Development of a rapid antibody test for point-of-care diagnosis of animal African trypanosomosis

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.

Download Full-text

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

10.1101/2020.11.17.20233296 ◽

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.

Download Full-text

Comparison of Rapid Antibody Test and Thorax Computed Tomography Results in Patients who Underwent RT‐PCR with the Pre‐Diagnosis of COVID‐19

International Journal of Clinical Practice ◽

10.1111/ijcp.14524 ◽

2021 ◽

Author(s):

Ilker Kızıloglu ◽

Aslı Sener ◽

Neslihan Siliv

Keyword(s):

Computed Tomography ◽

Antibody Test ◽

Rt Pcr ◽

Rapid Antibody

Download Full-text

Rapid point-of-care (POC) testing for Hepatitis C antibodies in a very high prevalence setting: persons injecting drugs in Tallinn, Estonia

Harm Reduction Journal ◽

10.1186/s12954-021-00485-5 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Anneli Uusküla ◽

Ave Talu ◽

Jürgen Rannap ◽

David M. Barnes ◽

Don Des Jarlais

Keyword(s):

Hepatitis C ◽

Point Of Care ◽

Antibody Test ◽

Hcv Rna ◽

Test Results ◽

Blood Draw ◽

Persons Who Inject Drugs ◽

Oral Swab ◽

High Prevalence ◽

Hcv Antibody

Abstract Background Between December 2018 and January of 2019, we evaluated the accuracy of the point-of-care Hepatitis C (HCV) antibody test (POC; OraQuick HCV) used at a community-based needle and syringe exchange program serving persons who inject drugs in Tallinn, Estonia. Methods We compared the results of screening for HCV antibodies by OraQuick (oral swab) and enzyme immunoassay (EIA; blood draw) and assessed test results implications in a high prevalence setting. Findings Of the 100 participants, 88 (88%) had reactive POC test results, and 93 were HCV antibody positive on EIA testing. Sensitivity, specificity and negative predictive value (NPV) for the POC assay with EIA as the relevant reference test were as follows: 94.6% (95% CI 90.0–99.2%), 100% and 58.3% (95% CI 30.4–86.2%). Of the 12 testing, HCV-negative with the POC only 7 (58.3%) were true negatives. Conclusions Oral swab rapid testing HCV screening in this nonclinical setting was sensitive and specific but had unacceptably low NPV. In high prevalence settings, POC tests with high sensitivity and that directly measure HCV RNA may be warranted.

Download Full-text

Feasibility and Success of Hiv Point-of-Care Testing in an Emergency Department in an Urban Canadian Setting

Canadian Journal of Infectious Diseases and Medical Microbiology ◽

10.1155/2013/164797 ◽

2013 ◽

Vol 24 (1) ◽

pp. 27-31 ◽

Cited By ~ 15

Author(s):

Marissa L Becker ◽

Laura H Thompson ◽

Carla Pindera ◽

Natalie Bridger ◽

Carmen Lopez ◽

...

Keyword(s):

Emergency Department ◽

Hiv Testing ◽

Point Of Care ◽

Venous Blood ◽

Tertiary Care ◽

Antibody Test ◽

Cross Sectional Study ◽

Cross Sectional ◽

Post Test ◽

Centre Hospital

BACKGROUND: Approximately 26% of Canadians living with HIV are unaware of their status. Point-of-care (POC) HIV tests have been introduced to simplify and expand HIV testing.OBJECTIVE: To evaluate the feasibility and acceptability of POC testing in an emergency department (ED) setting in Winnipeg, Manitoba.METHODS: A cross-sectional study of unselected adults presenting to the ED at the Health Sciences Centre Hospital (Winnipeg, Manitoba) was performed. Study procedures included pre- and post-test counselling, administration of the INSTI HIV-1/HIV-2 Antibody Test (bioLytical Laboratories, Canada) and a brief questionnaire. Venous blood samples were collected from participants for confirmatory testing on all reactive and indeterminate specimens.RESULTS: In total, 501 adults participated in the study. The majority of participants were younger than 40 years of age, approximately one-half (48.5%) were women and 53% self-identified as Aboriginal. Nearly one-half (49.1%) of the participants had undergone previous HIV testing, although 63% of these tests were performed more than a year earlier. A total of seven individuals tested reactive with the POC test, all of whom were confirmed positive using serological testing (1.4%) and were linked to an HIV specialist within 24 h. Nearly all of the participants (96%) reported satisfaction with the test and believed it belonged in the ED (93%).CONCLUSIONS: Of the participants tested, 1.4% tested reactive for HIV, which is significantly higher than the reported prevalence in Manitoba and in other similar studies conducted in North America. Furthermore, all individuals were linked to timely care. The present study demonstrated that this particular busy tertiary care ED is an important and feasible location for HIV POC testing.

Download Full-text

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.

Download Full-text

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.

Download Full-text

Evaluation of Aspergillus-Specific Lateral-Flow Device Test Using Serum and Bronchoalveolar Lavage Fluid for Diagnosis of Chronic Pulmonary Aspergillosis

Journal of Clinical Microbiology ◽

10.1128/jcm.00095-19 ◽

2019 ◽

Vol 57 (5) ◽

Cited By ~ 3

Author(s):

Takahiro Takazono ◽

Yuya Ito ◽

Masato Tashiro ◽

Keitaro Nishimura ◽

Tomomi Saijo ◽

...

Keyword(s):

Bronchoalveolar Lavage ◽

Bronchoalveolar Lavage Fluid ◽

Point Of Care ◽

Invasive Pulmonary Aspergillosis ◽

Antibody Test ◽

Lavage Fluid ◽

Serum Samples ◽

Pulmonary Aspergillosis ◽

Flow Device ◽

Chronic Pulmonary Aspergillosis

ABSTRACT The Aspergillus-specific lateral-flow device (AspLFD) test is a newly developed point-of-care diagnostic method for invasive pulmonary aspergillosis. However, evidence of the diagnostic performance of the AspLFD for chronic pulmonary aspergillosis (CPA) is limited. Therefore, we conducted a retrospective study to investigate this in comparison with the galactomannan (GM) β-d-glucan (BDG) test. Fifty patients with chronic pulmonary aspergillosis and 65 patients with respiratory disease, as a control, were enrolled in this study. The majority of the CPA disease entities were chronic pulmonary aspergillosis (64.0%, n = 32), followed by subacute invasive pulmonary aspergillosis (IPA) (20.0%, n = 10) and simple pulmonary aspergilloma (SPA) (16.0%, n = 8). The sensitivity and specificity of the AspLFD test in serum samples were 62.0% and 67.7%, respectively. The GM test (cutoff index, 1.54) showed a sensitivity of 22% and a specificity of 92.3%, while the sensitivity and specificity of the BDG test (cutoff, 19.3 pg/ml) were 48% and 90.8%, respectively. In bronchoalveolar lavage fluid samples, the AspLFD test showed a sensitivity of 66.7% and a specificity of 69.2%, while those of the GM test (cutoff index, 0.6) were 72.7% and 83.1%, respectively. The Aspergillus precipitating antibody test had 70% sensitivity. Unlike the Aspergillus precipitating antibody test, the AspLFD on serum samples showed similar sensitivity to non-fumigatus Aspergillus species. Patients with false-positive results for the AspLFD on serum samples were of a significantly higher age and had a higher prevalence of cavitary lesions in chest computed tomography than patients with negative results in the control group. Given the results in this study, the performance of the AspLFD using serum was acceptable as a point-of-care test for the diagnosis of CPA.

Download Full-text