Implementation considerations for a point-of-care Neisseria gonorrhoeae rapid diagnostic test at primary healthcare level in South Africa: a qualitative study.

BACKGROUND: South Africa maintains an integrated health system where syndromic management of sexually transmitted infections (STI) is the standard of care. An estimated 2 million cases of Neisseria gonorrhoeae (N. gonorrhoeae) occur in South Africa every year. Point-of-care diagnostic tests (POCT) may address existing STI control limitations such as overtreatment and missed cases. Subsequently, a rapid lateral flow assay with fluorescence-based detection (NG-LFA) with a prototype reader was developed for N. gonorrhoeae detection showing excellent performance and high usability; however, a better understanding is needed for device implementation and integration into clinics. METHODS: A qualitative, time-series assessment using 66 in-depth interviews was conducted among 25 trained healthcare workers involved in the implementation of the NG-LFA. Findings were informed by the Normalization Process Theory (NPT) as per relevant contextual (strategic intentions, adaptive execution, and negotiation capacity) and procedural constructs (coherence, cognitive participation, collective action, reflexive monitoring) to examine device implementation within primary healthcare levels. Interviews were audio-recorded, transcribed, and then analyzed using a thematic approach guided by NPT to interpret results. RESULTS: Overall, healthcare workers agreed that STI POCT could guide better STI clinical decision-making, with consideration for clinic integration such as space constraints, patient flow, and workload. Perceived NG-LFA benefits included enhanced patient receptivity and STI knowledge. Further, healthcare workers reflected on the suitability of the NG-LFA given current limitations with integrated primary care. Recommendations included sufficient STI education, and appropriate departments for first points of entry for STI screening. CONCLUSIONS: The collective action and participation by healthcare workers in the implementation of the NG-LFA revealed adaptive execution within the current facility environment including team compositions, facility-staff receptivity, and STI management experiences. User experiences support future clinic service integration, highlighting the importance of further assessing patient-provider communication for STI care, organizational readiness, and identification of relevant departments for STI screening.

Nanoplasmonic biosensors for multicolor visual analysis of acetylcholinesterase activity and drug inhibitor screening in point-of-care testing.

The monitoring of acetylcholinesterase (AChE) activity and the screening of its inhibitors are significance of the diagnosis and drug therapy of nervous diseases. A metal ions-mediated signal amplification strategy was developed for the highly sensitive and multicolor assay of AChE activity and visually screening its drug inhibitors. After the specific reaction between AChE and acetylthiocholine (ATCh), the hydrolysis product thiocholine (TCh) can directly and decompose the α-FeOOH nanorods (NRs) to release amounts of Fe2+, which was regarded as Fenton reagent to efficiently catalyze H2O2 to produce ·OH. Then, the as-formed ·OH can further largely shorten the gold nanobipyramids (Au NBPs), generating a series of palpable color variations. The linear range for AChE activity was 0.01-500.0 U/L with the limit of detection as low as 0.0074 U/L. The vivid visual effects could be easily distinguished for the multicolor assay of AChE activity by naked eye in visible light. To achieve the point-of-care testing, Au NBPs were further assembled on polymeric electrospun nanofibrous films (ENFs) surface as test strips for the easy-to-use test of AChE activity by RGB values with a smartphone. Fascinatingly, this proposed strategy can be used for the visual screening AChE inhibitors or non-inhibitors. Comparing with the clinical drugs (rivastigmine tartrate, and donepezil), some natural alkaloids such as evodiamine, caffeine, camptothecin, and berberine hydrochloride were selected as inhibitor modes to confirm the drug screening capability of this method. This proposed strategy may have great potential in the other disease-related enzymatic biomarkers assay and the rapid screening of drug therapy.

Evaluation of an immunochromatographic point-of-care test for the detection of failure of transfer of passive immunity in calves.

BACKGROUND: As calves are born without circulating immunoglobulin G (IgG) they depend on transfer of passive immunity via colostrum within the first hours of life. If calves are not sufficiently supplied with high qualitative colostrum they suffer from Failure of Transfer of Passive Immunity (FTPI). The objectives of this study were to evaluate a calf-side point-of-care test to detect calves with FTPI and to evaluate the cut-offs for a positive test result. Two hundred fifty calves from 11 dairy farms (born between September 2021 and September 2022) were included, whereof 23 were excluded due to incomplete data. Twelve to 16 h post partum the farmers carried out a point-of-care test (FASTest® IgG bovine, Megacor, Austria) using a whole blood sample. Between the 3rd and the 6th day of age, all calves were physically examined and blood samples were collected to carry out further point-of-care tests using whole blood supernatant and plasma and for measuring the Brix values in serum and plasma. Brix values in serum were used as reference for the evaluation of the point-of-care test between the 3rd and the 6th day of age, as radial immunodiffusion assays could not be conducted simultaneously. RESULTS: Brix values were not normally distributed (median at 8.6% and 9.3% in serum and plasma). In this study, the cut-off values for the point-of-care tests using whole blood supernatant and plasma were at 8.3% Brix in serum. FASTest® IgG bovine shows high sensitivities of 90% and 84% and specificities of 70% and 72% for whole blood supernatant and plasma. CONCLUSIONS: Of the 227 investigated calves, 39.7% showed Brix values of < 8.4% (cut-off for FTPI) which indicates an urgent need to improve colostrum management. The results of the study suggest that the FASTest® IgG bovine is a suitable on-farm method to assess FTPI in whole blood supernatant and plasma of calves between the 3rd and the 6th day of age. However, the results also show that FASTest® IgG bovine is not adequate to test for FTPI using whole blood at 12 to 16 h post partum.

Point-of-Care Testing of Enzyme Polymorphisms for Predicting Hypnotizability and Postoperative Pain.

Hypnotizability is a stable trait that moderates the benefit of hypnosis for treating pain, but limited availability of hypnotizability testing deters widespread use of hypnosis. Inexpensive genotyping of four single-nucleotide polymorphisms in the catechol-o-methyltransferase (COMT) gene was performed using giant magnetoresistive biosensors to determine if hypnotizable individuals can be identified for targeted hypnosis referrals. For individuals with the proposed optimal COMT diplotypes, 89.5% score highly on the Hypnotic Induction Profile (odds ratio, 6.12; 95% CI, 1.26-28.75), which identified 40.5% of the treatable population. Mean hypnotizability scores of the optimal group were significantly higher than the total population (P = 0.015; effect size = 0.60), an effect that was present in women (P = 0.0015; effect size = 0.83), but not in men (P = 0.28). In an exploratory cohort, optimal individuals also reported significantly higher postoperative pain scores (P = 0.00030; effect size = 1.93), indicating a greater need for treatment.

Aspirin Resistance in Vascular Disease: A Review Highlighting the Critical Need for Improved Point-of-Care Testing and Personalized Therapy.

Aspirin resistance describes a phenomenon where patients receiving aspirin therapy do not respond favorably to treatment, and is categorized by continued incidence of adverse cardiovascular events and/or the lack of reduced platelet reactivity. Studies demonstrate that one in four patients with vascular disease are resistant to aspirin therapy, placing them at an almost four-fold increased risk of major adverse limb and adverse cardiovascular events. Despite the increased cardiovascular risk incurred by aspirin resistant patients, strategies to diagnose or overcome this resistance are yet to be clinically validated and integrated. Currently, five unique laboratory assays have shown promise for aspirin resistance testing: Light transmission aggregometry, Platelet Function Analyzer-100, Thromboelastography, Verify Now, and Platelet Works. Newer antiplatelet therapies such as Plavix and Ticagrelor have been tested as an alternative to overcome aspirin resistance (used both in combination with aspirin and alone) but have not proven to be superior to aspirin alone. A recent breakthrough discovery has demonstrated that rivaroxaban, an anticoagulant which functions by inhibiting active Factor X when taken in combination with aspirin, improves outcomes in patients with vascular disease. Current studies are determining how this new regime may benefit those who are considered aspirin resistant.

Integrated care model and point of care diagnostics facilitate Hepatitis C treatment among patients receiving opioid agonist therapy: a retrospective review of medical records.

BACKGROUND: Hepatitis C virus (HCV) is common among individuals in opioid agonist therapy (OAT). HCV treatment has previously been unavailable for most HCV positive OAT patients in Finland. The removal of treatment restrictions and attempts to reach HCV elimination goals have increased the number of OAT patients needing HCV treatment. The objectives of this study were 1) to characterize Finnish HCV positive OAT patients and evaluate their eligibility for HCV treatment at addiction service units, and 2) to retrospectively review the outcomes of treated patients. METHODS: The study focused on HCV positive OAT patients (n = 235). Demographics and clinical parameters were retrospectively reviewed using the patients' medical records. The eligibility of providing HCV treatment to patients at addiction service units were evaluated based on patients' clinical characteristics, such as liver function and patterns of substance use. The outcomes of patients receiving HCV treatment were reviewed. RESULTS: Of HCV antibody positive OAT patients, 75% had chronic HCV. Of 103 HCV patients screened for liver fibrosis either with Fibroscan or APRI (aspartate aminotransferase to platelet ratio index), 83 patients (81%) had no indication of severe liver damage. Point of care (POC) HCV tests were used for 46 patients to lower the threshold of attending laboratory testing. All patients preferred POC testing to conventional blood testing. Twenty patients had received HCV treatment, 19 completed the treatment and achieved sustained virologic response (SVR) at the end of the treatment. Of the 18 patients available for evaluation of SVR at 12 weeks after the treatment (SVR12), 17 achieved SVR12. CONCLUSIONS: The integrated model consisting of HCV diagnostics and treatment at the addiction service unit was successfully implemented within normal OAT practice.

A Cluster-Randomized Trial of Traditional Healer-Delivered Counseling and Rapid HIV Testing in Tanzania.

Collaborations with traditional healers have been proposed to improve HIV testing uptake. We hypothesized that healer-delivered HIV testing would improve HIV testing uptake, compared with referral to clinic-based HIV testing. We conducted a cluster randomized trial to determine the effectiveness of traditional healers delivering counseling and HIV testing in Mwanza, Tanzania (ClinicalTrials.gov NCT#04071873). Intervention arm healers provided counseling and offered point-of-care HIV tests to adult clients of unknown HIV serostatus. Control arm healers provided referral for clinic-based testing. Primary outcome was receipt of an HIV test within 90 days of enrollment. Secondary outcomes were new HIV diagnosis and linkage to care. In the intervention, 100 clients (100%) received an HIV test, compared with 73 (73%) of control participants (p < 0.001). Two intervention arm participants (2%) had a new diagnosis compared with zero in the control arm (p = 0.50). Engaging traditional healers might provide a culturally concordant opportunity to improve HIV testing uptake.

Development of a Point-of-Care Test Based on Selenium Nanoparticles for Heart-Type Fatty Acid-Binding Proteins in Human Plasma and Blood.

Purpose: A rapid, convenient, cost-effective in-home test method for identifying heart-type fatty acid-binding protein (H-FABP) in plasma and blood by a lateral-flow immunoassay (LFIA) based on selenium nanoparticles (SeNPs) was developed. Methods: SeNPs were synthesized by using L-ascorbic acid to reduce seleninic acid at room temperature and conjugated with an anti-H-FABP monoclonal antibody. The limit of detection, specificity, and stability were measured, and clinical samples were analyzed. Results: The SeNPs were spherical with a diameter of 39.48 ± 3.72 nm and were conjugated successfully with an anti-H-FABP antibody, resulting in a total diameter of 46.52 ± 2.95 nm. The kit was designed for the determination of H-FABP in plasma specimens and whole blood specimens. The limit of detection was 1 ng/mL in plasma and blood, and the results could be determined within 10 min. No cross-reaction occurred with cardiac troponin I, creatine kinase-MB or myoglobin. The kits were stored at 40 °C for up to 30 days without significant loss of activity. The sensitivity was determined to be 100%, the specificity 96.67%, and the overall coincidence rate 97.83%. Conclusion: This SeNP assay kit can conveniently, rapidly, and sensitively detect H-FABP in plasma or blood with a readout of a simple color change visible to the naked eye with no special device, and can be used as an auxiliary means for the early screening of AMI. Clinical Trial Registration: Plasma and blood samples were used under approval from the Experimental Animal Ethics committee of the Joint National Laboratory for Antibody Drug Engineering, Henan University. The clinical trial registration number was HUSOM-2019-047.

A review on point of care tests in parasitology.

BACKGROUND: Infectious diseases can be of serious public concerns because of its transmissibility. The parasitic infectious diseases in particular are often seen as neglected diseases of poverty. The diagnostic tests for parasitic diseases barring malaria are not easily available specially in low resources settings where they are needed most. The conventional mode of diagnosis based on centralized laboratory is time consuming and resource intensive. The modern-day medicine has shifted the focus to patient care. The use of point of care tests (POCT) has increased worldwide because they provide rapid diagnosis within the consultation time that too near patient care areas. This is very useful for starting initial treatment. These POCT provide excellent solution for rural and hard to reach areas where parasitic diseases are most prevalent. Despite the high demand, a relatively limited number of validated rapid diagnostics are commercially available for parasitic infections. OBJECTIVES AND CONTENT: This review aims to discuss various POCT available for these neglected parasitic diseases. Accurate detection of parasitic infection underpins a holistic approach to its control and management. The POCT can also be used to screen mass population to detect asymptomatic reservoirs and monitor interventions planned for elimination programs for many parasitic diseases. Recently focus is on integrated platforms and analysis of multiple analytes from single sample. Researchers are striving to produce POCT based on innovative technology such as lab-on-chip that can be made more affordable and suitable for low resource settings.

Increasing demand for point-of-care testing and the potential to incorporate the Internet of medical things in an integrated health management system.

As the number of people with COVID-19 increases daily around the world, point-of-care testing (POCT) is gaining attention as a tool that can provide immediate test results and greatly help to deter infection and determine what to do next. POCT has several drawbacks such as a low sensitivity and specificity, but according to studies POCT has increased sensitivity on par with that of polymerase chain reaction testing. The advantage of POCT is that the results can be obtained quickly, regardless of the location. To further enhance its benefits, POCT is being developed and researched in conjunction with the Internet of medical things (IoMT), which allows POCT results to be collected, recorded, and managed over a network. IoMT will be beneficial not only for the use of POCT simply as a testing tool but also for its integration into diagnostic and health management systems. IoMT will enable people to regularly receive their test results in their daily lives and to provide personalized diagnosis and treatment of individual conditions, which will be beneficial in terms of disease prevention and maintenance of health.

Nicotinamide-Functionalized Carbon Quantum Dot as New Sensing Platform for Portable Quantification of Vitamin B12 in Fluorescence, UV-Vis and Smartphone Triple Mode.

Development of an efficient, portable and simple nanosensor-based systems with reliable analytical performance for on-site monitoring of vitamin B12 (VB12) are still major problems and a challenging work for quality control of manufacturers. Herein, a new fluorescence, UV-Vis and smartphone triple mode nanosensors were designed for the simultaneous detection of VB12 with high sensitivity and accuracy. A novel nanosensor was synthesized through nicotinamide-functionalizing of carbon quantum dot (NA-CQDs) by an one-step microwave-assisted method with green approach. The NA-CQDs sensor showed excellent fluorescence properties and wide linear ranges from 0.1-60 µM with the detection limits of 31.7 nM. Moreover, color changes of NA-CQDs induced by the VB12 could also be detected by UV-Vis spectrophotometer and inhouse-developed application installed on smartphone as a signal reader, simultanusly. The Red, Green and Blue (RGB) intensities of the colorimetric images of NA-CQDs/VB12 system which taken by smartphone's camera converted into quantitative values by the application. A smartphone-integrated with NA-CQDs as colorimetric sensing platform displays good linear ranges (4.16 to 66.6 µM) for on-site determination of VB12 with detection limit of 1.40 µM. The method was successfully applied in the determination of VB12 in complex pharmaceutical supplement formulations without any sample pre-treatment and matrix interfering effects. The recovery results (96.52% to 105.10%) which were in agreement with the reference methods, demonstrating the capability of the smartphone-assisted colorimetric sensing platform in many on-site practical applications of quality controls.

Real evidence to assess clinical testing interference risk (REACTIR): A strategy using real world data to assess the prevalence of interfering substances in patients undergoing clinical laboratory testing.

INTRODUCTION: Laboratory test interferences can cause spurious test results and patient harm. Knowing the frequency of various interfering substances in patient populations likely to be tested with a particular laboratory assay may inform test development, test utilization and strategies to mitigate interference risk. METHODS: We developed REACTIR (Real Evidence to Assess Clinical Testing Interference Risk), an approach using real world data to assess the prevalence of various interfering substances in patients tested with a particular type of assay. REACTIR uses administrative real world data to identify and subgroup patient cohorts tested with a particular laboratory test and evaluate interference risk. RESULTS: We demonstrate the application REACTIR to point of care (POC) blood glucose testing. We found that exposure to several substances with the potential to interfere in POC blood glucose tests, including N-acetyl cysteine (NAC) and high dose vitamin C was uncommon in most patients undergoing POC glucose tests with several key exceptions, such as burn patients receiving high dose IV-vitamin C or acetaminophen overdose patients receiving NAC. CONCLUSIONS: Findings from REACTIR may support risk mitigation strategies including targeted clinician education and clinical decision support. Likewise, adaptations of REACTIR to premarket assay development may inform optimal assay design and assessment.

Point-of-care ultrasound in a multiplace hyperbaric chamber.

Historically, electronic devices have been generally prohibited during hyperbaric oxygen (HBO2) therapy due to risk of fire in a pressurized, oxygen-rich environment. Point-of-care ultrasound (POCUS) however has emerged as a useful imaging modality in diverse clinical settings. Hyperbaric chambers treating critically ill patients would benefit from the application of POCUS at pressure to make real-time patient assessments. Thus far, POCUS during HBO2 therapy has been limited due to required equipment modifications to meet safety standards. Here we demonstrate proof of concept, safety, and successful performance of an off-the-shelf handheld POCUS system (SonoSite iViz) in a clinical hyperbaric environment without need for modification.

Molecular diagnostic of toxigenic Corynebacterium diphtheriae strain by DNA sensor potentially suitable for electrochemical point-of-care diagnostic.

The presented study is focused on the development of electrochemical genosensor for detection of tox gene fragment of toxigenic Corynebacterium diphtheriae strain. Together with our previous studies it fulfils the whole procedure for fast and accurate diagnostic of diphtheria at its early stage of infection with the use of electrochemical methods. The developed DNA sensor potentially can be used in more sophisticated portable device. After the electrochemical stem-loop probe structure optimization the conditions for real asymmetric PCR (aPCR) product detection were selected. As was shown it was crucial to optimize the magnesium and organic solvent concentrations in detection buffer. Under optimal conditions it was possible to selectively detect as low as 20.8 nM of complementary stand in 5 min or 0.5 nM in 30 min with sensitivity of 12.81 and 0.24 1⋅µM-1 respectively. The unspecific biosensor response was elucidated with the use of new electrode blocking agent, diethyldithiocarbamate. Its application in electrochemical genosensors lead to significant higher current values and the biosensor response even in conditions with magnesium ion depletion. The developed biosensor selectivity was examined using samples containing genetic material originated from a number of non-target bacterial species which potentially can be present in the human upper respiratory tract.

Pressure/colorimetric dual-readout immunochromatographic test strip for point-of-care testing of aflatoxin B1.

Immunochromatographic test strip (ITS) for point-of-care testing (POCT) has attracted prominent attention due to the advantages including rapid response, low cost and good portability. Here, we developed a sensitive ITS for detecting aflatoxin B1 (AFB1) by using dendritic platinum nanoparticles (DPNs) as novel pressure/colorimetric dual-readout probes. DPNs-labeled antibody of AFB1 were used as the signal tracer of the immunochromatographic process. After 10-min competitive immunoreaction, black color appeared on the test line of ITS due to the accumulation of DPNs, which was observed visually as a colorimetric readout for qualitation purpose. Furthermore, DPNs with peroxidase-like activity caused decomposition of hydrogen peroxide aqueous solution to produce pressure change signal in vials, which was detected by a hand-held pressure meter for quantitation purpose. With the pressure readout mode, the detection range was 0.05-10 ng mL-1, and the detection limit was 0.03 ng mL-1 (S/N = 3) for AFB1. The proposed ITS was successfully utilized for detecting AFB1 in herbal medicine samples, and the acceptable recoveries of 93.77-114.09% indicated the reliability for real sample detection. It provides a new avenue for POCT with great application potential in various area including drug and food quality control, pollutants monitoring as well as medical diagnosis.

Knittable and Sewable Spandex Yarn with Nacre-Mimetic Composite Coating for Wearable Health Monitoring and Thermo- and Antibacterial Therapies.

The emerging personal healthcare has significantly propelled the development of advanced wearable electronics with novel functions of providing diagnostic information and point-of-care therapies for specific diseases. However, it is still challenging to simultaneously achieve high sensitivity for health biomonitoring and multifunction integration for point-of-care therapies in a one single flexible, lightweight yet robust fiber-based device. Here, a knittable and sewable spandex yarn with conductive nacre-mimetic composite coating has been developed through an alternant dip-coating method employing MXene nanosheets as the "brick" and polydopamine (PDA)/Ni2+ as the "mortar". The resultant spandex yarn coating with MXene/PDA/Ni2+ (MPNi@Spandex) can be assembled as a strain sensor with high sensitivity (up to 5.7 × 104 for the gauge factor), wide sensing range (∼61.2%), and low detection limit (0.11%) to monitor the biological activities of the human body. Furthermore, MPNi@Spandex displays great potential to give on-demand thermotherapy by virtue of the fast response to near-infrared irradiation, controllable surface temperature, and applicability even under sewing conditions. In addition, MPNi@Spandex knitted textiles demonstrate a strong antibacterial effect due to the sharp edges, anionic, and hydrophilic nature of MXene nanosheets. Remarkably, near-infrared irradiation further improves the bacteria-killing efficiency of an MPNi@Spandex knitted textile to more than 99.9%. This work paves the way for the design of multifunctional wearable electronics with an all-in-one theranostic platform for personal healthcare.

The use of point-of-care ultrasound to guide clinical management in intra-abdominal hypertension.

INTRODUCTION: The Abdominal Compartment Society (WSACS) developed a medical management algorithm with a stepwise approach to keep intra-abdominal pressure (IAP) ≤ 15 mm Hg. The role of point-of-care ultrasound (POCUS) as a bedside modality in the critical care patients is not well studied in relation to the intra-abdominal hypertension (IAH) management algorithm. AIM: To test the role of point-of-care ultrasound (POCUS) in the medical management of patients with intra-abdominal hypertension (IAH). METHOD: We conducted a prospective observational study. Those who met the inclusion criteria were assigned to undergo POCUS and small bowel ultrasound as adjuvant tools in their IAH management. RESULTS: A total of 22 patients met the inclusion criteria and were included in the study. The mean age of the study participants was 65 ± 22.6 years, 61% were men, and the most frequent admission diagnoses were hepatic encephalopathy and massive ascites (five cases). Ultrasound and abdominal X-rays were comparable in confirming correct NGT position, but the ultrasound was superior in determining the gastric content (fluid vs. solid) and diagnoses of gastric paresis in two cases. Small bowel obstruction was present in four patients and confirmed with abdominal CT; two of the patients underwent surgical intervention for mesenteric vessel occlusion and transmesenteric internal hernia. Enema treatment was found to empty the bowel incompletely 72%, 56%, and 42% of the time on days 1, 2, and 3, respectively. Four patients with cirrhosis admitted with upper gastrointestinal bleeding and hepatic encephalopathy (out of a total of 8) were found to have large amounts of ascites, and US-guided paracentesis was performed. CONCLUSION: POCUS can be used in the nonoperative management of IAH. It is an important tool in the diagnosis and treatment of patients with IAH.

A point-of-care selenium nanoparticle-based test for the combined detection of anti-SARS-CoV-2 IgM and IgG in human serum and blood.

COVID-19 is a widespread and highly contagious disease in the human population. COVID-19 is caused by SARS-CoV-2 infection. There is still a great demand for point-of-care tests for detection, epidemic prevention and epidemiological investigation, both now and after the epidemic. We present a lateral flow immunoassay kit based on a selenium nanoparticle-modified SARS-CoV-2 nucleoprotein, which detects anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human serum, and the results can be read by the naked eye in 10 minutes. We expressed and purified the SARS-CoV-2 nucleoprotein in HEK293 cells, with a purity of 98.14% and a concentration of 5 mg mL-1. Selenium nanoparticles were synthesized by l-ascorbic acid reduction of seleninic acid at room temperature. After conjugation with the nucleoprotein, a lateral flow kit was successfully prepared. The IgM and IgG detection limits of the lateral flow kit reached 20 ng mL-1 and 5 ng mL-1, respectively, in human serum. A clinical study sample comprising 90 COVID-19-diagnosed patients and 263 non-infected controls was used to demonstrate a sensitivity and specificity of 93.33% and 97.34%, respectively, based on RT-PCR and clinical results. No cross-reactions with rheumatoid factor and positive serum for anti-nuclear antibodies, influenza A, and influenza B were observed. Moreover, the lateral flow kit remained stable after storage for 30 days at 37 °C. Our results demonstrate that the selenium nanoparticle lateral flow kit can conveniently, rapidly, and sensitively detect anti-SARS-CoV-2 IgM and IgG in human serum and blood; it can also be suitable for the epidemiological investigation of COVID-19.

Implementation planning for community-based point-of-care HIV testing for infants: Recommendations from community leaders in Kenya.

BACKGROUND: Early infant diagnosis (EID) establishes the presence of HIV infection in HIV-exposed infants and children younger than 18 months of age. EID services are hospital-based, and thus fail to capture HIV-exposed infants who are not brought to the hospital for care. Point-of-care (POC) diagnostic systems deployed in the community could increase the proportion tested and linked to treatment, but little feasibility and acceptability data is available. METHODS: Semi-structured interviews (n = 74) were conducted by a Kenyan team with community members (Community Health Workers/Volunteers [CHW/CHV], Traditional Birth Attendants [TBAs], community leaders) and parents of HIV-exposed infants at four study sites in Kenya to elicit feedback on the acceptability and feasibility of community-based POC HIV testing. RESULTS: Participants described existing community health resources that could be leveraged to support integration of community-based POC HIV testing; however, the added demand placed on CHW/CHV could pose a challenge. Participants indicated that other potential barriers (concerns about confidentiality, disclosure, and HIV stigma) could be overcome with strong engagement from trusted community leaders and health providers, community sensitization, and strategic location and timing of testing. These steps were seen to improve acceptability and maximize the recognized benefits (rapid results, improved reach) of community-based testing. CONCLUSION: Community members felt that with strategic planning and engagement, community-based POC HIV testing could be a feasible and acceptable strategy to overcome the existing barriers of hospital-based EID.