A Loop-Mediated Isothermal Amplification (Lamp)-Based Point-of-Care System for Rapid on-Site Clinical Detection of Sars-Cov-2 Viruses

In the ongoing COVID-19 pandemic, sensitive and rapid on-site detection of the SARS-CoV-2 coronavirus has been one of crucial objectives. A point-of-care (PoC) device called PATHPOD for quick, on-site detection of SARS-CoV-2 employing a real-time reverse-transcription loop-mediated isothermal amplification (RT-rLAMP) reaction on a polymer cartridge. The PATHPOD consists of a standalone device (weighing under 1.2 kg) and a cartridge, and can identify 10 distinct samples and 2 controls in less than 50 minutes. The PATHPOD PoC system is fabricated and clinically validated for the first time in this work © 2023 IEEE.

Advances in Electrochemical Biosensors Based on Nanomaterials for Protein Biomarker Detection in Saliva.

The focus on precise medicine enhances the need for timely diagnosis and frequent monitoring of chronic diseases. Moreover, the recent pandemic of severe acute respiratory syndrome coronavirus 2 poses a great demand for rapid detection and surveillance of viral infections. The detection of protein biomarkers and antigens in the saliva allows rapid identification of diseases or disease changes in scenarios where and when the test response at the point of care is mandated. While traditional methods of protein testing fail to provide the desired fast results, electrochemical biosensors based on nanomaterials hold perfect characteristics for the detection of biomarkers in point-of-care settings. The recent advances in electrochemical sensors for salivary protein detection are critically reviewed in this work, with emphasis on the role of nanomaterials to boost the biosensor analytical performance and increase the reliability of the test in human saliva samples. Furthermore, this work identifies the critical factors for further modernization of the nanomaterial-based electrochemical sensors, envisaging the development and implementation of next-generation sample-in-answer-out systems.

Assessing the Acceptability of Home Blood Monitoring for Patients With Cancer Who Are Receiving Systemic Anticancer Therapy From a Patient, Caregiver, and Clinician Perspective: Focus Group and Interview Study.

BACKGROUND: Regular blood testing is an integral part of systemic anticancer therapy delivery. Blood tests are required before every administration of treatment to ensure that a patient is sufficiently well to receive it. Blood testing is burdensome for patients as they require either an extra visit within 48 hours of planned administration of treatment or a significantly long visit if performed on the day of treatment. The additional time for appointments can have a significant impact on the quality of life of someone who is living with cancer. In the United Kingdom, the COVID-19 pandemic created unprecedented disruption to the delivery of cancer care. Face-to-face hospital visits were reduced, resulting in the need to develop more innovative ways of working to minimize treatment interruptions. This led to significant uptake of digital technologies, with new models of care rapidly deployed across the UK health service to meet these challenges. OBJECTIVE: This study aimed to explore the acceptability of a point-of-care home blood monitoring device for people with cancer who are receiving systemic anticancer therapy, which is being developed in response to the increased need for remote care for patients with cancer. METHODS: Qualitative focus groups and semistructured interviews were conducted with patients (23/47, 49%), caregivers (6/47, 13%), and health care professionals (18/47, 38%) over a 19-month time frame from May 2019 to December 2020. Data were analyzed using framework analysis guided by the Unified Theory of Acceptance and Use of Technology model. RESULTS: Analysis identified 4 overarching themes: performance expectancy, effort expectancy, social influence, and facilitating conditions. CONCLUSIONS: This study found that patients with cancer, their caregivers, and health care professionals had positive perceptions about home blood monitoring. Although they are often considered synonymously, self-testing and self-management are not mutually exclusive, and this study illustrated some disparity in opinions regarding patient self-management. Home blood monitoring has the potential to provide patients with cancer with a convenient option for blood monitoring. It would minimize hospital attendances, decrease late treatment deferrals, and provide prompt recognition of cancer treatment toxicities, thus enhancing the existing nurse-led protocols and clinical pathways. Home blood monitoring would create a long-term sustainable transformation for the delivery of cancer care, using digital health to act as a facilitator to address a pertinent issue regarding improving the efficiency of hospital resources and increasing the delivery of personalized patient care. Further studies are needed to determine how and where home blood monitoring would fit within clinical pathways, in a way that is robust and equitable.

Telemedicine can be a feasible means of guiding untrained general practitioners to perform point-of-care ultrasound in life-threatening situations: the case of a field hospital during the COVID-19 pandemic.

Objective: To evaluate the feasibility of telemedicine using a standardized multiorgan ultrasound assessment protocol to guide untrained on-site general practitioners at a field hospital during a life-threatening crisis. Materials and Methods: We evaluated 11 inpatients with shock, with or without acute dyspnea, for whom general practitioners spontaneously requested remote evaluation by a specialist. Results: All of the general practitioners accepted the protocol and were able to position the transducer correctly, thus obtaining key images of the internal jugular vein, lungs, and inferior vena cava when guided remotely by a telemedicine physician, who interpreted all of the findings. However, only four (36%) of the on-site general practitioners obtained the appropriate key image of the heart in the left parasternal long-axis view, and only three (27%) received an immediate interpretation of an image from the remote physician. The mean evaluation time was 22.7 ± 12 min (range, 7-42 min). Conclusion: Even in life-threatening situations, untrained general practitioners may be correctly guided by telemedicine specialists to perform multiorgan point-of-care ultrasound in order to improve bedside diagnostic evaluation.

Objetivo: Avaliar a viabilidade da orientação por telemedicina de médicos in situ não treinados na avaliação ultrassonográfica de múltiplos órgãos mediante protocolo padronizado, durante uma situação de risco de vida em hospital de campanha. Materiais e Métodos: Avaliamos 11 pacientes com choque e/ou dispneia de manifestação aguda durante a internação, cujos clínicos gerais solicitaram auxílio de especialista a distância. Resultados: Todos os médicos aceitaram o protocolo e, posicionando o transdutor, obtiveram imagens-chave da veia jugular interna, pulmão e veia cava inferior, quando guiados por um médico via telemedicina, que interpretou os achados desses órgãos. No entanto, apenas quatro (36%) médicos in situ obtiveram a imagem-chave apropriada do coração na janela paraesternal do eixo longo esquerdo e três (27%) tiveram imagem remotamente interpretada imediatamente. O tempo de avaliação variou de 7-42 minutos (média de 22,7 ± 12 minutos). Conclusão: Em situação de risco de vida, os clínicos gerais não treinados podem ser corretamente orientados por especialistas em telemedicina para realizar ultrassonografia multiórgãos in situ, melhorando o diagnóstico beira do leito.

Evaluation of the Roche SARS-CoV-2 Rapid Antibody Test in Samples from Vaccinated Individuals.

The study aimed to establish the performance of the SARS-CoV-2 Rapid Antibody Test (IgG and IgM) and the Elecsys Anti-SARS-CoV-2 S assay in vaccinated individuals. A panel of serum samples from Boca Biolistics was utilized to assess antibodies following vaccination, consisting of samples drawn prior to vaccination, after the first dose, or at least 14 days after the second dose of Moderna mRNA-1273 or Pfizer-BioNTech BNT162b2 COVID-19 vaccines. Agreement between the two methods was measured and stratified by test evaluator and assay lot. Agreement between the SARS-CoV-2 Rapid Antibody Test (IgG) and Elecsys Anti-SARS-CoV-2 S assay qualitative measurements at the different assessment points for both mRNA-1273 and BNT162b2 ranged between 97.06% (95% confidence interval [CI] 84.67, 99.93) to 100% (95% CI 82.35, 100). Agreement of the SARS-CoV-2 Rapid Antibody Test (IgG) with the Elecsys Anti-SARS-CoV-2 S assay was not highly influenced by either lot or evaluator. There was a medium-to-strong correlation between the semiquantitative SARS-CoV-2 Rapid Antibody Test (IgG) result and quantitative Elecsys Anti-SARS-CoV-2 S assay in samples taken after both doses of the vaccines, with higher intensity bands being associated with higher total anti-S antibody titer (mRNA-1273, P = 0.0019; BNT162b2, P < 0.0001). Conclusion Semiquantitative SARS-CoV-2 Rapid Antibody Test (IgG) and quantitative Elecsys Anti-SARS-CoV-2 S assay correlated well, suggesting that the SARS-CoV-2 Rapid Antibody Test (IgG) is helpful in understanding the immune response postvaccination. The current data support the use of the SARS-CoV-2 Rapid Antibody Test (IgG) in the vaccinated population. IMPORTANCE Serologic assays are an essential tool for seroprevalence surveys, for quality control of vaccines, and to determine the response to vaccination. Although a correlate of immunity has not yet been established for COVID-19 vaccines, antibody titers after natural infection and vaccination have been associated with protection from symptomatic SARS-CoV-2 infection. Rapid point-of-care assays can be of use in this context with advantages over centralized testing, such as speed and ease of use. The point-of-care SARS-CoV-2 Rapid Antibody Test (IgG) compared favorably to the Elecsys Anti-SARS-CoV-2 S assay with agreement rates above 97.06%, after one or two doses of Moderna mRNA-1273 or Pfizer-BioNTech BNT162b2. Semiquantitative SARS-CoV-2 Rapid Antibody Test (IgG) and quantitative Elecsys Anti-SARS-CoV-2 S assay results correlated well, suggesting that SARS-CoV-2 Rapid Antibody Test (IgG) is helpful in understanding the immune response postvaccination. The current data support the use of the SARS-CoV-2 Rapid Antibody Test (IgG) in the vaccinated population.

Clinical decision making is improved by BioFire Pneumonia Plus in suspected lower respiratory tract infection after lung transplantation: Results of the prospective DBATE-IT study.

BACKGROUND: Lower respiratory tract infections (LRTIs) are a significant cause of morbidity and mortality in lung transplant (LTx) recipients. Timely and precise pathogen detection is vital to successful treatment. Multiplex PCR kits with short turnover times like the BioFire Pneumonia Plus (BFPPp) (manufactured by bioMérieux) may be a valuable addition to conventional tests. METHODS: We performed a prospective observational cohort study in 60 LTx recipients with suspected LRTI. All patients received BFPPp testing of bronchoalveolar lavage fluid in addition to conventional tests including microbiological cultures and conventional diagnostics for respiratory viruses. Primary outcome was time-to-test-result; secondary outcomes included time-to-clinical-decision and BFPPp test accuracy compared to conventional tests. RESULTS: BFPPp provided results faster than conventional tests (2.3 h [2-2.8] vs. 23.4 h [21-62], p < 0.001), allowing for faster clinical decisions (2.8 [2.2-44] vs. virology 28.1 h [23.1-70.6] and microbiology 32.6 h [4.6-70.9], both p < 0.001). Based on all available diagnostic modalities, 26 (43%) patients were diagnosed with viral LRTI, nine (15 %) with non-viral LRTI, and five (8 %) with combined viral and non-viral LRTI. These diagnoses were established by BFPPp in 92%, 78%, and 100%, respectively. The remaining 20 patients (33 %) received a diagnosis other than LRTI. Preliminary therapies based on BFPPp results were upheld in 90% of cases. There were six treatment modifications based on pathogen-isolation by conventional testing missed by BFPPp, including three due to fungal pathogens not covered by the BFPPp. CONCLUSION: BFPPp offered faster test results compared to conventional tests with good concordance. The absence of fungal pathogens from the panel is a potential weakness in a severely immunosuppressed population.

Point-of-care testing technologies for the home in chronic kidney disease: a narrative review.

Point-of-care testing (POCT) performed by the patient at home, paired with eHealth technologies, offers a wealth of opportunities to develop individualized, empowering clinical pathways. The non-dialysis-dependent chronic kidney disease (CKD) patient who is at risk of or may already be suffering from a number of the associated complications of CKD represents an ideal patient group for the development of such initiatives. The current coronavirus disease 2019 pandemic and drive towards shielding vulnerable individuals have further highlighted the need for home testing pathways. In this narrative review we outline the evidence supporting remote patient management and the various technologies in use in the POCT setting. We then review the devices currently available for use in the home by patients in five key areas of renal medicine: anaemia, biochemical, blood pressure (BP), anticoagulation and diabetes monitoring. Currently there are few devices and little evidence to support the use of home POCT in CKD. While home testing in BP, anticoagulation and diabetes monitoring is relatively well developed, the fields of anaemia and biochemical POCT are still in their infancy. However, patients' attitudes towards eHealth and home POCT are consistently positive and physicians also find this care highly acceptable. The regulatory and translational challenges involved in the development of new home-based care pathways are significant. Pragmatic and adaptable trials of a hybrid effectiveness-implementation design, as well as continued technological POCT device advancement, are required to deliver these innovative new pathways that our patients desire and deserve.

SARS-CoV-2 infection in general practice in Ireland: a seroprevalence study.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody testing in community settings may help us better understand the immune response to this virus and, therefore, help guide public health efforts. AIM: To conduct a seroprevalence study of immunoglobulin G (IgG) antibodies in Irish GP clinics. DESIGN & SETTING: Participants were 172 staff and 799 patients from 15 general practices in the Midwest region of Ireland. METHOD: This seroprevalence study utilised two manufacturers' point-of-care (POC) SARS-CoV-2 immunoglobulin M (IgM)-IgG combined antibody tests, which were offered to patients and staff in general practice from 15 June to 10 July 2020. RESULTS: IgG seroprevalence was 12.6% in patients attending general practice and 11.1% in staff working in general practice, with administrative staff having the lowest seroprevalence at 2.5% and nursing staff having the highest at 17.6%. Previous symptoms suggestive of COVID-19 and history of a polymerase chain reaction (PCR) test were associated with higher seroprevalence. IgG antibodies were detected in approximately 80% of participants who had a previous PCR-confirmed infection. Average length of time between participants' positive PCR test and positive IgG antibody test was 83 days. CONCLUSION: Patients and healthcare staff in general practice in Ireland had relatively high rates of IgG to SARS-CoV-2 compared with the national average between 15 June and 10 July 2020 (1.7%). Four-fifths of participants with a history of confirmed COVID-19 disease still had detectable antibodies an average of 12 weeks post-infection. While not proof of immunity, SARS-CoV-2 POC testing can be used to estimate IgG seroprevalence in general practice settings.

Modelling of hypothetical SARS-CoV-2 point-of-care tests on admission to hospital from A&E: rapid cost-effectiveness analysis.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes coronavirus disease 2019. At the time of writing (October 2020), the number of cases of COVID-19 had been approaching 38 million and more than 1 million deaths were attributable to it. SARS-CoV-2 appears to be highly transmissible and could rapidly spread in hospital wards. OBJECTIVE: The work undertaken aimed to estimate the clinical effectiveness and cost-effectiveness of viral detection point-of-care tests for detecting SARS-CoV-2 compared with laboratory-based tests. A further objective was to assess occupancy levels in hospital areas, such as waiting bays, before allocation to an appropriate bay. PERSPECTIVE/SETTING: The perspective was that of the UK NHS in 2020. The setting was a hypothetical hospital with an accident and emergency department. METHODS: An individual patient model was constructed that simulated the spread of disease and mortality within the hospital and recorded occupancy levels. Thirty-two strategies involving different hypothetical SARS-CoV-2 tests were modelled. Recently published desirable and acceptable target product profiles for SARS-CoV-2 point-of-care tests were modelled. Incremental analyses were undertaken using both incremental cost-effectiveness ratios and net monetary benefits, and key patient outcomes, such as death and intensive care unit care, caused directly by COVID-19 were recorded. RESULTS: A SARS-CoV-2 point-of-care test with a desirable target product profile appears to have a relatively small number of infections, a low occupancy level within the waiting bays, and a high net monetary benefit. However, if hospital laboratory testing can produce results in 6 hours, then the benefits of point-of-care tests may be reduced. The acceptable target product profiles performed less well and had lower net monetary benefits than both a laboratory-based test with a 24-hour turnaround time and strategies using data from currently available SARS-CoV-2 point-of-care tests. The desirable and acceptable point-of-care test target product profiles had lower requirement for patients to be in waiting bays before being allocated to an appropriate bay than laboratory-based tests, which may be of high importance in some hospitals. Tests that appeared more cost-effective also had better patient outcomes. LIMITATIONS: There is considerable uncertainty in the values for key parameters within the model, although calibration was undertaken in an attempt to mitigate this. The example hospital simulated will also not match those of decision-makers deciding on the clinical effectiveness and cost-effectiveness of introducing SARS-CoV-2 point-of-care tests. Given these limitations, the results should be taken as indicative rather than definitive, particularly cost-effectiveness results when the relative cost per SARS-CoV-2 point-of-care test is uncertain. CONCLUSIONS: Should a SARS-CoV-2 point-of-care test with a desirable target product profile become available, this appears promising, particularly when the reduction on the requirements for waiting bays before allocation to a SARS-CoV-2-infected bay, or a non-SARS-CoV-2-infected bay, is considered. The results produced should be informative to decision-makers who can identify the results most pertinent to their specific circumstances. FUTURE WORK: More accurate results could be obtained when there is more certainty on the diagnostic accuracy of, and the reduction in time to test result associated with, SARS-CoV-2 point-of-care tests, and on the impact of these tests on occupancy of waiting bays and isolation bays. These parameters are currently uncertain. FUNDING: This report was commissioned by the National Institute for Health Research (NIHR) Evidence Synthesis programme as project number 132154. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 21. See the NIHR Journals Library website for further project information.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes coronavirus disease 2019 (COVID-19). SARS-CoV-2 is highly infectious, and this can cause problems in hospitals, where the virus can spread quickly. Laboratory-based tests can determine whether or not a patient has SARS-CoV-2, but these tests are not perfect and can require a considerable time to provide a result. Point-of-care tests to detect SARS-CoV-2 are being developed that may have much shorter times to a test result, although these are likely to be less accurate than laboratory-based tests. The benefit of quicker tests is that a decision to put a patient in a SARS-CoV-2-infected bay or in a non-SARS-CoV-2-infected bay can be made sooner, limiting contact between patients with SARS-CoV-2 and patients without SARS-CoV-2 and reducing the risk of infection transmission. The disadvantage of reduced accuracy is that some patients may be allocated to the wrong bay, increasing the risk of SARS-CoV-2 infection. A computer model was built to explore the impact of using SARS-CoV-2 point-of-care tests for people admitted to hospital. This model estimated the number of infections and deaths due to COVID-19, the costs of testing, and the number of people waiting to be put in an appropriate bay. Strategies were run using different values, including the time to get a test result, the accuracy of tests and whether or not staff who do not have symptoms should be tested. The results of the model indicated that point-of-care tests could be good if there was a large reduction in the time to get a test result and if accuracy was high. However, it is not certain whether or not such tests will become available. When newer SARS-CoV-2 tests are available, the model will allow an estimate of the clinical effectiveness and cost-effectiveness of the test to be made.

Point-of-care lung ultrasound in the assessment of patients with COVID-19: A tutorial.

The adoption of point-of-care lung ultrasound for both suspected and confirmed COVID-19 patients highlights the issues of accessibility to ultrasound training and equipment. Lung ultrasound is more sensitive than chest radiography in detecting viral pneumonitis and preferred over computed tomography for reasons including its portability, reduced healthcare worker exposure and repeatability. The main lung ultrasound findings in COVID-19 patients are interstitial syndrome, irregular pleural line and subpleural consolidations. Consolidations are most likely found in critical patients in need of ventilatory support. Hence, lung ultrasound may be used to timely triage patients who may have evolving pneumonitis. Other respiratory pathology that may be detected by lung ultrasound includes pulmonary oedema, pneumothorax, consolidation and large effusion. A key barrier to incorporate lung ultrasound in the assessment of COVID-19 patients is adequate decontamination of ultrasound equipment to avoid viral spread. This tutorial provides a practical method to learn lung ultrasound and a cost-effective method of preventing contamination of ultrasound equipment and a practical method for performing and interpreting lung ultrasound.

Nano-enabled biosensing systems for intelligent healthcare: towards COVID-19 management.

Biosensors are emerging as efficient (sensitive and selective) and affordable analytical diagnostic tools for early-stage disease detection, as required for personalized health wellness management. Low-level detection of a targeted disease biomarker (pM level) has emerged extremely useful to evaluate the progression of disease under therapy. Such collected bioinformatics and its multi-aspects-oriented analytics is in demand to explore the effectiveness of a prescribed treatment, optimize therapy, and correlate biomarker level with disease pathogenesis. Owing to nanotechnology-enabled advancements in sensing unit fabrication, device integration, interfacing, packaging, and sensing performance at point-of-care (POC) has rendered diagnostics according to the requirements of disease management and patient disease profile i.e. in a personalized manner. Efforts are continuously being made to promote the state of art biosensing technology as a next-generation non-invasive disease diagnostics methodology. Keeping this in view, this progressive opinion article describes personalized health care management related analytical tools which can provide access to better health for everyone, with overreaching aim to manage healthy tomorrow timely. Considering accomplishments and predictions, such affordable intelligent diagnostics tools are urgently required to manage COVID-19 pandemic, a life-threatening respiratory infectious disease, where a rapid, selective and sensitive detection of human beta severe acute respiratory system coronavirus (SARS-COoV-2) protein is the key factor.