scholarly journals 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

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.

scholarly journals 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

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.

scholarly journals Cost Consequences for the NHS of Using a Two-Step Testing Method for the Detection of Clostridium difficile with a Point of Care, Polymerase Chain Reaction Test as the First Step

Diagnostics ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. 819
Author(s):  
William S. Jones ◽  
Stephen Rice ◽  
H. Michael Power ◽  
Gregory Maniatopoulos ◽  
Jana Suklan ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Polymerase Chain Reaction ◽  
Clostridium Difficile ◽  
Point Of Care ◽  
Cost Savings ◽  
Polymerase Chain Reaction Test ◽  
Testing Strategy ◽  
Healthcare Associated Infection ◽  
Chain Reaction ◽  
Polymerase Chain

Clostridium difficile infection (CDI) is a common healthcare-associated infection. Current practice for diagnosing CDI in the Newcastle upon Tyne Hospitals NHS Foundation Trust involves a three-step, laboratory testing strategy using glutamate dehydrogenase (GDH) enzyme immunoassay (EIA), followed by a polymerase chain reaction (PCR) test then a toxin EIA. However, a PCR point of care test (POCT) for the C. difficile tcdB gene for screening suspected CDI cases, may provide a more efficient way of facilitating an equally effective, two-step, testing strategy with a toxin EIA. This study evaluated the cost consequences of changing from the three-step to a two-step testing strategy. A cost-consequences model was developed to compare the costs and consequences of the two strategies. Uncertainties in the model inputs were investigated with one- and two-way sensitivity analysis. The two-step, POCT strategy was estimated to save £283,282 per 1000 hospitalized NHS patients with suspected infectious diarrhea. Sensitivity analysis indicated that the turnaround time for the POCT was the largest driver for cost savings. Providing the POCT has sufficiently high diagnostic accuracy for detecting C. difficile, the two-step, POCT strategy for CDI identification is likely to be cost saving for NHS hospitals with an offsite laboratory.

scholarly journals Deploying a rapid point of care polymerase chain reaction test for SARS-CoV-2 in a clinical research unit to ensure healthy volunteer safety

Bioanalysis ◽  
2021 ◽  
Author(s):  
Radboud van Trigt ◽  
Jason Neat ◽  
Jan Leendert Brouwer ◽  
Amanda Hays ◽  
Hans Westerhof
Keyword(s):  
Polymerase Chain Reaction ◽  
Healthy Volunteer ◽  
Clinical Research ◽  
Early Phase ◽  
Point Of Care ◽  
Polymerase Chain Reaction Test ◽  
Chain Reaction ◽  
Reaction Test ◽  
Polymerase Chain ◽  
Chain Reaction Test

The entire world was severely affected by the outbreak of the SARS-CoV-2 virus. Early phase clinical research was no exception and clinical healthy volunteer trials were halted across the globe. To enable continuation of development of new drugs, we developed a testing strategy for nonsymptomatic trial participants in an early stage of the outbreak. A point-of-care polymerase chain reaction test combined with a gold standard polymerase chain reaction test and strict social distancing and hygiene measures limited the number of infected subjects entering our clinical research units and reduced further spread for the duration of the clinical trial. Thus, proving efficacy of this strategy to allow safe and effective continuation of early phase clinical trials during the COVID-19 pandemic.

scholarly journals EXPRESS: Clinical performance of the Elecsys® Anti-SARS-CoV-2 combined in an algorithm with two specific anti-IgG immunoassays for the evaluation of the serological response of patients with COVID-19 in a population with a high prevalence of infection

2021 ◽  
pp. 000456322110380
Author(s):  
Xavier Gabaldó-Barrios ◽  
Simona Iftimie ◽  
Anna Hernández-Aguilera ◽  
Isabel Pujol ◽  
Frederic Ballester ◽  
...  
Keyword(s):  
Immune Response ◽  
Polymerase Chain Reaction ◽  
Predictive Value ◽  
Clinical Performance ◽  
Polymerase Chain Reaction Test ◽  
Serological Response ◽  
Chain Reaction ◽  
Automated Assay ◽  
High Prevalence ◽  
Polymerase Chain

Background: Anti-SARS-CoV-2 antibodies have been used in the study of the immune response in infected patients. However, differences in sensitivity and specificity have been reported, depending on the method of analysis. The aim of the present study was to evaluate the diagnostic accuracy of an algorithm in which a high-throughput automated assay for total antibodies was used for screening and two semi-automated IgG-specific methods were used to confirm the results, and also to correlate the analytical results with the clinical data and the time elapsed since infection. Methods: We studied 306 patients, some hospitalized and some outpatients, belonging to a population with a high prevalence of COVID-19. One-hundred and ten patients were classified as SARS-CoV-2 negative and 196 as positive by polymerase chain reaction. Results: The algorithm and automated assay alone had a specificity and a positive predictive value of 100%, although the sensitivity and negative predictive value of the algorithm was higher. Both methods showed a good sensitivity from day 11 of the onset of symptoms in asymptomatic and symptomatic patients. The absorbance of the total antibodies was significantly higher in severely symptomatic than in asymptomatic or mildly symptomatic patients, which suggests the antibody level was higher. We found 15 patients that did not present seroconversion at 12 days from the onset of symptoms or the first polymerase chain reaction test. Conclusion: This study highlights the proper functioning of algorithms in the diagnosis of the immune response to COVID-19, which can help to define testing strategies against this disease.

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