Dual-Antigen System Allows Elimination of False Positive Results in COVID-19 Serological Testing

Komarov, Andrei M.; Kaznadzey, Anna; Li, Yue; Kireeva, Maria L.; Mazo, Ilya

doi:10.3390/diagnostics11010102

Cited by 9 publications

(20 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…During testing we expect a certain rate of false positive results. The assay has specificity for anti-N antibody detection of 97.8%, originally validated on 89 negative prepandemic samples [18]. In the current large cohort, 22 cases of candidate false positives out of 620 would indicate the specificity of 96.4%, which is not a significant change from the original value.…”

Section: Discussionmentioning

confidence: 73%

“…The antibody level for each individual was determined by comparison of the obtained optical density value of the respective sample to the threshold of the assay, as specified in the VirIntel test protocol [18]. This threshold value was obtained by measuring the signal for the positive control antibody solution in the respective wells of the assay.…”

Section: Elisa Results Analysismentioning

confidence: 99%

“…Using the VirIntel Dual-Antigen assay [18], we measured the IgG antibodies to the N and RBD antigens in the serum of 47 COVID-19 patients. All except one demonstrated positive signal for antibodies to the RBD antigen, for the N antigen, a positive signal was observed for 34 samples.…”

Section: Resultsmentioning

confidence: 99%

“…The signal to anti-RBD and anti-N IgG antibodies was analyzed using the dual-antigen VirIntel assay, previously developed in our laboratory [18]. Each of the 96-well ELISA plates of this testing system was coated with either of the two SARS-CoV-2 antigens diluted in PBS.…”

Section: Dual-antigen Testing Elisa Assaymentioning

confidence: 99%

See 3 more Smart Citations

IgG Antibodies Develop to Spike but Not to the Nucleocapsid Viral Protein in Many Asymptomatic and Light COVID-19 Cases

Tutukina

Kaznadzey

Kireeva³

et al. 2021

Viruses

Self Cite

View full text Add to dashboard Cite

Since SARS-CoV-2 appeared in late 2019, many studies on the immune response to COVID-19 have been conducted, but the asymptomatic or light symptom cases were somewhat understudied as respective individuals often did not seek medical help. Here, we analyze the production of the IgG antibodies to viral nucleocapsid (N) protein and receptor-binding domain (RBD) of the spike protein and assess the serum neutralization capabilities in a cohort of patients with different levels of disease severity. In half of light or asymptomatic cases the antibodies to the nucleocapsid protein, which serve as the main target in many modern test systems, were not detected. They were detected in all cases of moderate or severe symptoms, and severe lung lesions correlated with respective higher signals. Antibodies to RBD were present in the absolute majority of samples, with levels being sometimes higher in light symptom cases. We thus suggest that the anti-RBD/anti-N antibody ratio may serve as an indicator of the disease severity. Anti-RBD IgG remained detectable after a year or more since the infection, even with a slight tendency to raise over time, and the respective signal correlated with the serum capacity to inhibit the RBD interaction with the ACE-2 receptor.

show abstract

Section: Discussionmentioning

confidence: 73%

Section: Elisa Results Analysismentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Dual-antigen Testing Elisa Assaymentioning

confidence: 99%

See 2 more Smart Citations

IgG Antibodies Develop to Spike but Not to the Nucleocapsid Viral Protein in Many Asymptomatic and Light COVID-19 Cases

Tutukina

Kaznadzey

Kireeva³

et al. 2021

Viruses

Self Cite

View full text Add to dashboard Cite

show abstract

“…Individuals whose initially false-positive result had led them to adhere to recommended isolation protocols were assumed to return to the active population after a 3-day delay. 30 (This assumption ignored the small possibility of repeatedly false-positive confirmatory test findings. )…”

Section: Performance Of Testingmentioning

confidence: 99%

Clinical and Economic Impact of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission

Paltiel¹,

Zheng

Sax

2021

Preprint

View full text Add to dashboard Cite

Background: The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. Objective: To define performance standards and predict the clinical, epidemiological, and economic outcomes of nationwide, home-based, antigen testing. Design: A simple compartmental epidemic model estimated viral transmission, clinical history, and resource use, with and without testing. Data Sources: Parameter values and ranges informed by Centers for Disease Control guidance and published literature. Target Population: United States population. Time Horizon: 60 days. Perspective: Societal. Costs include: testing, inpatient care, and lost workdays. Intervention: Home-based SARS-CoV-2 antigen testing. Outcome Measures: Cumulative infections and deaths, numbers isolated and/or hospitalized, and total costs. Results of Base-Case Analysis: Without a testing intervention, the model anticipates 15 million infections, 125,000 deaths, and $10.4 billion in costs ($6.5 billion inpatient; $3.9 billion lost productivity) over a 60-day horizon. Weekly availability of testing may avert 4 million infections and 19,000 deaths, raising costs by $21.5 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.0 billion) and workdays lost ($13.9 billion), yielding incremental costs per infection (death) averted of $5,400 ($1,100,000). Results of Sensitivity Analysis: Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios: large reductions in infections, mortality, and hospitalizations; and costs per death averted roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5-17 million). Limitations: Analysis restricted to at-home testing and limited by uncertainties about test performance. Conclusion: High-frequency home testing for SARS-CoV-2 using an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy.

show abstract

The endogenous factors affecting the detection of serum SARS‐CoV‐2 IgG/IgM antibodies by ELISA

Liu

Xia

Wan

et al. 2022

Journal of Medical Virology

View full text Add to dashboard Cite

To investigate endogenous interference factors of the detection results of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG. Enzymelinked immunosorbent assay (ELISA) was used to detect SARS-CoV-2 IgM/IgG in sera of 200 patients without COVID-19 infection, including rheumatoid factor (RF) positive group, antinuclear antibody (ANA) positive group, pregnant women group, and normal senior group, with 50 in each group and 100 normal controls. The level of SARS-CoV-2 IgG in pregnant women was significantly higher than that in the normal control group (p = 0.000), but there was no significant difference between other groups. The levels of SARS-CoV-2 IgM in the pregnant women group, normal senior group, ANA positive group, and RF positive group were significantly higher than that in the normal control group (p < 0.05), with significant higher false-positive rates in these groups (p = 0.036, p = 0.004, p = 0.000, vs. normal control group).Serum RF caused SARS-CoV-2 IgM false-positive in a concentration-dependent manner, especially when its concentration was higher than 110.25 IU/L, and the urea dissociation test can turn the false positive to negative. ANA, normal seniors, pregnant women, and RF can lead to false-positive reactivity of SARS-CoV-2 IgM and/or IgG detected using ELISA. These factors should be considered when SARS-CoV-2 IgM or IgG detection is positive, false positive samples caused by RF positive can be used for urea dissociation test.

show abstract

Dual-Antigen System Allows Elimination of False Positive Results in COVID-19 Serological Testing

Cited by 9 publications

References 23 publications

IgG Antibodies Develop to Spike but Not to the Nucleocapsid Viral Protein in Many Asymptomatic and Light COVID-19 Cases

IgG Antibodies Develop to Spike but Not to the Nucleocapsid Viral Protein in Many Asymptomatic and Light COVID-19 Cases

Clinical and Economic Impact of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission

The endogenous factors affecting the detection of serum SARS‐CoV‐2 IgG/IgM antibodies by ELISA

Contact Info

Product

Resources

About