scholarly journals Evaluation of a Lateral Flow Immunoassay COVIDTECH® SARS-CoV-2 IgM/IgG Antibody Rapid Test

2021 ◽  
Author(s):  
Julien Exinger ◽  
Cédric Hartard ◽  
Fanny Lafferrière ◽  
Christelle Fenninger ◽  
Loic J. Charbonnière ◽  
...  
Keyword(s):  
Rapid Test ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Igg Antibody

Point-Of-Care Clinical Evaluation of the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test cassette with the Cobas® Roche RT-PCR platform in patients with or without Covid-19

2021 ◽  
Author(s):  
Fadi Haddad ◽  
Christopher C Lamb ◽  
Ravina Kullar ◽  
George Sakoulas
Keyword(s):  
Symptom Onset ◽  
Serological Test ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Rapid Test ◽  
Lateral Flow ◽  
Added Value ◽  
Lateral Flow Immunoassay ◽  
Rt Pcr ◽  
Past Infection

Background: Covid-19 remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness of results. We hypothesize that a rapid 15-minute Point-Of-Care serological test to evaluate past infection complements diagnostic testing for Covid-19 and significantly enhances testing availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene® lateral flow immunoassay (LFI) and compared with the Cobas® Roche RT PCR results. Arm 1: Thirty-five (35) subjects with confirmed Covid-19 using RT-PCR were tested twice: prior to 14 days following symptom onset and once between 12 and 70 days. Arm 2: Thirty (30) subjects with confirmed Covid-19 using RT-PCR were tested 12-70 days post symptom onset. Arm 3: Thirty (30) subjects with a negative RT-PCR for Covid-19 were tested 1-10 days following the RT-PCR test date. Results: Specificity of confirmed negative Covid-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% negative positive agreement between the RT-PCR and the Clungene® serological test results. Covid-19 subjects tested prior to day 7 symptom onset were antibody negative. In subjects 7-12 days following symptom onset with a confirmed positive Covid-19 by RT-PCR, the combined sensitivity of IgM and IgG was 58.6% (95% CI, 38.9%-76.5%). In subjects 13-70 days following symptom onset with a confirmed positive Covid-19 by RT-PCR the combined sensitivity of IgM and IgG was 90.5% (95% CI, 80.4%-96.4%). Conclusion: The Clungene® lateral flow immunoassay (LFI) is a useful tool to confirm individuals with an adaptive immune response to SARS-CoV-2 indicating past infection. Providing Point-Of-Care results within 15 minutes without any laboratory instrumentation or specialized software has an added value of increasing test availability to patients who have been symptomatic for more than one week to confirm past infection. Performance characteristics are optimal after 13 days with a sensitivity and specificity of 90% and 100%, respectively.

Development and Validation of a Lateral Flow Immunoassay Test Kit for Dual Detection of Casein and β-Lactoglobulin Residues

2016 ◽  
Vol 79 (3) ◽  
pp. 477-483 ◽  
Author(s):  
JONGKIT MASIRI ◽  
BRIANDA BARRIOS-LOPEZ ◽  
LORA BENOIT ◽  
JOSHUA TAMAYO ◽  
JEFFREY DAY ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Rapid Test ◽  
Lateral Flow ◽  
Test Method ◽  
Cow’S Milk ◽  
Lateral Flow Immunoassay ◽  
Screening Methods ◽  
Cow's Milk ◽  
Test Kit ◽  
Β Lactoglobulin

ABSTRACT Allergies to cow's milk are very common and can present as life-threatening anaphylaxis. Consequently, food labeling legislation mandates that foods containing milk residues, including casein and/or β-lactoglobulin, provide an indication of such on the product label. Because contamination with either component independent of the other can occur during food manufacturing, effective allergen management measures for containment of milk residues necessitates the use of dual screening methods. To assist the food industry in improving food safety practices, we have developed a rapid lateral flow immunoassay test kit that reliably reports both residues down to 0.01 μg per swab and 0.1 ppm of protein for foods. The assay utilizes both sandwich and competitive format test lines and is specific for bovine milk residues. Selectivity testing using a panel of matrices with potentially interfering substances, including commonly used sanitizing agents, indicated reduction in the limit of detection by one-to fourfold. With food, residues were easily detected in all cow's milk–based foods tested, but goat and sheep milk residues were not detected. Specificity analysis revealed no cross-reactivity with common commodities, with the exception of kidney beans when present at high concentrations (>1%). The development of a highly sensitive and rapid test method capable of detecting trace amounts of casein and/or β-lactoglobulin should aid food manufacturers and regulatory agencies in monitoring for milk allergens in environmental and food samples.

scholarly journals Detection of Bacillus anthracis in animal tissues using InBios active anthrax detect rapid test lateral flow immunoassay

2019 ◽  
Vol 68 (6) ◽  
pp. 480-484 ◽  
Author(s):  
C.B. Kolton ◽  
C.K. Marston ◽  
R.A. Stoddard ◽  
C. Cossaboom ◽  
J.S. Salzer ◽  
...  
Keyword(s):  
Bacillus Anthracis ◽  
Rapid Test ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Animal Tissues

scholarly journals Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048142
Author(s):  
Louise J Robertson ◽  
Julie S Moore ◽  
Kevin Blighe ◽  
Kok Yew Ng ◽  
Nigel Quinn ◽  
...  
Keyword(s):  
Northern Ireland ◽  
Post Infection ◽  
Rapid Test ◽  
Spike Protein ◽  
Lateral Flow Immunoassay ◽  
Plasma Samples ◽  
Igg Antibodies ◽  
Igg Antibody ◽  
The Uk ◽  
Antibody Levels

ObjectiveTo evaluate the dynamics and longevity of the humoral immune response to SARS-CoV-2 infection and assess the performance of professional use of the UK-RTC AbC-19 Rapid Test lateral flow immunoassay (LFIA) for the target condition of SARS-CoV-2 spike protein IgG antibodies.DesignNationwide serological study.SettingNorthern Ireland, UK, May 2020–February 2021.ParticipantsPlasma samples were collected from a diverse cohort of individuals from the general public (n=279), Northern Ireland healthcare workers (n=195), pre-pandemic blood donations and research studies (n=223) and through a convalescent plasma programme (n=183). Plasma donors (n=101) were followed with sequential samples over 11 months post-symptom onset.Main outcome measuresSARS-CoV-2 antibody levels in plasma samples using Roche Elecsys Anti-SARS-CoV-2 IgG/IgA/IgM, Abbott SARS-CoV-2 IgG and EuroImmun IgG SARS-CoV-2 ELISA immunoassays over time. UK-RTC AbC-19 LFIA sensitivity and specificity, estimated using a three-reference standard system to establish a characterised panel of 330 positive and 488 negative SARS-CoV-2 IgG samples.ResultsWe detected persistence of SARS-CoV-2 IgG antibodies for up to 10 months post-infection, across a minimum of two laboratory immunoassays. On the known positive cohort, the UK-RTC AbC-19 LFIA showed a sensitivity of 97.58% (95.28% to 98.95%) and on known negatives, showed specificity of 99.59% (98.53 % to 99.95%).ConclusionsThrough comprehensive analysis of a cohort of pre-pandemic and pandemic individuals, we show detectable levels of IgG antibodies, lasting over 46 weeks when assessed by EuroImmun ELISA, providing insight to antibody levels at later time points post-infection. We show good laboratory validation performance metrics for the AbC-19 rapid test for SARS-CoV-2 spike protein IgG antibody detection in a laboratory-based setting.

scholarly journals Carbon-Coated Superparamagnetic Nanoflowers for Biosensors Based on Lateral Flow Immunoassays

Biosensors ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. 80
Author(s):  
Amanda Moyano ◽  
Esther Serrano-Pertierra ◽  
María Salvador ◽  
José Martínez-García ◽  
Yolanda Piñeiro ◽  
...  
Keyword(s):  
Magnetic Properties ◽  
Limit Of Detection ◽  
Detection System ◽  
Rapid Test ◽  
Superparamagnetic Iron Oxide ◽  
Extracellular Vesicle ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Clear Correlation ◽  
One Pot

Superparamagnetic iron oxide nanoflowers coated by a black carbon layer (Fe3O4@C) were studied as labels in lateral flow immunoassays. They were synthesized by a one-pot solvothermal route, and they were characterized (size, morphology, chemical composition, and magnetic properties). They consist of several superparamagnetic cores embedded in a carbon coating holding carboxylic groups adequate for bioconjugation. Their multi-core structure is especially efficient for magnetic separation while keeping suitable magnetic properties and appropriate size for immunoassay reporters. Their functionality was tested with a model system based on the biotin–neutravidin interaction. For this, the nanoparticles were conjugated to neutravidin using the carbodiimide chemistry, and the lateral flow immunoassay was carried out with a biotin test line. Quantification was achieved with both an inductive magnetic sensor and a reflectance reader. In order to further investigate the quantifying capacity of the Fe3O4@C nanoflowers, the magnetic lateral flow immunoassay was tested as a detection system for extracellular vesicles (EVs), a novel source of biomarkers with interest for liquid biopsy. A clear correlation between the extracellular vesicle concentration and the signal proved the potential of the nanoflowers as quantifying labels. The limit of detection in a rapid test for EVs was lower than the values reported before for other magnetic nanoparticle labels in the working range 0–3 × 107 EVs/μL. The method showed a reproducibility (RSD) of 3% (n = 3). The lateral flow immunoassay (LFIA) rapid test developed in this work yielded to satisfactory results for EVs quantification by using a precipitation kit and also directly in plasma samples. Besides, these Fe3O4@C nanoparticles are easy to concentrate by means of a magnet, and this feature makes them promising candidates to further reduce the limit of detection.

scholarly journals The early detection of immunoglobulins via optical-based lateral flow immunoassay platform in COVID-19 pandemic

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254486
Author(s):  
Pang-Yen Chen ◽  
Cheng-Hao Ko ◽  
C. Jason Wang ◽  
Chien-Wei Chen ◽  
Wei-Huai Chiu ◽  
...  
Keyword(s):  
Early Detection ◽  
False Negative ◽  
Test Strip ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Quantitative Detection ◽  
Global Public Health ◽  
Rt Pcr ◽  
Antibody Testing ◽  
Igg Antibody

The coronavirus disease (COVID-19) is the global public health challenge currently persisting at a grand scale. A method that meets the rapid quantitative detection of antibodies to assess the body’s immune response from natural COVID-19 illness or vaccines’ effects is urgently needed. In the present study, an attempt was made to integrate a newly designed spectrometer to the COVID-19 test strip procedure; this augmentation provides the quantitative capacity to a lateral flow immunoassay (LFIA). Optical interpretation of results by quantitative α index, rather than visual qualification, can be done quickly, in 5–10 minutes. The developed product was compared with several other serological IgM/IgG antibody reagents on the market by recruiting 111 participants suspected of having COVID-19 infection from March to May 2020 in a hospital. Taking RT-PCR as the diagnostic gold standard, the quantitative spectral LIFA platform could correctly detect all 12 COVID-19 patients. Concerning RT-PCR negative patients, all three antibody testing methods found positive cases. The optical-based platform exhibited the ability of early detection of immunoglobulins of RT-PCR negative patients. There was an apparent trend that elevation of IgM levels in the acute phase of infection; then IgG levels rose later. It exhibited the risk of a false-negative diagnosis of RT-PCR in COVID-19 testing. The significant detection ability of this new optical-based platform demonstrated clinical potential.

scholarly journals Evaluating ELISA, Immunofluorescence, and Lateral Flow Assay for SARS-CoV-2 Serologic Assays

2020 ◽  
Vol 11 ◽  
Author(s):  
Moïse Michel ◽  
Amar Bouam ◽  
Sophie Edouard ◽  
Florence Fenollar ◽  
Fabrizio Di Pinto ◽  
...  
Keyword(s):  
Rapid Test ◽  
Antibody Test ◽  
Immunofluorescence Assay ◽  
Lateral Flow ◽  
Antibody Detection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Reliable Determination ◽  
Test Kit ◽  
Serological Status

BackgroundThe SARS-CoV-2 outbreak has emerged at the end of 2019. Aside from the detection of viral genome with specific RT-PCR, there is a growing need for reliable determination of the serological status. We aimed at evaluating five SARS-CoV-2 serology assays.MethodsAn in-house immunofluorescence assay (IFA), two ELISA kits (EUROIMMUN® ELISA SARS-CoV-2 IgG and NovaLisa® SARS-CoV-2 IgG and IgM) and two lateral flow assays (T-Tek® SARS-CoV-2 IgG/IgM Antibody Test Kit and Sure Bio-tech® SARS-CoV-2 IgM/IgG Antibody Rapid Test) were compared on 40 serums from RT-PCR-confirmed SARS-CoV-2 infected patients and 10 SARS-CoV-2 RT-PCR negative subjects as controls.ResultsControl subjects tested negative for SARS-CoV-2 antibodies with all five systems. Estimated sensitivities varied from 35.5 to 71.0% for IgG detection and from 19.4 to 64.5% for IgM detection. For IgG, in-house IFA, EuroImmun, T-Tek and NovaLisa displayed 50–72.5% agreement with other systems except IFA vs EuroImmun and T-Tek vs NovaLisa. Intermethod agreement for IgM determination was between 30 and 72.5%.DiscussionThe overall intermethod agreement was moderate. This inconsistency could be explained by the diversity of assay methods, antigens used and immunoglobulin isotype tested. Estimated sensitivities were low, highlighting the limited value of antibody detection in CoVID-19.ConclusionComparison of five systems for SARS-CoV-2 IgG and IgM antibodies showed limited sensitivity and overall concordance. The place and indications of serological status assessment with currently available tools in the CoVID-19 pandemic need further evaluations.

scholarly journals A New Saliva-Based Lateral-Flow SARS-CoV-2 IgG Antibody Test for mRNA Vaccination

2021 ◽  
Author(s):  
Dingying Shan ◽  
Jessica Hsiung ◽  
Kevin P. Bliden ◽  
Su Zhao ◽  
Tao Liao ◽  
...  
Keyword(s):  
Vaccine Dose ◽  
Rapid Test ◽  
High Sensitivity ◽  
Antibody Test ◽  
Lateral Flow ◽  
Igg Antibodies ◽  
Igg Antibody ◽  
Non Invasive ◽  
Antibody Persistence ◽  
Wide Range

Sensitive detection of IgG antibodies against SARS-CoV-2 is important to assessing immune responses to viral infection or vaccination and immunity duration. Antibody assays using non-invasive body fluids such as saliva could facilitate mass testing including young children, elderly and those who resist blood draws, and easily allowing longitudinal testing/monitoring of antibodies over time. Here, we developed a new lateral flow (nLF) assay that sensitively detects SARS-CoV-2 IgG antibodies in the saliva samples of vaccinated individuals and previous COVID-19 patients. The 25-minute nLF assay detected anti-spike protein (anti-S1) IgG in saliva samples with 100% specificity and high sensitivity from both vaccinated (99.51% for samples ≥ 19 days post 1st Pfizer/BioNTech or Moderna mRNA vaccine dose) and infected individuals. Antibodies against nucleocapsid protein (anti-NCP) was detected only in the saliva samples of COVID-19 patients and not in vaccinated samples, allowing facile differentiation of vaccination from infection. SARS-CoV-2 anti-S1 IgG antibody in saliva measured by nLF demonstrated similar evolution trends post vaccination to that in matching dried blood spot (DBS) samples measured by a quantitative pGOLD lab-test, enabling the nLF to be a valid tool for non-invasive personalized monitoring of SARS-CoV-2 antibody persistence. The new salivary rapid test platform can be applied for non-invasive detection of antibodies against infection and vaccination in a wide range of diseases.

Development of a lateral flow immunoassay strip for rapid detection of IgG antibody against SARS-CoV-2 virus

The Analyst ◽  
2020 ◽  
Vol 145 (15) ◽  
pp. 5345-5352 ◽  
Author(s):  
Tian Wen ◽  
Chao Huang ◽  
Feng-Juan Shi ◽  
Xiao-Yan Zeng ◽  
Tian Lu ◽  
...  
Keyword(s):  
Rapid Detection ◽  
Correct Diagnosis ◽  
Preliminary Test ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Testing Methods ◽  
Igg Antibody ◽  
Au Nps ◽  
Alternative Testing ◽  
Test Result

Rapid and simple LFIA strips based on Au NPs provide a preliminary test result for physicians to make the correct diagnosis of SARS-CoV-2 infections along with alternative testing methods.

An Aggregation-Induced Emission Material Labeling Antigen-Based Lateral Flow Immunoassay Strip for Rapid Detection of Escherichia coli O157:H7

2021 ◽  
pp. 247263032098193
Author(s):  
Cheng Liu ◽  
Shuiqin Fang ◽  
Yachen Tian ◽  
Youxue Wu ◽  
Meijiao Wu ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Rapid Detection ◽  
Foodborne Pathogen ◽  
Test Strip ◽  
Lateral Flow ◽  
Detection Sensitivity ◽  
Lateral Flow Immunoassay ◽  
Escherichia Coli O157 ◽  
Aggregation Induced Emission ◽  
E Coli

Escherichia coli O157:H7 ( E. coli O157:H7) is a dangerous foodborne pathogen, mainly found in beef, milk, fruits, and their products, causing harm to human health or even death. Therefore, the detection of E. coli O157:H7 in food is particularly important. In this paper, we report a lateral flow immunoassay strip (LFIS) based on aggregation-induced emission (AIE) material labeling antigen as a fluorescent probe for the rapid detection of E. coli O157:H7. The detection sensitivity of the strip is 105 CFU/mL, which is 10 times higher than that of the colloidal gold test strip. This method has good specificity and stability and can be used to detect about 250 CFU of E. coli O157:H7 successfully in 25 g or 25 mL of beef, jelly, and milk. AIE-LFIS might be valuable in monitoring food pathogens for rapid detection.

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