Point-of-care Research Articles

Healthcare provider and patient perspectives on the implementation of pharmacogenetic-guided treatment in routine clinical practice.

This study aims to understand patient and healthcare provider perspectives on the integration and application of pharmacogenetics (PGx) testing in routine clinical practice. Two anonymous online surveys were distributed globally for healthcare providers and patients respectively on the Qualtrics platform (version 3.24). The surveys were distributed through social platforms, email, and posters with QR codes from 27 October 2023 to 7 March 2024. The surveys evaluated participant familiarity with PGx, previous experience with PGx testing, perceived implementation challenges, and opinions on point-of-care (PoC) PGx testing devices. This study collected 78 responses from healthcare providers and 98 responses from patients. The results revealed that 64% of healthcare providers had some level of familiarity with PGx, however, PGx testing in clinical practice was low. The primary challenges identified by healthcare providers included limited access to testing and lack of knowledge on PGx test interpretation. In contrast, 52% of patient respondents were aware of PGx testing, with a significant association between awareness and positive opinions toward PGx. Both healthcare providers and patients recognized the value of PoC PGx testing devices, with 98% of healthcare providers and 71% of patients believing PoC devices would improve the accessibility and implementation of PGx testing. Comparative analysis revealed a statistically significant difference in PGx awareness between healthcare providers and patients, with providers being more informed. Improved PGx awareness, training, clinical guidelines, and PoC PGx testing devices may help promote the implementation of PGx-guided treatments in routine clinical practice.

Development of Gold Nanoparticle based Colorimetric Monkeypox Biosensors Suitable for Point of Care (POC) Analysis

AbstractPractical colorimetric biosensors were developed for the detections of A29 and A27L proteins which were defined as Monkeypox virus (MPXV) and smallpox target proteins. For this purpose, gold nanoparticles (AuNPs) were synthesized and used to detect specific interaction between heparan sulphate (HS) receptor and A29 or A27L target proteins. This study is the first colorimetric biosensor that was based on the interaction of HS and A29 or A27L protein. In this work first, HS was labeled with AuNPs. When AuNPs labeled HS was incubated with A29 or A27L protein structure, these proteins specifically bounded to HS. Next, obtained AuNP/HS‐A29 or AuNP/HS‐A27L structures began to aggregate, and then difference in absorbance value of AuNP at 530 nm occurred. Absorbance differences at 530 nm were monitored spectroscopically. After experimental parameters were optimized, analytical characteristics of developed biosensors were investigated. As a result, the limit of detection was calculated as 7.93 ng.mL−1 and 6.09 ng.mL−1for A29 protein and A27L, respectively. The relative standard deviation were calculated as 1.97 % and 5.72 % for 25 ng.mL−1 A29 and 12.5 ng.mL−1 A27, respectively. Sample application studies were also performed with the standard addition of A29 and A27L proteins to real serum samples taken from healthy individuals. As a result, very promising results were obtained.

2D Materials in Advanced Electronic Biosensors for Point-of-Care Devices.

Since two-dimensionalal (2D) materials have distinct chemical and physical properties, they are widely used in various sectors of modern technologies. In the domain of diagnostic biodevices, particularly for point-of-care (PoC) biomedical diagnostics, 2D-based field-effect transistor biosensors (bio-FETs) demonstrate substantial potential. Here, in this review article, the operational mechanisms and detection capabilities of biosensing devices utilizing graphene, transition metal dichalcogenides (TMDCs), black phosphorus, and other 2D materials are addressed in detail. The incorporation of these materials into FET-based biosensors offers significant advantages, including low detection limits (LOD), real-time monitoring, label-free diagnosis, and exceptional selectivity. The review also highlights the diverse applications of these biosensors, ranging from conventional to wearable devices, underscoring the versatility of 2D material-based FET devices. Additionally, the review provides a comprehensive assessment of the limitations and challenges faced by these devices, along with insights into future prospects and advancements. Notably, a detailed comparison of FET-based biosensors is tabulated along with various other biosensing platforms and their working mechanisms. Ultimately, this review aims to stimulate further research and innovation in this field while educating the scientific community about the latest advancements in 2D materials-based biosensors.

A Paper-Based Multiplexed Serological Test to Monitor Immunity against SARS-COV-2 Using Machine Learning.

The rapid spread of SARS-CoV-2 caused the COVID-19 pandemic and accelerated vaccine development to prevent the spread of the virus and control the disease. Given the sustained high infectivity and evolution of SARS-CoV-2, there is an ongoing interest in developing COVID-19 serology tests to monitor population-level immunity. To address this critical need, we designed a paper-based multiplexed vertical flow assay (xVFA) using five structural proteins of SARS-CoV-2, detecting IgG and IgM antibodies to monitor changes in COVID-19 immunity levels. Our platform not only tracked longitudinal immunity levels but also categorized COVID-19 immunity into three groups: protected, unprotected, and infected, based on the levels of IgG and IgM antibodies. We operated two xVFAs in parallel to detect IgG and IgM antibodies using a total of 40 μL of human serum sample in <20 min per test. After the assay, images of the paper-based sensor panel were captured using a mobile phone-based custom-designed optical reader and then processed by a neural network-based serodiagnostic algorithm. The serodiagnostic algorithm was trained with 120 measurements/tests and 30 serum samples from 7 randomly selected individuals and was blindly tested with 31 serum samples from 8 different individuals, collected before vaccination as well as after vaccination or infection, achieving an accuracy of 89.5%. The competitive performance of the xVFA, along with its portability, cost-effectiveness, and rapid operation, makes it a promising computational point-of-care (POC) serology test for monitoring COVID-19 immunity, aiding in timely decisions on the administration of booster vaccines and general public health policies to protect vulnerable populations.

Experimental studies on controlling dispersion and fluid flow in paper membranes/assays using hydrogel

Paper membranes find applications in various fields, including Point-of-Care (POC) diagnostics, separation, filtration, and fluid transport. Still, they are frequently plagued by dispersion-related issues that lead to uneven flow, further affecting sensitivity and specificity, especially in detection assays. Hence, flow control in paper membranes becomes essential to achieving an effective paper-based platform. The present work develops a novel methodology based on adaptive flow regulation to optimize dispersion and flow control. This approach leverages real-time data to measure the controlled flow rates and prevent dispersion using hydrogel across paper-based membranes. Effects of three major parameters, namely mixing speed (100 rpm – 400 rpm), hydrogel concentration (6.45 mg/ml–12.9 mg/ml) for preparing hydrogel, and types of filter paper membranes are investigated in detail. Imaging techniques are applied to capture high-resolution images of fluid behavior on the paper strip surface at various time intervals, and the results are demonstrated in terms of mean intensity as a quantifiable indicator (0−255). It was found that the hydrogel prepared using 400 rpm mixing speed at a specific concentration exhibited significant resistance to the fluid flow with minimal dispersion. Furthermore, the Filter-paper 441 membrane is compared with other filter-paper membranes used in this experiment. Notably, a 43 %-79 % reduction in dispersion was observed for the hydrogel-laden paper membranes. Additionally, the dispersion was largely minimized even when lower concentrations of sodium hydroxide were detected on hydrogel-based paper assays, enhancing its sensitivity. Overall, this research offers a multifaceted solution to reduce dispersion and optimize flow control in paper-based membranes using hydrogel to improve the performance of the paper assays.

A handheld fluorescent lateral flow immunoassay platform for highly sensitive point-of-care detection of methamphetamine and tramadol

The escalating issue of drug abuse poses a significant threat to public health and societal stability worldwide. An on-site drug detection platform is vital for combating drug abuse and trafficking, as it eliminates the need for additional tools, extensive processes, or specialized training. Therefore, it is imperative to develop a fast, sensitive, non-invasive, and reliable multiplex drug testing platform. In this study, we have presented a silica core@dual quantum dot-shell nanocomposite (SI/DQD)-based fluorescent lateral flow immunoassay (LFIA) platform for the highly sensitive and simultaneous point-of-care (POC) detection of methamphetamine (MET) and tramadol (TR). A 3D-printed attachment was designed to integrate optical and electrical components, facilitating the miniaturization of the instrument and reducing both cost and complexity. The device's advanced hardware and effective fluorescence extraction algorithm with waveform reconstruction enable swift, automatic noise reduction and data analysis. SI/DQD nanocomposites were utilized as fluorescent nanotags in the LFIA strips due to their outstanding luminous efficiency and robustness. This LFIA platform achieves impressive detection limits (LODs) of 0.11 ng mL−1 for MET and 0.017 ng mL−1 for TR. The method has also successfully detected MET and TR in complex biological samples, demonstrating its practical application capabilities. The proposed fluorescent LFIA platform, based on SI/DQD technology, holds significant promise for the swift and accurate POC detection of these substances. Its affordability, compact size, and excellent analytical performance make it suitable for on-site drug testing, including at borders and roadside checks, and open up new possibilities for the design and implementation of drug testing methods.

Comparison of the diagnostic accuracy of the Pluslife Mini Dock RHAM technology with Abbott ID Now and Cepheid GenXpert: A retrospective evaluation study

Rapid and sensitive detection of pathogens is critical in interrupting the transmission chain of infectious diseases. Currently, real-time (RT-)PCR represents the gold standard for the detection of SARS-CoV-2. RNase HII-assisted amplification (RHAM) is a promising technology, enabling reliable point-of-care (PoC) testing; however, its diagnostic accuracy has not yet been investigated. The present study compared the Pluslife Mini Dock (RHAM technology), with Abbott ID Now and Cepheid GeneXpert IV. The positive percent agreement (PPA) and negative percent agreement (NPA) were determined in 100 SARS-CoV-2 positive and 210 SARS-CoV-2 negative samples. Further, the reliability of the Pluslife Mini Dock was investigated in different SARS-CoV-2 variants (Delta and Omicron subvariants). The PPA was 99.00% for Pluslife, 100.00% for Abbott ID Now, and 99.00% for Cepheid GeneXpert, with an NPA of 100.00%, 98.90%, and 93.72%, respectively. Abbott ID Now demonstrated the highest rate of invalid results. All SARS-CoV-2 analysed variants were detected by the Pluslife device. Altogether, the Pluslife Mini Dock demonstrated a PPA of 99.16% (235/237) for CT < 36 and an NPA of 100.00% (313/313), respectively. In conclusion, the Pluslife Mini Dock demonstrated better analytical performance than Abbott ID Now and Cepheid GeneXpert IV, representing a highly accurate and rapid PoC alternative to RT-PCR.

Microfluidic Digital Immunoassay for Point-of-Care Detection of NT-proBNP from Whole Blood.

The high prevalence and economic burden of heart failure remain a challenge to global health. This lifelong disease leads to a buildup of permanent heart damage, making early detection and frequent monitoring crucial for effective treatment. N-terminal proBNP (NT-proBNP) is an important biomarker for monitoring the disease state, but current commercial and research NT-proBNP assays require phlebotomy and bulky equipment or do not satisfy clinical requirements such as sensitivity and detection thresholds. Here, we report a point-of-care (POC) compatible microfluidic digital immunoassay that can quantify the NT-proBNP concentration in a small volume of whole blood. Our automated microfluidic device takes whole blood samples mixed with biotinylated detection antibodies and passes through a plasma filter to react with a capture antibody-functionalized sensor surface. Streptavidin-coated gold nanoparticles (GNPs) are then released to mark the surface-bound single NT-proBNP immunocomplexes and recorded with bright-field microscopy. NT-proBNP concentrations in the sample are quantified via a hybrid digital/analog calibration curve. Digital counts of bound GNPs are used as readout signal at low concentrations for high sensitivity detection, and GNP pixel occupancies are used at high concentrations for extended dynamic range. With this approach, we detected NT-proBNP in the range of 8.24-10 000 pg/mL from 7 μL of whole blood in 10 min, with a limit of detection of 0.94 pg/mL. Finally, the method was validated with 15 clinical serum samples, showing excellent linear correlation (r = 0.998) with Roche's Elecsys proBNP II assay. This evidence indicates that this method holds promise for decentralized monitoring of heart failure.

Spicy Recipe for At-Home Diagnostics: Smart Salivary Sensors for Point-of-Care Diagnosis of Jaundice.

Even though significant advances have been made, there is still a lack of reliable sensors capable of noninvasively monitoring bilirubin and diagnosing jaundice as the most common neonatal disease, particularly at the point-of-care (POC) where blood sampling from infants is accompanied by serious challenges and concerns. Herein, for the first time, using an easy-to-fabricate/use assay, we demonstrate the capability of curcumin embedded within paper for noninvasive optical monitoring of bilirubin in saliva. The highly selective sensing of the developed sensor toward bilirubin is attributed to bilirubin photoisomerization under blue light exposure, which can selectively restore the bilirubin-induced quenched fluorescence of curcumin. We also fabricated an IoT-enabled hand-held optoelectronic reader to measure and quantify the fluorescence and color signals of our sensor. Clinical analysis on the saliva of 18 jaundiced infants by using our developed smart salivary sensor proved that it is amenable to be widely exploited in POC applications for bilirubin monitoring as there are good correlations between its results with those of reference methods in saliva and blood. Meeting all WHO's REASSURED criteria by our developed sensor makes it a highly promising sensor for smart noninvasive diagnosis and therapeutic monitoring of jaundice, hepatitis, and other bilirubin-induced neurologic diseases at the POC.

Amplification- and Enzyme-Free Magnetic Diagnostics Circuit for Whole-Genome Detection of SARS-CoV-2 RNA.

Polymerase chain reaction (PCR) requires thermal cycling and enzymatic reactions for sequence amplification, hampering their applications in point-of-care (POC) settings. Magnetic bioassays based on magnetic particle spectroscopy (MPS) and magnetic nanoparticles (MNPs) are isothermal, wash-free, and can be quantitative. Realizing them amplification- and enzyme-free on a benchtop device, they will become irreplaceable for POC applications. Here we demonstrate a first-in-class magnetic signal amplification circuit (MAC) that enables detection of whole genome of SARS-CoV-2 by combining the specificity of toehold-mediated DNA strand displacement with the magnetic response of MNPs to declustering processes. Using MAC, we detect the N gene of SARS-CoV-2 samples at a concentration of 104 RNA copies/μl as determined by droplet digital PCR. Further, we demonstrate that MAC can reliably distinguish between SARS-CoV-2 and other human coronaviruses. Being a wash-, amplification- and enzyme-free biosensing concept and working at isothermal conditions (25 °C) on a low-cost benchtop MPS device, our MAC biosensing concept offers several indispensable features for translating nucleic acid detection to POC applications.

Rapid, equipment-free extraction of DNA from skin biopsies for point-of-care diagnostics

Kaposi’s sarcoma (KS) is a cancer affecting skin and internal organs for which the Kaposi’s sarcoma associated herpesvirus (KSHV) is a necessary cause. Previous work has pursued KS diagnosis by quantifying KSHV DNA in skin biopsies using a point-of-care (POC) device which performs quantitative loop-mediated isothermal amplification (LAMP). These previous studies revealed that extracting DNA from patient biopsies was the rate limiting step in an otherwise rapid process. In this study, a simplified, POC-compatible alkaline DNA extraction, ColdSHOT, was optimized for 0.75 mm human skin punch biopsies. The optimized ColdSHOT extraction consistently produced 40,000+ copies of DNA per 5 µl reaction from 3 mg samples—a yield comparable to standard spin column extractions—within 1 h without significant equipment. The DNA yield was estimated sufficient for KSHV detection from KS-positive patient biopsies, and the LAMP assay was not affected by non-target tissue in the unpurified samples. Furthermore, the yields achieved via ColdSHOT were robust to sample storage in phosphate-buffered saline (PBS) or Tris-EDTA (TE) buffer prior to DNA extraction, and the DNA sample was stable after extraction. The results presented in this study indicate that the ColdSHOT DNA extraction could be implemented to simplify and accelerate the LAMP-based diagnosis of Kaposi’s sarcoma using submillimeter biopsy samples.

Innovative COVID-19 Point-of-Care Diagnostics Suitable for Tuberculosis Diagnosis: A Scoping Review.

Rapid and accurate point-of-care (POC) tuberculosis (TB) diagnostics are a key priority to close the TB diagnostic gap of 3.1 million people without a diagnosis. Leveraging the recent surge in COVID-19 diagnostic innovation, we explored the potential adaptation of commercially available SARS-CoV-2 tests for TB diagnosis, aligning with World Health Organization (WHO) target product profiles (TPPs). A scoping review was conducted following PRISMA-ScR guidelines to systematically map commercially available POC molecular and antigen SARS-CoV-2 diagnostic tests potentially meeting the TPPs for TB diagnostic tests for peripheral settings. Data were gathered from PubMed/MEDLINE, bioRxiv, and medRxiv, along with publicly accessible in vitro diagnostic test databases, and developer websites, up to November 23, 2022. Data on developer and test attributes, operational characteristics, pricing, and clinical performance were charted using standardized data extraction forms. Each identified test was evaluated using a standardized scorecard. A narrative synthesis of the charted data is presented. Our database search yielded 2,003 studies, from which 408 were considered eligible. Among these, we identified 58 commercialized diagnostic devices, including 17 near-POC antigen tests, one POC molecular test, 29 near-POC molecular tests, and 11 low-complexity molecular tests. We summarized the detailed characteristics, regulatory status, and clinical performance data of these tests. The LumiraDx (Roche, Switzerland) emerged as the highest- scoring near-POC antigen platform, while Visby (Visby, USA) was the highest-performing near-POC molecular platform. The Lucira Check-It (Pfizer, USA) was noted as the sole POC molecular test. The Idylla TM (Biocartis, Switzerland) was identified as the leading low- complexity molecular test. We highlight a diverse landscape of commercially available diagnostic tests suitable for potential adaptation to TB POC testing. This work aims to bolster global TB initiatives by fostering stakeholder collaboration, leveraging COVID-19 diagnostic technologies for TB diagnosis, and uncovering new commercial avenues to tackle longstanding challenges in TB diagnosis.

Performance of a point-of-care test for the detection of anti-Leishmania infantum antibodies is associated with immunofluorescent antibody titer and clinical stage of leishmaniosis in dogs from endemic regions

Canine leishmaniosis (CanL) is caused by the protozoal parasite Leishmania infantum, which is transmitted by sand flies in warm climates across the world. Because dogs are considered a primary domestic reservoir for the parasite that causes leishmaniosis in humans, it is important from a One Health perspective that CanL be properly managed. In endemic regions, CanL is a common differential diagnosis in sick dogs because the clinical signs and clinicopathological disorders of the disease are non-specific, variable, and may overlap those of other common conditions. Diagnosis is based on the presence of compatible clinical signs, laboratory abnormalities, and confirmation by serological and parasitological evidence of infection. Here, we describe the performance of a point-of-care (POC) immunoassay that uses recombinant antigens to detect canine anti- L. infantum antibodies in a convenience sample set from a diagnostic laboratory, a group of canine patients with clinical staging, and in apparently healthy dogs from endemic areas. An immunofluorescence antibody test (IFAT) was used as the semiquantitative reference method. In the convenience sample set with high IFAT titers (≥ 1:800), the POC immunoassay demonstrated perfect agreement with IFAT (100%; 90/90). Using samples from dogs staged as either LeishVet Stage 2 or 3 or LeishVet Stage 1, positive agreement of the POC immunoassay with the IFAT was 98.8% (82/83) and 83.8% (31/37), respectively. The negative agreement with IFAT was 98.9% (272/275) in apparently healthy dogs from endemic areas of Greece and Italy. Since the performance of the POC immunoassay was associated with IFAT titer and clinical stage of CanL, the test may help veterinarians when determining if CanL is likely responsible for a patient's clinical picture or when evaluating an apparently healthy patient prior to vaccination.

Performance of Continuous Glucose Monitoring in Patients With Acute Respiratory Failure: A Prospective, Single-Center Observational Study

ObjectiveContinuous glucose monitoring (CGM) may have benefits in achieving glycemic control in critically ill patients. The aim of this study was to assess the accuracy of the Freestyle Libre H (professional version similar to the Libre Pro) in patients with acute respiratory failure (ARF) in the intensive care unit (ICU). MethodsFifty-two adult patients with ARF were selected. The performance of CGM was evaluated using the arterial blood glucose (aBG) and point-of-care (POC) glucose levels as the reference values. Numerical accuracy was evaluated by the mean absolute relative difference, Bland-Altman analysis, %15/15 (the percentage of CGM values within 15 mg/dL or 15% of reference values <100 or >100 mg/dL, respectively), %20/20, and %30/30. Clinical accuracy was assessed using the Clarke error grid analysis. ResultsA total of 519 and 1504 pairs of aBG/CGM and POC/CGM glucose values were analyzed. The mean absolute relative difference values were 13.8% and 14.7%, respectively. The mean deviations of the Bland-Altman analysis were 0.82 mmol/L and 0.81 mmol/L. The proportions of CGM values within %15/15, %20/20, and %30/30 of the aBG values were 62.6%, 75.5%, and 92.4%, respectively; those within %15/15, %20/20, and %30/30 of the POC values were 57.1%, 72.9%, and 88.7%, respectively. The Clarke error grid analysis showed that 97.8% and 99.3% of the values were located in zone A + B. Additionally, the accuracy of CGM was not affected by general patient factors. ConclusionThis study demonstrated that the accuracy of CGM in patients with ARF is lower than that in most outpatients and it is not affected by general patient factors. Whether CGM is beneficial to glucose management in the intensive care unit needs further evaluation.

A Conjugated Polymer-Based Portable Smartphone Platform for Sensitive and Point-Of-Care Detection of Monoamine Neurotransmitter.

The precise and effective detection of neurotransmitters (NTs) is crucial for clinical investigation of neuronal processes, and timely monitoring of NT-related chronic diseases. However, sensitive detection of specific NT with unprecedented selectivity is highly challenging due to similarities in chemical and electronic structures of various interfering neurochemicals. Herein, an anionic conjugated polyelectrolyte Poly[(9,9-bis(4'-sulfonatobutyl)fluorene-co-alt-1,4-phenylene) sodium], PFPS was rationally designed and synthesized for amplified detection and point-of-care (PoC) determination of monoamine neurotransmitter, serotonin (5-Hydroxy tryptamine or 5-HT, also diagnostic biomarker of carcinoid tumor) in human blood plasma. The PFPS displayed a remarkable sensing response with an exceptionally high fluorescence quenching constant of 1.14×105 M-1 and an ultralow detection limit of 0.67 μM or 0.142 ppm, much below the clinical range. Furthermore, a smartphone-enabled portable platform was constructed for real-time onsite detection of 5-HT by quantification of visual fluorescence response of PFPS into RGB values using a color recognizer android application. The smartphone platform could be readily applied for convenient, non-invasive PoC testing of 5-HT levels in complex biological fluids accurately and is expected to revolutionize clinical diagnosis and personalized health care devices.

Paper-based immunosensor integrated with bioinspired Cu-polydopamine nanozyme for voltammetric detection of CA-15-3 tumor marker

This manuscript describes the fabrication and characterization of a highly conductive paper-based nanoplatform for immobliztion of anti-CA 15-3 antibodies. For this purpose, cellulosic filter paper (FP) was first coated with Cu nanosponges (CuNSs) through ion beam sputtering deposition (IBSD) method and then covered with Cu-doped polydopamine nanospheres (Cu-PDA). Polydopamine doped with copper exhibited laccase (multi-copper oxidase)-mimicking properties. Bioinspired by the structure of the active site and the electron transfer mechanism of laccase, Cu-PDA nanozyme catalyzed the oxidation of hydroquinone (HQ) signal probe. In this design, CA-15-3, a prognostic biomarker in the breast cancer, was chosen as a model target. To the best of our knowledge, this is the only paper on the design of an electrochemical biosensor based on dense and uniform CuNSs produced by IBSD. More importantly, Cu-PDA is biocompatible and biodegradable, which makes it a potential competitor in the point-of-care (POC) biosensing applications. Thus, this paper-based sensing strategy can be used in designing cost-effective flexible chips consisting of electrodes printed on paper for in-situ and real-time monitoring biomarkers under clinical conditions. In addition to these outstanding features, the LOD (1.3 mU mL 1) and LOQ (4.3 mU mL 1) of the Ab/HQ/Cu-PDA/CuNSs/FP-based immunosensor was significantly lower than the clinically relevant cut-off level (30 U mL 1). In the practical applications, one of the key superiorities of this immuosensor is the wide DLR (5 mU mL 1–280 U mL 1) which covers the ultimate value of healthy and patient individuals.

Electrochemical DNA biosensor for HPV-16 detection based on novel carbon quantum dots/APTES composite nanofilm

Detection of high-risk human papillomavirus (HR-HPV) is critical for early warning and accurate screening of cervical disease in women. Electrochemical biosensors offer a promising analytical strategy that can circumvent the structural complexity of traditional optical components found in current bioassays. In this work, an innovative electrochemical biosensor for HPV-16 detection was developed, utilizing advanced nanomaterial technology and optimized DNA probe grafting processes. The self-assembled composite nanofilm was optimized by conducting an orthogonal analysis. The nanofilm exploited the unique advantages and outstanding performance of (3-aminopropyl)triethoxysilane (APTES) and carbon quantum dots (CQDs), which act as a “molecular bridge” between the biosensing interface and the electrode substrate. The electroactive molecule [Ru(NH3)6]3+ facilitated the highly sensitive signaling of the target DNA by interacting with the double-stranded DNA. Under optimal conditions, the developed electrochemical DNA biosensor exhibited high sensitivity in detecting HPV-16, with a limit of detection (LOD) of 0.73 fM, which showed exceptional potential to be used in widespread point-of-care (PoC) screening programs, opening up new opportunities for various applications.

Preliminary assessment of using mobile point-of-care human papillomavirus (HPV) testing with the option of immediate colposcopy in a rural area in a high-income country: a case study.

Cervical cancer is now preventable with human papillomavirus (HPV) vaccination and HPV screening. However, structural health system barriers in rural areas can inhibit screening access. Inequitable access for rural Māori is exacerbated by social determinants and racism. Pro-equity tools, such as self-taken swabs point of care (POC) testing, now exist. This study aimed to investigate whether POC HPV testing and immediate offer of colposcopy by a mobile colposcopy service is possible at a rural community event. This case study was a collaboration between a research centre, a women's health bus, a molecular diagnostics company, a Māori health provider and a community charity, and took place prior to the new cervical screening programme introduction at a 2-day community event-a shearathon. Eligible participants were offered a self-taken swab for HPV, which was analysed by POC testing. If high-risk HPV was detected, they were offered an immediate colposcopy. The Māori-centred qualitative component explored women's experiences of the process. Fourteen women undertook a self-test for HPV. High-risk HPV was detected in six women and all were offered immediate colposcopy. Six women were interviewed. All were supportive of the service. Culturally safe staff taking time to put women at ease contributed to acceptability and positive experiences. This case study shows that provision of POC HPV testing and colposcopy at a rural community event setting is possible through cross-sector collaboration. This service was acceptable to rural transient workers who face barriers to healthcare in a high-income country.

Point-of-care high-sensitivity cardiac troponin in suspected acute myocardial infarction assessed at baseline and 2 h.

Strategies to assess patients with suspected acute myocardial infarction (AMI) using a point-of-care (POC) high-sensitivity cardiac troponin I (hs-cTnI) assay may expedite emergency care. A 2-h POC hs-cTnI strategy for emergency patients with suspected AMI was derived and validated. In two international, multi-centre, prospective, observational studies of adult emergency patients (1486 derivation cohort and 1796 validation cohort) with suspected AMI, hs-cTnI (Siemens Atellica® VTLi) was measured at admission and 2 h later. Adjudicated final diagnoses utilized the hs-cTn assay in clinical use. A risk stratification algorithm was derived and validated. The primary diagnostic outcome was index AMI (Types 1 and 2). The primary safety outcome was 30-day major adverse cardiac events incorporating AMI and cardiac death. Overall, 81 (5.5%) and 88 (4.9%) patients in the derivation and validation cohorts, respectively, had AMI. The 2-h algorithm defined 66.1% as low risk with a sensitivity of 98.8% [95% confidence interval (CI) 89.3%-99.9%] and a negative predictive value of 99.9 (95% CI 99.2%-100%) for index AMI in the derivation cohort. In the validation cohort, 53.3% were low risk with a sensitivity of 98.9% (95% CI 92.4%-99.8%) and a negative predictive value of 99.9% (95% CI 99.3%-100%) for index AMI. The high-risk metrics identified 5.4% of patients with a specificity of 98.5% (95% CI 96.6%-99.4%) and a positive predictive value of 74.5% (95% CI 62.7%-83.6%) for index AMI. A 2-h algorithm using a POC hs-cTnI concentration enables safe and efficient risk assessment of patients with suspected AMI. The short turnaround time of POC testing may support significant efficiencies in the management of the large proportion of emergency patients with suspected AMI.

Liquid-metal-based microfluidic nanoplasmonic platform for point-of-care naked-eye antibody detection

Despite high sensitivity of nanoparticle-on-mirror cavities, a crucial branch of plasmonic nanomaterials, complex preparation and readout processes limit their extensive application in biosensing. Alternatively, liquid metals (LMs) combining fluidity and excellent plasmonic characteristics have become potential candidates for constructing plasmonic nanostructures. Herein, we propose a microfluidic-integration strategy to construct LM-based immunoassay platform, enabling LM-based nanoplasmonic sensors to be used for point-of-care (POC) clinical biomarker detection. Flowable LM is introduced onto protein-coated Au nanoparticle monolayer to form a “mirror-on-nanoparticle” nanostructure, simplifying the fabrication process in the conventional nanoparticle-on-mirror cavities. When antibodies were captured by antigens coated on the Au nanoparticle monolayer, devices respond both thickness and refractive index change of biomolecular layers, outputting naked-eye readable signals with high sensitivity (limit of detection: ∼ 604 fM) and a broad dynamic range (6 orders). This new assay, which generates quantitative results in 30 min, allows for high-throughput, smartphone-based detection of SARS-CoV-2 antibodies against multiple variants in clinical serum or blood samples. These results establish an advanced avenue for POC testing with LM materials, and demonstrate its potential to facilitate diagnostics, surveillance and prevalence studies for various infectious diseases.