Trends and Challenges of Nanotechnology in Self-test at Home

Abstract Introduction: Patients with polycythemia vera (PV) have an increased risk of morbidity and mortality from thromboembolic events and cardiovascular disease, particularly for hematocrit (Hct) levels > 45% (Marchioli et al., 2013). Maintaining Hct < 45% is therefore important to reduce these risks. A device that patients can use to frequently monitor their own Hct levels could provide a detailed picture of the change in Hct over time, enable timely clinical visits and disease management, reduce disease burden, and increase patients' quality of life (QoL). A meter to measure hemoglobin (Hb) and Hct that has been approved for medical professional use (StatStrip Xpress ® 2 Hb/Hct meter, Nova Biomedical Corporation) has potential as an at-home, self-testing device. Purpose: To carry out a proof-of-concept study in clinical practice to test the accuracy of the StatStrip Xpress 2 Hb/Hct meter, to evaluate its feasibility for patient self-testing, and to assess its impact on patient-reported outcomes. Methods: Adults (aged > 18 years) who had PV (according to the World Health Organization 2016 criteria), or conditions with Hct < 35% or Hct > 50%, who required monitoring of Hct/Hb values in clinical practice and who provided informed consent were enrolled from two Swiss centers in this observational study. During each routine visit, patients collected and analyzed a finger-prick blood sample using StatStrip Xpress 2 Hb/Hct (self-test) without guidance or intervention from healthcare professionals (HCPs); HCPs then repeated this test (professional test). At each visit, HCPs also collected and analyzed a venous blood sample using a laboratory hematology analyzer (Sysmex), and patients completed a 15-minute questionnaire about use of the self-test device. The primary endpoint was mean difference in absolute percentage points between Hct values from the professional test and the analyzer (mdiff, 90% confidence interval [CI]; Spearman correlation [r]). Secondary endpoints included mdiff for Hct (%) and Hb (g/dl) between values obtained from the self-test and professional test, and the self-test and analyzer. Other endpoints included the correlation between the professional test Hct values and other blood cell counts. The study was approved by local ethics committees. Results: Blood measurements from 68 visits for 60 patients (PV = 32; other conditions with Hct < 35% or > 50% = 28) were included in the analysis. For the primary endpoint, Hct values were very similar for the analyzer and professional test (66 data points after removal of 1 outlier; mdiff = 0.1% [CI: ‒0.5-0.8]; r = 0.95, p < 0.001). Importantly, Hct results were also similar for the self-test and professional test (63 data points after removal of 2 outliers; mdiff = -0.2% [CI: ‒0.98-0.5]; r = 0.93, p < 0.001) and the analyzer and self-test (64 data points after removal of 2 outliers; mdiff = 0.1% [CI: ‒0.6-0.8]; r = 0.93, p < 0.001). Similar results were obtained for Hb measurements across the tests. There was no correlation between the accuracy of Hct values from the professional test (vs the analyzer) and blood cell counts, but this should be interpreted with caution because there was a limited number of patients with extreme white blood cell and platelet counts. There was no influence of sex (male/female), age (≤ 75 years/> 75 years) or, in the case of patients with PV, time from diagnosis on the results. Responses to the patient questionnaire showed that 92% of patients were satisfied or very satisfied with the self-test device, 100% found it easy to use, and 97% were willing to start using it at home. Of patients with PV, 71% stated that using a self-testing device would make them feel safer and 56% felt that it would have a positive effect on their QoL. Conclusions: This study demonstrates the accuracy of the StatStrip Xpress 2 Hct/Hb meter vs a laboratory analyzer for measuring Hct and Hb levels. Importantly, it shows that measurements taken by patients are as accurate as those taken by HCPs. These findings highlight the potential benefits of introducing an instrument for at-home self-testing to the management of patients with PV or other hematological conditions that require regular Hct/Hb monitoring. Benefits to patients may include increased QoL, improved clinical outcomes, and reduced morbidity and mortality through timely clinical action. In addition, fewer outpatient appointments may mean reduced healthcare costs. Figure 1 Figure 1. Disclosures Rovo: Novartis: Honoraria; BMS: Honoraria; Amgen: Other: Financial support for congresses and conference travel; AstraZeneca: Other; Swedish Orphan Biovitrum AG: Honoraria; AG Alexion: Honoraria; OrPhaSwiss GmbH: Honoraria; AstraZeneca: Honoraria; BMS: Other; Sanofi: Other; Roche: Other; Novartis: Research Funding; CSL Behring: Research Funding; AG Alexion: Research Funding. Baierlein-Leimbach: Novartis Pharma Schweiz AG: Current Employment. Triemer: Novartis Pharma Schweiz AG: Current Employment. McCarthy-Pontier: Novartis Pharma Schweiz AG: Current Employment. Lehmann: AbbVie: Honoraria; Novartis: Research Funding; Janssen: Honoraria; Swedish Orphan Biovitrum AG: Honoraria; Janssen: Other; Roche: Other; Abbvie: Other: Financial support for congress and conference travel ; Amgen: Other: Financial support for congress and conference travel ; Celgene: Research Funding; Incyte: Honoraria; BMS: Honoraria; Amgen: Honoraria.

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Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home

Scientific Reports ◽

10.1038/s41598-021-89236-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Paula Iruzubieta ◽

Tatiana Fernández-Lanas ◽

Laura Rasines ◽

Lorena Cayon ◽

Ana Álvarez-Cancelo ◽

...

Keyword(s):

Large Scale ◽

Rapid Test ◽

The Self ◽

Healthcare Personnel ◽

Testing Strategy ◽

Self Testing ◽

Scale Population ◽

Self Test ◽

Test Result ◽

At Home

AbstractThe simplicity and low cost of rapid point-of-care tests greatly facilitate large-scale population testing, which can contribute to controlling the spread of the COVID-19 virus. We evaluated the applicability of a self-testing strategy for SARS-CoV2 in a population-based, cross-sectional study in Cantabria, Spain, between April and May 2020. For the self-testing strategy, participants received the necessary material for the self-collection of blood and performance of a rapid antibody test using lateral flow immunoassay at home without the supervision of healthcare personnel. A total of 1,022 participants were enrolled. Most participants correctly performed the COVID-19 self-test the first time (91.3% [95% CI 89.4–92.9]). Only a minority of the participants (0.7%) needed the help of healthcare personnel, while 6.9% required a second kit delivery, for a total valid test result in 96.9% of the participants. Incorrect use of the self-test was not associated with the educational level, age over 65, or housing area. Prevalence of IgG antibodies against SARS-CoV2 for subjects with a valid rapid test result was 3.1% (95% CI 2.2–4.4), similar to the seroprevalence result obtained using a conventional approach carried out by healthcare professionals. In conclusion, COVID-19 self-testing should be considered as a screening tool.

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Diagnostic Accuracy of an At-Home, Rapid Self-Test for Influenza: A Prospective Comparative Accuracy Study (Preprint)

JMIR Public Health and Surveillance ◽

10.2196/28268 ◽

2021 ◽

Author(s):

Rachel E. Geyer ◽

Jack Henry Kotnik ◽

Victoria Lyon ◽

Elisabeth Brandstetter ◽

Monica Zigman Suchsland ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Influenza A ◽

Comparative Accuracy ◽

Accuracy Study ◽

Self Test ◽

At Home

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Diagnostic Accuracy of an At-Home, Rapid Self-Test for Influenza (Preprint)

10.2196/preprints.28268 ◽

2021 ◽

Author(s):

Rachel E. Geyer ◽

Jack Henry Kotnik ◽

Victoria Lyon ◽

Elisabeth Brandstetter ◽

Monica Zigman Suchsland ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Symptom Onset ◽

Reference Sample ◽

Rnase P ◽

Severe Illness ◽

Influenza B ◽

Convenience Sample ◽

Self Test ◽

The Impact ◽

At Home

BACKGROUND Rapid diagnostic tests (RDT) for influenza used by individuals at home could potentially expand access to testing and reduce the impact of influenza on health systems. Improving access to testing could lead to earlier diagnosis following symptom onset, allowing more rapid interventions on those who test positive, including behavioral changes to minimize spread. However, the accuracy of RDTs for influenza has not been determined among self-testing populations. OBJECTIVE To assess the accuracy of an influenza RDT conducted at home by lay users with acute respiratory illness (ARI), compared to a self-collected sample conducted by the same individual mailed to a laboratory for reference testing. METHODS A comparative accuracy study of an at-home influenza RDT (Ellume, Brisbane, Qld, Australia) in a convenience sample of individuals experiencing ARI symptoms. Participants were enrolled in February and March 2020, from the greater Seattle region, Washington, USA. Participants were mailed the influenza RDT and reference sample collection materials, which they completed and returned for RT-qPCR influenza testing in a central laboratory. We explored the impact of age, influenza type, duration, and severity of symptoms on RDT accuracy, viral CT (cycle threshold), and a marker of human DNA (RNase P). RESULTS 605 participants completed all study steps and were included in our analysis, of whom 87 (14.4%) tested positive for influenza by RT-qPCR (70 influenza A, 17 influenza B). The overall sensitivity and specificity of the RDT compared to the reference test were 61% (95%CI 50-71) and 95% (95%CI 93-97), respectively. Among individuals with symptom onset ≤72 hours, sensitivity was 63% (95%CI 48-76) and specificity was 94% (95% CI 91-97), while for those with duration > 72 hours, sensitivity and specificity were 58% (95%CI 41-74) and 96% (95%CI 93-98), respectively. Viral load on reference swabs was negatively correlated with symptom onset, while quantities of the endogenous marker gene RNase P did not differ between PCR positive/negative groups, age groups, or influenza subtypes. The RDT did not have higher sensitivity or specificity among those who reported more severe illness. CONCLUSIONS The sensitivity and specificity of the self-test was comparable to that of influenza RDTs used in clinical settings. False negative self-test results were more common when the test was used after 72 hours of symptom onset, but were not related to inadequate swab collection, or severity of illness. Deployment of home tests may provide a valuable tool to support management of influenza and other respiratory infections.

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Siblings of Children with Mental Retardation Living at Home or in Residential Placement

Journal of Child Psychology and Psychiatry ◽

10.1017/s0021963097002084 ◽

1998 ◽

Vol 39 (3) ◽

pp. 355-363 ◽

Cited By ~ 36

Author(s):

Laurie Eisenberg ◽

Bruce L. Baker ◽

Jan Blacher

Keyword(s):

Mental Retardation ◽

Residential Placement ◽

At Home

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Systematic Modification of Parental Input to Train Language Symbols

Language Speech and Hearing Services in Schools ◽

10.1044/0161-1461.1201.04 ◽

1981 ◽

Vol 12 (1) ◽

pp. 4-12 ◽

Cited By ~ 6

Author(s):

Barbara Culatta ◽

Donna Horn

Keyword(s):

Language Learning ◽

Meaningful Use ◽

Hearing Impaired ◽

Specific Language ◽

Parental Input ◽

Language Exposure ◽

Therapy Sessions ◽

Impaired Children ◽

Hearing Impaired Children ◽

At Home

This study attempted to maximize environmental language learning for four hearing-impaired children. The children's mothers were systematically trained to present specific language symbols to their children at home. An increase in meaningful use of these words was observed during therapy sessions. In addition, as the mothers began to generalize the language exposure strategies, an increase was observed in the children's use of words not specifically identified by the clinician as targets.

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Iterative Development of a Home Review Program to Promote Preschoolers' Vocabulary Skills: Social Validity and Learning Outcomes

Language Speech and Hearing Services in Schools ◽

10.1044/2019_lshss-19-00011 ◽

2020 ◽

Vol 51 (2) ◽

pp. 371-389 ◽

Cited By ~ 2

Author(s):

Xigrid Soto ◽

Yagmur Seven ◽

Meaghan McKenna ◽

Keri Madsen ◽

Lindsey Peters-Sanders ◽

...

Keyword(s):

High Stress ◽

Social Validity ◽

Home Language ◽

Single Subject ◽

Considerable Difficulty ◽

Home Program ◽

Iterative Development ◽

Vocabulary Skills ◽

Validity Measures ◽

At Home

Purpose This article describes the iterative development of a home review program designed to augment vocabulary instruction for young children (ages 4 and 5 years) occurring at school through the use of a home review component. Method A pilot study followed by two experiments used adapted alternating treatment designs to compare the learning of academic words taught at school to words taught at school and reviewed at home. At school, children in small groups were taught academic words embedded in prerecorded storybooks for 6 weeks. Children were given materials such as stickers with review prompts (e.g., “Tell me what brave means”) to take home for half the words. Across iterations of the home intervention, the home review component was enhanced by promoting parent engagement and buy-in through in-person training, video modeling, and daily text message reminders. Visual analyses of single-subject graphs, multilevel modeling, and social validity measures were used to evaluate the additive effects and feasibility of the home review component. Results Social validity results informed each iteration of the home program. The effects of the home program across sites were mixed, with only one site showing consistently strong effects. Superior learning was evident in the school + home review condition for families that reviewed words frequently at home. Although the home review program was effective in improving the vocabulary skills of many children, some families had considerable difficulty practicing vocabulary words. Conclusion These studies highlight the importance of using social validity measures to inform iterative development of home interventions that promote feasible strategies for enhancing the home language environment. Further research is needed to identify strategies that stimulate facilitators and overcome barriers to implementation, especially in high-stress homes, to enrich the home language environments of more families.

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