COVID-19 Neutralizing Antibody Rapid Test Kit (Omicron JN.1 or Omicron XBB.1.5 variant) 

GenHunter offers 2 different rapid test kits to test for neutralizing antibodies (NAb) against the SARS-CoV-2 Omicron JN.1 variant or the Omicron XBB.1.5 variant. Results in 15 minutes.

Purpose: To determine the presence or absence of neutralizing antibodies (NAb) against a specific SARS-CoV-2 Omicron variant (JN.1 or XBB.1.5) from serum/plasma samples.

Applications:
 - Epidemiological studies on necessity for vaccine update.
 - Vaccine efficacy before and after a booster shot.
 - Vaccine durability on current and future VOCs.

Features:
 - Currently available for Omicron JN.1 or XBB.1.5 variants.
 - 2 or 5 test kit sizes.
 - Colloidal gold-based tests with results in 15 minutes.
 - Tests applicable to human serum, plasma, venous whole blood, or capillary blood.
 - Also applicable to non-human primates.
 - Sensitive & high concordance to live virus neutralizing assays.

Background: The emergence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) in late 2019 led to a global pandemic that disrupted lives and global economies on a scale unseen in recent human history. SARS-CoV-2 has continued to evolve, mutate, and give rise to multiple variants (Hu-1/WT, Beta, Delta, Omicron BA 4/5, EG.5, XBB, JN.1, FLiRT, LB.1, KP.2, KP.3, XEC, etc.) that evade the immunity built up by previous infections or vaccinations. It has become evident that we will have to live with SARS-CoV-2 for years to come.

Even though the majority of the human population has been exposed to SARS-CoV-2, often multiple times, a seasonal COVID-19 vaccine update is needed to combat the emergence of future variants. WHO and FDA have recommended a JN.1-based COVID vaccine for the 2024 season. Pfizer & Moderna vaccines will target the KP.2 variant, a JN.1 descendant. Novavax will target JN.1.

In collaboration with Clover Biopharmaceuticals, using GenHunter's patented Trimer-Tag technology, we developed this rapid test for JN.1 neutralizing antibody which may help vaccine developers as well as the CDC to evaluate the vaccine's efficacy before and after vaccination, as well as to assess the baseline in humoral immunity in the general population prior to vaccination. The tests are also useful for assessing durability for humoral immunity after a vaccination or infection. We also have a rapid test for XBB.1.5 neutralizing antibodies.

Kit options: 2 or 5 tests; for Omicron JN.1 or Omicron XBB.1.5.  (Catalog numbers displayed above when you select variant & kit size; also listed in the chart below)

Sample types: Can be used to test human serum, plasma, venous whole blood, or capillary blood for the presence of neutralizing antibodies. Also applicable to non-human primates.

Kit contains:
- Test cassettes for COVID-19 Neutralizing Antibody Rapid Test Kit, either Omicron JN.1 or Omicron XBB.1.5
- Sample diluent
- Plastic pipettes.

Test Principle: This product uses the lateral flow chromatography competition method with the conjugate pad coated with colloidal gold-labeled rabbit IgG and recombinant SARS-CoV-2 Omicron JN.1 (or XBB.1.5) variant "S-Trimer". The T (TEST) line on the nitrocellulose membrane is coated with recombinant ACE2 (human angiotensin-converting enzyme 2) receptor protein and the C (CONTROL) line is coated with goat anti-rabbit IgG polyclonal antibody.

Interpreting results (see images above): If the samples have no SARS-CoV-2 Omicron JN.1 (or XBB.1.5) NAb against the SARS-CoV-2 S, or the amount is too small, the colloidal gold-labeled S-Trimer will move on the nitrocellulose membrane by lateral flow chromatography to the T line. There it combines with ACE2 to form a colloidal gold complex, resulting in a red T line. However, if there is an appropriate amount of NAb against the S antigen in the sample, it will combine with the colloidal gold-labeled "S-Trimer" and competitively prevent the binding of S-Trimer to recombinant human ACE2 receptor protein, thus eliminating (strong positive = have NAb) or reducing the color development of the T line. Meanwhile, the colloidal gold-labeled rabbit IgG continues to move forward to the quality control C line, where the colloidal gold-labeled rabbit IgG combines with the goat anti-rabbit IgG polyclonal antibody, forming a red line, indicating that the detection system is effective.

FOR RESEARCH USE ONLY, not for clinical diagnosis. 

More Antibodies & Antigens: GenHunter also has 13 monoclonal antibodies against SARS-CoV-2 (Hu-1/WT, Beta, Delta, Omicron BA.1, Omicron BA.2, Omicron BA.2.76, Omicron BA.4, Omicron BA.5, Omicron XBB.1.5, Omicron EG.5, Omicron JN.1, and Human ACE2; more details below and in "Ordering" tab) as well as 9 different SARS-CoV-2 antigens (WT, Beta, Delta, Omicron BA.1, Omicron BA.5, Omicron XBB.1.5, Omicron EG.5.1, Omicron JN.1, & Human ACE2). SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), also known as COVID-19 coronavirus or 2019-nCoV, can infect human respiratory epithelial cells by interacting with the human ACE2 receptor. The spike protein is a large type I transmembrane protein composed of two subunits, S1 and S2. S1 primarily contains a receptor-binding domain (RBD) responsible for recognizing the cell surface receptor, while S2 includes the essential elements for membrane fusion. The S protein plays a crucial role in inducing antibody and T cell responses, as well as protective immunity. The main functions of the spike protein can be summarized as follows: mediating receptor binding and membrane fusion, defining the host range and viral specificity, serving as the primary target for neutralizing antibodies, being a critical target for vaccine design, and enabling transmission between different hosts through genetic recombination or mutations in the receptor-binding domain (RBD). References listed below.

SARS-CoV-2 Antibody & Antigen Products Available:

References:

1. Liang, J.G. et al (2021, February). S-Trimer, a COVID-19 subunit vaccine candidate, induces protective immunity in nonhuman primates. Nature Communications. 12:1346, 1-12. https://www.nature.com/articles/s41467-021-21634-1
2. Ma, J. et al (2021, June). Cryo-electron Microscopy Structure of S-Trimer, a Subunit Vaccine Candidate for COVID-19. Journal of Virology. 95:11, 1-14. https://journals.asm.org/doi/10.1128/jvi.00194-21
3. Richmond, P. et al (2021, February). Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial. The Lancet. 397, 682-694. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00241-5/fulltext
4. Bravo, L. et al. (2022, January). Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial. The Lancet. 399, 461-472. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00055-1/fulltext

All products are FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.
These statements have not been evaluated by the FDA.These products will only be shipped to research institutions.