Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation

Introduction Successful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of the contextual and usability factors that affect test results and minimise biosafety risks. This paper presents a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes. Methods A mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was conducted to explore biosafety issues. Results The agreement analysis was conducted on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI:1.3%−98.7%) positive agreement and 96% (95% CI: 92.5%−98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857−0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%−99.6%) positive agreement and 100% (95% CI: 63.1%−100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549−1). The dry run highlighted four main sources of contamination that led to the modification of the standard operating procedures. Simulation post-modification showed no further evidence of contamination. Conclusion Careful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

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Point of Care Testing using rapid automated Antigen Testing for SARS-COV-2 in Care Homes – an exploratory safety, usability and diagnostic agreement evaluation

10.1101/2021.04.22.21255948 ◽

2021 ◽

Author(s):

Massimo Micocci ◽

Peter Buckle ◽

Gail Hayward ◽

A. Joy Allen ◽

Kerrie Davies ◽

...

Keyword(s):

Test Performance ◽

Point Of Care ◽

Care Home ◽

Immunofluorescence Assay ◽

Careful Consideration ◽

Care Homes ◽

Performance Study ◽

Mixed Methods Evaluation ◽

Point Of Care Tests ◽

Positive Agreement

AbstractIntroductionSuccessful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of contextual and usability factors that affect test results and minimise biosafety risks. This paper presents findings from a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes.MethodsA mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was carried out to explore biosafety issues.ResultsThe agreement analysis was carried out on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI: 1.3%-98.7%) positive agreement and 96% (95% CI: 92.5%-98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857-0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 100% (95% CI: 63.1%-100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549-1).The dry run showed four main sources of contamination that led to the modification of the standard operating procedures. Simulation after modification showed no further evidence of contamination.ConclusionCareful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

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Is Point-of-Care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of Point-of-Care Polymerase Chain Reaction test for SARS-COV-2

10.1101/2020.11.30.20240010 ◽

2020 ◽

Author(s):

Massimo Micocci ◽

Adam L Gordon ◽

Mikyung Kelly Seo ◽

A. Joy Allen ◽

Kerrie Davies ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

Point Of Care ◽

Care Home ◽

Care Homes ◽

Polymerase Chain Reaction Test ◽

List Type ◽

Point Of Care Testing ◽

Chain Reaction ◽

Polymerase Chain ◽

Positive Agreement

AbstractIntroductionReliable rapid testing on COVID-19 is needed in care homes to reduce the risk of outbreaks and enable timely care. Point-of-care testing (POCT) in care homes could provide rapid actionable results. This study aimed to examine the usability and test performance of point of care polymerase chain reaction (PCR) for COVID-19 in care homes.MethodsPoint-of-care PCR for detection of SARS-COV2 was evaluated in a purposeful sample of four UK care homes. Test agreement with laboratory real-time PCR and usability and use errors were assessed.ResultsPoint of care and laboratory polymerase chain reaction (PCR) tests were performed on 278 participants. The point of care and laboratory tests returned uncertain results or errors for 17 and 5 specimens respectively. Agreement analysis was conducted on 256 specimens. 175 were from staff: 162 asymptomatic; 13 symptomatic. 69 were from residents: 59 asymptomatic; 10 symptomatic. Asymptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 98.7% negative agreement (95% CI: 96.2%-99.7%), with overall prevalence and bias-adjusted kappa (PABAK) of 0.965 (95% CI: 0.932 – 0.999). Symptomatic specimens showed 100% (95% CI: 2.5%-100%) positive agreement and 100% negative agreement (95% CI: 85.8%-100%), with overall PABAK of 1. No usability-related hazards emerged from this exploratory study.ConclusionApplications of point-of-care PCR testing in care homes can be considered with appropriate preparatory steps and safeguards. Agreement between POCT and laboratory PCR was good. Further diagnostic accuracy evaluations and in-service evaluation studies should be conducted, if the test is to be implemented more widely, to build greater certainty on this initial exploratory analysis.Key pointsPoint of care tests (POCT) in care homes are feasible and could increase testing capacity for the control of COVID-19 infection.The test of agreement between POCT and laboratory PCR for care home residents and the staff was good.Adoption of POCT in care homes can be considered with appropriate preparatory steps and safeguards in place.Repetitive errors and test malfunctioning can be mitigated with bespoke training for care home staff.Integrated care pathways should be investigated to test the high variability of the context of use.

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Is Point-of-Care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a Point-of-Care Polymerase Chain Reaction test for SARS-COV-2

Age and Ageing ◽

10.1093/ageing/afab072 ◽

2021 ◽

Author(s):

Massimo Micocci ◽

Adam L Gordon ◽

Mikyung Kelly Seo ◽

A Joy Allen ◽

Kerrie Davies ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

Test Performance ◽

Point Of Care ◽

Evaluation Studies ◽

Care Homes ◽

Polymerase Chain Reaction Test ◽

Accuracy Evaluation ◽

Chain Reaction ◽

Polymerase Chain ◽

Positive Agreement

Abstract Introduction Reliable rapid testing for COVID-19 is needed in care homes to reduce the risk of outbreaks and enable timely care. This study aimed to examine the usability and test performance of a point of care polymerase chain reaction (PCR) test for detection of SARS-COV2 (POCKITTM Central) in care homes. Methods POCKITTM Central was evaluated in a purposeful sample of four UK care homes. Test agreement with laboratory real-time PCR and usability and use errors were assessed. Results No significant usability-related hazards emerged, and the sources of error identified were found to be amendable with minor changes in training or test workflow. POCKITTM Central has acceptable sensitivity and specificity based on RT-PCR as the reference standard, especially for symptomatic cases. Asymptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 98.7% negative agreement (95% CI: 96.2%-99.7%), with overall prevalence and bias-adjusted kappa (PABAK) of 0.965 (95% CI: 0.932– 0.999). Symptomatic specimens showed 100% (95% CI: 2.5%-100%) positive agreement and 100% negative agreement (95% CI: 85.8%-100%), with overall PABAK of 1. Recommendations are provided to mitigate the frequency of occurrence of the residual use errors observed. Integration pathways were discussed to identify opportunities and limitations of adopting POCKIT™ Central for screening and diagnostic testing purposes. Conclusion Point-of-care PCR testing in care homes can be considered with appropriate preparatory steps and safeguards. Further diagnostic accuracy evaluations and in-service evaluation studies should be conducted, if the test is to be implemented more widely, to build greater certainty on this initial exploratory analysis.

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COVID-19 testing in English care homes and implications for staff and residents

Age and Ageing ◽

10.1093/ageing/afab015 ◽

2021 ◽

Author(s):

Massimo Micocci ◽

Adam L Gordon ◽

A Joy Allen ◽

Timothy Hicks ◽

Patrick Kierkegaard ◽

...

Keyword(s):

Infection Prevention ◽

Point Of Care ◽

Care Home ◽

Care Homes ◽

Framework Analysis ◽

Current Testing ◽

Test Management ◽

Point Of Care Tests ◽

Staff Resource

Abstract Introduction Care home residents are at high risk of dying from coronavirus disease 2019 (COVID-19). Regular testing, producing rapid and reliable results is important in this population because infections spread quickly, and presentations are often atypical or asymptomatic. This study evaluated current testing pathways in care homes to explore the role of point-of-care tests (POCTs). Methods A total of 10 staff from eight care homes, purposively sampled to reflect care organisational attributes that influence outbreak severity, underwent a semi-structured remote videoconference interview. Transcripts were analysed using process mapping tools and framework analysis focussing on perceptions about, gaps within and needs arising from current pathways. Results Four main steps were identified in testing: infection prevention, preparatory steps, swabbing procedure and management of residents. Infection prevention was particularly challenging for mobile residents with cognitive impairment. Swabbing and preparatory steps were resource-intensive, requiring additional staff resource. Swabbing required flexibility and staff who were familiar to the resident. Frequent approaches to residents were needed to ensure they would participate at a suitable time. After-test management varied between sites. Several homes reported deviating from government guidance to take more cautious approaches, which they perceived to be more robust. Conclusion Swab-based testing is organisationally complex and resource-intensive in care homes. It needs to be flexible to meet the needs of residents and provide care homes with rapid information to support care decisions. POCT could help address gaps but the complexity of the setting means that each technology must be evaluated in context before widespread adoption in care homes.

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Comparison of Four Commercially Available Point-of-Care Tests to Detect Antibodies against Canine Parvovirus in Dogs

Viruses ◽

10.3390/v13010018 ◽

2020 ◽

Vol 13 (1) ◽

pp. 18

Author(s):

Michèle Bergmann ◽

Mike Holzheu ◽

Yury Zablotski ◽

Stephanie Speck ◽

Uwe Truyen ◽

...

Keyword(s):

Test Performance ◽

Point Of Care ◽

Reference Method ◽

Canine Parvovirus ◽

P Value ◽

Important Indicator ◽

Specificity And Sensitivity ◽

Specific Pathogen ◽

The One ◽

Point Of Care Tests

Measuring antibodies to evaluate dogs´ immunity against canine parvovirus (CPV) is useful to avoid unnecessary re-vaccinations. The study aimed to evaluate the quality and practicability of four point-of-care (POC) tests for detection of anti-CPV antibodies. The sera of 198 client-owned and 43 specific pathogen-free (SPF) dogs were included; virus neutralization was the reference method. Specificity, sensitivity, positive and negative predictive value (PPV and NPV), and overall accuracy (OA) were calculated. Specificity was considered to be the most important indicator for POC test performance. Differences between specificity and sensitivity of POC tests in the sera of all dogs were determined by McNemar, agreement by Cohen´s kappa. Prevalence of anti-CPV antibodies in all dogs was 80% (192/241); in the subgroup of client-owned dogs, it was 97% (192/198); and in the subgroup of SPF dogs, it was 0% (0/43). FASTest® and CanTiCheck® were easiest to perform. Specificity was highest in the CanTiCheck® (overall dogs, 98%; client-owned dogs, 83%; SPF dogs, 100%) and the TiterCHEK® (overall dogs, 96%; client-owned dogs, 67%; SPF dogs, 100%); no significant differences in specificity were observed between the ImmunoComb®, the TiterCHEK®, and the CanTiCheck®. Sensitivity was highest in the FASTest® (overall dogs, 95%; client-owned dogs, 95%) and the CanTiCheck® (overall dogs, 80%; client-owned dogs, 80%); sensitivity of the FASTest® was significantly higher compared to the one of the other three tests (McNemars p-value in each comparison: <0.001). CanTiCheck® would be the POC test of choice when considering specificity and practicability. However, differences in the number of false positive results between CanTiCheck®, TiterCHEK®, and ImmunoComb® were minimal.

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Risk of bias and limits of reporting in diagnostic accuracy studies for commercial point-of-care tests for respiratory pathogens

Epidemiology and Infection ◽

10.1017/s0950268818000596 ◽

2018 ◽

Vol 146 (6) ◽

pp. 747-756

Author(s):

J.M. Hughes ◽

C. Penney ◽

S. Boyd ◽

P. Daley

Keyword(s):

Diagnostic Accuracy ◽

Test Performance ◽

Point Of Care ◽

Risk Of Bias ◽

Financial Impact ◽

Test Accuracy ◽

Respiratory Pathogens ◽

Study Results ◽

Group A ◽

Point Of Care Tests

AbstractCommercial point-of-care (POC) diagnostic tests for Group A Streptococcus, Streptococcus pneumoniae, and influenza virus have large potential diagnostic and financial impact. Many published reports on test performance, often funded by diagnostics companies, are prone to bias. The Standards for Reporting of Diagnostic Accuracy (STARD 2015) are a protocol to encourage accurate, transparent reporting. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool evaluates risk of bias and transportability of results. We used these tools to evaluate diagnostic test accuracy studies of POC studies for three respiratory pathogens. For the 96 studies analysed, compliance was <25% for 14/34 STARD 2015 standards, and 3/7 QUADAS-2 domains showed a high risk of bias. All reports lacked reporting of at least one criterion. These biases should be considered in the interpretation of study results.

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Understanding COVID-19 testing pathways in English care homes to identify the role of point-of-care testing: an interview-based process mapping study

10.1101/2020.11.02.20224550 ◽

2020 ◽

Author(s):

Massimo Micocci ◽

Adam L Gordon ◽

A. Joy Allen ◽

Timothy Hicks ◽

Patrick Kierkegaard ◽

...

Keyword(s):

Infection Prevention ◽

Point Of Care ◽

Care Home ◽

Care Homes ◽

List Type ◽

Process Mapping ◽

Point Of Care Testing ◽

Testing Procedures ◽

People With Dementia

AbstractIntroductionCare home residents are at high risk of dying from COVID-19. Regular testing producing rapid and reliable results is important in this population because infections spread quickly and presentations are often atypical or asymptomatic. This study evaluated current testing pathways in care homes to explore the role of point-of-care tests (POCTs).MethodsTen staff from eight care homes, purposively sampled to reflect care organisational attributes that influence outbreak severity, underwent a semi-structured remote videoconference interview. Transcripts were analysed using process mapping tools and framework analysis focussing on perceptions about, gaps within, and needs arising from, current pathways.ResultsFour main steps were identified in testing: infection prevention, preparatory steps, swabbing procedure, and management of residents. Infection prevention was particularly challenging for mobile residents with cognitive impairment. Swabbing and preparatory steps were resource-intensive, requiring additional staff resource. Swabbing required flexibility and staff who were familiar to the resident. Frequent approaches to residents were needed to ensure they would participate at a suitable time. After-test management varied between sites. Several homes reported deviating from government guidance to take more cautious approaches, which they perceived to be more robust.ConclusionSwab-based testing is organisationally complex and resource-intensive in care homes. It needs to be flexible to meet the needs of residents and provide care homes with rapid information to support care decisions. POCT could help address gaps but the complexity of the setting means that each technology must be evaluated in context before widespread adoption in care homes.Key-pointsTesting for COVID-19 in care homes is complex and requires reconfiguration of staffing and environment.Isolation and testing procedures are challenged when providing person-centred care to people with dementia.Point-of-care testing results could give care homes greater flexibility to test in person-centred ways.There was evidence that care home staff interpret testing guidance, rather than follow it verbatim.Each POCT must be evaluated in the context of care homes to understand its effect on care home processes.

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Point-of-care tests for bovine clinical mastitis: what do we have and what do we need?

Journal of Dairy Research ◽

10.1017/s002202992000062x ◽

2020 ◽

Vol 87 (S1) ◽

pp. 60-66

Author(s):

Francisco B. Malcata ◽

P. Theo Pepler ◽

Emily L. O'Reilly ◽

Nicola Brady ◽

P. David Eckersall ◽

...

Keyword(s):

Test Performance ◽

Point Of Care ◽

Clinical Mastitis ◽

Antimicrobial Use ◽

Culture Independent ◽

Improved Performance ◽

Point Of Care Tests ◽

On Farm ◽

Mastitis Control

AbstractMastitis, inflammation of the bovine mammary gland, is generally caused by intramammary infection with bacteria, and antimicrobials have long been a corner stone of mastitis control. As societal concern about antimicrobial use in animal agriculture grows, there is pressure to reduce antimicrobial use in dairy farming. Point-of-care tests for on-farm use are increasingly available as tools to support this. In this Research Reflection, we consider available culture-dependent and culture-independent tests in the context of ASSURED criteria for low-resource settings, including convenience criteria, scientific criteria and societal criteria that can be used to evaluate test performance. As tests become more sophisticated and sensitive, we may be generating more data than we need. Special attention is given to the relationship between test outcomes and treatment decisions, including issues of diagnostic refinement, antimicrobial susceptibility testing, and detection of viable organisms. In addition, we explore the role of technology, big data and people in improved performance and uptake of point-of-care tests, recognising that societal barriers may limit uptake of available or future tests. Finally, we propose that the 3Rs of reduction, refinement and replacement, which have been used in an animal welfare context for many years, could be applied to antimicrobial use for mastitis control on dairy farms.

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Epidemiological analysis of 3,219 COVID-19 outbreaks in the state of Baden-Wuerttemberg, Germany

Epidemiology and Infection ◽

10.1017/s0950268821000911 ◽

2021 ◽

Vol 149 ◽

Author(s):

Aparna Dressler ◽

Iris Finci ◽

Christiane Wagner-Wiening ◽

Martin Eichner ◽

Stefan O Brockmann

Keyword(s):

Point Of Care ◽

Care Home ◽

Median Number ◽

Supported Housing ◽

The State ◽

Care Homes ◽

Mortality Trends ◽

Staff Members ◽

Exponential Increase ◽

Care Facilities

Abstract The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has emerged as an unprecedented global crisis challenging health systems. This paper aims to assess and characterise SARS-CoV-2 outbreaks in the state of Baden-Wuerttemberg to identify groups at greatest risk, to establish early measures to curb transmission. We analysed all mandatory notified (i.e. laboratory-confirmed) coronavirus disease (COVID-19) outbreaks with more than two cases in Baden-Wuerttemberg from calendar weeks 18–49 (from 27 April to 6 December 2020). We used the following classification for settings: asylum and refugee accommodation, care homes, care facilities, day care child centres, hobby-related, hospitality, hospitals, households, other, residence halls, schools, supported housing, training schools, transportation, treatment facilities and workplace (occupational). We used R program version 3.6.3 for analysis. In our analysis, 3219 outbreaks with 22 238 individuals were included. About 48% were in household and hobby-related settings. Care homes accounted for 9.5% of outbreaks and 21.6% of cases. The median age across all settings was 43 (interquartile range (IQR) 24–63). The median age of cases in care homes was 81 (IQR 56–88). Of all reported cases in care homes, 72.1% were women. Over 30% (466/1511) of hospitalisations were among cases in care homes compared to 17.7% (268/1511) in households. Overall, 70% (500/715) of all deceased persons in outbreaks in the study period were in care homes compared to 4.2% in household settings (30/715). We observed an exponential increase in the number of notified outbreaks starting around the 41st week with N = 291 outbreaks reported in week 49. The median number of cases in outbreaks in care homes and care facilities after the 40th week was 14 (IQR 5–29) and 11 (IQR 5–20), respectively, compared to 3 (IQR 3–5) in households. We observed an increase in hospitalisations, and mortality associated with COVID-19 outbreaks in care homes after the 40th week. We found the care home demographic to be at greatest risk after the 40th week, based on the exponential increase in outbreaks, the number of cases, hospitalisations and mortality trends. Our analysis highlights the necessity of targeted, setting-specific approaches to control transmission in this vulnerable population. Regular screening of staff members and visitors' using rapid antigen point-of-care-tests could be a game-changer in curbing transmission in this setting.

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Potential for Point-of-Care Tests to Reduce Chlamydia-associated Burden in the United States: A Mathematical Modeling Analysis

Clinical Infectious Diseases ◽

10.1093/cid/ciz519 ◽

2019 ◽

Vol 70 (9) ◽

pp. 1816-1823 ◽

Cited By ~ 2

Author(s):

Minttu M Rönn ◽

Nicolas A Menzies ◽

Thomas L Gift ◽

Harrell W Chesson ◽

Tom A Trikalinos ◽

...

Keyword(s):

United States ◽

Test Performance ◽

Point Of Care ◽

Credible Interval ◽

The United States ◽

Treatment Delay ◽

Transmission Model ◽

Screening Coverage ◽

Point Of Care Tests ◽

The Impact

Abstract Background Point-of-care testing (POCT) assays for chlamydia are being developed. Their potential impact on the burden of chlamydial infection in the United States, in light of suboptimal screening coverage, remains unclear. Methods Using a transmission model calibrated to data in the United States, we estimated the impact of POCT on chlamydia prevalence, incidence, and chlamydia-attributable pelvic inflammatory disease (PID) incidence, assuming status quo (Analysis 1) and improved (Analysis 2) screening frequencies. We tested the robustness of results to changes in POCT sensitivity, the proportion of patients getting treated immediately, the baseline proportion lost to follow-up (LTFU), and the average treatment delay. Results In Analysis 1, high POCT sensitivity was needed to reduce the chlamydia-associated burden. With a POCT sensitivity of 90%, reductions from the baseline burden only occurred in scenarios in which over 60% of the screened individuals would get immediate treatment and the baseline LTFU proportion was 20%. With a POCT sensitivity of 99% (baseline LTFU 10%, 2-week treatment delay), if everyone were treated immediately, the prevalence reduction was estimated at 5.7% (95% credible interval [CrI] 3.9–8.2%). If only 30% of tested persons would wait for results, the prevalence reduction was only 1.6% (95% CrI 1.1–2.3). POCT with 99% sensitivity could avert up to 12 700 (95% CrI 5000–22 200) PID cases per year, if 100% were treated immediately (baseline LTFU 20% and 3-week treatment delay). In Analysis 2, when POCT was coupled with increasing screening coverage, reductions in the chlamydia burden could be realized with a POCT sensitivity of 90%. Conclusions POCT could improve chlamydia prevention efforts if test performance characteristics are significantly improved over currently available options.

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