scholarly journals Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection

2020 ◽  
Author(s):  
Clarence W Chan ◽  
Sajid Shahul ◽  
Cheyenne Coleman ◽  
Vera Tesic ◽  
Kyle Parker ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Reference Sample ◽  
Rapid Test ◽  
Antibody Test ◽  
Cross Reactivity ◽  
Antibody Detection ◽  
Antibody Assay ◽  
Widespread Application ◽  
Global Pandemic ◽  
Polymerase Chain

Abstract Objectives To evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test. Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation. Methods The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set. Results The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%. Conclusions The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.

scholarly journals Humoral Immune Response to SARS-CoV-2

2020 ◽  
Vol 154 (5) ◽  
pp. 610-619 ◽  
Author(s):  
Pauline H Herroelen ◽  
Geert A Martens ◽  
Dieter De Smet ◽  
Koen Swaerts ◽  
An-Sofie Decavele
Keyword(s):  
Comparative Evaluation ◽  
Rapid Test ◽  
Cross Reactivity ◽  
Antibody Detection ◽  
Specific Detection ◽  
Chain Reaction ◽  
Humoral Immune ◽  
Polymerase Chain ◽  
Kinetics Of ◽  
Post Onset

Abstract Objectives Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology tests are clinically useful to document prior SARS-CoV-2 infections. Data are urgently needed to select assays with optimal sensitivity at acceptable specificity for antibody detection. Methods A comparative evaluation was performed of 7 commercial SARS-CoV-2 serology assays on 171 sera from 135 subjects with polymerase chain reaction–confirmed SARS-CoV-2 infection (71 hospitalized patients and 64 paucisymptomatic individuals). Kinetics of IgA/IgM/IgG seroconversion to viral N and S protein epitopes were studied from 0 to 54 days after onset of symptoms. Cross-reactivity was verified on 57 prepandemic samples. Results Wantai SARS-COV-2 Ab ELISA and Orient Gene COVID-19 IgG/IgM Rapid Test showed superior overall sensitivity for detection of SARS-CoV-2 antibodies. Elecsys Anti-SARS-CoV-2 assay and EUROIMMUN Anti-SARS-CoV-2 combined IgG/IgA showed acceptable sensitivity (>95%) vs the consensus result of all assays from 10 days post onset of symptoms. Wantai SARS-COV-2 Ab ELISA, Elecsys Anti-SARS-CoV-2 assay, and Innovita 2019-nCoV Ab rapid test showed least cross-reactivity, resulting in an optimal analytical specificity greater than 98%. Conclusions Wantai SARS-COV-2 Ab ELISA and Elecsys Anti-SARS-CoV-2 assays are suitable for sensitive and specific detection of SARS-CoV-2 antibodies from 10 days after onset of symptoms.

DETEKSI ANTIBODI MULTIPEL HEPATITIS C DALAM DARAH DONOR

2016 ◽  
Vol 21 (3) ◽  
pp. 261
Author(s):  
Ranti Permatasari ◽  
Aryati Aryati ◽  
Budi Arifah
Keyword(s):  
Hepatitis C ◽  
Predictive Value ◽  
Core Protein ◽  
Rapid Test ◽  
Antibody Test ◽  
Diagnostic Value ◽  
Hcv Infection ◽  
Antibody Detection ◽  
Hcv Rna ◽  
Hcv Antibody

Hepatitis C (HCV) infection could be spread by blood transfusion. Screening of HCV in donor blood could prevent HCV infection to the recipient. HCV antibody test using rapid test of multiple antibody detection by immunochromatography method is an easy and rapid test that could detect four HCV antibodies separately. The aim of this study was to evaluate the diagnostic value of antibody HCV using multiple antibody detection rapid test in diagnosing HCV infection. This was an analytical observational study with a cross sectional design. The samples consisted of 42 donors’ blood serum from the Surabaya Branch of the Indonesian Red Cross which underwent HCV infection test using ELISA method. The samples were then tested using PCR HCV RNA as the gold standard and antibody HCV multiple antibodydetection rapid test The diagnostic value of HCV antibody test using multiple antibody detection rapid test by immunochromatography method showed a diagnostic sensitivity of 100%, diagnostic specificity of 75%, positive predictive value of 66.7% and negative predictive value of 100%, a diagnostic efficiency of 83.3%, with a positive probability ratio of 4 times. The most often positive antibody pattern was four (4) positive antibodies (core protein, NS3, NS4 and NS5). Core protein (CP) and NS3 were the most often positive antibodies. Based on this study result, the HCV antibody test using multiple antibody detection rapid test by immunochromatography method has a good diagnostic value.

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 Prevalence and genetic characterization of Toxoplasma gondii in naturally infected backyard pigs intended for familial consumption in Romania

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Anamaria Ioana Paştiu ◽  
Anamaria Cozma-Petruț ◽  
Aurélien Mercier ◽  
Anamaria Balea ◽  
Lokman Galal ◽  
...  
Keyword(s):  
Toxoplasma Gondii ◽  
Rural Areas ◽  
Antibody Test ◽  
Antibody Detection ◽  
Serum Samples ◽  
Potential Threat ◽  
Polymerase Chain ◽  
Pcr Targeting ◽  
Backyard Pigs

Abstract Background Foodborne toxoplasmosis in humans can be due to the exposure to tissue cysts of Toxoplasma gondii through the consumption of meat, including pork, of infected animals. Traditional Romanian food habits include pork as the preferred meat, while backyard pig rearing remains a common practice in many rural areas of Romania. The aims of the present study were to estimate the prevalence of T. gondii infection in naturally infected backyard pigs slaughtered for familial consumption and to genetically characterize the T. gondii strains obtained. Methods Paired blood and heart samples were collected from 94 backyard pigs, home slaughtered for private consumption. Serum samples were analyzed using the immunofluorescence antibody test (IFAT) for anti-T. gondii antibody detection. Heart samples were screened by polymerase chain reaction (PCR) targeting the 529-bp repeat region (REP529) for T. gondii detection. In addition, heart samples from IFAT positive animals were bioassayed in mice. The T. gondii isolates were genotyped by the analysis of 15 microsatellite markers. Results The results showed that almost half of the pigs investigated were T. gondii seropositive (46.8%, 95% confidence interval (CI): 36.4–57.4%) and in more than a quarter of the pigs (26.6%, 95% CI: 18.0–36.7%), the parasite was detected by PCR. Three (3/44) T. gondii strains were isolated from hearts of seropositive pigs and they all belonged to genotype II. Conclusions The present study showed the presence of T. gondii infection in backyard pigs in Romania, which suggests that consumption of pork from animals reared and slaughtered at home may pose a potential threat to human health and should be given attention. In addition, to our knowledge, this is the first study to provide data concerning T. gondii strains circulating in pigs from Romania.

Analytical and Clinical Performance of an Improved Qualitative Troponin T Rapid Test in Laboratories and Critical Care Units

2000 ◽  
Vol 124 (4) ◽  
pp. 583-587 ◽  
Author(s):  
Michael M. Hirschl ◽  
Harald Herkner ◽  
Anton N. Laggner ◽  
Christer Sylvén ◽  
Gundars Rasmanis ◽  
...  
Keyword(s):  
Critical Care ◽  
Clinical Performance ◽  
Troponin T ◽  
Rapid Test ◽  
Cross Reactivity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Critical Care Units ◽  
Hospital Units ◽  
Risk Patients ◽  
Coronary Syndromes

Abstract Objective.—To evaluate the performance of a visual troponin T rapid test in the hands of nontraditionally trained personnel of 2 critical care units in comparison to 3 laboratories. Methods.—Method comparisons of the troponin T rapid test versus cardiac troponin T enzyme-linked immunosorbent assay were performed with 804 samples from 510 patients with suspected acute coronary syndromes. Cross-reactivity with skeletal troponin T was studied up to 5000 μg/L. Results.—Laboratories and critical care units obtained comparable results in the analytical cutoff of the test (0.11 and 0.10 μg/L) and in the diagnostic sensitivities in the detection of acute myocardial infarction (96% and 93% after 8 hours) and of high-risk patients with unstable angina pectoris (100% and 100%). Different percentages of false-positive results (0.2% and 3%) were found, which may reflect different objectives and strategies in these hospital units. The cross-reactivity with skeletal troponin T was less than 0.01%. Conclusions.—The troponin T rapid test gives reliable results not only when used by laboratory personnel experienced in the execution of analytical methods, but also in the hands of nurses and physicians working in clinical units outside the laboratory.

scholarly journals Clinical evaluation of the Abbott Alinity SARS-CoV-2 spike-specific quantitative IgG and IgM assays among infected, recovered, and vaccinated groups

2021 ◽  
Author(s):  
Madhusudhanan Narasimhan ◽  
Lenin Mahimainathan ◽  
Ellen Araj ◽  
Andrew E. Clark ◽  
John Markantonis ◽  
...  
Keyword(s):  
Immune Responses ◽  
Clinical Performance ◽  
Antibody Test ◽  
Cross Reactivity ◽  
Antibody Responses ◽  
Spike Protein ◽  
Clinical Sensitivity ◽  
Health Infrastructure ◽  
Archived Samples ◽  
Significant Burden

The COVID-19 pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remains important, laboratories must now pivot and consider an assessment of SARS-CoV-2 immunity in the setting of the recent availability of multiple COVID-19 vaccines. Here we have utilized the latest Abbott Alinity semi-quantitative IgM and quantitative IgG spike protein (SP) serology assays (IgMSP and IgGSP) in combination with Abbott Alinity IgG nucleocapsid (NC) antibody test (IgGNC) to assess antibody responses in a cohort of 1236 unique participants comprised of naïve, SARS-CoV-2 infected, and vaccinated (including both naïve and recovered) individuals. The IgMSP and IgGSP assays were highly specific (100%) with no cross-reactivity to archived samples collected prior to the emergence of SARS-CoV-2, including those from individuals with seasonal coronavirus infections. Clinical sensitivity was 96% after 15 days for both IgMSP and IgGSP assays individually. When considered together, the sensitivity was 100%. A combination of NC- and SP-specific serologic assays clearly differentiated naïve, SARS-CoV-2-infected, and vaccine-related immune responses. Vaccination resulted in a significant increase in IgGSP and IgMSP values, with a major rise in IgGSP following the booster (second) dose in the naïve group. In contrast, SARS-CoV-2 recovered individuals had several fold higher IgGSP responses than naïve following the primary dose, with a comparatively dampened response following the booster. This work illustrates the strong clinical performance of these new serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination.

scholarly journals “Evaluation of a COVID-19 IgM and IgG Rapid Test and Assessment of Specific Antibody Response in COVID-19 patients, Tunisia 2020”

2021 ◽  
Author(s):  
letaief hejer ◽  
Sonia Dhaouadi ◽  
Aicha Hechaichi ◽  
Mouna Safer ◽  
Chahida Harizi ◽  
...  
Keyword(s):  
Antibody Response ◽  
Clinical Performance ◽  
Rapid Test ◽  
Antibody Test ◽  
Antibody Responses ◽  
Rt Pcr ◽  
Serological Tests ◽  
Clinical Sensitivity ◽  
Negative Results ◽  
Finger Stick

Abstract Background COVID-19 pandemic is a massive global health emergency. Although RT-PCR is the gold standard for diagnosing suspected cases, there is a need of serological tests to investigate antibody responses. Many serologic immunoassays have been developed to detect antibodies to SARS-CoV2, including rapid tests. This study assessed the clinical performance of the SARS-CoV-2 antibody test (colloidal gold immunochromatography, LEPU TECHNOLOGY) and evaluated the kinetic antibody response in COVID-19 patients.Methods: Samples collected by finger stick; obtained from RT-PCR confirmed cases and samples of negative controls were tested with the IgM/IgG Detection Kit . Results: The kit shows a clinical sensitivity of 65.7 % [59.7%-71.3%] and a specificity of 96.3% [93.0%-98.3%]. The predictive positive value and negative predictive value were respectively 95.2% [91.0%-97.8%] and 71.4% [66.1%-76.2%]. The seroconversion of specific IgM and IgG antibodies were observed as early as the 2nd day after symptom onset.Conclusions: This test is quite useful for assessing previous virus exposure, although negative results may be unreliable during the first weeks after infection. Longitudinal studies on antibody responses during and post infection are needed.

scholarly journals High-Accuracy Multiplexed SARS-CoV-2 Antibody Assay with Avidity and Saliva Capability on a Nano-Plasmonic Platform

2020 ◽  
Author(s):  
Tiancheng Liu ◽  
Jessica Hsiung ◽  
Su Zhao ◽  
Jessica Kost ◽  
Deepika Sreedhar ◽  
...  
Keyword(s):  
Near Infrared ◽  
Human Saliva ◽  
Cross Reactivity ◽  
Antibody Detection ◽  
Analytical Sensitivity ◽  
Serum Samples ◽  
Igg Antibody ◽  
Antibody Maturation ◽  
Global Pandemic ◽  
Rapid Spread

AbstractThe outbreak and rapid spread of SARS-CoV-2 virus has led to a dire global pandemic with millions of people infected and ~ 400,000 deaths thus far. Highly accurate detection of antibodies for COVID-19 is an indispensable part of the effort to combat the pandemic1,2. Here we developed two-plex antibody detection against SARS-CoV-2 spike proteins3 (the S1 subunit and receptor binding domain RBD) in human serum and saliva on a near-infrared nano-plasmonic gold (pGOLD) platform4–8. By testing nearly 600 serum samples, pGOLD COVID-19 assay achieved ~ 99.78 % specificity for detecting both IgG and IgM with 100 % sensitivity in sera collected > 14 days post disease symptom onset, with zero cross-reactivity to other diseases. Two-plex correlation analysis revealed higher binding of serum IgM to RBD than to S1. IgG antibody avidity toward multiple antigens were measured, shedding light on antibody maturation in COVID-19 patients and affording a powerful tool for differentiating recent from remote infections and identifying re-infection by SARS-CoV-2. Just as important, due to high analytical sensitivity, the pGOLD COVID-19 assay detected minute amounts of antibodies in human saliva, offering the first non-invasive detection of SARS-CoV-2 antibodies.

EVALUATION OF PERFORMANCE OF NINE SEROLOGICALASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES.

2021 ◽  
pp. 60-62
Author(s):  
Tagajdid Mohamed Rida ◽  
Konzi Clémence ◽  
El Kochri Safae ◽  
Elannaz Hicham ◽  
Abi Rachid ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Current Knowledge ◽  
False Negative ◽  
Antibody Test ◽  
Antibody Detection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Serological Tests ◽  
Blood Samples ◽  
Test Kit

Introduction: Currently, polymerase chain reaction (PCR) based viral RNAdetection is the standard for COVID-19 diagnosis [2]. Though, RNA testing based on throat or nasopharyngeal swabs has shown a number of false-negative results. Antibody detection tests have been developed to detect specic antibodies, IgM and IgG, to SRAS-CoV-2 virus. The clinical relevance of these tests is still under evaluation and is highly related to their clinical performance. Our objective is to assess analytical performances of nine SARS-CoV-2 antibodies immunoassays. Materiel and Method: We collected 80 blood samples from PCR-conrmed COVID-19 patients diagnosed in our Virology department (20 samples collected at day 10 after the onset of symptoms, 60 collected after day 14 following the onset of symptoms) and 20 blood samples from patients SARS-CoV-2 RT-PCR negative. All sera were tested with nine SARS-CoV-2 antibodies immunoassays ARCHITECT SARS-CoV-2 IgG® (Abbott), COVID-19 VIRCLIA® IgG MONOTEST (Vircell), COVID-19 VIRCLIA® IgM+IgA MONOTEST (Vircell), COVID-19 ELISA IgG® (Vircell), COVID-19 ELISA IgM+IgA® (Vircell), Elecsys® Anti-SARS-CoV-2 (Roche), FREND® COVID-19 IgG/IgM Duo (NanoEntek), COVID-PRESTO® (AAZ) and COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit® (Labnovation Technologies). Results: Sensitivity of tests increases once the seroconversion to anti-SARS-CoV-2 IgG positive in most individuals occurs toward the end of week 2 post-infection. COVID-19 PRESTO had the best accuracy in our study showing 100% sensitivity after day 14 following the onset of symptoms. All of the tests had a specicity of 100%. Conclusion: Serological tests are sensitive for the latest stages of COVID-19 infection. Recommendations on using SRAS-COV-2 antibody detection tests are continuously improving based on current knowledge of host antibody responses during infection. They are of great value in cases presenting COVID-19 symptoms with negative RT-PCR.

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