scholarly journals Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1441
Author(s):  
Suelen Basgalupp ◽  
Giovana dos Santos ◽  
Marina Bessel ◽  
Lara Garcia ◽  
Ana Carolina de Moura ◽  
...  

Serological assays emerged as complementary tools to RT-PCR in the diagnosis of SARS-CoV-2 as well as being needed for epidemiological studies. This study aimed to assess the performance of a rapid test (RT) compared to that of serological tests using finger prick blood samples. A total of 183 samples were evaluated, 88 of which were collected from individuals with negative RT-PCR and 95 from positive RT-PCR individuals. The diagnostic performance of RT (WONDFO®) and LUMIT (PROMEGA®) were compared to that of ELISA (EUROIMMUN®) for detecting antibodies against SARS-CoV-2 according to time from symptoms onset. The IgG antibody tests were detected in 77.4% (LUMIT), 77.9% (RT), and 80.0% (ELISA) of individuals. The detection of antibodies against SARS-CoV-2 increases in accordance with increasing time from symptoms onset. Considering only time from symptoms onset >21 days, the positivity rate ranged from 81.8 to 97.0% between the three tests. The RT and LUMIT showed high agreement with ELISA (agreement = 91.5%, k = 0.83, and agreement = 96.3%, k = 0.9, respectively) in individuals who had symptoms 15 to 21 days before sample collection. Compared to that of the ELISA assay, our results show sensitivity ranged from 95% to 100% for IgG antibody detection in individuals with symptoms onset between 15 and 21 days before sample collection. The specificity was 100% in individuals with symptoms onset >15 days before serological tests. This study shows good performance and high level of agreement of three immunoassays for the detection of SARS-CoV-2 antibodies.

2011 ◽  
Vol 18 (12) ◽  
pp. 2095-2101 ◽  
Author(s):  
Stuart D. Blacksell ◽  
Richard G. Jarman ◽  
Mark S. Bailey ◽  
Ampai Tanganuchitcharnchai ◽  
Kemajittra Jenjaroen ◽  
...  

ABSTRACTSix assays were evaluated in this study to determine their suitability for the diagnosis of acute dengue infection using samples from 259 Sri Lankan patients with acute fevers (99 confirmed dengue cases and 160 patients with other confirmed acute febrile illnesses): (i) the Merlin dengue fever IgG & IgM combo device (Merlin), (ii) the Standard Diagnostics Dengue Duo nonstructural 1 (NS1) antigen and IgG/IgM combo device (Standard Diagnostics, South Korea), (iii) the Biosynex Immunoquick dengue fever IgG and IgM (Biosynex, France) assay, (iv) the Bio-Rad NS1 antigen strip (Bio-Rad, France), (v) the Panbio Dengue Duo IgG/IgM Cassette (Inverness, Australia), and (vi) the Panbio dengue NS1 antigen strip (Inverness, Australia). The median number of days of fever prior to admission sample collection was 5 days (interquartile range, 3 to 7 days). Sensitivity and specificity of the NS1 antigen tests ranged from 49 to 59% and from 93 to 99%, respectively, and sensitivity and sensitivity of the IgM antibody test ranged from 71 to 80% and from 46 to 90%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics Dengue Duo test gave the best compromise of sensitivity and specificity (93% and 89%, respectively) and provided the best sensitivity in patients presenting at different times after fever onset. The Merlin IgM/IgG antibody tests correctly classified 64% and 86% of the primary and secondary dengue infection cases, respectively, and the Standard Diagnostics IgM/IgG antibody tests correctly classified 71% and 83% of the primary and secondary dengue infection cases, respectively. This study provides strong evidence of the value of combining dengue antigen- and antibody-based test results in the rapid diagnostic test (RDT) format for the acute diagnosis of dengue.


2021 ◽  
pp. 60-62
Author(s):  
Tagajdid Mohamed Rida ◽  
Konzi Clémence ◽  
El Kochri Safae ◽  
Elannaz Hicham ◽  
Abi Rachid ◽  
...  

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.


2020 ◽  
Vol 11 ◽  
Author(s):  
Moïse Michel ◽  
Amar Bouam ◽  
Sophie Edouard ◽  
Florence Fenollar ◽  
Fabrizio Di Pinto ◽  
...  

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.


Author(s):  
Oskar Ekelund ◽  
Kim Ekblom ◽  
Sofia Somajo ◽  
Johanna Pattison-Granberg ◽  
Karl Olsson ◽  
...  

Background: The recently launched high-throughput assays for the detection of antibodies against SARS-CoV-2 may change the managing strategies for the COVID-19 pandemic. This study aimed at investigating the performance of three high-throughput assays and one rapid lateral flow test relative to the recommended criteria defined by regulatory authorities. Methods: A total of 133 samples, including 100 pre-pandemic samples, 20 samples from SARS-CoV-2 RT-PCR positive individuals, and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott), Elecsys Anti-SARS-CoV-2 (Roche), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co). Results: All assays performed with a high level of specificity; however, only Abbott reached 100% (95% CI 96.3-100). The pre-pandemic samples analysed with Roche, DiaSorin and Dynamiker Biotechnology resulted in two to three false-positive results per method (specificity 96.9-98.0%). Sensitivity differed more between the assays, Roche exhibiting the highest sensitivity (100%, CI 83.9-100). The corresponding figures for Abbott, DiaSorin and Dynamiker Biotechnology were 85.0%, 77.8% and 75.0%, respectively. Conclusions: The results of the evaluated SARS-CoV-2 assays vary considerably as well as their ability to fulfil the performance criteria proposed by regulatory authorities. Introduction into clinical use in low-prevalent settings, should therefore, be made with caution.


Author(s):  
Julie Toubiana ◽  
Clement Poirault ◽  
Alice Corsia ◽  
Fanny Bajolle ◽  
Jacques Fourgeaud ◽  
...  

Background: Acute clinical manifestations of SARS-CoV-2 infection are less frequent and less severe in children than in adults. However, recent observations raised concerns about potential post-viral severe inflammatory reactions in children infected with SARS-CoV-2. Methods: We describe an outbreak of cases of Kawasaki disease (KD) admitted between April 27 and May 7, 2020, in the general paediatrics department of a university hospital in Paris, France. All children prospectively underwent nasopharyngeal swabs for SARS-CoV-2 RT-PCR, SARS-CoV-2 IgG serology testing, and echocardiography. The number of admissions for KD during the study period was compared to that observed since January 1, 2018, based on discharge codes, using Poisson regression. Results: A total of 17 children were admitted for KD over an 11-day period, in contrast with a mean of 1.0 case per 2-week period over 2018-2019 (Poisson incidence rate ratio: 13.2 [95% confidence interval: 7.3-24.1], p <0.001). Their median age was 7.5 (range, 3.7-16.6) years, and 59% of patients originated from sub-Saharan Africa or Caribbean islands. Eleven patients presented with KD shock syndrome (KDSS) requiring intensive care support, and 12 had myocarditis. All children had marked gastrointestinal symptoms at the early stage of illness and high levels of inflammatory markers. Fourteen patients (82%) had evidence of recent SARS-CoV-2 infection (positive RT-PCR 7/17, positive IgG antibody detection 14/16). All patients received immunoglobulins and some received corticosteroids (5/17). The clinical outcome was favourable in all patients. Moderate coronary artery dilations were detected in 5 cases (29%) during hospitalisation. Conclusions: The ongoing outbreak of KD in the Paris might be related to SARS-CoV2, and shows an unusually high proportion of children with gastrointestinal involvement, KDSS and African ancestry.


2020 ◽  
Author(s):  
Isabelle Piec ◽  
Emma English ◽  
M Annette Thomas ◽  
Samir Dervisevic ◽  
William D Fraser ◽  
...  

AbstractBackgroundIn the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations.MethodsSARS-CoV-2 patient samples (n=43) were analysed alongside pre-pandemic control specimen (n=50), confirmed respiratory infections (n=50), inflammatory polyarthritis (n=22) and positive for thyroid stimulating immunoglobulin (n=30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen.ResultsEDI and EuroImmun imprecision was 0.02-14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2% - 8.1% and 8.2% - 9.6% respectively. Diagnostic sensitivity of the assays were 100% (CI: 80-100%) for Abbott, EDI and EuroImmun and 95% (CI: 73-100%) for DiaSorin at ≥14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI: 91-100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%.ConclusionsSerological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.


2018 ◽  
Vol 5 (2) ◽  
pp. 395
Author(s):  
Abhra Banerjee ◽  
Uttam Kumar Paul ◽  
Arup Bandyopadhyay

Background: Dengue fever is currently the most important arthropod borne viral disease. Since occurrence of dengue infections has been an epidemic in many parts of India and complications like DHF and DSS are increasing, while at the same time the diagnosis is challenging, particularly the laboratory diagnosis is confusing, this study was conducted to evaluate the different laboratory test methods and to compare their respective efficacy, timing, advantages and disadvantages.Methods: This study was done in the Department of Microbiology in collaboration with the Department of Medicine and Pediatrics in two tertiary care medical colleges and hospitals in eastern India. Blood samples from 319 patients with clinical features suggestive of Dengue fever were included in this study. Laboratory investigations were done which included immunological assays that were performed using commercially available kits - SD dengue duo NS1Ag + Ab combo rapid test, NS1 Ag capture ELISA, IgM capture ELISA, IgG capture ELISA test for dengue and other routine tests -full blood cell count, coagulation tests, routine biochemical and lipid profile were also done. Ethical considerations were taken care of and statistical evaluations were done.Results: An increased detection of IgM antibody (46.15%) was seen in the early febrile period (1-5 days) as compared to the mid-febrile period (6-10 days), and late febrile period (6-10 days) when it is 6.89%. IgG antibody is much less in early febrile period (4.16%). Compared to mid-febrile period (24.13%), and late febrile period (62.5%). IgM antibodies were detected in 44.5% of the samples, IgG antibodies were detected in 43.5% of the samples, Rapid test was positive in 36.9% and NS1AG ELISA was detected in 43.5% of the samples in the study.Conclusions: It can be inferred from our study that for detection of dengue in the early febrile period (1-5 days), estimation of dengue-specific serum IgM is the most sensitive antibody detection method.


2020 ◽  
Author(s):  
Berhanu Nega Alemu ◽  
Adamu Addissie ◽  
Gemechis Mamo ◽  
Negussie Deyessa ◽  
Tamrat Abebe ◽  
...  

AbstractBackgroundAnti-SARS-CoV-2 antibody tests are being increasingly used for sero-epidemiological purposes to provide better understanding of the extent of the infection in the community, and monitoring the progression of the COVID-19 epidemic. We conducted sero-prevalence study to estimate prior infection with with SARS-CoV-2 in Addis Ababa.MethodsA cross-sectional study was done from April 23 to 28, 2020 among 301 randomly selected residents of Addis Ababa; with no known history of contact with confirmed COVID-19 person. Interviews on socio demographic and behavioural risk factor followed by serological tests were performed for SARS-CoV-2 IgM, and IgG antibodies, using COVID-19 IgG/IgM Rapid Test Cassette. The test has sensitivity of 87·9% and specificity of 100% for lgM; and a sensitivity of 97·2% and specificity of 100% for IgG. RT-PCR test was also done on combined nasopharyngeal and oropharengeal swabs as an important public health consideration.FindingsThe unadjusted antibody-based crude SARS-CoV-2 prevalence was 7·6% and the adjusted true SARS-CoV-2 prevalence was estimated at 8·8% (95% CI 5·5%-11·6%) for the study population. Higher sero-prevalence were observed for males (9.0%), age below 50 years (8.2%), students and unemployed (15.6%), those with primary education (12.1%), smokers (7.8%), alcohol consumers (8.6%), chatt-chewers (13.6%) and shish smokers (18.8%). Seroprevalence was not significantly associated neither with socio-demographic not behavioral characteristics. According to the findings, possibly more individuals had been infected in Addis Ababa than what was being detected and reported by RT-PCR test suggestive of community transmission. The use of serological test for epidemiological estimation of the extent of SARS-CoV-2 epidemic gives a more precise estimate of magnitude which would be used for further monitoring and surveillance of the magnitude of the SARS CoV-2 infection.


Author(s):  
Niko Kohmer ◽  
Sandra Westhaus ◽  
Cornelia Rühl ◽  
Sandra Ciesek ◽  
Holger F. Rabenau

AbstractAs the current SARS-CoV-2 pandemic continues, serological assays are urgently needed for rapid diagnosis, contact tracing and for epidemiological studies. So far, there is little data on how commercially available tests perform with real patient samples and if detected IgG antibodies provide protective immunity. Focusing on IgG antibodies, we demonstrate the performance of two ELISA assays (Euroimmun SARS-CoV-2 IgG & Vircell COVID-19 ELISA IgG) in comparison to one lateral flow assay ((LFA) FaStep COVID-19 IgG/IgM Rapid Test Device) and two in-house developed assays (immunofluorescence assay (IFA) and plaque reduction neutralization test (PRNT)). We tested follow up serum/plasma samples of individuals PCR-diagnosed with COVID-19. Most of the SARS-CoV-2 samples were from individuals with moderate to severe clinical course, who required an in-patient hospital stay.For all examined assays, the sensitivity ranged from 58.8 to 76.5% for the early phase of infection (days 5-9) and from 93.8 to 100% for the later period (days 10-18) after PCR-diagnosed with COVID-19. With exception of one sample, all positive tested samples in the analysed cohort, using the commercially available assays examined (including the in-house developed IFA), demonstrated neutralizing (protective) properties in the PRNT, indicating a potential protective immunity to SARS-CoV-2. Regarding specificity, there was evidence that samples of endemic coronavirus (HCoV-OC43, HCoV-229E) and Epstein Barr virus (EBV) infected individuals cross-reacted in the ELISA assays and IFA, in one case generating a false positive result (may giving a false sense of security). This need to be further investigated.


2020 ◽  
Vol 54 ◽  
Author(s):  
Aldrich Ivan Lois D. Burog ◽  
Clarence Pio Rey C. Yacapin ◽  
Renee Rose O. Maglente ◽  
Anna Angelica Macalalad-Josue ◽  
Elenore Judy B. Uy ◽  
...  

KEY FINDINGS Current evidence does NOT support use of IgM/IgG rapid test kits for the definitive diagnosis of COVID-19 in currently symptomatic patients. • The present standard for diagnosis of COVID-19 is through qualitative detection of COVID-19 virus nucleic acid via reverse transcription polymerase chain reaction (RT-PCR). • Due to long turnaround times and complicated logistical operations, a rapid and simple field test alternative is needed to diagnose and screen patients. • An alternative to the direct detection and measurement of viral load (RT-PCR) is the qualitative detection of specific antibodies to COVID-19. ELISA (discussed in a separate rapid review) and lateral flow immunoassay (LFIA) IgM/IgG rapid test kits are two currently available, qualitative, antibody tests for COVID-19. • Two low quality clinical trials showed that there is insufficient evidence to support the use of IgM/IgG rapid test kits for the definitive diagnosis of COVID-19. Diagnostic accuracy varies greatly depending on the timing of the test. The test performed very poorly during the early phase of the disease (i.e., less than eight days from onset of symptoms). • Existing guidelines do not recommend serologic antibody tests for the diagnosis of COVID-19 in currently symptomatic patients.


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