scholarly journals Assessing the performance of a serological point-of-care test in measuring detectable antibodies against SARS-CoV-2

2021 ◽  
Author(s):  
Peter V. Coyle ◽  
Reham Awni El Kahlout ◽  
Soha R. Dargham ◽  
Hiam Chemaitelly ◽  
Mohamed Ali Ben Hadj Kacem ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Point Of Care ◽  
Rapid Test ◽  
Antibody Test ◽  
Serological Testing ◽  
Cohen’S Kappa ◽  
The Public ◽  
Point Of Care Test ◽  
Cohen's Kappa ◽  
Antibody Titers

AbstractObjectiveTo investigate the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay.MethodsSerological testing was conducted on 708 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity.ResultsSARS-CoV-2 seroprevalence was 63.4% (449/708; 95% CI 59.8%-66.9%) using the BioMedomics assay and 71.9% (509/708; 95% CI 68.5%-75.1%) using the Elecsys assay. There were 62 discordant results between the two assays. One specimen was seropositive in the BioMedomics assay, but seronegative in the Elecsys assay, while 61 specimens were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Positive, negative, and overall percent agreements between the two assays were 88.0% (95% CI 84.9%-90.6%), 99.5% (95% CI 97.2%-99.9%), and 91.2% (95% CI 88.9%-93.1%), respectively, with a Cohen’s kappa of 0.80 (95% CI 0.77-0.83), indicating excellent agreement. Excluding specimens with lower antibody titers, the agreement improved with positive, negative, and overall percent concordance of 91.2% (95% CI 88.2%-93.6%), 99.5% (95% CI 97.2%-99.9%), and 93.9% (95% CI 91.7%-95.5%), respectively, and a Cohen’s kappa of 0.87 (95% CI 0.84-0.89). Logistic regression confirmed better agreement with higher antibody titers.ConclusionThe BioMedomics COVID-19 IgM/IgG Rapid Test demonstrated excellent performance in measuring detectable antibodies against SARS-CoV-2, supporting the utility of such rapid point-of-care serological testing to guide the public health responses and possible vaccine prioritization.

Testing for resistance: Point-of-care testing as a communicational tool in antibiotic prescribing

2018 ◽  
Vol 14 (3) ◽  
pp. 229-240
Author(s):  
Johanna Lindell
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
Antibiotic Use ◽  
Treatment Recommendation ◽  
Antibiotic Prescribing ◽  
Communicative Practices ◽  
Effective Strategies ◽  
Reactive Protein ◽  
Point Of Care Test ◽  
Test Result

As antibiotic resistance becomes a growing health emergency, effective strategies are needed to reduce inappropriate antibiotic use. In this article, one such strategy – communicative practices associated with the C-reactive protein point-of care test – is investigated. Building on a collection of 31 videorecorded consultations from Danish primary care, and using conversation analysis, this study finds that the rapid test can be used throughout the consultation to incrementally build the case for a nonantibiotic treatment recommendation, both when the test result is forecast and reported. The study also finds that the format of reports of elevated results differs from that of ‘normal’ results, resulting in a subtle shift of authority from doctor to test.

scholarly journals Point-of-care serological assays for SARS-CoV-2 in a UK hospital population: potential for enhanced case finding

2020 ◽  
Author(s):  
Scott Pallett ◽  
Aatish Patel ◽  
Gary Davies ◽  
Luke Moore
Keyword(s):  
Test Performance ◽  
Serological Test ◽  
Point Of Care ◽  
Rapid Test ◽  
Antibody Test ◽  
Preliminary Evaluation ◽  
Hospital Inpatient ◽  
Case Identification ◽  
Global Pandemic ◽  
Population Potential

Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic, causing over 3,600,000 reported cases and 250,000 deaths worldwide.1 Case identification has predominantly been made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. Where a plurality of point-of-care (POC) SARS-CoV-2 antibody test kits have become available, we will therefore aim to evaluate a range of kits against the current available gold-standard diagnostic test of PCR in an initial, exploratory study. We will then proceed to carry out testing with 200 hospital inpatients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette against PCR in order to undergo a preliminary evaluation of POC serological test performance characteristics within a hospital inpatient cohort.

scholarly journals Assessment of the Field Utility of a Rapid Point-of-Care Test for SARS-CoV-2 Antibodies in a Household Cohort

2021 ◽  
Author(s):  
Mehal Churiwal ◽  
Kelly D. Lin ◽  
Salman Khan ◽  
Srijana Chhetri ◽  
Meredith S. Muller ◽  
...  
Keyword(s):  
Cohort Study ◽  
Confidence Interval ◽  
Point Of Care ◽  
Natural Infection ◽  
Field Performance ◽  
Antibody Test ◽  
Asymptomatic Infection ◽  
Point Of Care Test ◽  
Antibody Tests ◽  
Rapid Antibody

Point-of-care (POC) tests to detect SARS-CoV-2 antibodies offer quick assessment of serostatus after natural infection or vaccination. We compared the field performance of the BioMedomics COVID-19 IgM/IgG Rapid Antibody Test against an ELISA in 303 participants enrolled in a SARS-CoV-2 household cohort study. The rapid antibody test was easily implemented with consistent interpretation across 14 users in a variety of field settings. Compared with ELISA, detection of seroconversion lagged by 5 to 10 days. However, it retained a sensitivity of 90% (160/177, 95% confidence interval [CI] 85–94%) and specificity of 100% (43/43, 95% CI 92–100%) for those tested 3 to 5 weeks after symptom onset. Sensitivity was diminished among those with asymptomatic infection (74% [14/19], 95% CI 49–91%) and early in infection (45% [29/64], 95% CI 33–58%). When used appropriately, rapid antibody tests offer a convenient way to detect symptomatic infections during convalescence.

scholarly journals Point-of-Care Measurement of Activated Clotting Time for Cardiac Surgery as measured by the Hemochron Signature Eliteand the Abbott i-STAT: Agreement, Concordance, and Clinical Reliability

2019 ◽  
Author(s):  
Daniel Dirkmann ◽  
Elisabeth Nagy ◽  
Martin Walter Britten ◽  
Juergen Peters
Keyword(s):  
Cardiac Surgery ◽  
Linear Correlation ◽  
Point Of Care ◽  
Clotting Time ◽  
Cohen’S Kappa ◽  
Cohen's Kappa ◽  
Activated Clotting Time ◽  
Target Values ◽  
Heparin Anticoagulation ◽  
Parallel Measurements

Abstract Background: Since inadequate heparin anticoagulation and insufficient reversal can result in complications during cardiopulmonary bypass (CPB) surgery, heparin anticoagulation monitoring by point-of-care (POC) activated clotting time (ACT) measurements is essential for CPB initiation, maintainance, and anticoagulant reversal. However, concerns exist regarding reproducibility of ACT assays and comparability of devices. Methods: We evaluated the agreement of ACT assays using four parallel measurements performed on two commonly used devices each (i.e., two Hemochron Signature Elite (Hemochron) and two Abbott i-STAT (i-STAT) devices, respectively). Blood samples from 30 patients undergoing cardiac surgery on CPB were assayed at specified steps (baseline, after heparin administration, after protamine administration) with four parallel measurements (two of each device type) using commercial Kaolin activated assays provided by the respective manufactures. Measurements were compared between identical and different device types using linear regression, Bland-Altman analyses, and calculation of Cohen’s kappa coefficient. Results: Parallel i-STAT ACTs demonstrated a good linear correlation (r=0.985). Bias, as determined by Bland-Altman analysis, was low (-3.8s; 95% limits of agreement (LOA): -77.8 -70.2s), and Cohen’s Kappa demonstrated good agreement (kappa=0.809). Hemochron derived ACTs demonstrated worse linear correlation (r=0.782), larger bias with considerably broader LOA (-13.14s; 95%LOA:-316.3-290s), and lesser concordance between parallel assays (kappa=0.554). Although demonstrating a fair linear correlation (r=0.815), parallel measurements on different ACT-devices showed large bias (-20s; 95% LOA: -290-250s) and little concordance (kappa=0.368). Overall, disconcordant results according to clinically predefined target values were more frequent with the Hemochron than i-STAT. Furthermore, while discrepancies in ACT between two parallel iSTAT assays showed little or no clinical relevance, deviations from parallel Hemochron assays and iSTAT versus Hemochron measurements revealed marked and sometimes clinically critical deviations. Conclusion: Currently used ACT point-of-care devices cannot be used interchangeably. Furthermore, our data question the reliability of the Hemochron in assessing adequacy of heparin anticoagulation monitoring for CPB.

scholarly journals Is There a Role of Using a Rapid Finger Prick Antibody Test in Screening for Celiac Disease in Children?

2019 ◽  
Vol 2019 ◽  
pp. 1-5 ◽  
Author(s):  
Kristina Baraba Dekanić ◽  
Ivona Butorac Ahel ◽  
Lucija Ružman ◽  
Jasmina Dolinšek ◽  
Jernej Dolinšek ◽  
...  
Keyword(s):  
Celiac Disease ◽  
Point Of Care ◽  
Tissue Transglutaminase ◽  
Rapid Test ◽  
Antibody Test ◽  
First Grade ◽  
Iga Deficiency ◽  
Iga Antibodies ◽  
Point Of Care Tests

Introduction. Celiac disease (CD) is an autoimmune disease triggered by gluten in genetically predisposed individuals. Despite the increasing prevalence of CD, many patients remain undiagnosed. Standard serology tests are expensive and invasive, so several point-of-care tests (POC) for CD have been developed. We aimed to determine the prevalence of CD in first-grade pupils in Primorje-Gorski Kotar County, Croatia, using a POC test. Methods. A Biocard celiac test that detects IgA antibodies to tissue transglutaminase in whole blood was used to screen for celiac disease in healthy first-grade children born in 2011 and 2012 who consumed gluten without restrictions. Results. 1478 children were tested, and none of them were tested positive with a rapid test. In 10 children (0,6%), IgA deficiency has been suspected; only 4 of them agreed to be tested further for total IgA, anti-tTG, and anti-DGP antibodies. IgA deficiency was confirmed in 3 patients, and in all 4 children, CD has been excluded. Conclusion. Our results have not confirmed the usefulness of the POC test in screening the general population of first-grade schoolchildren. Further research is needed to establish the true epidemiology of CD in Primorje-Gorski Kotar County and to confirm the value of the rapid test in comparison with standard antibody CD testing.

scholarly journals Accuracy of Rapid Point-of-Care Antibody Test in patients with suspected or confirmed COVID-19

2020 ◽  
Author(s):  
Rama Vancheeswaran ◽  
Merlin L Willcox ◽  
Beth Stuart ◽  
Matthew Knight ◽  
Hala Kandil ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antibody Test ◽  
Reference Laboratory ◽  
List Type ◽  
Reference Standard ◽  
Point Of Care Test ◽  
History Of ◽  
Antibody Tests ◽  
Composite Reference Standard ◽  
Rapid Antibody

AbstractObjectivesTo assess the real-world diagnostic accuracy of the Livzon point-of-care rapid test for antibodies to SARS-COV-2DesignProspective cohort studySettingDistrict general hospital in EnglandParticipants173 Patients and 224 hospital staff with a history of COVID-19 symptoms, and who underwent PCR and/or reference antibody testing for COVID-19.InterventionsThe Livzon point-of-care (POC) lateral flow immunoassay rapid antibody test (IgM and IgG) was conducted at least 7 days after onset of symptoms and compared to the composite reference standard of PCR for SARS-COV-2 plus reference laboratory testing for antibodies to SARS-COV-2. The SARS-CoV-2 RT-PCR was tested using the available molecular technology during the study time (PHE laboratories, GeneXpert® system Xpert, Xpress SARS-CoV-2 and Source bioscience laboratory). All molecular platforms/assays were PHE/NHSE approved. The reference antibody test was the Elecsys Anti-SARS-CoV-2 assay (Roche diagnostics GmBH).Main outcome measuresSensitivity and specificity of the rapid antibody testResultsThe reference antibody test was positive in 190/268 (70.9%) of participants with a history of symptoms suggestive of COVID-19; in the majority (n=312) the POC test was taken 35 days or more after onset of symptoms. The POC antibody test had an overall sensitivity of 90.1% (292/328, 95% CI 86.3 – 93.1) and specificity of 100% (68/68, 95% CI 94.7 - 100) for confirming prior SARS-CoV-2 infection when compared to the composite reference standard. Sensitivity was 97.8% (89/92, 95% CI 92.3% to 99.7%) in participants who had been admitted to hospital and 84.4% (124/147, 95% CI 77.5% to 89.8%) in those with milder illness who had never been seen in hospital.ConclusionsThe Livzon point-of-care antibody test had comparable sensitivity and specificity to the reference laboratory antibody test, so could be used in clinical settings to support decision-making about patients presenting with more than 10 days of symptoms of COVID-19.What is already known on this topic-Presence of IgG and IgM antibodies to SARS-COV-2 indicates that the person was infected at least 7 days previously and is usually no longer infectious.-Rapid point-of-care tests for antibodies to SARS-COV-2 are widely available, cheap and easy to use-Preliminary evaluations suggested that rapid antibody tests may have insufficient accuracy to be useful for testing individual patients.What this study adds-The rapid point-of-care test for antibodies to SARS-COV-2 was 90.1% sensitive and 100% specific compared to reference standards for prior infection with COVID-19.-This is comparable to reference antibody tests-The point-of-care test evaluated in this study could be used to support clinical decision-making in real time, for patients presenting with symptoms of possible COVID-19 with at least 10 days of symptoms.

scholarly journals Utility of lateral flow tests in SARS-CoV-2 infection monitorization

2020 ◽  
Vol 33 (4) ◽  
pp. 258-266 ◽  
Author(s):  
Francisco Javier Candel González ◽  
José Manuel Viñuela-Prieto ◽  
Juan González del Castillo ◽  
Pablo Barreiro García ◽  
Marcos Fragiel Saavedra ◽  
...  
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
Antibody Test ◽  
Field Hospital ◽  
The Mean ◽  
Asymptomatic Infections ◽  
Severity Of The Disease ◽  
Lateral Flow Tests ◽  
Mean Time ◽  
Serology Testing

Introduction. The diagnosis of SARS-CoV-2 infection is crucial for medical and public health reasons, to allow the best treatment of cases and the best control of the pandemic. Serology testing allows for the detection of asymptomatic infections and 19-COVID cases once the virus has been cleared. We analyzed the usefulness of the SARS-CoV-2 rapid test of Autobio and tried to correlate its pattern with the severity of COVID19 infection. Material and methods. We analyzed the accuracy and clinical usefulness of a point-of-care IgM and/or IgG test for SARS-CoV-2 in 35 COVID-19 patients [12 (34.3%) mild-moderate and 23 (65.7%) severe-critical] admitted to a field hospital in Madrid, as well as in 5 controls. Results. The mean time from the first day of symptoms to the antibody test was 28 days (SD: 8.7), similar according to the severity of the disease. All patients with SARS-CoV-2 PCR+ showed the corresponding IgG positivity, while these results were negative in all control individuals. A total of 26 (74%) cases also presented with positive IgM, 19 (83%) were severe-critical cases and 7 (58%) were mild-moderate cases. The IgM response lasted longer in the severe critical cases (mean: 29.7 days; SD: 8.4) compared to the moderate cases (mean: 21.2 days; SD: 2.0). Conclusions. Rapid serology tests are useful for the diagnosis of patients with COVID-19 (mainly IgG detection) and may also be correlated with the severity of the infection (based on IgM detection).

scholarly journals Dynamic characteristic of SARS-CoV-2 and its antibody detection

2021 ◽  
Vol 7 (4) ◽  
pp. 100-101
Author(s):  
Bahrul Fikri ◽  
◽  
Andi Dwi Bahagia Febriani ◽  
Muhamad Ali ◽  
Nasrum Massi ◽  
...  
Keyword(s):  
Point Of Care ◽  
Diagnostic Testing ◽  
Rapid Test ◽  
Turnaround Time ◽  
Antibody Detection ◽  
Point Of Care Test ◽  
Specimen Collection ◽  
Excess Morbidity ◽  
Sensitivity Specificity ◽  
Testing Solution

To prevent excess morbidity and mortality of Covid-19, a prompt and accurate diagnosis is crucial. Antibody-based rapid diagnostic test (RDT) is a rapid, fairly reliable, and useful diagnostic testing solution for COVID-19. As a point-of-care test with fast turnaround time, the kit permits quick screening in hospitals to avoid the crowding of specimen collection. However, available RDTs kits have different sensitivity, specificity, and accuracy profiles due to antigen and antibody variability because of the sequence mutation of the SARS-CoV-2 gene. Therefore, it is strongly recommended to either re-measure the accuracy of a rapid test before using it in a different country or use tests developed based on local viral characteristics

scholarly journals Point-of-Care Measurement of Activated Clotting Time for Cardiac Surgery as measured by the Hemochron Signature Eliteand the Abbott i-STAT: Agreement, Concordance, and Clinical Reliability

2019 ◽  
Author(s):  
Daniel Dirkmann ◽  
Elisabeth Nagy ◽  
Martin Walter Britten ◽  
Juergen Peters
Keyword(s):  
Cardiac Surgery ◽  
Linear Correlation ◽  
Point Of Care ◽  
Clotting Time ◽  
Cohen’S Kappa ◽  
Cohen's Kappa ◽  
Activated Clotting Time ◽  
Target Values ◽  
Heparin Anticoagulation ◽  
Parallel Measurements

Abstract Background: Since inadequate heparin anticoagulation and insufficient reversal can result in complications during cardiopulmonary bypass (CPB) surgery, heparin anticoagulation monitoring by point-of-care (POC) activated clotting time (ACT) measurements is essential for CPB initiation, maintainance, and anticoagulant reversal. However, concerns exist regarding reproducibility of ACT assays and comparability of devices. Methods: We evaluated the agreement of ACT assays using four parallel measurements performed on two commonly used devices each (i.e., two Hemochron Signature Elite (Hemochron) and two Abbott i-STAT (i-STAT) devices, respectively). Blood samples from 30 patients undergoing cardiac surgery on CPB were assayed at specified steps (baseline, after heparin administration, after protamine administration) with four parallel measurements (two of each device type) using commercial Kaolin activated assays provided by the respective manufactures. Measurements were compared between identical and different device types using linear regression, Bland-Altman analyses, and calculation of Cohen’s kappa coefficient. Results: Parallel i-STAT ACTs demonstrated a good linear correlation (r=0.985). Bias, as determined by Bland-Altman analysis, was low (-3.8s; 95% limits of agreement (LOA): -77.8 -70.2s), and Cohen’s Kappa demonstrated good agreement (kappa=0.809). Hemochron derived ACTs demonstrated worse linear correlation (r=0.782), larger bias with considerably broader LOA (-13.14s; 95%LOA:-316.3-290s), and lesser concordance between parallel assays (kappa=0.554). Although demonstrating a fair linear correlation (r=0.815), parallel measurements on different ACT-devices showed large bias (-20s; 95% LOA: -290-250s) and little concordance (kappa=0.368). Overall, disconcordant results according to clinically predefined target values were more frequent with the Hemochron than i-STAT. Furthermore, while discrepancies in ACT between two parallel iSTAT assays showed little or no clinical relevance, deviations from parallel Hemochron assays and iSTAT versus Hemochron measurements revealed marked and sometimes clinically critical deviations. Conclusion: Currently used ACT point-of-care devices cannot be used interchangeably. Furthermore, our data question the reliability of the Hemochron in assessing adequacy of heparin anticoagulation monitoring for CPB.

scholarly journals Mass spectrometry and machine learning for the accurate diagnosis of benzylpenicillin and multidrug resistance of Staphylococcus aureus in bovine mastitis

2021 ◽  
Vol 17 (6) ◽  
pp. e1009108
Author(s):  
Necati Esener ◽  
Alexandre Maciel Guerra ◽  
Katharina Giebel ◽  
Daniel Lea ◽  
Martin J. Green ◽  
...  
Keyword(s):  
Neural Network ◽  
Machine Learning ◽  
Mass Spectrometry ◽  
Staphylococcus Aureus ◽  
Logistic Regression ◽  
Bovine Mastitis ◽  
Cohen’S Kappa ◽  
Mlp Neural Network ◽  
Cohen's Kappa ◽  
Linear Svm

Staphylococcus aureus is a serious human and animal pathogen threat exhibiting extraordinary capacity for acquiring new antibiotic resistance traits in the pathogen population worldwide. The development of fast, affordable and effective diagnostic solutions capable of discriminating between antibiotic-resistant and susceptible S. aureus strains would be of huge benefit for effective disease detection and treatment. Here we develop a diagnostics solution that uses Matrix-Assisted Laser Desorption/Ionisation–Time of Flight Mass Spectrometry (MALDI-TOF) and machine learning, to identify signature profiles of antibiotic resistance to either multidrug or benzylpenicillin in S. aureus isolates. Using ten different supervised learning techniques, we have analysed a set of 82 S. aureus isolates collected from 67 cows diagnosed with bovine mastitis across 24 farms. For the multidrug phenotyping analysis, LDA, linear SVM, RBF SVM, logistic regression, naïve Bayes, MLP neural network and QDA had Cohen’s kappa values over 85.00%. For the benzylpenicillin phenotyping analysis, RBF SVM, MLP neural network, naïve Bayes, logistic regression, linear SVM, QDA, LDA, and random forests had Cohen’s kappa values over 85.00%. For the benzylpenicillin the diagnostic systems achieved up to (mean result ± standard deviation over 30 runs on the test set): accuracy = 97.54% ± 1.91%, sensitivity = 99.93% ± 0.25%, specificity = 95.04% ± 3.83%, and Cohen’s kappa = 95.04% ± 3.83%. Moreover, the diagnostic platform complemented by a protein-protein network and 3D structural protein information framework allowed the identification of five molecular determinants underlying the susceptible and resistant profiles. Four proteins were able to classify multidrug-resistant and susceptible strains with 96.81% ± 0.43% accuracy. Five proteins, including the previous four, were able to classify benzylpenicillin resistant and susceptible strains with 97.54% ± 1.91% accuracy. Our approach may open up new avenues for the development of a fast, affordable and effective day-to-day diagnostic solution, which would offer new opportunities for targeting resistant bacteria.

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