COVID-19 test kit Fluo-800

for neutralizing antibodyserumplasma

Product overview
Qualitative test kit for detection of neutralizing antibodies to 2019-nCoV in clinical samples (serum, plasma, whole blood) using fluorescence immunochromatography with fluorescent microsphere labeling.

Key features

• Qualitative detection of 2019-nCoV neutralizing antibodies
• Rapid time-to-result: 15 minutes
• Compatible sample types: whole blood, serum, plasma
• Designed for use with immunoassay analyzers (e.g. LEPU Fluo-800)

Principle
The kit contains fluorescently labeled 2019-nCoV Spike Protein (RBD), ACE2 protein immobilized in the test area (T) and a control antibody in the control area (C). Binding competition determines inhibition rate.

Operation steps

• Step 1: Add two drops (≈20 µl) of whole blood or one drop (≈10 µl) of serum/plasma into well A.
• Step 2: Add three drops (≈100 µl) of sample dilution into well B, then start timing.
• Step 3: After 15 minutes, insert the cartridge into the immunoassay analyzer to read the result.

Applicable instrument
LEPU Fluo-800

Result interpretation
Reference range: Inhibition rate ≥ 20%

• Positive: Inhibition rate ≥ 20% — sample contains 2019-nCoV neutralizing antibodies.
• Negative: Inhibition rate < 20% — sample does not contain detectable 2019-nCoV neutralizing antibodies or level is below the limit of detection.
• Invalid: No fluorescent signal detected.

Technical specifications

• Intended use: Qualitative detection of neutralizing antibodies to 2019-nCoV in clinical samples.
• Method: Fluorescence immunochromatography (fluorescent microsphere labeling combined with immunochromatography).
• Sample types: Whole blood, serum, plasma.
• Sample volume: Whole blood ≈ 2 drops (≈20 µl); Serum/plasma ≈ 1 drop (≈10 µl).
• Sample dilution volume: ≈ 3 drops (≈100 µl) to well B.
• Incubation / Time to result: 15 minutes.
• Readout: Insert cartridge into an immunoassay analyzer to obtain qualitative result.
• Applicable analyzer example: LEPU Fluo-800.
• Result threshold: Inhibition rate ≥ 20% = Positive; < 20% = Negative; No fluorescent signal = Invalid.
• Labeling: Fluorescently labeled Spike Protein (RBD); ACE2 immobilized at test area; control antibody at quality control area.