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TestLine COVID-19 products

Enzyme immunoassays for the detection of specific IgA, IgG, and IgM antibodies against specific SARS-CoV-2 infection.

Microblot-Array

Microblot-Array

A new generation of a unique immunoblot array in the form of microtiter plate for effective multiplex diagnostics. It enables parallel testing of multiple markers simultaneously with analysis of up to 96 samples per plate with low sample consumption.

Used antigens: NP, RBD, S2, ACE2, E. PLPro, MERS-CoV, SARS-CoV. HCoV 229 Np, and HCoV NL63.

For monitoring antibodies after vaccination and infection

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Elisa

ELISA

EIA COVID-19 RBD - Anti-RBD antibodies significantly correlates with the formation of neutralizing antibodies. It can be used for monitoring antibodies after vaccination.

EIA COVID-19 NP - The presence of anti-NP antibodies is important for the diagnosis of post-infectious immunity.

The kits are available in SmartEIA format designed for automated processing and evaluation using the Agility® analyzer.

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  • Complex information about immune status after infection and vaccination.

    The kits are intended for quantitative detection of specific IgA, IgG, and IgM antibodies against recombinant SARS-CoV-2 markers. Due to the comprehensive antigenic composition, you can distinguish between post-infection and post-vaccination immunity.

  • Unique antigenic composition you wont find anywhere else.

    Microblot-Array kits inlcude 10 different antigens. It contains main antigens for diagnostic, antigen which can provide supplementary information and antigens to exclude cross-reactivities with other coronaviruses.

  • Kits are ready for automation and focused on ease of use.

    All components are ready to use with CE IVD certification. We can provide remote troubleshooting. There is a possibility of automated processing using any ELISA instruments for both (MBA, EIA).

Vaccination study

Monitoring antibodies play a crucial role in vaccination as it is being used as a tool to find out whether a COVID-19 vaccine has worked or not. TestLine COVID-19 kits were used to verify post-vaccination immunity in vaccinated healthcare professionals after the Pfizer vaccine, which is mRNA vaccine. The mRNA vaccines carry a specially designed mRNA sequence that is incorporated into our cells. When this mRNA encounters our ribosomes, they use it as an instruction to produce Spike protein. Immune system recognized it as foreign, which stimulate the production of antibodies against Spike protein.



EIA COVID-19 RBD

  • Mean values after the 1st dose of vaccination against SARS-CoV-2
  • Mean values after the 2nd dose of vaccination against SARS-CoV-2

Interpretation of EIA results – Index of Positivity (IP)
Negative: lower than 0.9
Borderline: 0.9 to 1.1
Positive: higher than 1.1



MBA COVID-19

  • Mean values after the 1st dose of vaccination against SARS-CoV-2
  • Mean values after the 2nd dose of vaccination against SARS-CoV-2

Interpretation of MBA results – Units per millilitre (U/ml)
Negative: lower than 185
Borderline: 185 to 210
Positive: higher than 210

The most important antigen for monitoring post-vaccination reactivity is the Receptor-Binding Domain (RBD) that specifically binds to the host cell angiotensin-converting enzyme 2 (ACE2). This binding is highly correlated with the formation of neutralizing antibodies. In the case of the Microblot-Array COVID-19 kits, post-vaccination reactivity was tested on antigens: RBD, NP, S2, ACE2, PLpro, and E as they are part of the kit. The presence of anti-NP antibodies indicates post-infectious immunity as the samples.

If you want to see more data from the testing, download the leaflet at the end of the page.

VNT Correlation study

According to the latest literature, it is most suitable to use a virus neutralization test (VNT) to determine the protective activity of antibodies. However, the determination of neutralizing antibodies (NAbs) by the VNT method is time-consuming (2-4 days) and requires work with a live virus. Standard commercially available assays detect anti-SARS-Cov-2 binding antibodies (BAbs) and cannot differentiate between NAbs and BAbs. The correlation between VNT and TestLine diagnostics kits was performed in a comparative study of 100 samples. Show more

Mean values of U/ml IgG anti-RBD antibodies in relation to individual VNT titers.

  • EIA COVID-19 RBD

  • MBA COVID-19

  • VNT Correlation

  • VNT Correlation

TestLine confirmed the high level of agreement between results obtained by the VNT and TestLine kits, based on the correlation study. The level of neutralizing antibodies corresponds with the level of anti-RBD IgG antibodies. Therefore, the kits can be used to determine if the concentration of antibodies has a protective effect.

If you want to see more data from the testing, download the leaflet at the end of the page.

Verification by International Standards

A variety of serological assays for the detection of SARS-CoV-2 antibodies and antibody response after vaccination are used globally. WHO has highlighted the importance of the availability of International Standards and reference reagents for anti-SARS-CoV-2 antibodies. It will facilitate the development, validation, assessment, and comparability of assays. International Standards and panels, which are listed below, were tested on EIA COVID-19 RBD, and Microblot-Array COVID-19 kits, in IgA, IgG, and IgM antibody classes. By titrating these Standards, TestLine responded to the requirement to accurately determine the level of antibodies, sensitivity, and dilution of strongly positive results. By harmonization with International Standards, the kits can be used for monitoring the antibody concentration after vaccination. Show more


Titration of the First WHO International standard for anti-SARS-CoV-2 immunoglobulin IgG (20/136) (NIBSC code: 20/136)

  • EIA COVID-19 RBD

  • MBA COVID-19


Titration of Anti–SARS–CoV–2 Antibody Diagnostic Calibrant IgG (NIBSC code: 20/162)

  • EIA COVID-19 RBD

  • MBA COVID-19


Titration of First WHO International Reference Panel for anti–SARS–CoV–2 immunoglobulin, human (NIBSC code: 20/268)

  • MBA COVID-19

    Reactivity of MBA (RBD - IgA, IgG, IgM) and correlation with neutralization antibodies from Reference Panel

  • Reactivity of MBA (RBD and S2 antibodies - IgG) and correlation with anti-RBD, anti-S1, and anti-Spike antibodies (IgG) from Reference Panel


Titration of Anti–SARS–CoV–Verification Panel for Serology Assays (NIBSC code: 20/B770)

  • MBA COVID-19


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Results from testing show that MBA has comparable results with other commercially available assays.

If you want to see more data from the testing, download the leaflet at the end of the page.

Downloads

Correlation with virus neutralization test (VNT)

  • Leaflet COVID-19 correlation VNT WHO EIA (here)
  • Leaflet COVID-19 correlation VNT WHO MBA (here)

Overview of post-vaccination reactivity

  • Leaflet COVID-19 post-vaccination reactivity EIA (here)
  • Leaflet COVID-19 post-vaccination reactivity MBA (here)

Verification by International Standards and Reference panels

  • Leaflet COVID-19 International Standards and Reference panels MBA (here)
  • Leaflet COVID-19 International Standards and Reference panels EIA (here)

COVID-19 leaflets (here)





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