, and identities. For providers, five themes emerged: (1) knowledge, skills, and confidence for HCV testing, (2) professional roles and their intersection with identity and lived experience, (3) resources and integration of services, (4) social and emotional factors, and (5) behavioral regulation and incentives for HCV testing. Intersectional stigma amplified access, emotional and informational barriers to HCV care for clients. In contrast, identity and lived experience acted as powerful enablers for providers in the provision of HCV care. CONCLUSION: The application of an intersectionality lens provides a nuanced understanding of multilevel barriers and enablers to point-of-care HCV testing. Findings underscore the need for tailored strategies that address stigma, improve provider roles and communication, and foster an inclusive environment for equitable HCV care. Using an intersectionality lens in implementation research can offer valuable insights, guiding the design of equity-focused implementation strategies.

Performance evaluation of a SARS-CoV-2 and influenza A/B combo rapid antigen test.

Introduction: The global COVID-19 pandemic and seasonal influenza outbreaks have drawn attention to the critical need for accurate and efficient diagnostic tools. Methods: The performance of the InstaView COVID-19/Flu Ag Combo Test, which was designed to simultaneously detect the SARS-CoV-2, influenza A, and influenza B viruses, was analytically and clinically evaluated. Results: The InstaView COVID-19/Flu Ag Combo Test exhibited robust detection capabilities, accurately identifying SARS-CoV-2, influenza A, and influenza B viruses over a wide concentration range (1.41 × 103 to 7.05 × 104 TCID50/mL). Extensive testing against potential cross-reactants and interferences yielded no false-positive results, indicating the high specificity of the test. Clinical evaluation further confirmed the kit's reliability, with sensitivity ranging from 95.1% to 98.2% for SARS-CoV-2, 88.9%-95.2% for influenza A, and 91.7%-100% for influenza B depending on the sample type. The specificity was consistently 100% for all of the targeted viruses. Discussion: The InstaView COVID-19/Flu Ag Combo Test thus demonstrated high performance, ease of use, rapid results, and the ability to precisely detect SARS-CoV-2 and influenza A/B infections, making it an effective tool in streamlining diagnostic workflows, optimizing resource allocation, and improving patient outcomes.

[Health promotion and prevention : what role for community pharmacists ?] / Prévention et promotion de la santé : quels rôles pour le pharmacien d'officine ?

Belgian community pharmacists play a pivotal role in both primary and tertiary preventive health activities. Their involvement extends beyond the pharmaceutical care associated with dispensing to include innovative services such as medication review. Additionally, they offer therapeutic education sessions to patients as part of the «Good Use of Medicines¼ programme. The recent pandemic has precipitated significant changes in pharmacists' responsibilities: they have been temporarily granted authority to prescribe and administer vaccines for COVID-19 and influenza, as well as to perform nasopharyngeal screenings for SARS-CoV-2. As frontline healthcare providers, pharmacists have the potential to expand their role in secondary prevention, particularly in screening and providing diagnostic guidance using in vitro diagnostic medical assays. The skills developed in the vaccination domain could be leveraged to enhance vaccination coverage for other diseases, emulating models used in other countries. Furthermore, the challenges posed by climate change present opportunities for pharmacists to contribute meaningfully to public health.

Le pharmacien d'officine belge participe activement aux activités de prévention primaire et tertiaire, non seulement par le biais des soins pharmaceutiques accompagnant la délivrance de médicaments ou dispositifs médicaux, mais aussi via les nouveaux services, comme la revue de la médication. Il réalise aussi des séances d'éducation thérapeutique des patients dans le cadre des entretiens d'accompagnement de Bon Usage des Médicaments (BUM). La récente pandémie a mené à une évolution rapide des missions confiées au pharmacien : il est maintenant (temporairement) autorisé à prescrire et à administrer les vaccins contre la COVID-19 et la grippe et à effectuer le dépistage nasopharyngé du SARS-CoV-2. Professionnel de santé de première ligne, le pharmacien pourrait remplir davantage de missions de prévention secondaire, notamment en matière de dépistage et d'orientation diagnostique au moyen de dispositifs médicaux de diagnostic in vitro. Les nouvelles compétences acquises en matière de vaccination pourraient être mises à profit pour contribuer à étendre la couverture vaccinale vis-à-vis d'autres pathologies, à l'instar des missions exercées par les pharmaciens d'officine à l'étranger. Enfin, les enjeux climatiques offrent de nouvelles perspectives.

Advancements in Biosensors for Point-of-Care Testing of Nucleic Acid.

Rapid, low-cost and high-specific diagnosis based on nucleic acid detection is pivotal in both detecting and controlling various infectious diseases, effectively curbing their spread. Moreover, the analysis of circulating DNA in whole blood has emerged as a promising noninvasive strategy for cancer diagnosis and monitoring. Although traditional nucleic acid detection methods are reliable, their time-consuming and intricate processes restrict their application in rapid field assays. Consequently, an urgent emphasis on point-of-care testing (POCT) of nucleic acids has arisen. POCT enables timely and efficient detection of specific sequences, acting as a deterrent against infection sources and potential tumor threats. To address this imperative need, it is essential to consolidate key aspects and chart future directions in POCT biosensors development. This review aims to provide an exhaustive and meticulous analysis of recent advancements in POCT devices for nucleic acid diagnosis. It will comprehensively compare these devices across crucial dimensions, encompassing their integrated structures, the synthesized nanomaterials harnessed, and the sophisticated detection principles employed. By conducting a rigorous evaluation of the current research landscape, this review will not only spotlight achievements but also identify limitations, offering valuable insights into the future trajectory of nucleic acid POCT biosensors. Through this comprehensive analysis, the review aspires to serve as an indispensable guide for fostering the development of more potent biosensors, consequently fostering precise and efficient POCT applications for nucleic acids.

Pre-hospital evaluation of chest pain patients using the modified HEART-score: rationale and design.

Background: This study assesses how ambulance paramedics using the modified HEART-score with a point-of-care cardiac troponin (cTn) compare to the emergency physicians using the modified HEART-score with a high-sensitive cTn (hs-cTn) in patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS), focusing on interobserver agreement and diagnostic performance. Methods: In this prospective multicenter cohort, we compare four cTn testing strategies (serial point of care and hs-cTn cTn measurement) with and without the HEART-score. Outcomes include the HEART-score's interobserver agreement, NSTE-ACS at discharge, major adverse cardiovascular events (MACE) after 30 days, and diagnostic accuracy of the different strategies. Conclusion: The POPular HEART study aims to improve NSTE-ACS diagnostic pathways, promoting pre-hospital detection and ruling out of NSTE-ACS to minimize unnecessary hospitalizations and associated costs.Clinical Trial Registration: NCT04851418 (ClinicalTrials.gov).

What & why? Many people visit the emergency department (ED) due to chest pain, often worried about the possibility of a heart attack. While acute heart attacks can often be detected through an electrocardiogram (ECG; a test of the heart's electrical activity), a significant number of patients with a heart attack have a normal ECG. These patients require further testing to measure cardiac troponin (cTn; an indicator of heart damage) in the hospital to rule out a heart attack, known as non-ST-elevation acute coronary syndrome (NSTE-ACS). To improve diagnosis and care for these patients, we compared two approaches: ambulance paramedics using a quick bedside cTn test and the HEART-score, versus hospital doctors using a more sensitive cTn test with the HEART-score. The HEART score combines factors like the patient's medical history, ECG results, age, risk factors, and cTn levels to assess the risk of heart problems. In this comparison, the key difference lies in how cTn levels are measured ­ either through a quick finger prick test in an ambulance using a point-of-care device or a more detailed analysis in a hospital laboratory.How? We focused on patients visited by emergency medical services for chest pain suspected of a heart attack and transported to the hospital. We assessed the quick bedside test by paramedics and the detailed hospital test by doctors, alongside the use of the HEART score in both settings. Our evaluation looked at the agreement between these methods and their effectiveness in identifying or excluding an NSTE-ACS.What? Our research, known as the POPular HEART study, seeks to simplify the early identification or rule-out of an NSTE-ACS in patients with chest pain directly by ambulance. This approach aims to decrease unnecessary hospital admissions and reduce healthcare costs.Main points We're exploring innovative methods to safely identify patients with a very low risk of NSTE-ACS in individuals with chest pain outside the hospital. Our objective is to safely minimize hospital admissions that may not be necessary, thereby saving resources. By doing so, we aim to alleviate the pressure on EDs and contribute to more cost-effective healthcare.