Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Basgalupp, Suelen Porto; Santos, Gabriela dos; Bessel, Marina; García, Lara Catalán; Moura, Ana Carolina de; Rocha, Ana Carolina; Brito, Emerson Silveira de; Miranda, Giovana de; Dornelles, Thayane Martins; Dartora, William Jones; Pellanda, Lúcia C.; Hallal, Pedro Curi; Wendland, Eliana Márcia

doi:10.3390/diagnostics11081441

Cited by 6 publications

(4 citation statements)

References 25 publications

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“…The findings revealed that antibody responses were highly heterogeneous between individuals and assays, consistent with previous reports [ 21 – 28 ]. Comparable trends in antibody response kinetics observed between the different assays suggest that the different antigen targets (NP, N and S) were similarly immunogenic.…”

Section: Discussionsupporting

confidence: 91%

Longitudinal profile of antibody response to SARS-CoV-2 in patients with COVID-19 in a setting from Sub–Saharan Africa: A prospective longitudinal study

et al. 2022

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Background Serological testing for SARS-CoV-2 plays an important role for epidemiological studies, in aiding the diagnosis of COVID-19, and assess vaccine responses. Little is known on dynamics of SARS-CoV-2 serology in African settings. Here, we aimed to characterize the longitudinal antibody response profile to SARS-CoV-2 in Ethiopia. Methods In this prospective study, a total of 102 PCR-confirmed COVID-19 patients were enrolled. We obtained 802 plasma samples collected serially. SARS-CoV-2 antibodies were determined using four lateral flow immune-assays (LFIAs), and an electrochemiluminescent immunoassay. We determined longitudinal antibody response to SARS-CoV-2 as well as seroconversion dynamics. Results Serological positivity rate ranged between 12%-91%, depending on timing after symptom onset. There was no difference in positivity rate between severe and non-severe COVID-19 cases. The specificity ranged between 90%-97%. Agreement between different assays ranged between 84%-92%. The estimated positive predictive value (PPV) for IgM or IgG in a scenario with seroprevalence at 5% varies from 33% to 58%. Nonetheless, when the population seroprevalence increases to 25% and 50%, there is a corresponding increases in the estimated PPVs. The estimated negative-predictive value (NPV) in a low seroprevalence scenario (5%) is high (>99%). However, the estimated NPV in a high seroprevalence scenario (50%) for IgM or IgG is reduced significantly to 80% to 85%. Overall, 28/102 (27.5%) seroconverted by one or more assays tested, within a median time of 11 (IQR: 9–15) days post symptom onset. The median seroconversion time among symptomatic cases tended to be shorter when compared to asymptomatic patients [9 (IQR: 6–11) vs. 15 (IQR: 13–21) days; p = 0.002]. Overall, seroconversion reached 100% 5.5 weeks after the onset of symptoms. Notably, of the remaining 74 COVID-19 patients included in the cohort, 64 (62.8%) were positive for antibody at the time of enrollment, and 10 (9.8%) patients failed to mount a detectable antibody response by any of the assays tested during follow-up. Conclusions Longitudinal assessment of antibody response in African COVID-19 patients revealed heterogeneous responses. This underscores the need for a comprehensive evaluation of seroassays before implementation. Factors associated with failure to seroconvert needs further research.

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Section: Discussionsupporting

confidence: 91%

Longitudinal profile of antibody response to SARS-CoV-2 in patients with COVID-19 in a setting from Sub–Saharan Africa: A prospective longitudinal study

et al. 2022

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“…SARS-CoV-2-specific serum total Ig assays. SARS-CoV-2 spike protein-specific total antibody titers were measured using the Lumit Dx SARS-CoV-2 Immunoassay (Promega Corp.) (42). The test detects total Ig specific for the RBD antigen within the SARS-CoV-2 spike protein.…”

Section: Discussionmentioning

confidence: 99%

Contralateral second dose improves antibody responses to a 2-dose mRNA vaccination regimen

Fazli,

Thomas,

Estrada

et al. 2024

Journal of Clinical Investigation

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BACKGROUND.Vaccination is typically administered without regard to site of prior vaccination, but this factor may substantially affect downstream immune responses. METHODS.We assessed serological responses to initial COVID-19 vaccination in baseline seronegative adults who received second-dose boosters in the ipsilateral or contralateral arm relative to initial vaccination. We measured serum SARS-CoV-2 spike-specific Ig, receptor-binding domain-specific (RBD-specific) IgG, SARS-CoV-2 nucleocapsid-specific IgG, and neutralizing antibody titers against SARS-CoV-2.D614G (early strain) and SARS-CoV-2.B.1.1.529 (Omicron) at approximately 0.6, 8, and 14 months after boosting. RESULTS.In 947 individuals, contralateral boosting was associated with higher spike-specific serum Ig, and this effect increased over time, from a 1.1-fold to a 1.4-fold increase by 14 months (P < 0.001). A similar pattern was seen for RBDspecific IgG. Among 54 pairs matched for age, sex, and relevant time intervals, arm groups had similar antibody levels at study visit 2 (W2), but contralateral boosting resulted in significantly higher binding and neutralizing antibody titers at W3 and W4, with progressive increase over time, ranging from 1.3-fold (total Ig, P = 0.007) to 4.0-fold (pseudovirus neutralization to B.1.1.529, P < 0.001). CONCLUSIONS.In previously unexposed adults receiving an initial vaccine series with the BNT162b2 mRNA COVID-19 vaccine, contralateral boosting substantially increases antibody magnitude and breadth at times beyond 3 weeks after vaccination. This effect should be considered during arm selection in the context of multidose vaccine regimens.

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“…Rapid lateral flow assay is a valuable tool for diagnosing and monitoring various diseases [ 39 , 40 , 41 , 42 ]. To date, rapid diagnostics of COVID-19 to determine the antigen and the presence of IgG/IgM antibodies to SARS-CoV-2 to prevent the spread of the virus is carried out using lateral flow tests [ 43 , 44 ]. In parallel, other methods of virus identification are being developed, including electrochemical sensors, colorimetric tests, and SERS sensors [ 45 , 46 , 47 ].…”

Section: Discussionmentioning

confidence: 99%

Lateral Flow Immunoassay of SARS-CoV-2 Antigen with SERS-Based Registration: Development and Comparison with Traditional Immunoassays

et al. 2021

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The current COVID-19 pandemic has increased the demand for pathogen detection methods that combine low detection limits with rapid results. Despite the significant progress in methods and devices for nucleic acid amplification, immunochemical methods are still preferred for mass testing without specialized laboratories and highly qualified personnel. The most widely used immunoassays are microplate enzyme-linked immunosorbent assay (ELISA) with photometric detection and lateral flow immunoassay (LFIA) with visual results assessment. However, the disadvantage of ELISA is its considerable duration, and that of LFIA is its low sensitivity. In this study, the modified LFIA of a specific antigen of the causative agent of COVID-19, spike receptor-binding domain, was developed and characterized. This modified LFIA includes the use of gold nanoparticles with immobilized antibodies and 4-mercaptobenzoic acid as surface-enhanced Raman scattering (SERS) nanotag and registration of the nanotag binding by SERS spectrometry. To enhance the sensitivity of LFIA-SERS analysis, we determined the optimal compositions of SERS nanotags and membranes used in LFIA. For benchmark comparison, ELISA and conventional colorimetric LFIA were used with the same immune reagents. The proposed method combines a low detection limit of 0.1 ng/mL (at 0.4 ng/mL for ELISA and 1 ng/mL for qualitative LFIA) with a short assay time equal to 20 min (at 3.5 h for ELISA and 15 min for LFIA). The results obtained demonstrate the promise of using the SERS effects in membrane immuno-analytical systems.

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Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Cited by 6 publications

References 25 publications

Longitudinal profile of antibody response to SARS-CoV-2 in patients with COVID-19 in a setting from Sub–Saharan Africa: A prospective longitudinal study

Longitudinal profile of antibody response to SARS-CoV-2 in patients with COVID-19 in a setting from Sub–Saharan Africa: A prospective longitudinal study

Contralateral second dose improves antibody responses to a 2-dose mRNA vaccination regimen

Lateral Flow Immunoassay of SARS-CoV-2 Antigen with SERS-Based Registration: Development and Comparison with Traditional Immunoassays

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