A decentralised point-of-care testing model to address inequities in the COVID-19 response.
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ABSTRACT:
SUBMITTER: Hengel B
PROVIDER: S-EPMC7758179 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Serological tests play an important role in the fight against Coronavirus Disease 2019 (COVID-19), including monitoring the dynamic immune response after vaccination, identifying past infection and determining community infection rate. Conventional methods for serological testing, such as enzyme-linked immunosorbent assays and chemiluminescence immunoassays, provide reliable and sensitive antibody detection but require sophisticated laboratory infrastructure and/or lengthy assay time. Conversely, lateral flow immunoassays are suitable for rapid point-of-care tests but have limited sensitivity. Here, we describe the development of a rapid and sensitive magnetofluidic immuno-PCR platform that can address the current gap in point-of-care serological testing for COVID-19. Our magnetofluidic immuno-PCR platform automates a magnetic bead-based, single-binding, and one-wash immuno-PCR assay in a palm-sized magnetofluidic device and delivers results in ∼30 min. In the device, a programmable magnetic arm attracts and transports magnetically-captured antibodies through assay reagents pre-loaded in a companion plastic cartridge, and a miniaturized thermocycler and a fluorescence detector perform immuno-PCR to detect the antibodies. We evaluated our magnetofluidic immuno-PCR with 108 clinical serum/plasma samples and achieved 93.8% (45/48) sensitivity and 98.3% (59/60) specificity, demonstrating its potential as a rapid and sensitive point-of-care serological test for COVID-19.
| S-EPMC8458161 | biostudies-literature
Project description: Not available
| S-EPMC9056993 | biostudies-literature
Project description:ObjectivesRisk of hospital-acquired COVID-19 (HA-COVID-19) infection is increased by cohorting infected and non-infected patients together in assessment areas, whist awaiting laboratory PCR results. Molecular point-of-care tests (mPOCT) reduce time to results and improve patient flow but the impact on HA-COVID-19 is unknown.MethodsIn this pre and post implementation study patients were evaluated across two time periods: March 1st to August 13th 2020, prior to the introduction of mPOCT in medical admissions areas, and 14th August 2020 to 1st April 2021, after mPOCT introduction. The primary outcome was proportion of HA-COVID-19 infection among all COVID-19 positive patients. Secondary outcome measures included time to SARS-CoV-2 results, length of time spent in the medical assessment area and comparison of local, regional and national proportions of HA-COVID-19.Results1988 patients were admitted through the acute medicine admission cohorting area and tested for SARS-CoV-2 prior to introducing mPOCT and 4640 afterwards. Median (IQR) time to SARS-CoV-2 result was 6.5 (2.1-17.9) hours prior to introducing mPOCT and 1.0 (0.8-1.3) hours afterwards (p < 0.0001). Median (IQR) duration in the assessment cohort area was 12.0 (4.8-20.6) hours prior to introduction of POCT and 3.2 (2.0-5.6) hours afterwards (p < 0.0001). The proportion of hospital-acquired COVID-19 cases was 108 (16.5%) of 654 prior to introducing mPOCT compared with 168 (9.4%) of 1782 afterwards, (HR 0.55, 95%CI 0.43-0.70; p < 0.0001). In the period following the introduction of mPOCT up to 1st April 2021 the median proportion of HA-COVID-19 was 13.6% (95%CI 8.2-18.9%) locally, compared with 43.8% (95%CI 37.8-49.9%) for all acute NHS trusts regionally and 30.9% (95%CI 28.4-33.5%) for all NHS trusts nationally.ConclusionsRoutine mPOCT for SARS-CoV-2 was associated with reduced time to results, time spent in admission cohort areas, and hospital-acquired COVID-19, compared to laboratory PCR.
| S-EPMC8802147 | biostudies-literature
Project description:ObjectivesThe Abbot ID NOW COVID-19 assay and Quidel Sofia 2 SARS Antigen FIA are point-of-care assays that offer rapid testing for severe acute respiratory syndrome coronavirus 2 viral RNA and nucleocapsid protein, respectively. Given the utility of these devices in the field, we investigated the feasibility and safety of using the ID NOW and Sofia assays in the public health response to the coronavirus disease 2019 pandemic and in future public health emergencies.MethodsA combination of utilization and contamination testing in addition to a review of instrument workflows was conducted.ResultsUtilization testing demonstrated that both tests are intuitive, associated with high user test success (85%) in our study, and could be implemented by staff after minimal training. Contamination tests revealed potential biosafety concerns due to the open design of the ID NOW instrument and the transfer mechanisms with the Sofia. When comparing the workflow of the ID NOW and the Sofia, we found that the ID NOW was more user-friendly and that the transfer technology reduces the chance of contamination.ConclusionsThe ID NOW, Sofia, and other emerging point-of-care tests should be used only after careful consideration of testing workflow, biosafety risk mitigations, and appropriate staff training.
| S-EPMC8336596 | biostudies-literature
Project description:Testing for SARS-CoV-2 infection has been a key strategy to mitigate and control the COVID-19 pandemic. Wide spatial and racial/ethnic disparities in COVID-19 outcomes have emerged in US cities. Previous research has highlighted the role of unequal access to testing as a potential driver of these disparities. We described inequities in spatial accessibility to COVID-19 testing locations in 30 large US cities. We used location data from Castlight Health Inc corresponding to October 2021. We created an accessibility metric at the level of the census block group (CBG) based on the number of sites per population in a 15-minute walkshed around the centroid of each CBG. We also calculated spatial accessibility using only testing sites without restrictions, i.e., no requirement for an appointment or a physician order prior to testing. We measured the association between the social vulnerability index (SVI) and spatial accessibility using a multilevel negative binomial model with random city intercepts and random SVI slopes. Among the 27,195 CBG analyzed, 53% had at least one testing site within a 15-minute walkshed, and 36% had at least one site without restrictions. On average, a 1-decile increase in the SVI was associated with a 3% (95% Confidence Interval: 2% - 4%) lower accessibility. Spatial inequities were similar across various components of the SVI and for sites with no restrictions. Despite this general pattern, several cities had inverted inequity, i.e., better accessibility in more vulnerable areas, which indicates that some cities may be on the right track when it comes to promoting equity in COVID-19 testing. Testing is a key component of the strategy to mitigate transmission of SARS-CoV-2 and efforts should be made to improve accessibility to testing, particularly as new and more contagious variants become dominant.
| S-EPMC9420026 | biostudies-literature
Project description:IntroductionRT-PCR has suboptimal sensitivity for the diagnosis of COVID-19. A composite reference standard comprising RT-PCR plus radiological and clinical features has been recommended for diagnostic accuracy studies. The FebriDx finger prick point-of-care test detects an antiviral host response protein (MxA) in 10 min. We evaluated the diagnostic accuracy of FebriDx and RT-PCR compared to a composite reference standard.MethodsAdults presenting to hospital with suspected COVID-19 were tested by FebriDx and RT-PCR. A composite reference standard was used to classify patients as having COVID-19 based on RT-PCR positivity, or RT-PCR negativity with COVID-19 radiological findings or other clinical criteria. Measures of accuracy were calculated for MxA alone, RT-PCR alone, and both combined. This study is registered with the ISRCTN (ISRCTN14966673) and has completed.ResultsA total of 478 patients were tested, with valid results in 475. Of these 475 patients, 222 (46.7%) were classified as having COVID-19; 192 (40.4%) were RT-PCR positive, and 30 (6.3%) were RT-PCR negative and diagnosed on radiological/clinical criteria. Sensitivity of FebriDx MxA vs the composite reference standard was 186/222 (83.8%, 95% CI 78.3-88.4) and was similar to the sensitivity of RT-PCR (192/222 (86.5%, 95% CI 81.3-90.7), (difference of 2.7%, 95% CI - 3.9 to 9.3, p = 0.42). The sensitivity of combined FebriDx and RT-PCR was 208/222 (93.7%) which was superior to both RT-PCR alone (difference of 9.9, 95% CI 4.1-15.9; p = 0.001) and FebriDx MxA alone (difference of 7.2, 95% CI 1.6-12.9; p = 0.011).ConclusionSensitivity of combined FebriDx and RT-PCR testing was superior to each alone for the detection of COVID-19 in hospital and may improve infection control and treatment decisions.
| S-EPMC9083481 | biostudies-literature
Project description:PurposeHealthcare workers have experienced high levels of anxiety during the COVID-19 pandemic, particularly when caring for patients with unknown infection status. We trialled rapid preoperative point-of-care COVID-19 testing using the Abbott ID NOW™ COVID-19 for clinical validation in an urgent surgical population at a single centre in British Columbia, Canada. Here, we sought to determine the opinions and beliefs of operating room (OR) staff on the usefulness and effectiveness of point-of-care tests on workflow and wellbeing in the OR.MethodsThis descriptive study used a mixed-methods cross-sectional survey of all OR staff (nurses, anesthesiologists, surgeons, and ancillary staff) at a single centre after using the ID NOW for three months. Outcomes of interest included healthcare worker satisfaction with the ID NOW, effects on OR workflow, and worries about COVID-19 transmission.ResultsThe overall response rate was 56% (n = 133), and was highest among anesthesiologists (100%, n = 38). Respondents were satisfied with the performance of the ID NOW for rapid COVID-19 testing in preoperative patients, giving it a mean (standard deviation [SD]) rate of 4.4 [1.4] on a five-point scale. Most (115/128, 90%) recommended continued use of the ID NOW on asymptomatic patients while there are active cases of COVID-19 in the community. Respondents felt that preoperative COVID-19 testing with the ID NOW made the OR safer for staff (mean [SD] rate, 4.2 [0.8]) and patients (mean [SD] rate, 4.0 [0.9]).ConclusionDuring the COVID-19 pandemic, it is important to maintain the physical and mental wellbeing of hospital staff. Rapid point-of-care testing increased the sense of workplace safety, improved morale, and reduced worry associated with COVID-19 without excessive disruption of OR workflow.
| S-EPMC8296831 | biostudies-literature
Project description:BackgroundThe aim of RApid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) is to assess the diagnostic accuracy of multiple current and emerging point-of-care tests (POCTs) for active and past SARS-CoV2 infection in the community setting. RAPTOR-C19 will provide the community testbed to the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR).MethodsRAPTOR-C19 incorporates a series of prospective observational parallel diagnostic accuracy studies of SARS-CoV2 POCTs against laboratory and composite reference standards in patients with suspected current or past SARS-CoV2 infection attending community settings. Adults and children with suspected current SARS-CoV2 infection who are having an oropharyngeal/nasopharyngeal (OP/NP) swab for laboratory SARS-CoV2 reverse transcriptase Digital/Real-Time Polymerase Chain Reaction (d/rRT-PCR) as part of clinical care or community-based testing will be invited to participate. Adults (≥ 16 years) with suspected past symptomatic infection will also be recruited. Asymptomatic individuals will not be eligible. At the baseline visit, all participants will be asked to submit samples for at least one candidate point-of-care test (POCT) being evaluated (index test/s) as well as an OP/NP swab for laboratory SARS-CoV2 RT-PCR performed by Public Health England (PHE) (reference standard for current infection). Adults will also be asked for a blood sample for laboratory SARS-CoV-2 antibody testing by PHE (reference standard for past infection), where feasible adults will be invited to attend a second visit at 28 days for repeat antibody testing. Additional study data (e.g. demographics, symptoms, observations, household contacts) will be captured electronically. Sensitivity, specificity, positive, and negative predictive values for each POCT will be calculated with exact 95% confidence intervals when compared to the reference standard. POCTs will also be compared to composite reference standards constructed using paired antibody test results, patient reported outcomes, linked electronic health records for outcomes related to COVID-19 such as hospitalisation or death, and other test results.DiscussionHigh-performing POCTs for community use could be transformational. Real-time results could lead to personal and public health impacts such as reducing onward household transmission of SARS-CoV2 infection, improving surveillance of health and social care staff, contributing to accurate prevalence estimates, and understanding of SARS-CoV2 transmission dynamics in the population. In contrast, poorly performing POCTs could have negative effects, so it is necessary to undertake community-based diagnostic accuracy evaluations before rolling these out.Trial registrationISRCTN, ISRCTN14226970.
| S-EPMC7868893 | biostudies-literature
Project description:Rationale & objectiveA number of serologic tests for immunoglobulin G (IgG) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are now commercially available, including multiple lateral flow immunoassays (LFIAs), which have the advantage of being inexpensive and easy to use, without the reliance on laboratory facilities. However, data on the development of humoral immunity to SARS-CoV-2 in patients with kidney disease is limited, and the utility of an LFIA to test for antibodies in these patients has not been assessed.Study designObservational study.Setting & participants60 patients (40 hemodialysis and 20 kidney transplant recipients) with SARS-CoV-2 infection confirmed by viral reverse transcriptase-polymerase chain reaction (RT-PCR) testing and 88 historic negative-control samples (collected before September 2019).TestA commercially available LFIA to test for SARS-CoV-2 IgG in patients with infection confirmed by viral RT-PCR testing.OutcomesSensitivity and specificity of the LFIA to detect SARS-CoV-2 IgG in dialysis patients and transplant recipients.Results56/58 (96.6%) patients (38/39 hemodialysis and 18/19 transplant recipients) tested positive for SARS-CoV-2 IgG. 5/7 (71.4%) patients who were negative on preliminary testing had detectable IgG when retested more than 21 days postdiagnosis. Median times to first and second tests after diagnosis were 17 (interquartile range, 15-20) and 35 (interquartile range, 30-39) days, respectively. Calculation of test characteristics gave sensitivity of 96.6% (95% CI, 88.3%-99.4%) and specificity of 97.7% (95% CI, 92.0-99.6%).LimitationsPossible exposure to other beta-coronaviruses that may cross-react with the antigen used in the LFIA cannot be excluded.ConclusionsSymptomatic dialysis patients and transplant recipients commonly develop an immune response against SARS-CoV-2 infection that can be detected using an LFIA. Used diligently, an LFIA could be used to help screen the dialysis populations or confirm exposure on a patient level, especially in facilities in which laboratory resources are limited.
| S-EPMC7834810 | biostudies-literature
Project description:ObjectiveThere is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests (POCTs) and (2) examine the implications of these findings on real-world settings.DesignWe used a content analysis methodology in two stages to systematically, code and analyse textual data from documents of commercial manufacturers. A deductive approach was applied using a coding guide based on the validated Point-of-Care Key Evidence Tool (POCKET) multidimensional checklist. An inductive approach was used to identify new patterns or themes generated from our textual analysis.SettingPublicly available supportive information documents by commercial manufacturers for lateral flow serology, were identified and gathered from online searches.ParticipantsSupportive information documents retrieved from online searches over 3 months (March 2020 to June 2020).ResultsA total of 79 POCTs were identified that met the study inclusion criteria. Using the POCKET coding guide, we found that the quality of information varied significantly between the manufacturers and was often lacking in detail. Our inductive approach further examined these topics and found that several statements were vague and that significant variations in the level of details existed between manufacturers.ConclusionsThis study revealed significant concerns surrounding the supportive information reported by manufacturers for lateral flow serology assays. Information transparency was poor and human factor issues were not properly addressed to mitigate the risk of improper device use, although it should be noted that the results of our study are limited by the data that manufactures were prepared to disclose. Overall, commercial manufacturers should improve the quality and value of information presented in their supporting documentation.
| S-EPMC7985936 | biostudies-literature