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Alberta's Ministry of Health recently announced plans to enable residents to privately purchase diagnostic testing services, including laboratory and imaging tests, without a referral from a health care provider. The stated rationale is to achieve \"better health outcomes and patient autonomy for Albertans, and reduc[e] health care system strain.\" The ministry asserts that better out comes and cost savings will be achieved through earlier detection of disease, including cancers and cognitive impairment. Although these intentions are laudable, non referred, privately paid, direct-to-consumer diagnostic testing is unlikely to achieve these objectives and could, in fact, worsen patient health out comes while adding strain on the publicly supported health system in Alberta. They focus on the potential harms of direct-to- consumer whole-body imaging and laboratory testing. Most health systems use screening programs to identify diseases in asymptomatic patients (e.g., mammography screening for breast cancer). Such programs must meet certain criteria. They must employ tests that accurately identify disease; the condition being tested for should be one whose outcome is improved with early detection; and there should be a system in place that is adequately resourced to act on and treat identified cases. Most direct-to-consumer tests conducted without a health care provider's guidance do not meet these criteria.

Sickle cell diseases (SCD) are the most common genetic disorders with significant morbidity and mortality worldwide, including in India. The high prevalence of this disorder in many geographical regions calls for the use of a point-of-care rapid diagnostic test (RDT) for early screening and management of the diagnosed cases to reduce the allied clinical severity. In view of this, the present study was undertaken for the validation of a point-of-care RDT kit (SICKLECHECK.sup.TM) for the screening of SCD. This validation and diagnostic accuracy study was conducted among the cases advised for screening of SCD. For validation, all the recruited cases were investigated for both the SICKLECHECK.sup.TM RDT kit and HPLC (Variant-II) considering HPLC as a gold standard. A total of 400 cases were screened for both tests. For the presence and absence of sickle cell hemoglobin in the samples, SICKLECHECK.sup.TM RDT kit results showed a sensitivity and specificity of 99.39% and 98.73% respectively with references to HPLC findings. For the detection of the 'AS' pattern, the SICKLECHECK.sup.TM RDT kit has shown a sensitivity and specificity of 99.07% and 98.81% respectively. For the detection of the 'SS' pattern, the SICKLECHECK.sup.TM RDT kit has shown a sensitivity and specificity of 97.92% and 100.0% respectively. Cases with [beta] thalassemia trait, hemoglobin E trait, hemoglobin Lepore trait and trait for hereditary-persistence-of-fetal-hemoglobin (high HbF %) diagnosed in HPLC were resulted with 'AA' pattern in SICKLECHECK.sup.TM RDT kit. The high sensitivity and specificity of the SICKLECHECK.sup.TM RDT kit insist on its use as a point-of-care screening tool for SCD especially where there is a lack of laboratory facilities as well as in hospital-based set-up requiring immediate diagnosis and management of SCD. However, for further confirmation, the samples should be analyzed with other gold standard techniques like HPLC.

There is a clear requirement for an accurate SARS-CoV-2 antibody test, both as a complement to existing diagnostic capabilities and for determining community seroprevalence. We therefore evaluated the performance of a variety of antibody testing technologies and their potential use as diagnostic tools. Highly specific in-house ELISAs were developed for the detection of anti-spike (S), -receptor binding domain (RBD) and -nucleocapsid (N) antibodies and used for the cross-comparison of ten commercial serological assays-a chemiluminescence-based platform, two ELISAs and seven colloidal gold lateral flow immunoassays (LFIAs)-on an identical panel of 110 SARS-CoV-2-positive samples and 50 pre-pandemic negatives. There was a wide variation in the performance of the different platforms, with specificity ranging from 82% to 100%, and overall sensitivity from 60.9% to 87.3%. However, the head-to-head comparison of multiple sero-diagnostic assays on identical sample sets revealed that performance is highly dependent on the time of sampling, with sensitivities of over 95% seen in several tests when assessing samples from more than 20 days post onset of symptoms. Furthermore, these analyses identified clear outlying samples that were negative in all tests, but were later shown to be from individuals with mildest disease presentation. Rigorous comparison of antibody testing platforms will inform the deployment of point-of-care technologies in healthcare settings and their use in the monitoring of SARS-CoV-2 infections.

Background Mobile phone applications (apps) have been shown to successfully facilitate the self-management of chronic disease. This study aims to evaluate firstly the experiences, barriers and facilitators to app usage among people with Type 2 Diabetes Mellitus (T2DM) and secondly determine recommendations to improve usage of diabetes apps. Methods Participants were aged ≥ 18 years with a diagnosis of T2DM for ≥ 6 months. Semi-structured phone-interviews were conducted with 16 app and 14 non-app users. Interviews were based on the Technology Acceptance Model, Health Information Technology Acceptance Model (HITAM) and the Mobile Application Rating Scale. Data were analysed using deductive content analysis. Results Most app-users found apps improved their T2DM self-management and health. The recommendation of apps by health professionals, as well as positive interactions with them, improved satisfaction; however, only a minority of patients had practitioners involved in their app use. All non-app users had never had the concept discussed with them by a health professional. Facilitators to app use included the visual representation of trends, intuitive navigation and convenience (for example, discretion and portability). Barriers to app use were participant’s lack of knowledge and awareness of apps as healthcare tools, perceptions of disease severity, technological and health literacy or practical limitations such as rural connectivity. Factors contributing to app use were classified into a framework based on the Health Belief Model and HITAM. Recommendations for future app design centred on educational features, which were currently lacking (e.g. diabetes complications, including organ damage and hypoglycaemic episodes), monitoring and tracking features (e.g. blood glucose level monitoring with trends and dynamic tips and comorbidities) and nutritional features (e.g. carbohydrate counters). Medication reminders were not used by participants. Lastly, participants felt that receiving weekly text-messaging relating to their self-management would be appropriate. Conclusions The incorporation of user-centred features, which engage T2DM consumers in self-management tasks, can improve health outcomes. The findings may guide app developers and entrepreneurs in improving app design and usability. Given self-management is a significant factor in glycaemic control, these findings are significant for GPs, nurse practitioners and allied health professionals who may integrate apps into a holistic management plan which considers strategies outside the clinical environment.

PurposeGlycemic control poses a challenge in intensive care unit (ICU) patients and dysglycemia is associated with poor outcomes. Continuous glucose monitoring (CGM) has been successfully implemented in the type 1 diabetes out-patient setting and renewed interest has been directed into the transition of CGM into the ICU. This scoping review aimed to provide an overview of CGM accuracy in ICU patients to inform future research and CGM implementation.MethodsWe systematically searched PubMed and EMBASE between 5th of December 2023 and 21st of May 2024 and reported findings in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline for scoping reviews (PRISMA-ScR). We assessed studies reporting the accuracy of CGM in the ICU and report study characteristics and accuracy outcomes.ResultsWe identified 2133 studies, of which 96 were included. Most studies were observational (91.7%), conducted in adult patients (74%), in mixed ICUs (47.9%), from 2014 and onward, and assessed subcutaneous CGM systems (80%) using arterial blood samples as reference test (40.6%). Half of the studies (56.3%) mention the use of a prespecified reference test protocol. The mean absolute relative difference (MARD) ranged from 6.6 to 30.5% for all subcutaneous CGM studies. For newer factory calibrated CGM, MARD ranged from 9.7 to 20.6%. MARD for intravenous CGM was 5–14.2% and 6.4–13% for intraarterial CGM.ConclusionsIn this scoping review of CGM accuracy in the ICU, we found great diversity in accuracy reporting. Accuracy varied depending on CGM and comparator, and may be better for intravascular CGM and potentially lower during hypoglycemia.

Background Partner-delivered HIV self-testing kits has previously been highlighted as a safe, acceptable and effective approach to reach men. However, less is known about its real-world implementation in reaching partners of people living with HIV. We evaluated programmatic implementation of partner-delivered self-testing through antenatal care (ANC) attendees and people newly diagnosed with HIV by assessing use, positivity, linkage and cost per kit distributed. Methods Between April 2018 and December 2019, antenatal care (ANC) clinic attendees and people or those newly diagnosed with HIV clients across twelve clinics in three cities in South Africa were given HIVST kits (OraQuick Rapid HIV-1/2 Antibody Test, OraSure Technologies) to distribute to their sexual partners. A follow-up telephonic survey was administered to all prior consenting clients who were successfully reached by telephone to assess primary outcomes. Incremental economic costs of the implementation were estimated from the provider’s perspective. Results Fourteen thousand four hundred seventy-three HIVST kits were distributed – 10,319 (71%) to ANC clients for their male partner and 29% to people newly diagnosed with HIV for their partners. Of the 4,235 ANC clients successfully followed-up, 82.1% (3,475) reportedly offered HIVST kits to their male partner with 98.1% (3,409) accepting and 97.6% (3,328) using the kit. Among ANC partners self-testing, 159 (4.8%) reported reactive HIVST results, of which 127 (79.9%) received further testing; 116 (91.3%) were diagnosed with HIV and 114 (98.3%) initiated antiretroviral therapy (ART). Of the 1,649 people newly diagnosed with HIV successfully followed-up; 1,312 (79.6%) reportedly offered HIVST kits to their partners with 95.8% (1,257) of the partners accepting and 95.9% (1,206) reported that their partners used the kit. Among these index partners, 297 (24.6%) reported reactive HIVST results of which 261 (87.9%) received further testing; 260 (99.6%) were diagnosed with HIV and 258 (99.2%) initiated ART. The average cost per HIVST distributed in the three cities was US$7.90, US$11.98, and US$14.81, respectively. Conclusions Partner-delivered HIVST in real world implementation was able to affordably reach many male partners of ANC attendees and index partners of people newly diagnosed with HIV in South Africa. Given recent COVID-19 related restrictions, partner-delivered HIVST provides an important strategy to maintain essential testing services.

Options to increase the ease of testing for SARS-CoV-2 infection and immune response are needed. Self-collection of diagnostic specimens at home offers an avenue to allow people to test for SARS-CoV-2 infection or immune response without traveling to a clinic or laboratory. Before this study, survey respondents indicated willingness to self-collect specimens for COVID-related tests, but hypothetical willingness can differ from post-collection acceptability after participants collect specimens. 153 US adults were enrolled in a study of the willingness and feasibility of patients to self-collect three diagnostic specimens (saliva, oropharyngeal swab (OPS) and dried blood spot (DBS) card) while observed by a clinician through a telehealth session. After the specimens were collected, 148 participants participated in a survey about the acceptability of the collection, packing and shipping process, and their confidence in the samples collected for COVID-related laboratory testing. A large majority of participants (>84%) reported that collecting, packing and shipping of saliva, OPS, and DBS specimens were acceptable. Nearly nine in 10 (87%) reported being confident or very confident that the specimens they collected were sufficient for laboratory analysis.There were no differences in acceptability for any specimen type, packing and shipping, or confidence in samples, by gender, age, race/ethnicity, or educational level. Self-collection of specimens for SARS-CoV-2 testing, and preparing and shipping specimens for analysis, were acceptable in a diverse group of US adults. Further refinement of materials and instructions to support self-collection of saliva, OPS and DBS specimens for COVID-related testing is needed.

Clinical laboratories perform a variety of tests for which biomedical waste is a byproduct. Of these, the complete metabolic panel (CMP) produces a significant portion of this waste. We investigated specific waste subsequent to performing CMPs over the course of a year and analyzed what percentage of the waste produced could have been recycled. Patient testing volumes were collected retrospectively from July 14, 2021, to July 14, 2022, for individual assays within the CMP performed on Abbott Alinity c instruments (n = 6). The average weights for components of the reagent kits, which includes wedges, boxes, and package inserts, were calculated. These weights, in conjunction with total patient testing volumes, were used to determine the amount of waste produced. A total of 1089.2 kg of reagent kit waste was estimated to be produced by performing CMPs throughout a year. Of this waste, most (855.5 kg) was not recyclable, but a subset (233.6 kg) was. Overall, 21.4% of the total specific waste weight was found to be recyclable. The CMP contributes a substantial amount of waste when performed on chemistry analyzer platforms in the clinical laboratory. Paper inserts and cardboard packaging, however, presented opportunities for recycling.

Early and rapid confirmation of dengue infections strengthens disease surveillance program and are critical to the success of vector control measures. Rapid diagnostics tests (RDTs) are increasingly used to confirm recent dengue infections due to their ease of use and short turnaround time for results. Several studies undertaken in dengue-endemic Southeast Asia have reported the performance of RDTs against enzyme-linked immunosorbent assay (ELISA), reverse transcriptase polymerase chain reaction (RT-PCR) and virus isolation methods. However, few studies have compared multiple RDTs for the detection of dengue NS1 antigen and IgM antibody in a single combo cassette. We evaluated six RDTs in Singapore for their utility in routine clinical testing to detect recent dengue infections. The evaluation comprised two phases. The first phase sought to determine each RDT's specificity to dengue NS1 and IgM using zika and chikungunya virus supernatant and zika convalescent samples. RDTs that cross-reacted with zika or chikungunya were not further tested in phase 2. The second phase sought to determine the sensitivity and specificity of the remaining RDTs to dengue NS1 and IgM using pre-characterised dengue specimens and non-dengue/chikungunya febrile clinical specimens. None of the RDTs cross-reacted with zika IgM in Phase 1. Truquick and Quickprofile cross reacted with zika and chikungunya viruses and were not evaluated thereafter. Standard Q had the highest dengue NS1 and IgM sensitivity at 87.0% and 84.3% respectively whereas Bioline (68.5%) and Multisure (58.3%) had the lowest dengue NS1 and IgM sensitivity respectively. Combining dengue NS1/IgM detection results greatly improved the RDT ability to detect recent dengue infection; Standard Q had the highest sensitivity at 99.1% while Multisure had the lowest at 92.6%. All the RDTs were highly specific for dengue NS1 and IgM (96.7% to 100%). All the RDTs had high positive predictive values (98.4% to 100%) for NS1, IgM and combined NS1/IgM parameters whereas Standard Q had the highest negative predictive values at 68.2% (NS1), 63.8% (IgM) and 96.8% (NS1/IgM). For the RDTs, detection of NS1 declined from acute to convalescent phase of illness whereas IgM detection rate gradually increased over time. In our study, several RDTs were evaluated for their diagnostic accuracy and capability in detecting recent dengue infection. Standard Q demonstrated a high degree of diagnostic accuracy and capability in the detection of NS1 and IgM biomarkers. RDTs can provide rapid and accurate confirmation of recent dengue infections and augment dengue surveillance and control programmes. Further studies are required to assess the usefulness of these RDTs in other epidemiology settings.