Assessment of immune response to SARS-CoV-2 with fully automated MAGLUMI 2019-nCoV IgG and IgM chemiluminescence immunoassays

Lippi, Giuseppe; Salvagno, Gian Luca; Pegoraro, M.; Militello, Valentina; Caloi, Cecilia; Peretti, Alessandro; Gaino, Stefania; Bassi, Antonella; Bovo, Chiara; Cascio, Giuliana Lo

doi:10.1515/cclm-2020-0473

Cited by 113 publications

(111 citation statements)

References 9 publications

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“…The validation of the method was performed according to the ISO15189 standard requirements. The quality of conformance declared by the manufacturer regarding serum inactivation, intra-and inter-day repeatability, and linearity was confirmed 4,5 . Diagnostic sensitivity and specificity provided by the manufacturer and deriving from two Chinese clinical studies are as follows: clinical sensitivity and specificity 78.65% and 97.50% for IgM, 91.21% and 97.33% for IgG, 89.89-95.6% and 96.5-96.0% for IgM+IgG, respectively.…”

mentioning

confidence: 61%

Severe Acute Respiratory Syndrome Coronavirus 2 Serology in Asymptomatic Healthcare Professionals: Preliminary Experience of a Tertiary Italian Academic Center

Tosato

Pelloso

Gallo

et al. 2020

Preprint

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We investigated the SARS-CoV-2 specific antibody titers in 133 asymptomatic healthcare providers working at the Department of Laboratory Medicine of our tertiary center. A commercial chemiluminescence immunoassay, validated according to the ISO15189 standard requirements, was used. All the enrolled healthcare professionals underwent, simultaneously to the blood sampling, a nasopharyngeal swab for molecular testing with quantitative reverse-transcriptase-based polymerase chain reaction (RT-PCR). An overall positiveness of 5.25% was found. We strongly promote a wide use of validated serologic assays in asymptomatic, healthy individuals, as a crucial information for epidemiological surveillance.Keywords SARS-CoV-2, Serology, Epidemiological Surveillance.The current pandemic of coronavirus disease 2019 (COVID-19) requires a global and tremendous effort not only to treat the symptomatic patients but also to implement active surveillance programs and assure the development and use of accurate diagnostic, prognostic, and therapeutic tools 1 .

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mentioning

confidence: 61%

Severe Acute Respiratory Syndrome Coronavirus 2 Serology in Asymptomatic Healthcare Professionals: Preliminary Experience of a Tertiary Italian Academic Center

Tosato

Pelloso

Gallo

et al. 2020

Preprint

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“…Many automated or point-of-care serological tests have been rapidly manufactured to meet the urgent clinical and epidemiological needs to cope with the unprecedented spread and tremendous impact of the COVID-19 pandemic [ 14 , 15 , 17 ]. An ideal serological test for SARS-CoV-2 should have a high diagnostic sensitivity, low or no cross-reactivity with other existing antibodies, and a high sample throughput to prevent the delay of timely therapeutic decisions due to false-negative results, erroneous assumption of immunity to SARS-CoV-2 due to false-positive result, and facility collapse due to staff burn-out [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan

Chen

Lee

Lin

et al. 2020

Emerging Microbes & Infections

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This multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e. two chemiluminescence immunoassays (CLIAs): Roche Elecsys® Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4–99.0%), Abbott Test (94.0%, 89.1–96.8%), Wondfo Test (91.4%, 85.8–94.9%), ASK Test (97.4%, 93.4–99.0%), and Dynamiker Test (90.1%, 84.3–94.0%) after >21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3–99.7%) for the Roche Test, 97.9% (95% CI, 94.8–99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1–100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.

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“…11 The aim of the this study was to assess the diagnostic performance of a novel fully automated CLIA for the quantitative detection of anti-SARS-CoV-2 IgM and IgG antibodies. [12][13][14][15] However, it is unclear which antibodies are optimally effective in the scenario of COVID-19 and which of them are neutralizing. There is also uncertainty as to which antibody isotype (IgM, IgG or IgA) (single or combined) is the best choice in these different contexts.…”

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confidence: 99%

Diagnostic accuracy of an automated chemiluminescent immunoassay for anti‐SARS‐CoV‐2 IgM and IgG antibodies: an Italian experience

Infantino

Grossi

Lari

et al. 2020

Journal of Medical Virology

146

124

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A pandemic of coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play. Sixty-one COVID-19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti-SARS CoV-2 antibodies IgM and IgG. All COVID-19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab reversetranscription polymerase chain reaction result. The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer's cutoff values of 10 AU/mL for both isotypes. The receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively. iFlash1800 CLIA analyzer has shown highly accurate results for the anti-SARS-CoV-2 antibodies profile and can be considered an excellent tool for COVID-19 diagnostics.

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Assessment of immune response to SARS-CoV-2 with fully automated MAGLUMI 2019-nCoV IgG and IgM chemiluminescence immunoassays

Cited by 113 publications

References 9 publications

Severe Acute Respiratory Syndrome Coronavirus 2 Serology in Asymptomatic Healthcare Professionals: Preliminary Experience of a Tertiary Italian Academic Center

Severe Acute Respiratory Syndrome Coronavirus 2 Serology in Asymptomatic Healthcare Professionals: Preliminary Experience of a Tertiary Italian Academic Center

Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan

Diagnostic accuracy of an automated chemiluminescent immunoassay for anti‐SARS‐CoV‐2 IgM and IgG antibodies: an Italian experience

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