Use Of Point-of-care Testing Research Articles

Protocol for the development of an intervention to improve the use of Point-of-caRE DiagnostICs in the management of respiraTOry tRact infectionS in primary care (the PREDICTORS study)

Background Antimicrobial resistance is a significant global health challenge, exacerbated by inappropriate antibiotic prescribing, particularly in primary care where up to 50% of antibiotic prescriptions prescribed by general practitioners (GPs) and dispensed by community pharmacists (CPs) are deemed inappropriate. Respiratory tract infections (RTIs) are among the most common conditions leading to GP consultations and subsequent antibiotic prescribing, much of which is inappropriate as most RTIs are viral in nature or self-limiting bacterial infections. Point-of-care tests (POCTs) have emerged as tools to improve the diagnosis and appropriate treatment of RTIs. Objective This study aims to develop and test an intervention to improve the use of POCTs in managing RTIs involving GPs and CPs in Irish primary care, following the UK’s Medical Research Council’s (MRC) framework for complex intervention development, involving five work-packages (WPs). Methods WP1 involves creating best practice guidance for using POCT in managing RTIs, informed by a scoping review and validated with an expert Delphi panel. This guidance will be used to define target behaviour(s) for GPs and CPs related to POCT use. WP2 explores GP and CP perceived barriers and facilitators to these behaviours using the Theoretical Domains Framework, mapping influential domains to Behaviour Change Techniques to develop draft interventions. WP3 gathers patients’ perspectives on using POCTs for RTIs. In WP4, a task group will review and finalise the intervention(s). They will consider patients’ perspectives from WP3 and assess feasibility of the intervention(s). WP5 involves a proof-of-concept study to test the feasibility of the newly developed intervention(s). Conclusion A theoretically informed intervention(s) for using POCT(s) in the management of RTIs in primary care in Ireland will be developed and tested in a proof-of-concept study, following MRC guidance. Further refinement and larger studies will be needed to determine its effectiveness before widespread implementation.

Point-of-care tests to manage acute respiratory tract infections in primary care: a systematic review and qualitative synthesis of healthcare professional and patient views.

To review the evidence on healthcare professionals' (HCPs) and patients' views of the use of point-of-care tests (POCTs) in the management of acute respiratory tract infections (RTIs) in primary care settings. We conducted a systematic review of studies up to 28 April 2023. We included studies that included qualitative methods and results; focused on HCPs' and/or patients' views/experiences of POCTs for acute RTIs; and were conducted in primary care settings. We conducted a thematic synthesis to identify how their views on POCTs and interventions can support test use (PROSPERO registration: CRD42019150347). We included 33 studies, developing 9 categories each for HCP and patient data. We identified 38 factors affecting POCT use: 28 from HCPs and 10 from patients. Factors exist outside and within consultations, and post-consultations, illustrating that some cannot be addressed by HCPs alone. Fourteen interventions were identified that could address factors and support POCT use, with 7 interventions appearing to address the most factors. Some interventions were beyond the scope of HCPs and patients and needed to be addressed at system and organizational levels. Both groups had mixed views on the use of POCTs and highlighted implementation challenges. This review highlights numerous factors affecting POCT use in primary care. Policy-makers planning to implement POCTs are likely to achieve more by providing multi-faceted interventions that target factors outside, within, and post-consultation. Some interventions may need to be already established before POCT introduction. Whilst evidence beyond general practice is limited, similar factors suggest that similar context-tailored interventions would be appropriate.

NFC Smartphone-Based Electrochemical Microfluidic Device Integrated with Nanobody Recognition for C-Reactive Protein.

Point-of-care testing (POCT) devices play a crucial role as tools for disease diagnostics, and the integration of biorecognition elements with electronic components into these devices widens their functionalities and facilitates the development of complex quantitative assays. Unfortunately, biosensors that exploit large conventional IgG antibodies to capture relevant biomarkers are often limited in terms of sensitivity, selectivity, and storage stability, considerably restricting the use of POCT in real-world applications. Therefore, we used nanobodies as they are more suitable for fabricating electrochemical biosensors with near-field communication (NFC) technology. Moreover, a flow-through microfluidic device was implemented in this system for the detection of C-reactive protein (CRP), an inflammation biomarker, and a model analyte. The resulting sensors not only have high sensitivity and portability but also retain automated sequential flow properties through capillary transport without the need for an external pump. We also compared the accuracy of CRP quantitative analyses between commercial PalmSens4 and NFC-based potentiostats. Furthermore, the sensor reliability was evaluated using three biological samples (artificial serum, plasma, and whole blood without any pretreatment). This platform will streamline the development of POCT devices by combining operational simplicity, low cost, fast analysis, and portability.

Point-of-Care Tests for COVID-19 and Influenza in Canada

What Is the Issue? Health care providers rely on laboratory tests to differentiate between respiratory illnesses that manifest in similar symptoms, such as COVID-19 and influenza. However, samples may travel to centralized laboratories to process, delaying test results and treatment. Point-of-care tests (POCTs) allow for diagnosis at the site of care but at the expense of diagnostic performance. Several commercial POCTs, specifically for COVID-19, have become increasingly available in Canada since the start of the pandemic. Decision-makers will need to consider which commercial POCT can meet their jurisdiction’s testing needs. POCTs in Canada and their Potential Impact Some POCTs, called “Multiplex tests,” can detect and differentiate between certain illnesses using a single sample. Some studies suggest that using POCTs for respiratory illness in hospitals and emergency departments can expedite diagnosis, improve patient flow, reduce admissions, and shorten the length of stay. Commercial POCTs vary in diagnostic performance, complexity, and costs. There are at least 37 authorized POCTs for COVID-19, influenza, or both in Canada. All devices accept a nasal, nasopharyngeal sample, or both sample types for testing. Some tests require a reader or analyzer to use test kits for diagnosis. POCTs can provide results in 1 hour or less. However, laboratory testing (i.e., nucleic acid amplification tests) remains the standard of care to diagnose COVID-19 and influenza, given their better diagnostic performance compared to POCTs. What Else Do We Need to Know? Confirmatory laboratory tests can reaffirm the diagnosis from POCTs. However, budget impact analyses and clinical studies on authorized tests in Canada do not consider how confirmatory lab tests impact findings on POCT use. Future studies should investigate the cost-effectiveness of POCTs with confirmatory testing, as well as the impact of incorrect diagnosis from POCT on patient outcomes. Rural and remote communities may benefit from POCTs for respiratory illness, given their distance to centralized laboratories.

Prehospital use of point-of-care tests by community health workers: a scoping review.

Point-of-Care Tests (POCTs) are utilized daily in resource abundant regions, however, are limited in the global south, particularly in the prehospital setting. Few studies exist on the use of non-malarial POCTs by Community Health Workers (CHWs). The purpose of this scoping review is to delineate the current diversity in and breadth of POCTs evaluated in the prehospital setting. A medical subject heading (MeSH) analysis of known key articles was done by an experienced medical librarian and scoping searches were performed in each database to capture "point of care testing" and "community health workers." This review was guided by the PRISMA Extension for scoping reviews. 2735 publications were returned, 185 were nominated for full-text review, and 110 studies were confirmed to meet study criteria. Majority focused on malaria (74/110; 67%) or HIV (25/110; 23%); 9/110 (8%) described other tests administered. Results from this review demonstrate a broad geographic range with significant heterogeneity in terminology for local CHWs. The use of new POCTs is on the rise and may improve early risk stratification in limited resource settings. Current evidence from decades of malaria POCTs can guide future implementation strategies.

Is qualitative social research in global health fulfilling its potential?: a systematic evidence mapping of research on point-of-care testing in low- and middle-income contexts

BackgroundQualitative social research has made valuable contributions to understanding technology-based interventions in global health. However, we have little evidence of who is carrying out this research, where, how, for what purpose, or the overall scope of this body of work. To address these questions, we undertook a systematic evidence mapping of one area of technology-focused research in global health, related to the development, deployment and use of point-of-care tests (POCTs) for low-and middle-income countries (LMICs).MethodsWe conducted an exhaustive search to identify papers reporting on primary qualitative studies that explore the development, deployment, and use of POCTs in LMICs and screened results to identify studies meeting the inclusion criteria. Data were extracted from included studies and descriptive analyses were conducted.ResultsOne hundred thirty-eight studies met our inclusion criteria, with numbers increasing year by year. Funding of studies was primarily credited to high income country (HIC)-based institutions (95%) and 64% of first authors were affiliated with HIC-based institutions. Study sites, in contrast, were concentrated in a small number of LMICs. Relatively few studies examined social phenomena related to POCTs that take place in HICs. Seventy-one percent of papers reported on studies conducted within the context of a trial or intervention. Eighty percent reported on studies considering POCTs for HIV and/or malaria. Studies overwhelmingly reported on POCT use (91%) within primary-level health facilities (60%) or in hospitals (30%) and explored the perspectives of the health workforce (70%).ConclusionsA reflexive approach to the role, status, and contribution of qualitative and social science research is crucial to identifying the contributions it can make to the production of global health knowledge and understanding the roles technology can play in achieving global health goals. The body of qualitative social research on POCTs for LMICs is highly concentrated in scope, overwhelmingly focuses on testing in the context of a narrow number of donor-supported initiatives and is driven by HIC resources and expertise. To optimise the full potential of qualitative social research requires the promotion of open and just research ecosystems that broaden the scope of inquiry beyond established public health paradigms and build social science capacity in LMICs.

Barriers, enablers, benefits, and drawbacks to point-of-care testing: a survey of the general practice out-of-hours service in Scotland.

The general practice out-of-hours (GPOOH) service is under pressure to treat more patients in less time, while reducing referrals and minimising diagnostic errors. Point-of-care (POC) testing involves rapid clinical tests that can be used to generate results during the consultation, and has the potential to facilitate managing these competing demands safely. To describe current availability of POC tests in GPOOH in Scotland, and identify barriers, enablers, benefits, and drawbacks to its use. Cross-sectional mixed-methods study, which surveyed opinions of clinicians working in the GPOOH service in NHS Scotland. An electronic questionnaire was developed, designed, piloted, and distributed to clinicians, which had closed questions and areas for free text. In total, 142 responses were received. Urine dipstick testing (99.2%), pregnancy tests (98.5%), oxygen saturation (97.7%), and blood glucose testing (93.9%), were the only POC tests commonly available in GPOOH in NHS Scotland. There was strongest support for the provision of POC tests, particularly C-reactive protein (CRP; 79.4%), strep A (76.0%), and D-dimer (75.2%). Responders felt that POC tests would improve confidence (92.3%) and safety (89.8%) surrounding clinical decision making, improve patient satisfaction (80.6%), and reduce hospital and secondary care referrals (77.5%). Barriers to POC test use were availability of the test kits and machines (94.5%), training requirements on how to use the machine (71.1%) and interpret results (56.3%), and time to do the test (62.0%). Few POC tests are in regular use in GPOOH in Scotland. GPOOH clinicians are supportive of using POC testing. They identified a number of benefits to its use, with very few drawbacks. Increased provision of POC testing in GPOOH in NHS Scotland should be considered urgently.

Reducing Antibiotic Misuse through the Use of Point-of-Care Tests in Germany: A Survey of 1257 Medical Practices.

Though more than 80% of acute pharyngitis (AP) cases have a viral etiology, it remains one of the most common causes for the unnecessary prescription of antibiotics (ABs). Half of patients receive antibiotics in general practice. Point-of-Care Tests (POCTs) distinguish between bacterial and viral pharyngitis. The objective of this study was to evaluate the use of POCTs using throat swabs to detect β-Streptococcus pyogenes Group A (strep A) infection among patients with sore throat/acute pharyngitis in primary care practices across Germany. A study was conducted in 1257 primary care practices. Two questionnaires were administered concerning frequency, POCT results and whether antibiotics were prescribed. Of the 1257 physicians, 60% used POCTs. Of these, 25% used a POCT before prescribing an antibiotic, 39% in cases of severe sore throat, 40% in cases of long-lasting pharyngitis and 25% in other cases. In total, 83% considered the adoption of POCTs in everyday practice to be important or very important for the diagnosis of strep A, 90% considered it important or very important for achieving a more sensible use of antibiotics and the prevention of bacterial resistance and 80% considered it important or very important for justifying to patients whether or not an antibiotic is needed. POCT results and information on AB prescriptions were available for 583 patients. Of these, 22.5% tested positive for strep A, and 21.8% were prescribed antibiotics. Our study shows that the use of swab tests in patients with sore throat in primary care practices results in high levels of physician satisfaction and can strongly reduce the misuse of antibiotics in clinical practice.

Point-of-care laboratory testing in primary care: utilization, limitations and perspectives of general practitioners in Germany

BackgroundDue to their fast turnaround time and user-friendliness, point-of-care tests (POCTs) possess a great potential in primary care. The purpose of the study was to assess general practitioners’ (GPs) perspectives on POCT use in German primary care, including utilization, limitations and requirements.MethodsWe conducted a cross-sectional survey study among GPs in Germany (federal states of Thuringia, Bremen and Bavaria (Lower Franconia), study period: 04/22–06/2022).ResultsFrom 2,014 GPs reached, 292 participated in our study (response rate: 14.5%). The median number of POCTs used per GP was 7.0 (IQR: 5.0–8.0). Six POCTs are used by the majority of surveyed GPs (> 50%): urine dipstick tests (99%), glucose (urine [91%] and plasma [69%]), SARS-CoV-2 (80%), urine microalbumin (77%), troponin I/T (74%) and prothrombin time / international normalized ratio (65%). The number of utilized POCTs did not differ between GP practice type (p = 0.307) and population size of GP practice location (p = 0.099). The great majority of participating German GPs (93%) rated POCTs as useful diagnostic tools in the GP practice. GPs ranked immediate decisions on patient management and the increase in diagnostic certainty as the most important reasons for performing POCTs. The most frequently reported limitations of POCT use in the GP practice were economic aspects (high costs and inadequate reimbursement), concerns regarding diagnostic accuracy, and difficulties to integrate POCT-testing into practice routines (e.g. time and personnel expenses).ConclusionAlthough participating German GPs generally perceive POCTs as useful diagnostic tools and numerous POCTs are available, several test-related and contextual factors contribute to the relatively low utilization of POCTs in primary care.

Development over time in point-of-care test use in Danish daytime and out-of-hours general practice: a register-based study

Objective To describe the development over time of the use of C-reactive protein (CRP) and rapid streptococcal detection test (RADT) point-of-care tests (POCT) in Danish general practice and to explore associations between patient characteristics and POCT use (i.e. CRP and RADT). Design and settings A register-based study including all general practice clinic consultations in daytime and out-of-hours (OOH) settings in Denmark between 2003 and 2018. Subjects All citizens who had at least one clinic consultation in daytime or OOH general practice within the study period. Main outcome measures We estimated the total and relative use of CRP and RADT POCTs and described the development over time. Crude and adjusted proportion ratios (PRs) were calculated to explore associations between patient characteristics and POCT use. Results Overall, the relative use of CRP POCTs increased. At OOH, a steep increase was noticed around 2012. The relative use of RADT decreased. Patient age 40–59 years and existing comorbidity were significantly associated with a higher use of CRP testing in both settings. A significantly lower use of CRP testing was found for patients with higher educational level. We found a significantly higher use of RADT testing for patients aged 0–19 years and with higher household educational level, whereas comorbidity was associated with a lower use of RADT testing. Conclusion The use of CRP POCT increased over time, whereas the use of RADT POCT decreased. Perhaps the success of implementing CRP as a tool for reducing antibiotic use has reached it limit. Future studies should focus on how and when POCT are used most optimal. Key points CRP POC tests and RADT POCTs are frequently used diagnostic tools in general practice, both in daytime and in the out-of-hours setting. There was an increased use of CRP POCTs, particularly in out-of-hours general practice, whereas the use of RADT POCTs declined between 2003 and 2018. CRP POCTs were associated with age of 40–59 years and co-morbidity, while the use of RADT was mostly associated with younger age.

Cost-of-illness comparison between clinical judgment and molecular point-of-care testing for influenza-like illness patients in Germany

A high economic burden stems from seasonal influenza as a well-known but serious public health problem. Rapid diagnostic tests have not yet been integrated into routine use in German primary care, even though they are likely to reduce overall costs in cases of suspected infection. This study aims to demonstrate that the use of point-of-care testing (POCT) produces lower costs of illness compared to the costs incurred by relying on clinical judgment alone. With the help of a decision tree model, two different diagnostic approaches for influenza-like illness (ILI) in primary care were compared: (1) clinical judgment with no technical support and (2) POCT. The costs of illness, as well as their differences, vary widely among the three age groups considered (elderly people, adults, and children). For the pathway of using clinical judgment alone, the costs of illness sum up to 155.99 € for elderly people compared to 76.31 € for adults and 74.15 € for children. With POCT, the costs of illness for the elderly amount to 115,09 €, which is 26% lower than the costs without diagnostic support. The costs for adults and children are 74.42 € and 75.66 €, respectively, which means 2.5% lower costs of illness for adults and 2% higher costs for children. The results demonstrate that the use of POCT to support detecting influenza in ILI patients may reduce the overall cost of illness. The provided data can help governments make informed decisions about potential cost savings by integrating POCT into the reimbursement scheme.

A low-cost portable microfluidic chemiluminometer for point-of-care testing of adiponectin for early risk assessment of diabetes

It is of great significance to implement early risk assessment of diabetes using point-of-care testing (POCT) strategies, particularly in the resource-limited settings. Here we proposed a low-cost portable microfluidic POCT chemiluminometer for the determination of adiponectin, an effective biomarker of diabetes. The determination is based on the immunoassay on a centrifugal microfluidic chip made of polycarbonate with 40 parallel detection microchannels. Centrifugation assisted washing processes made the entire immunoassay workflow semi-automatic and easy to perform. The chemiluminescence signal was recorded by a specially designed portable chemiluminometer. The whole set of the device costs less than $600 and weighs only 0.5 kg, which is suitable for POCT use. A limit of detection of 2.7 ng/ml was achieved with a linear response up to 70.5 ng/ml (R2 = 0.975) for serum adiponectin, covering the physiological blood adiponectin levels. Successful determination of adiponectin in six clinical specimens was demonstrated by a comparison with standard enzyme-linked immunosorbent assay.

A 3D Capillary-Driven Multi-Micropore Membrane-Based Trigger Valve for Multi-Step Biochemical Reaction

Point-of-care testing (POCT) techniques based on microfluidic devices enabled rapid and accurate tests on-site, playing an increasingly important role in public health. As the critical component of capillary-driven microfluidic devices for POCT use, the capillary microfluidic valve could schedule multi-step biochemical operations, potentially being used for broader complex POCT tasks. However, owing to the reciprocal relationship between the capillary force and aperture in single-pore microchannels, it was challenging to achieve a high gating threshold and high operable liquid volume simultaneously with existing 2D capillary trigger valves. This paper proposed a 3D capillary-driven multi-microporous membrane-based trigger valve to address the issue. Taking advantage of the high gating threshold determined by micropores and the self-driven capillary channel, a 3D trigger valve composed of a microporous membrane for valving and a wedge-shaped capillary channel for flow pumping was implemented. Utilizing the capillary pinning effect of the multi-micropore membrane, the liquid above the membrane could be triggered by putting the drainage agent into the wedge-shaped capillary channel to wet the underside of the membrane, and it could also be cut off by taking away the agent. After theoretical analysis and performance characterizations, the 3D trigger valve performed a high gating threshold (above 1000 Pa) and high trigger efficiency with an operable liquid volume above 150 μL and a trigger-to-drain time below 6 s. Furthermore, the retention and trigger states of the valve could be switched for repeatable triggering for three cycles within 5 min. Finally, the microbead-based immunoreaction and live cell staining applications verified the valve's ability to perform multi-step operations. The above results showed that the proposed 3D trigger valve could be expected to play a part in wide-ranging POCT application scenarios.

Availability and use of rapid diagnostic tests for the management of acute childhood infections in Europe: A cross-sectional survey of paediatricians.

Point-of-care-tests (POCTs) have been advocated to optimise care in patients with infections but their actual use varies. This study aimed to estimate the variability in the adoption of current POCTs by paediatricians across Europe, and to explore the determinants of variability. A cross-sectional survey was conducted of hospital and primary care paediatricians, recruited through professional networks. Questions focused on the availability and use of currently available POCTs. Data were analysed descriptively and using Median Odds Ratio (MOR) to measure variation between countries. Multilevel regression modelling using changes in the area under the receiver operating characteristic curve of models were used to assess the contribution of individual or workplace versus country level factors, to the observed variation. The commonest POCT was urine dipsticks (UD) which were available to >80% of primary care and hospital paediatricians in 68% (13/19) and 79% (23/29) countries, respectively. Availability of all POCTs varied between countries. In primary care, the country (MOR) varied from 1.61 (95%CI: 1.04-2.58) for lactate to 7.28 (95%CI: 3.04-24.35) for UD. In hospitals, the country MOR varied from 1.37 (95%CI:1.04-1.80) for lactate to 11.93 (95%CI:3.35-72.23) for UD. Most paediatricians in primary care (69%, 795/1154) and hospital (81%, 962/1188) would use a diagnostic test in the case scenario of an infant with undifferentiated fever. Multilevel regression modelling showed that the country of work was more important in predicting both the availability and use of POCTs than individual or workplace characteristics. There is substantial variability in the adoption of POCTs for the management of acute infections in children across Europe. To inform future implementation of both existing and innovative tests, further research is needed to understand what drives the variation between countries, the needs of frontline clinicians, and the role of diagnostic tests in the management of acute childhood infections.

AACC Guidance Document on the Use of Point-of-Care Testing in Fertility and Reproduction.

The AACC Academy revised the reproductive testing section of the Laboratory Medicine Practice Guidelines: Evidence-Based Practice for Point-of-Care Testing (POCT) published in 2007. A panel of Academy members with expertise in POCT and laboratory medicine was formed to develop guidance for the use of POCT in reproductive health, specifically ovulation, pregnancy, premature rupture of membranes (PROM), and high-risk deliveries. The committee was supplemented with clinicians having Emergency Medicine and Obstetrics/Gynecology training. Key recommendations include the following. First, urine luteinizing hormone (LH) tests are accurate and reliable predictors of ovulation. Studies have shown that the use of ovulation predicting kits may improve the likelihood of conception among healthy fertile women seeking pregnancy. Urinary LH point-of-care testing demonstrates a comparable performance among other ovulation monitoring methods for timing intrauterine insemination and confirming sufficient ovulation induction before oocyte retrieval during in vitro fertilization. Second, pregnancy POCT should be considered in clinical situations where rapid diagnosis of pregnancy is needed for treatment decisions, and laboratory analysis cannot meet the required turnaround time. Third, PROM testing using commercial kits alone is not recommended without clinical signs of rupture of membranes, such as leakage of amniotic fluid from the cervical opening. Finally, fetal scalp lactate is used more than fetal scalp pH for fetal acidosis due to higher success rate and low volume of sample required. This revision of the AACC Academy POCT guidelines provides recommendations for best practice use of POCT in fertility and reproduction.

Antimicrobial Stewardship Strategies Including Point-of-Care Testing (POCT) for Pediatric Patients with Upper-Respiratory-Tract Infections in Primary Care: A Systematic Review of Economic Evaluations.

Upper-respiratory-tract infections (URTIs) are among the main causes of antibiotic prescriptions in pediatric patients. Over one-third of all antibiotic prescriptions for URTIs in children are estimated to be inappropriate, as the majority of URTIs are caused by viral agents. Several strategies, including clinical scoring algorithms and different point-of-care tests (POCTs) have been developed to help discriminate bacterial from viral URTIs in the outpatient clinical setting. A systematic review of the literature was conducted following PRISMA guidelines with the objective of summarizing evidence from health–economic evaluations on the use of POCT for URTIs in pediatric outpatients. A total of 3375 records identified from four databases and other sources were screened, of which 8 met the inclusion criteria. Four studies were classified as being of high reporting quality, and three were of medium quality. Five out of eight studies concluded in favor of strategies that included POCTs, with an additional study finding several POCTs to be cost-effective compared to usual care but over an acceptable WTP threshold. This review found POCT could be a valuable tool for antimicrobial stewardship strategies targeted towards childhood URTIs in primary care.

P-062: MATRIX COMPARISON OF HEMOTYPESC AND SICKLESCAN POINT-OF-CARE DIAGNOSTICS FOR EARLY DIAGNOSIS OF SICKLE CELL DISEASE IN RURAL SUB-SAHARAN AFRICA

Purpose: In sub-Saharan Africa, universal sickle cell disease-newborn screening (SCD-NBS) programs are nonexistent due to high costs associated with conventional laboratory technologies, competing for national healthcare priorities, and budgetary constraints. However, the recent emergence of lateral-flow immunoassay microtechnology point-of-care tests (POCT) such the SickleSCAN™ and HemoTypeSC™ present exciting opportunities to change the status quo and potentially revolutionize healthcare for children as best practice for early diagnosis of SCD. Materials and methods: We perform a matrix comparison of diagnostic accuracy in field conditions for the SickleSCAN™ and HemoTypeSC™ tests. We assessed the performance characteristics of SickleSCAN™ and HemoTypeSC™ by evaluating children with positive Emmel test for HbSS, HbSC, and HbAS; and children, including newborns, without known coagulopathy in a rural district in Sierra Leone. Results: A total of seventy-four (33 females/41 males) children from three participating community health centers were analyzed by both methods. The ages ranged from twenty-four hours old to seventeen years old. HemoTypeSC™ and SickleSCAN™ correctly identified hemoglobinopathy phenotypes in 26 children with positive Emmel test as follows: twenty HbSS and four HbAS. Two positive Emmel test results (HbAS) were identified as HbAC and HbAA by the two tests indicating that the two tests have excellent sensitivity and specificity for the identification of the HbS pattern, consistent with SCD. Of the 74 samples that had two SCD POCT scores, there was no discordant result between the HemoTypeSC™ and the SickleSCAN™. Results for both tests were as follows: HbAA 36 (46.8%), HbAS 17 (22.1%), HbSC 1 (1.3%), and HbSS (26.0%). No newborns were identified with sickle cell disease (HbSS). The two tests identified seven newborns with sickle cell trait (HbAS). Twenty-one newborns had the normal HbAA genotype. Overall, HemoTypeSC™ and SickleSCAN™ exhibited sensitivity and specificity of 100% and 100% respectively for all possible phenotypes (HbAA, HbAS, and HbSS) detected. Conclusion: The HemoTypeSC and SickleSCAN tests demonstrated 100% concordance for identifying homozygote healthy people, sickle cell trait, and disease patients in this study. Our matrix comparison study highlighted the potential use of POCTs as both first?tier and second-tier screening and confirmation tests when presumptive SCD or trait is indicated. This is an acceptable practice for SCD screening as the current consensus is to use the same method on the same sample if no second?tier screening method is available and to confirm the screening result with a second method on a second sample to make a diagnosis. We, therefore, conclude that POCTs are suitable for population and newborn screening for the HbS phenotype in limited-resource settings where the disease burden is greatest and conventional laboratory methods are nonexistent. The authors do not declare any conflict of interest

Policy analysis: User monitoring of in-vitro diagnostic medical devices used for near-patient testing of infectious diseases

Abstract Background All individuals should have equitable access to accurate and timely testing for infectious diseases, which underpins diagnosis and treatment, safeguards blood supplies, and is used to determine disease prevalence. Disadvantaged populations have limited access to laboratory-based testing, so near-patient or point-of-care testing (PoCT) has been developed and implemented. Unlike laboratory-based testing, PoCT is often performed by non-laboratory staff and outside regulatory frameworks. Quality assurance (QA) of PoCT is often lacking or inappropriate, meaning inaccurate testing can go undetected, leading to poor patient outcomes. Objective To review the application of QA of PoCT use to detect infectious diseases and propose fit-for-purpose alternatives. Method A review of the current QA of PoCT was undertaken by experienced QA providers by mapping the points of failure. Barriers to providing PoCT QA include inappropriate and unstable sample types; expensive shipping to remote sites, including dry ice shipment; cost of international QA programmes; regulatory costs; fixed test events; and a lack of technology for simple, centralized data collection facilitating rapid analysis and reporting of test results. Based on these findings, a novel, fit-for-purpose model of QA for PoCT for infectious diseases is described. Results The new model for QA for PoCT identifies and describes novel sample types, including dry tube samples, dried swabs, or liquid-stable clinical samples that are inactivated and stable at ambient temperature; modified distribution channels; and a method for data collection and analysis using mobile phone technology. Conclusion The findings of this paper seek to describe a fit-for-purpose process, which aims to improve the quality of testing for infectious diseases at PoCT, globally.

Canadian Public Health Laboratory Network guidelines for the use of point-of-care tests for Treponema pallidum in Canada.

Over the past few years, the increase in infectious syphilis outbreaks in major urban centres and remote or rural locations in Canada, often affecting hard-to-reach patient populations, has renewed an interest and urgency in studying the use of point-of-care tests (POCTs) that can provide test results at the time and place of primary health care delivery, obviating the repeat visit necessary with traditional syphilis serology or molecular diagnostic tests. In 2015, the Canadian Public Health Laboratory Network released its first laboratory guideline for the use of POCTs in the diagnosis of syphilis in Canada. Although Canada has no licensed POCT, two POCTs (Syphilis Health Check and the DPP® HIV Syphilis System) have received US Food and Drug Administration (FDA) approval under premarket approval applications. Most syphilis POCTs detect antibodies to treponemal antigens, so their results cannot be used to differentiate between active and past infection. The only POCT that detects antibodies to both treponemal and non-treponemal antigens does not yet have Health Canada or FDA approval. In this updated guideline, the current landscape of POCTs for syphilis, with an emphasis on data from low-prevalence countries, is described. Individual operators should consider the questions of where, when, how, and why a POCT is used before its actual implementation. Training in the operation and interpretation, quality control, proficiency program, safety, and careful documentation of the process and results are especially important for the successful implementation of POCTs.

The impact of point-of-care hepatitis C testing in needle and syringe exchange programs on linkage to care and treatment uptake among people who inject drugs: An Australian pilot study.

Point-of-care (POC) diagnostics overcome barriers to conventional hepatitis C (HCV) testing in people who inject drugs. This study assessed impact on hepatitis C treatment uptake of POC HCV testing in needle and syringe exchange programs (NSPs). Rapid EC was a single-arm interventional pilot study of HCV POC testing conducted in three inner-city community clinics with NSPs. Twelve months after the POC testing, a retrospective medical record and Pharmaceutical Benefits Scheme audit was performed to determine the number of HCV RNA-positive participants who were prescribed HCV treatment. 70 HCV RNA-positive Rapid EC study participants were included. 44 (63%) were prescribed DAAs; 26 (59%) completed treatment and 15 (34%) had SVR testing, all of whom were cured. Age≥40years (aOR 3.45, 95% CI 1.10-11.05, p=.03) and secondary school education (aOR 5.8, 95% CI 1.54-21.80, p=.009) had higher likelihood of being prescribed DAAs, whereas homelessness was inversely associated with prescription of DAAs (aOR 0.30, 95% CI 0.09-1.04, p=.057). Median time to receive a DAA script from date of diagnosis was seven days (IQR 0 to 14days), and time to filling the DAA prescription was 2days (IQR 0-12days). In conclusion, provision of POC testing through NSPs was effective for linking new clients to HCV treatment and reduced the time to treatment. Further studies are needed to define the most cost-effective use of POC testing in models of care for people who inject drugs to increase HCV treatment uptake.