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The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.
Tove Hoffman; Linda Kolstad; Bengt Rönnberg; Åke Lundkvist. Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2. Viruses 2021, 13, 1043 .
AMA StyleTove Hoffman, Linda Kolstad, Bengt Rönnberg, Åke Lundkvist. Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2. Viruses. 2021; 13 (6):1043.
Chicago/Turabian StyleTove Hoffman; Linda Kolstad; Bengt Rönnberg; Åke Lundkvist. 2021. "Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2." Viruses 13, no. 6: 1043.
Due to the current, rapidly increasing Coronavirus disease 2019 (COVID-19) pandemic, efficient and highly specific diagnostic methods are needed. The receptor-binding part of the spike (S) protein, S1, has been suggested to be highly virus-specific; it does not cross-react with antibodies against other coronaviruses. Three recombinant partial S proteins of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) expressed in mammalian or baculovirus-insect cells were evaluated as antigens in a Luminex-based suspension immunoassay (SIA). The best performing antigen (S1; amino acids 16-685) was selected and further evaluated by serum samples from 76 Swedish patients or convalescents with COVID-19 (previously PCR and/or serologically confirmed), 200 pre-COVID-19 individuals (180 blood donors and 20 infants), and 10 patients with acute Epstein-Barr virus infection. All 76 positive samples showed detectable antibodies to S1, while none of the 210 negative controls gave a false positive antibody reaction. We further compared the COVID-19 SIA with a commercially available enzyme immunoassay and a previously evaluated COVID-19 rapid antibody test. The results revealed an overall assay sensitivity of 100%, a specificity of 100% for both IgM and IgG, a quantitative ability at concentrations up to 25 BAU/mL, and a better performance as compared to the commercial assays, suggesting the COVID-19 SIA as a most valuable tool for efficient laboratory-based serology.
Tove Hoffman; Linda Kolstad; Johanna Lindahl; Bo Albinsson; Anders Bergqvist; Bengt Rönnberg; Åke Lundkvist. Diagnostic Potential of a Luminex-Based Coronavirus Disease 2019 Suspension Immunoassay (COVID-19 SIA) for the Detection of Antibodies against SARS-CoV-2. Viruses 2021, 13, 993 .
AMA StyleTove Hoffman, Linda Kolstad, Johanna Lindahl, Bo Albinsson, Anders Bergqvist, Bengt Rönnberg, Åke Lundkvist. Diagnostic Potential of a Luminex-Based Coronavirus Disease 2019 Suspension Immunoassay (COVID-19 SIA) for the Detection of Antibodies against SARS-CoV-2. Viruses. 2021; 13 (6):993.
Chicago/Turabian StyleTove Hoffman; Linda Kolstad; Johanna Lindahl; Bo Albinsson; Anders Bergqvist; Bengt Rönnberg; Åke Lundkvist. 2021. "Diagnostic Potential of a Luminex-Based Coronavirus Disease 2019 Suspension Immunoassay (COVID-19 SIA) for the Detection of Antibodies against SARS-CoV-2." Viruses 13, no. 6: 993.
Background and objectives Several antibody tests are available to detect SARS-CoV-2 specific antibodies, many of which address different antigens. Rapid point-of-care (POC) tests have been doubted due to an eventual risk of production errors, although it is unstudied whether such error would affect test sensitivity and/or specificity. We aimed to evaluate two separate production lots of a commercially available test intended for rapid detection of IgM and IgG against the N-terminal part of the SARS-CoV-2 spike protein (S1). Materials and methods Serum samples from individuals with confirmed SARS-CoV-2 infection, by RT-PCR and/or serology, and pre-COVID-19 negative control sera gathered from a biobank during 2018 were collected. The presence of anti-S1 IgM/IgG was verified by an in-house Luminex-based serological assay, serving as reference method. The index test was a commercially available rapid POC-test (the COVID-19 IgG/IgM Rapid Test Cassette [Zhejiang Orient Gene Biotech Co Ltd, Huzhou, Zhejiang, China/Healgen Scientific, LLC, U.S.A.]). Results One hundred samples were verified positive for anti-S1 IgG (median fluorescence intensity (MFI) ≥900) and 74 for anti-S1 IgM (MFI ≥700), confirmed by RT-PCR (n=90) and/or serology (n=89). None of the negative controls (n=200; MFI Conclusion The rapid POC-test used in this study is suitable to assess SARS-CoV-2 anti-S1 specific IgM/IgG, as a measure of previous virus exposure on an individual level. While the specificity was not affected by production lot, external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.
Tove Hoffman; Linda Kolstad; Bengt Rönnberg; Åke Lundkvist. Evaluation of production lots of a rapid point-of-care lateral flow serological test intended for identification of IgM and IgG against the N-terminal part of the spike protein (S1) of SARS-CoV-2. 2020, 1 .
AMA StyleTove Hoffman, Linda Kolstad, Bengt Rönnberg, Åke Lundkvist. Evaluation of production lots of a rapid point-of-care lateral flow serological test intended for identification of IgM and IgG against the N-terminal part of the spike protein (S1) of SARS-CoV-2. . 2020; ():1.
Chicago/Turabian StyleTove Hoffman; Linda Kolstad; Bengt Rönnberg; Åke Lundkvist. 2020. "Evaluation of production lots of a rapid point-of-care lateral flow serological test intended for identification of IgM and IgG against the N-terminal part of the spike protein (S1) of SARS-CoV-2." , no. : 1.
COVID-19 is the most rapidly growing pandemic in modern time, and the need for serological testing is most urgent. Although the diagnostics of acute patients by RT-PCR is both efficient and specific, we are also crucially in need of serological tools for investigating antibody responses and assessing individual and potential herd immunity. We evaluated a commercially available test developed for rapid (within 15 minutes) detection of SARS-CoV-2-specific IgM and IgG by 29 PCR-confirmed COVID-19 cases and 124 negative controls. The results revealed a sensitivity of 69% and 93.1% for IgM and IgG, respectively, based solely on PCR-positivity due to the absence of a serological gold standard. The assay specificities were shown to be 100% for IgM and 99.2% for IgG. This indicates that the test is suitable for assessing previous virus exposure, although negative results may be unreliable during the first weeks after infection. More detailed studies on antibody responses during and post infection are urgently needed.
Tove Hoffman; Karolina Nissen; Janina Krambrich; Bengt Rönnberg; Dario Akaberi; Mouna Esmaeilzadeh; Erik Salaneck; Johanna Lindahl; Åke Lundkvist. Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2. Infection Ecology & Epidemiology 2020, 10, 1754538 .
AMA StyleTove Hoffman, Karolina Nissen, Janina Krambrich, Bengt Rönnberg, Dario Akaberi, Mouna Esmaeilzadeh, Erik Salaneck, Johanna Lindahl, Åke Lundkvist. Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2. Infection Ecology & Epidemiology. 2020; 10 (1):1754538.
Chicago/Turabian StyleTove Hoffman; Karolina Nissen; Janina Krambrich; Bengt Rönnberg; Dario Akaberi; Mouna Esmaeilzadeh; Erik Salaneck; Johanna Lindahl; Åke Lundkvist. 2020. "Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2." Infection Ecology & Epidemiology 10, no. 1: 1754538.
We report a new tool for improved serological diagnostics in suspected tick-borne encephalitis (TBE) vaccine failure cases. Due to an increase in the incidence of disease as well as the number of vaccinees, specific and simplified diagnostic methods are needed. Antibody responses to TBE-virus (TBEV) non-structural protein 1 (NS1) are detectable post TBEV infection but not post vaccination. We have used samples from 14 previously confirmed Swedish TBEV vaccine failure patients to study antibody responses against NS1 and whole virus antigens, respectively. Our conclusion is that the detection of antibodies directed to TBEV NS1 antigen is a useful tool to considerably simplify and improve the quality in investigations regarding suspected TBEV infection in vaccinated patients.
Bo Albinsson; Bengt Rönnberg; Sirkka Vene; Åke Lundkvist. Antibody responses to tick-borne encephalitis virus non-structural protein 1 and whole virus antigen–a new tool in the assessment of suspected vaccine failure patients. Infection Ecology & Epidemiology 2019, 9, 1696132 .
AMA StyleBo Albinsson, Bengt Rönnberg, Sirkka Vene, Åke Lundkvist. Antibody responses to tick-borne encephalitis virus non-structural protein 1 and whole virus antigen–a new tool in the assessment of suspected vaccine failure patients. Infection Ecology & Epidemiology. 2019; 9 (1):1696132.
Chicago/Turabian StyleBo Albinsson; Bengt Rönnberg; Sirkka Vene; Åke Lundkvist. 2019. "Antibody responses to tick-borne encephalitis virus non-structural protein 1 and whole virus antigen–a new tool in the assessment of suspected vaccine failure patients." Infection Ecology & Epidemiology 9, no. 1: 1696132.
Tick-borne encephalitis virus (TBEV) is an important European vaccine-preventable pathogen. Discrimination of vaccine-induced antibodies from those elicited by infection is important. We studied anti-TBEV IgM/IgG responses, including avidity and neutralisation, by multiplex serology in 50 TBEV patients and 50 TBEV vaccinees. Infection induced antibodies reactive to both whole virus (WV) and non-structural protein 1 (NS1) in 48 clinical cases, whereas 47 TBEV vaccinees had WV, but not NS1 antibodies, enabling efficient discrimination of infection/vaccination.
Bo Albinsson; Sirkka Vene; Lars Rombo; Jonas Blomberg; Åke Lundkvist; Bengt Ronnberg. Distinction between serological responses following tick-borne encephalitis virus (TBEV) infection vs vaccination, Sweden 2017. Eurosurveillance 2018, 23, 17-00838 .
AMA StyleBo Albinsson, Sirkka Vene, Lars Rombo, Jonas Blomberg, Åke Lundkvist, Bengt Ronnberg. Distinction between serological responses following tick-borne encephalitis virus (TBEV) infection vs vaccination, Sweden 2017. Eurosurveillance. 2018; 23 (3):17-00838.
Chicago/Turabian StyleBo Albinsson; Sirkka Vene; Lars Rombo; Jonas Blomberg; Åke Lundkvist; Bengt Ronnberg. 2018. "Distinction between serological responses following tick-borne encephalitis virus (TBEV) infection vs vaccination, Sweden 2017." Eurosurveillance 23, no. 3: 17-00838.
The recent spread of Zika virus (ZIKV) in the Americas and Asia necessitates an increased preparedness for improved maternal and perinatal health and blood safety. However, serological cross-reactions, especially to Dengue virus (DENV), complicate ZIKV antibody serodiagnosis. A novel “pan-Flavi” suspension multiplex immunoassay (PFSMIA) using 25 antigens, whole virus (WV), non-structural protein 1 (NS1), and envelope (E) proteins, from 7 zoonotic flaviviruses for specific detection of ZIKV and DENV IgM and IgG was developed. Patterns of antibody cross-reactivity, avidity, and kinetics were established in 104 sera from returning travelers with known ZIKV and DENV infections. PFSMIA gave IgM- and IgG-sensitivities for both viruses of 96–100%, compared to an immunofluorescence assay. Main IgM cross-reactions were to NS1, for IgG to the E and WV antigens. Infecting virus yielded reactivity to several antigens of the homologous virus, while cross-reactions tended to occur only to a single antigen from heterologous virus(es). A specificity-enhancing computer procedure took into account antibody isotype, number of antibody-reactive antigens per virus, avidity, average degree of cross-reactivity to heterologous flavivirus antigens, and reactivity changes in serial sera. It classified all 50 cases correctly. Applied to sera from 200 pregnant women and 173 blood donors from Sweden, one blood donor was found ZIKV NS1 IgM positive, and another as ZIKV NS1 IgG positive. These samples did not react with other ZIKV antigens and were thereby judged as false-positives. PFSMIA provided sensitive and specific ZIKV and DENV serology, warranting high-throughput serological surveillance and a minimized need for laborious and expensive virus neutralization assays.
Bengt Ronnberg; Åke Gustafsson; Olli Vapalahti; Petra Emmerich; Åke Lundkvist; Jonas Schmidt-Chanasit; Jonas Blomberg. Compensating for cross-reactions using avidity and computation in a suspension multiplex immunoassay for serotyping of Zika versus other flavivirus infections. Medical Microbiology and Immunology 2017, 206, 383 -401.
AMA StyleBengt Ronnberg, Åke Gustafsson, Olli Vapalahti, Petra Emmerich, Åke Lundkvist, Jonas Schmidt-Chanasit, Jonas Blomberg. Compensating for cross-reactions using avidity and computation in a suspension multiplex immunoassay for serotyping of Zika versus other flavivirus infections. Medical Microbiology and Immunology. 2017; 206 (5):383-401.
Chicago/Turabian StyleBengt Ronnberg; Åke Gustafsson; Olli Vapalahti; Petra Emmerich; Åke Lundkvist; Jonas Schmidt-Chanasit; Jonas Blomberg. 2017. "Compensating for cross-reactions using avidity and computation in a suspension multiplex immunoassay for serotyping of Zika versus other flavivirus infections." Medical Microbiology and Immunology 206, no. 5: 383-401.
Introduction: Hantaviruses are globally distributed zoonotic pathogens. Great diversity and high antigenic cross-reactivity makes diagnosis by traditional methods cumbersome. Materials and methods: ‘Megapeptides’, 119–120-mers from the amino terminus of the nucleoprotein of 16 hantaviruses, representing the four major branches of the hantavirus phylogenetic tree, were utilized in a novel IgG-based hantavirus suspension multiplex immunoassay (HSMIA) for detection of past hantavirus infections in 155 North European human samples. We compared HSMIA with established EIAs and focus reduction neutralization test (FRNT). Results and discussion: The Puumala hantavirus (PUUV) component in the HSMIA gave concordant results with a PUUV IgG EIA in 142 sera from Northern Sweden (of which 31 were EIA positive, 7 borderline and 104 EIA negative, sensitivity 30/31 = 97%, specificity 104/ 104 = 100%, 134/135 = 99% concordance), with another immunoassay in 40 PUUV IgG positive sera from Finland (36/40 = 90% sensitivity), and was concordant in 8 of 11 cases with PUUV and DOBV neutralization titers, respectively. Two major IgG reactivity patterns were found: (i) a PUUV-specific pattern covering phylogroup IV and its serogroups B and C; and (ii) a Dobrava virus (DOBV)-specific pattern, covering the serogroup A portion of phylogroup III. In addition, we found several minor patterns with reactivity to only one or two megapeptides indicating additional hantaviruses infecting humans in the Swedish and Finnish populations. Conclusion: The broadly reactive and rational HSMIA yielded results highly correlated with the established PUUV EIAs and the NT results. It is a sensitive and specific assay, which will be suited for efficient serosurveillance of hantaviruses in humans. Its use in animals should be further investigated.
Bengt Rönnberg; Olli Vapalahti; Marco Goeijenbier; Chantal Reusken; Åke Gustafsson; Jonas Blomberg; Åke Lundkvist. Serogrouping and seroepidemiology of North European hantaviruses using a novel broadly targeted synthetic nucleoprotein antigen array. Infection Ecology & Epidemiology 2017, 7, 1350086 -1350086.
AMA StyleBengt Rönnberg, Olli Vapalahti, Marco Goeijenbier, Chantal Reusken, Åke Gustafsson, Jonas Blomberg, Åke Lundkvist. Serogrouping and seroepidemiology of North European hantaviruses using a novel broadly targeted synthetic nucleoprotein antigen array. Infection Ecology & Epidemiology. 2017; 7 (1):1350086-1350086.
Chicago/Turabian StyleBengt Rönnberg; Olli Vapalahti; Marco Goeijenbier; Chantal Reusken; Åke Gustafsson; Jonas Blomberg; Åke Lundkvist. 2017. "Serogrouping and seroepidemiology of North European hantaviruses using a novel broadly targeted synthetic nucleoprotein antigen array." Infection Ecology & Epidemiology 7, no. 1: 1350086-1350086.
Background: Antibodies to microbes, or to autoantigens, are important markers of disease. Antibody detection (serology) can reveal both past and recent infections. There is a great need for development of rational ways of detecting and quantifying antibodies, both for humans and animals. Traditionally, serology using synthetic antigens covers linear epitopes using up to 30 amino acid peptides. Methods: We here report that peptides of 100 amino acids or longer (“megapeptides”), designed and synthesized for optimal serological performance, can successfully be used as detection antigens in a suspension multiplex immunoassay (SMIA). Megapeptides can quickly be created just from pathogen sequences. A combination of rational sequencing and bioinformatic routines for definition of diagnostically-relevant antigens can, thus, rapidly yield efficient serological diagnostic tools for an emerging infectious pathogen. Results: We designed megapeptides using bioinformatics and viral genome sequences. These long peptides were tested as antigens for the presence of antibodies in human serum to the filo-, herpes-, and polyoma virus families in a multiplex microarray system. All of these virus families contain recently discovered or emerging infectious viruses. Conclusion: Long synthetic peptides can be useful as serological diagnostic antigens, serving as biomarkers, in suspension microarrays.
Muhammad Rizwan; Bengt Rönnberg; Maksims Cistjakovs; Åke Lundkvist; Rudiger Pipkorn; Jonas Blomberg. Serology in the Digital Age: Using Long Synthetic Peptides Created from Nucleic Acid Sequences as Antigens in Microarrays. Microarrays 2016, 5, 22 .
AMA StyleMuhammad Rizwan, Bengt Rönnberg, Maksims Cistjakovs, Åke Lundkvist, Rudiger Pipkorn, Jonas Blomberg. Serology in the Digital Age: Using Long Synthetic Peptides Created from Nucleic Acid Sequences as Antigens in Microarrays. Microarrays. 2016; 5 (3):22.
Chicago/Turabian StyleMuhammad Rizwan; Bengt Rönnberg; Maksims Cistjakovs; Åke Lundkvist; Rudiger Pipkorn; Jonas Blomberg. 2016. "Serology in the Digital Age: Using Long Synthetic Peptides Created from Nucleic Acid Sequences as Antigens in Microarrays." Microarrays 5, no. 3: 22.