Lepu Medical - 2019-nCoV Neutralization Antibody Test Kit - Fluorescence Immunochromatography EC - IVD

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Lepu Medical - 2019-nCoV Neutralization Antibody Test Kit - Fluorescence Immunochromatography EC - IVD

Test for the qualitative detection of SARS-CoV-2 specific neutralizing antibodies in clinical samples (serum, plasma, whole blood). The kit requires the use of the Quant-fluo 800 Fluorescence Immunochromatographic Analyzer.

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    The Lepu Neut ralization Antibody Test Kit is used for the qualitative detection of SARS-CoV-2 specific neutralizing antibodies in clinical samples (serum, plasma, whole blood).

    Neutralization Antibody Test Kit Lepu: to evaluate the efficacy of the vaccine

    Principles of the test

    The product is based on the principle of antigen-antibody reaction and immunoassay technique. The assay device contains Spike protein (RBD) marked with a fluorochrome and pre-immobilized on a polyurethane membrane, ACE2 receptor (human, recombinant) immobilized in the assay area (T) and goat anti-mouse antibody blocked in the quality control area (C).

    During the test, if the sample does not contain neutralizing antibodies to Sars-CoV-2, the fluorescent RBD domain migrates upward by capillary effect and binds directly to the immobilized ACE2 receptor in the test region (T) while if the sample contains neutralizing antibodies specific for Sars-CoV-2, they bind to the fluorescent RBD domain immobilized on the test buffer thus blocking the binding of RBD to ACE2.

    Therefore, the content of neutralizing antibodies in the sample is inversely proportional to the fluorescence intensity and the inhibition rate is calculated using a specific formula. Regardless of the presence of 2019-nCoV neutralizing antibodies in the sample, there is a concentration of fluorescent substances in the quality control area (C). The accumulation of fluorescent substances present in the quality control area (C) is a criterion for judging whether enough sample has been loaded and whether this separation process has taken place correctly. Quality control is used as an effective internal control standard.

    Sample requirements

    The Lepu Neutralization Antibody Test Kit can be performed with serum, plasma, or whole blood. Blood must be collected by professional medical personnel. It is suggested that serum/plasma be used preferentially and, under emergency or special conditions, whole blood from patients may be used for rapid testing. After collection the sample should be tested immediately. Prolonged exposure of the sample to room temperature is prohibited. Whole blood sample, if it cannot be tested quickly, can be stored for 24 hours between 2 and 8 ℃. Serum/plasma samples can be stored for 3 days at 2 to 8 ℃, and for long-term storage, they can be frozen at a temperature below -20 ℃, avoiding repeated freeze-thaw cycles.

    Before the test, the sample must be brought back to room temperature, ready for application only after homogeneity. The sample should be brought back to room temperature before testing and should be used after mixing. Do not use samples with severe hemolysis, severe lipids and jaundice.

    Test Components

    The test card consists of a fluorescent holder (containing the RBD domain of the fluorophore-labeled Sars-CoV-2 virus Spike protein), a sample collection holder, a cellulose nitrate membrane on which the recombinant human ACE2 receptor is immobilized, and a goat anti-mouse antibody immobilized in control area C.

    Performance Index of the Neutralization Antibody Test Kit Lepu

    1. Analytical specificity
      1. Cross Reactivity: this test device has no cross-reactivity with human endemic coronavirus antibody OC43, human endemic coronavirus antibody HKU1, human endemic coronavirus antibody NL63, human endemic coronavirus antibody 229E, antibody to influenza A virus, antibody to influenza B virus, adenovirus antibody, rhinovirus antibody, enterovirus antibody, EB virus antibody, measles virus antibody, cytomegalovirus antibody, rotavirus antibody, norovirus antibody, mumps virus antibody, varicella-zoster virus antibody, and mycoplasma pneumoniae antibody.
      2. Interfering Substances: Test results are not affected by substances at the following concentrations: bilirubin concentration ≤ 250 μmol / l; triglyceride concentration ≤ 15 mmol / l; hemoglobin concentration ≤ 10 g / dL; rheumatoid factor concentration ≤ 80 RU / mL; anti-mitochondrial antibody concentration ≤ 80 U / mL; antinuclear antibody concentration ≤ 80 U / mL; total IgG concentration ≤ 14 g / L. The test results are not affected by the following substance: α-interferon, zanamivir, ribavirin, oseltamivir and paramivir, Lopinavir, ritonavir, abidol, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin, histamine hydrochloride, phenylethroline sodium (containing preservatives), beclomethasone, dexamethasone, flunisolide, triamcinolone, budesonide, mometasone, and fluticasone.
    2. Clinical Performance
      A total of 184 samples were collected, including 72 positive and 112 negative samples. After comparing the test results of this product and the sVNT GenScript kit, the results of the comparison are summarized in the table below:

    2019-nCoV Neutralization Antibody Test Kit

    GenScript sVNT Kit
    Sample Quantity72112
    Diagnostic Sensitivity, 95% CI95.83% (88.45%~98.57%)/
    Diagnostic Specificity, 95% CI/96.43% (91.18%-98.60%)

    Analyzer QUANT FLUO 800

    Considering its superior performance, high quality, ease of use and minimal maintenance, Quant-fluo 800 is the optimal choice for clinics, research laboratories and biotech companies.


    QUANT FLUO 800 features

    • Intelligence: the test strip is automatically identified with the standard curve. LIS / HIS connectivity. Test results are displayed directly on the screen.
    • High quality: long standby of the instrument. Good storage capacity.
    • Convenient: user-friendly graphical interface. 7 inch touch screen and sensitive touch feeling. Built-in lithium battery for mobile monitoring.
    • Accurate: High quality raw materials are used to ensure accuracy and stability. The fluoroimmunoassay has a high sensitivity and specificity.


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