Accurate patient DLMO measurements facilitated by convenient at-home sample collection kits, cell-phone based app and robust salivary immunoassay

ABSTRACT:Not so long ago I interviewed a computer engineer in her home. Surrounded with toys and a napping baby—the interview time had been chosen carefully—she talked about how she worked as an independent contractor for a large electronics company. Connected by high-speed broadband, two telephone lines, and a cell phone, she felt fully integrated into the work, exchanging electronic files with her colleagues and having telephone conversations with customers two continents and umpteen time zones away. She told me she often worked late after the baby was in bed and during the baby's afternoon nap before she went to pick her older child up from school. Despite these odd working times, however, she was convinced that none of the company's customers and only some of her work colleagues knew that she worked at home. She was very contented with the arrangement.

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A serological assay to detect SARS-CoV-2 antibodies in at-home collected finger-prick dried blood spots

10.1101/2020.05.29.20116004 ◽

2020 ◽

Author(s):

Donna Grace Karp ◽

Kenneth Danh ◽

David Seftel ◽

Peter Robinson ◽

Cheng-ting Tsai

Keyword(s):

Healthcare Worker ◽

Large Scale ◽

Health Care Systems ◽

Dried Blood Spots ◽

Sample Collection ◽

Finger Prick ◽

Care Systems ◽

Hard To Reach Populations ◽

Development And Validation ◽

At Home

Accurate surveillance of coronavirus disease 2019 (COVID-19) incidence requires large-scale testing of the population. Current testing methods require in-person collection of biospecimens by a healthcare worker, limiting access of individuals who do not have access to testing facilities while placing both the patient and healthcare worker at risk of exposure to infection. We report the development and validation of a at-home finger-prick dried blood spot collection kit and an analysis method. We demonstrated 100% sensitivity and specificity using at-home collected specimens across the US. Such methods may facilitate the conduct of unbiased serosurveys within hard to reach populations and help reduce the sample collection burden of serological testing on both health care systems and individuals alike.

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Development of at-home sample collection logistics for large scale SARS-CoV-2 seroprevalence studies

10.1101/2021.01.14.21249824 ◽

2021 ◽

Author(s):

Aishani V. Aatresh ◽

Kate Cummings ◽

Hilary Gerstein ◽

Christopher S. Knight ◽

Andreas Limberopolous ◽

...

Keyword(s):

Healthcare Workers ◽

Age Groups ◽

Population Level ◽

Lower Income ◽

Sample Collection ◽

Serological Studies ◽

High Engagement ◽

Future Population ◽

At Home

AbstractIn the midst of a pandemic, serologic studies are a valuable tool to understand the course of the outbreak and guide public health and general pandemic management. However, given significant safety constraints including social distancing and stay-at-home orders, sample collection becomes more difficult given traditional phlebotomy protocols. For such studies, a representative sample of the underlying population is paramount to elicit meaningful insights that capture the spread of the infection, particularly when different sub-populations face varying disease burden. We aimed to address these challenges by conducting a fully remote study to investigate the seroprevalence of SARS-CoV-2 in the state of Massachusetts. Leveraging electronic study engagement and at-home self-collection of finger-prick samples, we enrolled 2,066 participants representative of the ethnic and racial composition of Massachusetts. SARS-CoV-2 total IgG seropositivity was 3.15%, and follow-up measurements at days 7, 15, 45, and 90 indicate a generally durable antibody response. A higher risk of infection was observed for healthcare workers and their cohabitants and those with comorbidities, as well as lower-income, less educated, Hispanic, and those in the age groups of 18-29 and 50-59-years-old. High engagement and positive feedback from the participants and quality of self-collected specimens point to the usefulness of this design for future population-level serological studies that more effectively and safely reach a broad representative cohort, thus yielding more comprehensive insights into the burden of infection and disease in populations.Key pointsQuestionWe aimed to implement a fully remote seroprevalence study for SARS-CoV-2, leveraging electronic methods and at-home self-collection of specimens to engage a representative study population.FindingsThe population enrolled reflected the ethnic and racial composition of Massachusetts, revealing a SARS-CoV-2 seroprevalence of 3.15% and higher risk of previous infection associated with healthcare workers/their cohabitants, those with comorbidities, lower-income, less educated, Hispanic, and those in age groups 18-29 and 50-59 years old.MeaningHigh engagement and positive feedback from participants as well as quality of self-collected specimens point to the usefulness of this design for future population-level serological studies.

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Guided sputum sample collection and culture contamination rates in the diagnosis of pulmonary TB

Jornal Brasileiro de Pneumologia ◽

10.1590/s1806-37132009000500012 ◽

2009 ◽

Vol 35 (5) ◽

pp. 460-463 ◽

Cited By ~ 8

Author(s):

Ethel Leonor Noia Maciel ◽

Thiago Nascimento do Prado ◽

Renata Lyrio Peres ◽

Moises Palaci ◽

John L. Johnson ◽

...

Keyword(s):

Comparative Study ◽

Sputum Sample ◽

Contamination Rate ◽

Patient Orientation ◽

Sample Collection ◽

Pulmonary Tb ◽

Hygiene Measures ◽

At Home

A comparative study to evaluate contamination in cultures of morning sputum samples, comparing those collected at home under currently recommended conditions and those collected under supervision after patient orientation and education. The home and supervised collection groups produced 43 and 76 sputum samples, respectively. The contamination rate was nearly 3-times higher among samples collected at home than among those collected under supervision (37% vs. 13%, p < 0.05; OR = 0.25). The simple educational and hygiene measures described can decrease the contamination rate among sputum samples collected for diagnostic culture.

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O-18 Clinical studies at-home: feasibility of data and sample collection in paediatric pain management after tonsillectomy (tomachi)

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-esdppp.18 ◽

2017 ◽

Vol 102 (10) ◽

pp. A8.1-A8

Author(s):

Von Niederhäusern ◽

Saccilotto ◽

Schädelin ◽

Benkert ◽

Summerer ◽

...

Keyword(s):

Pain Management ◽

Clinical Studies ◽

Sample Collection ◽

O 18 ◽

At Home

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Acceptability and Feasibility of a Telehealth Intervention for Sexually Transmitted Infection Testing Among Male Couples: Protocol for a Pilot Study (Preprint)

10.2196/preprints.14481 ◽

2019 ◽

Author(s):

Stephen Sullivan ◽

Patrick Sullivan ◽

Rob Stephenson

Keyword(s):

United States ◽

Pilot Study ◽

Online Survey ◽

The United States ◽

Valuable Insight ◽

Sample Collection ◽

Male Couples ◽

Sexually Transmitted ◽

Sti Testing ◽

At Home

BACKGROUND Gay, bisexual, and other men who have sex with men (MSM) are at elevated risk for acquiring sexually transmitted infections (STIs) in the United States, especially chlamydia and gonorrhea. While research has indicated main partners over casual partners may play a central role in STI risk, the frequency of STI screening among MSM couples is particularly low. Self-sample collection for chlamydia and gonorrhea screening has been shown to be highly accurate, and at-home STI testing has been shown to be highly acceptable among diverse populations. However, there is little research exploring the feasibility and acceptability of at-home chlamydia and gonorrhea screening among MSM couples. Our pilot study aims to help evaluate the viability of this screening modality as an intervention tool for MSM couples OBJECTIVE The objective of this study was to assess the feasibility and acceptability of an at-home chlamydia and gonorrhea sample collection and remote lab testing program among a sample of 50 MSM couples living in the United States. METHODS This pilot study enrolled 50 MSM couples, ranging from 18-40 years old and living in the United States, who participated in a larger at-home HIV testing randomized controlled trial. Participating couples completed a pretest instructional video call and then had the option of completing at-home sample collection across three bodily sites (rectal swab, pharyngeal swab, and urine sample) for remote chlamydia and gonorrhea lab testing. For participants who completed any sample collection, they received their results via a posttest video call. All participants completed an online survey examining satisfaction and acceptability of the home testing process, experience with logistics, willingness to test at home in the future, recent sexual risk behavior, STI testing history, and linkage to care. A subset of 10 couples completed an in-depth interview about their attitudes towards the sample collection process, different decisions they made while collecting their samples, and their experience accessing treatment (for those who received a positive result). RESULTS Recruitment began in September 2017, and as of March 2019 a total of 50 couples have been enrolled. Overall, 49/50 couples have returned their samples and completed the posttest delivery call, and 10 in-depth interviews have been completed and transcribed. CONCLUSIONS Screening MSM couples at home for chlamydia and gonorrhea and providing video-facilitated results delivery may offer a tailored approach to address the increasing prevalence of these STIs. By collecting data on how MSM couples experience at-home STI screening, this project will provide valuable insight into the utility of such a service delivery program to public health interventionists and researchers alike.

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COVID-19 Diagnostic Testing For All - Using Non-Dilutive Saliva Sample Collection, Stabilization and Ambient Transport Devices

10.1101/2021.01.20.20243782 ◽

2021 ◽

Author(s):

Yuan Carrington ◽

Justin Orlino ◽

Alejandro Romero ◽

Jessica Gustin ◽

Mahssa Rezaei ◽

...

Keyword(s):

Ambient Temperature ◽

Saliva Sample ◽

Rna Stability ◽

Test Site ◽

Viral Rna ◽

Sample Collection ◽

Saliva Collection ◽

Asymptomatic Individuals ◽

Rna Stabilization ◽

At Home

AbstractCOVID-19 testing is not accessible for millions during this pandemic despite our best efforts. Without greatly expanded testing of asymptomatic individuals, contact tracing and subsequent isolation of spreaders remains as a means for control. In an effort to increase RT-PCR assay testing for the presence of the novel beta-coronavirus SARS-CoV-2 as well as improve sample collection safety, GenTegra LLC has introduced two products for saliva collection and viral RNA stabilization: GTR-STM™ (GenTegra Saliva Transport Medium) and GTR-STMdk™ (GenTegra Saliva Transport Medium Direct to PCR). Both products contain a proprietary formulation based on GenTegra’s novel “Active Chemical Protection™” (ACP) technology that gives non-dilutive, error-free saliva sample collection using RNA stabilization chemicals already dried in the collection tube.GTR-STM can be used for safer saliva-based sample collection at home (or at a test site). Following saliva collection, the sample-containing GTR-STM can be kept at ambient temperature during shipment to an authorized CLIA lab for analysis. SARS-CoV-2 viral RNA in GTR-STM is stable for over a month at ambient temperature, easily surviving the longest transit times from home to lab. GTR-STM enhances patient comfort, convenience, compliance and reduces infectious virus exposure to essential medical and lab professionals.Alternatively, the GTR-STMdk direct-into-PCR product can be used to improve lab throughput and reduce reagent costs for saliva sample collection and testing at any lab site with access to refrigeration. GTR-STMdk reduces lab process time by 25% and reagent costs by 30% compared to other approaches. Since GTR-STMdk retains SARS-CoV-2 viral RNA stability for three days at ambient temperature, it is optimized for lab test site rather than at home saliva collection. SARS-COV-2 viral RNA levels as low as 0.4 genome equivalents/uL are detected in saliva samples using GTR-STMdk. The increased sensitivity of SARS-CoV-2 detection can expand COVID-19 testing to include asymptomatic individuals using pooled saliva.One Sentence SummaryGTR-STM and Direct-into-PCR GTR-STMdk offer substantive improvements in SARS-CoV-2 viral RNA stability, safety, and RT-PCR process efficiency for COVID-19 testing by using a non-dilutive saliva sample collection system for individuals at home or onsite respectively.

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Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and People Are Allergic to Me (PATM) Conditions: Insights From a Virtually Conducted Clinical Trial (Preprint)

10.2196/preprints.10508 ◽

2020 ◽

Author(s):

Irene S Gabashvili

Keyword(s):

Gut Microbiome ◽

Online Survey ◽

Research Quality ◽

Rank Test ◽

Symptom Improvement ◽

Skin Microbiome ◽

Body Odor ◽

Sample Collection ◽

Diagnosis And Management ◽

At Home

BACKGROUND The skin is a dynamic ecosystem of microbes and the source of many chemical compounds that affect human health. Skin-microbiome interactions can cause persistent, psychosocially devastating body smell despite good hygiene. Since odor production is often transient, malodors may not be perceptible during medical examinations. Therefore, having odor complaints can be diagnosed as body dysmorphic disorder and referred for psychological evaluations. Development of simple at-home tests and virtual care programs could improve the diagnosis and management of socially debilitating malodor conditions. OBJECTIVE The aim of this study was to assess potential effectiveness of at-home gut microbiome testing in the diagnosis and management of idiopathic body and breath odor and in people are allergic to me (PATM) syndrome. METHODS We contacted participants of prior metabolic body odor (MEBO) and PATM studies and online support groups by email or social media. Individuals who consented to participate were mailed test kits for at-home collection of gut microbiome samples. Participants completed an online survey (specially developed for this study) addressing their symptoms and other quality-of-life indicators at baseline and after sampling. Participants collected stool samples after flare-ups or symptom improvements and mailed them to the laboratory to be processed and analyzed. We evaluated between-group differences in symptom severity, as well as symptom improvement observations for the same individuals. For differential abundance testing of microbial taxa, we performed nonparametric statistical analyses using Mann-Whitney U tests for unpaired samples and Wilcoxon signed rank test for paired samples. RESULTS A total of 112 individuals from 21 countries consented to participate. About half the participants had been tested for the metabolic disorder trimethylaminuria, and about half of those tested were diagnosed with the disorder. The levels of bacteria previously associated with cutaneous body odor were significantly elevated in gut samples. For the combination of species from Anaerococcus, Corynebacterium, Campylobacter, and Propionibacterium genera, the differences were P=.002 for active (73 participants, 182 samples) versus regression or remission groups (30 participants, 51 samples); P=.01 for those experiencing symptoms most or all of the time (46 participants, 88 samples) versus those who had symptoms sometimes, rarely, or never (25 participants, 74 samples); and P<.001 for improvement of symptoms in the same individuals (22 participants, 43 sets of matched samples). Changes in microbial diversity were significant for between- but not within-participant comparisons. CONCLUSIONS Changes in the gut microbiome composition affect MEBO and PATM severity. In particular, an increase in intestinal bacteria producing odor when in skin flexures was associated with increased intensity of self-reported symptoms. The changes were consistent in the within-group and between-group analyses. Our findings support the feasibility of remote and decentralized clinical studies of malodor conditions. Supplementary sample collection procedures may help to meet established research quality standards. CLINICALTRIAL ClinicalTrials.gov NCT03582826; http://clinicaltrials.gov/ct2/show/NCT03582826 INTERNATIONAL REGISTERED REPORT RR2-10.1101/2020.08.21.20179242

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Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and People Are Allergic to Me (PATM) Conditions: Insights From a Virtually Conducted Clinical Trial

JMIR Dermatology ◽

10.2196/10508 ◽

2020 ◽

Vol 3 (1) ◽

pp. e10508

Author(s):

Irene S Gabashvili

Keyword(s):

Gut Microbiome ◽

Online Survey ◽

Research Quality ◽

Rank Test ◽

Symptom Improvement ◽

Skin Microbiome ◽

Body Odor ◽

Sample Collection ◽

Diagnosis And Management ◽

At Home

Background The skin is a dynamic ecosystem of microbes and the source of many chemical compounds that affect human health. Skin-microbiome interactions can cause persistent, psychosocially devastating body smell despite good hygiene. Since odor production is often transient, malodors may not be perceptible during medical examinations. Therefore, having odor complaints can be diagnosed as body dysmorphic disorder and referred for psychological evaluations. Development of simple at-home tests and virtual care programs could improve the diagnosis and management of socially debilitating malodor conditions. Objective The aim of this study was to assess potential effectiveness of at-home gut microbiome testing in the diagnosis and management of idiopathic body and breath odor and in people are allergic to me (PATM) syndrome. Methods We contacted participants of prior metabolic body odor (MEBO) and PATM studies and online support groups by email or social media. Individuals who consented to participate were mailed test kits for at-home collection of gut microbiome samples. Participants completed an online survey (specially developed for this study) addressing their symptoms and other quality-of-life indicators at baseline and after sampling. Participants collected stool samples after flare-ups or symptom improvements and mailed them to the laboratory to be processed and analyzed. We evaluated between-group differences in symptom severity, as well as symptom improvement observations for the same individuals. For differential abundance testing of microbial taxa, we performed nonparametric statistical analyses using Mann-Whitney U tests for unpaired samples and Wilcoxon signed rank test for paired samples. Results A total of 112 individuals from 21 countries consented to participate. About half the participants had been tested for the metabolic disorder trimethylaminuria, and about half of those tested were diagnosed with the disorder. The levels of bacteria previously associated with cutaneous body odor were significantly elevated in gut samples. For the combination of species from Anaerococcus, Corynebacterium, Campylobacter, and Propionibacterium genera, the differences were P=.002 for active (73 participants, 182 samples) versus regression or remission groups (30 participants, 51 samples); P=.01 for those experiencing symptoms most or all of the time (46 participants, 88 samples) versus those who had symptoms sometimes, rarely, or never (25 participants, 74 samples); and P<.001 for improvement of symptoms in the same individuals (22 participants, 43 sets of matched samples). Changes in microbial diversity were significant for between- but not within-participant comparisons. Conclusions Changes in the gut microbiome composition affect MEBO and PATM severity. In particular, an increase in intestinal bacteria producing odor when in skin flexures was associated with increased intensity of self-reported symptoms. The changes were consistent in the within-group and between-group analyses. Our findings support the feasibility of remote and decentralized clinical studies of malodor conditions. Supplementary sample collection procedures may help to meet established research quality standards. Trial Registration ClinicalTrials.gov NCT03582826; http://clinicaltrials.gov/ct2/show/NCT03582826 International Registered Report Identifier (IRRID) RR2-10.1101/2020.08.21.20179242

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