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

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).

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

10.21203/rs.3.pex-930/v1 ◽

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.

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

Gastroenterology Research and Practice ◽

10.1155/2019/4504679 ◽

2019 ◽

Vol 2019 ◽

pp. 1-5 ◽

Cited By ~ 1

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.

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Comparison of time taken to obtain an arterial blood gas result at the bedside using the ProximaTM point of care machine vs. a standard remote arterial blood gas analyser: A randomized controlled trial

Journal of the Intensive Care Society ◽

10.1177/1751143720973847 ◽

2020 ◽

pp. 175114372097384

Author(s):

Kay Mitchell ◽

Karen E Salmon ◽

David Egbosimba ◽

Gavin Troughton ◽

Mike PW Grocott

Keyword(s):

Point Of Care ◽

Controlled Trial ◽

Blood Gas ◽

Sampling System ◽

Arterial Blood Gas ◽

Arterial Blood ◽

The Mean ◽

Time Away ◽

Mean Time ◽

Reduced Time

Introduction The ProximaTM point of care (POC) device enables arterial blood gas (ABG) samples to be analysed without the nurse leaving the patient. The benefits of this for work efficiency have not been evaluated. Methods We compared the time taken to obtain an ABG result using ProximaTM versus a standard ABG sampling system. Twenty patients were randomized to ABG sampling using ProximaTM, or a standard ABG system. Nurses were observed performing all ABG sampling episodes for a minimum of 24 hours and no more than 72 hours. Results The mean time taken to obtain a result using ProximaTM was 4:56 (SD = 1:40) minutes compared to 6:31 (SD = 1:53) minutes for the standard ABG technique (p < 0.001). Mean time away from the patient's bedside was 3.07 (SD = 1:17) minutes using the standard system and 0 minutes using ProximaTM (p < 0.001). Conclusions Reduced time for blood gas sampling and avoidance of time away from patients may have significant patient safety and resource management implications, but the clinical and financial significance were not evaluated.

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Prognosis of hospitalized children under 2 years of age with co-detection of influenza A and respiratory syncytial virus at the healthcare facility

Revista Brasileira de Saúde Materno Infantil ◽

10.1590/1806-93042021000200010 ◽

2021 ◽

Vol 21 (2) ◽

pp. 531-537

Author(s):

Elisa Teixeira Mendes ◽

Hadassa L. Paranhos ◽

Isabela C. M. Santos ◽

Lais Bomediano de Souza ◽

José Luis Braga de Aquino ◽

...

Keyword(s):

Influenza A ◽

Point Of Care ◽

Rapid Test ◽

Healthcare Facility ◽

Orotracheal Intubation ◽

Younger Age ◽

Co Detection ◽

Syncytial Virus ◽

The Impact ◽

Mean Time

Abstract Objectives: the aim of this study is to evaluate the impact of co-detection of Flu A and RSV using rapid immunochromatographic tests at the point of care, in pediatric patients under 2 years of age in a general hospital. Methods: a retrospective cohort study was conducted to analyze clinical outcomes in hospitalized infants with viral respiratory disease with positive results of rapid immunochromatographic test for RSV and/or Flu-A, from 2013 to 2018. A logistic regression model was adjusted to analyze predictors of orotracheal intubation during hospitalization. Results: we analyzed 220 cases: RSV (192), Flu-A (9), co-detection (19). Lethality rate was 1.8% (2 cases), and 88% (194) were under 1 year of age. Mean time of hospitalizations was higher in patients with co-detection. Variables significantly associated with orotracheal intubation were: younger age in months, comorbidities, RSV and Flu-A co-detection, and bacterial pneumonia during hospitalization. Conclusions: RSV and Flu-Aco-detection was associated with the least favorable clinical prognoses in this study. Rapid test diagnosis may provide important information at the point of care, because molecular panels are not widely accessible in general hospitals. Rapid diagnosis allows timely evaluation and treatment.

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Analysis of a DKA protocol: Laboratory tests and outcomes

The Southwest Respiratory and Critical Care Chronicles ◽

10.12746/swrccc.v9i40.891 ◽

2021 ◽

Vol 9 (40) ◽

pp. 20-26

Author(s):

Arunee Motes ◽

Fabiana Fernandez ◽

Hawa Edriss

Keyword(s):

Diabetic Ketoacidosis ◽

Point Of Care ◽

Insulin Dose ◽

Anion Gap ◽

Glucose Levels ◽

Icu Length Of Stay ◽

Gap Closure ◽

Key Words Diabetic Ketoacidosis ◽

The Mean ◽

Mean Time

Most hospitals use protocols to manage diabetic ketoacidosis using laboratory criteria to monitor the response to insulin and fluid therapy. This study analyzed information collected prospectively on a group of patients with diabetic ketoacidosis to review outcomes and management details. The study included 37 patients with a mean age of 38.1 ± 18.5 years. The initial blood glucose was 546.4 ± 296.3 mg/dL. The initial anion gap was 31.8 ± 7.8 meq/L. The mean time to anion gap closure twice was 19.2 ± 12.8 hours. The mean fluid administered until anion gap closure was 3694.9 ± 2484.6 mL. The insulin dose during the first day of management was 69.5 ± 49.9 units; the mean number of point-of-care glucose levels during the first 24 hours was 21.2 ± 6. The number of basic metabolic panels collected during hospital management was 12.2 ± 13.7. The mean ICU length of stay was 2.5 ± 3.8 days with no mortality. This study indicates that patients with diabetic ketoacidosis had a large number of basic metabolic panel tests and a large number of point of care glucose measurements using this protocol. This protocol needs review to determine whether or not the number of tests can be reduced, and transfer out of the ICU can occur more quickly. Key words: Diabetic ketoacidosis, glucose levels, anion gap, basic metabolic panels, outcomes

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Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population

Scientific Reports ◽

10.1038/s41598-021-85247-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

S. J. C. Pallett ◽

S. J. Denny ◽

A. Patel ◽

E. Charani ◽

N. Mughal ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Late Complications ◽

Case Definition ◽

Case Finding ◽

Infectious Period ◽

Serological Tests ◽

Specific Patient ◽

Infection Period

AbstractSevere Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently 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. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5–9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.

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Updated Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

Healthcare ◽

10.3390/healthcare9091124 ◽

2021 ◽

Vol 9 (9) ◽

pp. 1124

Author(s):

Christopher C. Lamb ◽

Fadi Haddad ◽

Christopher Owens ◽

Alfredo Lopez-Yunez ◽

Marion Carroll ◽

...

Keyword(s):

False Positive ◽

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Cross Reactivity ◽

Blood Collection ◽

Rt Pcr ◽

Antibody Testing ◽

Reactivity Study ◽

Positive Results

Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette was evaluated for its utility to aide healthcare professionals. Method: Two studies were performed by using the CLUNGENE® Rapid Test. (1) An expanded Point-of-Care (POC) study at two clinical sites was conducted to evaluate 99 clinical subjects: 62 positive subjects and 37 negative subjects were compared to RT-PCR, PPA, and NPA (95% CI). Sensitivity was calculated from blood-collection time following symptom onset. (2) A cross-reactivity study was performed to determine the potential for false-positive results from other common infections. Results: The specificity of subjects with confirmed negative COVID-19 by RT-PCR was 100% (95% CI, 88.4–100.0%). The sensitivity of subjects with confirmed positive COVID-19 by RT-PCR was 96.77% (95% CI, 88.98–99.11%). In the cross-reactivity study, there were no false-positive results due to past infections or vaccinations unrelated to the SARS-CoV-2 virus. Conclusion: There is a need for a rapid, user-friendly, and inexpensive on-site monitoring system for diagnosis. The CLUNGENE® Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation.

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

10.21203/rs.3.rs-28006/v1 ◽

2020 ◽

Cited By ~ 3

Author(s):

Scott Pallett ◽

Sarah Denny ◽

Aatish Patel ◽

Esmita Charani ◽

Nabeela Mughal ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Late Complications ◽

Case Definition ◽

Case Finding ◽

Serological Tests ◽

Specific Patient ◽

Infection Period ◽

Population Potential

Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently 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.We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n=15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5-9 post symptom onset), with 100% sensitivity not seen until day 13. Specificity was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95·4%), supporting use of serology testing in carefully targeted populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.

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Risk Assessment for Preterm Delivery using the Fetal Fibronectin Test Associated with the Measurement of Uterine Cervix Length in Symptomatic Pregnant Women

Revista Brasileira de Ginecologia e Obstetrícia / RBGO Gynecology and Obstetrics ◽

10.1055/s-0038-1667185 ◽

2018 ◽

Vol 40 (09) ◽

pp. 507-512

Author(s):

Tadeu Pinheiro Filho ◽

Vanessa Pessoa ◽

Thaisa Lima ◽

Marcela Castro ◽

José Linhares

Keyword(s):

Pregnant Women ◽

Preterm Delivery ◽

Uterine Cervix ◽

Rapid Test ◽

Maternity Hospital ◽

Fetal Fibronectin ◽

Delivery Date ◽

The Mean ◽

Mean Time ◽

Larger Sample

Objective To analyze the use of the measurement of uterine cervix length (MUCL) and the fetal fibronectin (fFN) rapid test as predictors of preterm delivery (PTD) in symptomatic pregnant women assisted at the Santa Casa de Misericórdia de Sobral Maternity Hospital. Methods This was a prospective and analytic study involving 53 parturients assisted between September of 2015 and July of 2016; the participants were between 24 and 34 weeks of gestational age (GA) and presented complaints related to preterm labor (PTL) prodromes. Vaginal secretion was collected for fFN testing, and the MUCL was obtained via transvaginal ultrasonography. Results A total of 58.49% of the subjects showed MUCL < 25 mm, and 41.51% were positive in the fFN rapid test. A total of 48 patients were followed-up until their delivery date, and 54.17% resulted in PTL. The relative risk (RR) for PTD in patients with MUCL < 25 mm was 1.83 (p = 0.09, 0.99–3.36, 95% confidence interval [CI]), with a mean time before delivery of 2.98 weeks. Based on fFN positive results, the RR was 3.50 (p = 0.002, 1.39–8.79, 95%CI) and the mean time until delivery was 1.94 weeks. The RR was 2.70 (p = 0.002, 1.08–6.72, 95%CI) when both tests were used. The RR of PTD within 48 hours, and 7 and 14 days were, respectively, 1.30 (p = 0.11, 95% CI 1.02–1.67), 1.43 (p = 0.12, 95% CI % 0.99–2.06), and 2.03 (p = 0.008, 95% CI 1.26–3.27), when based on the MUCL, and 1.75 (p = 0.0006, 95% CI 1.20–2.53), 2.88 (p = 0.0001, 95% CI, 1.57–5.31), and 3.57 (p = 0.0002, 95% CI 1.63–7.81) when based on positive fFN results. The RR at 48 hours and 7 and 14 days considering both tests was 1.74 (p = 0.0001, 95% CI 1.14–2.64), 2.22 (p = 0.0001, 95% CI 1.22–4.04), and 2.76 (p = 0.0002, 95% CI 1.27–5.96), respectively. Conclusion In symptomatic pregnant women, we concluded that the MUCL < 25 mm associated with positive fFN rapid test indicate increased the risk for PTD. Further studies with larger sample sizes could contribute in supporting the results presented in the current study.

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

10.1101/2021.02.04.21251126 ◽

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.

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