Comprehensive Comparison of Seven SARS-CoV-2-Specific Surrogate Virus Neutralization and Anti-Spike IgG Antibody Assays Using a Live-Virus Neutralization Assay as a Reference

Microbiology Spectrum, Journal Year: 2023, Volume and Issue: 11(1)

Published: Jan. 9, 2023

Neutralizing antibodies (nAbs) are considered a valuable marker for measuring humoral immunity against SARS-CoV-2. However, live-virus neutralization tests (NTs) require high-biosafety-level laboratories and time-consuming. Therefore, surrogate virus (sVNTs) have been widely applied, but unlike most anti-spike (S) antibody assays, NTs sVNTs not harmonized, requiring further evaluation comparative analyses. This study compared seven commercial anti-S-antibody assays with NT as reference, using panel of 720 single longitudinal serum samples from 666 convalescent patients after SARS-CoV-2 infection. The sensitivity these detecting ranged 48 to 94% PCR-confirmed infection 56% 100% relative positivity in the in-house NT. Furthermore, we performed receiver operating characteristic (ROC) curve analyses determine which immunoassays were suitable assessing nAb titers exceeding specific cutoff (NT titer, ≥80) found that NeutraLISA cPass reached highest area under (AUC), 0.91. In addition, when their correlation kinetics over time set samples, extent measured decrease nAbs varied among evaluated immunoassays. Finally, vaccinated patients, high exceeded upper limit assays' quantification ranges. Based on data this study, conclude acceptable substitutes NTs, particularly additional adapted cutoffs employed detect beyond threshold titer. IMPORTANCE While measurement neutralizing is tool protection SARS-CoV-2, employ isolates cell culture, advanced laboratory biosafety levels. Including large sample (over 700 samples), provides values calculated (including four protein-based microarray) robustly correlate antibodies.

Language: Английский

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Seroprevalence of Antibodies to SARS-CoV-2 in Rural Households in Eastern Uganda, 2020-2022

JAMA Network Open, Journal Year: 2023, Volume and Issue: 6(2), P. e2255978 - e2255978

Published: Feb. 15, 2023

Importance Estimating the true burden of SARS-CoV-2 infection has been difficult in sub-Saharan Africa owing to asymptomatic infections and inadequate testing capacity. Antibody responses from serologic surveys can provide an estimate exposure at population level. Objective To seroprevalence, attack rates, reinfection eastern Uganda using surveillance 2020 early 2022. Design, Setting, Participants This cohort study was conducted Tororo Busia districts Uganda. Plasma samples participants Program for Resistance, Immunology, Surveillance, Modeling Malaria Border Cohort were obtained 4 sampling intervals: October November 2020, March April 2021, August September February Each participant contributed up time points serology, with almost half all contributing points, 90% 3 or points. Information on vaccination status collected participants, earliest reported vaccinations occurring May 2021. Main Outcomes Measures The main outcomes this antibody spike protein as measured a bead-based assay. Individual-level aggregated population-level boosting rates. Estimates weighted by local age distribution according census data. Results A total 1483 441 living 76 households tested. Of 245 (55.6%) female, their mean (SD) 16.04 (16.04) years. By end Delta wave before widespread vaccination, adjusted seroprevalence 67.7% (95% credible interval [CrI], 62.5%-72.6%) population. During subsequent Omicron wave, 84.8% CrI, 67.9%-93.7%) unvaccinated, previously seronegative individuals infected first time, 50.8% 40.6%-59.7%) already seropositive likely reinfected, leading overall seropositivity 96.0% 93.4%-97.9%) These results suggest lower probability higher preexisting levels. There evidence household clustering seroconversion. No significant associations found between seroconversion gender, size, recent Plasmodium falciparum malaria exposure. Conclusions Relevance In rural Uganda, there very high rates throughout pandemic inconsistent national level case data during wave.

Language: Английский

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Testing for SARS-CoV-2: lessons learned and current use cases

Clinical Microbiology Reviews, Journal Year: 2024, Volume and Issue: 37(2)

Published: March 17, 2024

SUMMARY The emergence and worldwide dissemination of SARS-CoV-2 required both urgent development new diagnostic tests expansion testing capacity on an unprecedented scale. rapid evolution technologies that allowed to move out traditional laboratories into point-of-care centers the home transformed landscape. Four years later, with end formal public health emergency but continued global circulation virus, it is important take a fresh look at available consider how they should be used going forward. This review considers current use case scenarios for antigen, nucleic acid amplification, immunologic tests, incorporating latest evidence analytical/clinical performance characteristics advantages/limitations each test type inform debates about or not used.

Language: Английский

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Long term anti-SARS-CoV-2 antibody kinetics and correlate of protection against Omicron BA.1/BA.2 infection

Nature Communications, Journal Year: 2023, Volume and Issue: 14(1)

Published: May 26, 2023

Binding antibody levels against SARS-CoV-2 have shown to be correlates of protection infection with pre-Omicron lineages. This has been challenged by the emergence immune-evasive variants, notably Omicron sublineages, in an evolving immune landscape high cumulative incidence and vaccination coverage. turn limits use widely available commercial high-throughput methods quantify binding antibodies as a tool monitor at population-level. Here we show that anti-Spike RBD levels, quantified immunoassay used this study, are indirect correlate BA.1/BA.2 for individuals previously infected SARS-CoV-2. Leveraging repeated serological measurements between April 2020 December 2021 on 1083 participants population-based cohort Geneva, Switzerland, using kinetic modeling, found up three-fold reduction hazard having documented positive during wave anti-S above 800 IU/mL (HR 0.30, 95% CI 0.22-0.41). However, did not detect among uninfected participants. These results provide reassuring insights into continued interpretation independent marker both individual population levels.

Language: Английский

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An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies

AIMS Microbiology, Journal Year: 2023, Volume and Issue: 9(2), P. 375 - 401

Published: Jan. 1, 2023

Over the last three years, after outbreak of COVID-19 pandemic, an unprecedented number novel diagnostic tests have been developed. Assays to evaluate immune response SARS-CoV-2 widely considered as part control strategy. The lateral flow immunoassay (LFIA), detect both IgM and IgG against SARS-CoV-2, has studied a point-of-care (POC) test. Compared laboratory tests, LFIAs are faster, cheaper user-friendly, thus available also in areas with low economic resources. Soon onset numerous kits for rapid antibody detection were put on market emergency use authorization. However, since then, scientists tried better define accuracy these their usefulness different contexts. In fact, while during first phase pandemic auxiliary molecular diagnosis COVID-19, successively became tool seroprevalence surveillance address infection policies. When 2021 massive vaccination campaign was implemented worldwide, interest LFIA reemerged due need establish extent longevity immunization vaccinated population priorities guide health policies low-income countries limited access vaccines. Here, we summarize accuracy, advantages limits POC detection, highlighting efforts that made improve this technology over few years.

Language: Английский

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Validation of a SARS-CoV-2 Surrogate Neutralization Test Detecting Neutralizing Antibodies against the Major Variants of Concern

International Journal of Molecular Sciences, Journal Year: 2023, Volume and Issue: 24(19), P. 14965 - 14965

Published: Oct. 6, 2023

SARS-CoV-2 infection and/or vaccination elicit a broad range of neutralizing antibody responses against the different variants concern (VOC). We established new variant-adapted surrogate virus neutralization test (sVNT) and assessed activity ancestral B.1 (WT) VOC Delta, Omicron BA.1, BA.2, BA.5. Analytical performances were compared respective to reference (VNT) two CE-IVD labeled kits using three cohorts collected during COVID-19 waves. Correlation analyses showed moderate strong correlation for sub-variants (Spearman's r = 0.7081 0.7205 0.6042 BA.5), WT (r 0.8458) Delta-sVNT 0.8158), respectively. Comparison WT-sVNT performance with kits, "Icosagen Neutralizing Antibody ELISA kit" "Genscript cPass, revealed an overall good ranging from 0.8673 -0.8773 midway profile between both commercial 87.76% sensitivity 90.48% clinical specificity. The BA.2-sVNT was similar BA.2 Genscript test. Finally, analysis association 0.8583) BA.5-sVNT VNT sVNT double-vaccinated cohort (n 100) Omicron-breakthrough 91). In conclusion, allows efficient prediction immune protection various VOCs.

Language: Английский

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A novel method for detecting SARS-CoV-2 IgM and IgG based on the gold immune chromatography assay

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: Feb. 10, 2025

A novel method was proposed based on gold immune chromatography assay (GICA) including the detection of antibodies targeting different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epitopes to improve SARS-CoV-2 IgM and IgG performance. Sera from 282 confirmed Coronavirus Disease 2019 (COVID-19) patients were obtained at times as or experimental group. 148 uninfected unvaccinated individuals used control. The serum single-epitope against detected via GICA; two epitope with high performance construct a method, then compared chemiluminescence immunoassay (CLIA). diagnostic specificity screening sensitivity S2-IgM N-IgM combined GICA 99.32% 98.81%, respectively, which higher than those CLIA test (83.78% 82.14%; P < 0.001). RBD-IgG N-IgG in 100.00%, same that CLIA. showed excellent for IgG, effectively avoiding omissions misdiagnoses early clinical stages diagnosing COVID-19.

Language: Английский

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Performance Analysis of Serodiagnostic Tests to Characterize the Incline and Decline of the Individual Humoral Immune Response in COVID-19 Patients: Impact on Diagnostic Management

Viruses, Journal Year: 2024, Volume and Issue: 16(1), P. 91 - 91

Published: Jan. 6, 2024

Serodiagnostic tests for antibody detection to estimate the immunoprotective status regarding SARS-CoV-2 support diagnostic management. This study aimed investigate performance of serological assays COVID-19 and elaborate on test-specific characteristics. Sequential samples (n = 636) four panels (acute COVID-19, convalescent (partly vaccinated post-infection), pre-pandemic, cross-reactive) were tested IgG by indirect immunofluorescence test (IIFT) EUROIMMUN EUROLINE Anti-SARS-CoV-2 Profile (IgG). Neutralizing antibodies determined a virus neutralization (VNT) two surrogate (sVNT, GenScript cPass, NeutraLISA). Analysis acute revealed high positive (78.3% 91.6%) negative (91.6%) agreement between IIFT IgG. The sVNTs differences in their (cPass: 89.4% 97.0%, NeutraLISA: 71.5% 72.1%) with VNT 92.3% 50.0%, 95.1% 92.5%) at specificity 100% all tests. cPass showed higher inhibition rates than NeutraLISA titers below 1:640. Cross-reactivities only found (57.1%). tests, which substantial fast runtime, could provide alternatives cell-based assays. findings this suggest that careful interpretation serodiagnostic results obtained different times after antigen exposure is crucial decision-making

Language: Английский

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Three rounds of a national external quality assessment reveal a link between disharmonic anti-SARS-CoV-2 antibody quantifications and the infection stage

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(7), P. 1349 - 1358

Published: Feb. 9, 2023

The WHO's standardized measuring unit, "binding antibody units per milliliter (BAU/mL)," should allow the harmonization of quantitative results by different commercial Anti-SARS-CoV-2 immunoassays. However, multiple studies demonstrate inter-assay discrepancies. antigenic changes Omicron variant affect performance Spike-specific This study evaluated variation Anti-SARS-CoV-2-Spike measurements among 46, 50, and 44 laboratories in three rounds a national external quality assessment (EQA) prior to after emergence diagnostic near-to-real-life setting.

Language: Английский

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A Multivariant Surrogate Neutralization Assay Identifies Variant-Specific Neutralizing Antibody Profiles in Primary SARS-CoV-2 Omicron Infection

Diagnostics, Journal Year: 2023, Volume and Issue: 13(13), P. 2278 - 2278

Published: July 5, 2023

Primary infection with the Omicron variant of Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) can be serologically identified distinct profiles neutralizing antibodies (nAbs), as indicated by high titers against and low ancestral wild-type (WT). Here, we evaluated whether a novel surrogate virus neutralization assay (sVNT) that simultaneously quantifies binding inhibition angiotensin-converting enzyme (ACE2) to proteins WT- Omicron-specific receptor-binding domains (RBDs) identify nAb after primary accuracy similar variant-specific live-virus tests (NTs). Therefore, comparatively tested 205 samples from individuals WT, vaccinated subjects or without breakthrough infections. Indeed, RBD-ACE2 levels significantly correlated respective NT (p < 0.0001, Spearman’s r = 0.92 0.80 for WT Omicron, respectively). In addition, were securely sVNT according their distinctive (area under curve 0.99; sensitivity: 97.2%; specificity: 97.84%). Thus, when laborious NTs are not feasible, in this study may serve an acceptable substitute serological identification infection.

Language: Английский

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