Intended use
The Novel coronavirus（SARS-CoV-2）Neutralizing Antibody Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibody of Coronavirus Disease 2019 in human whole blood,
serum, or plasma as an aid in the Evaluation levels of human anti-novel coronavirus neutralizing antibody titer.
The IgG test provides preliminary test results.It’s used as a supplementary indicator for the detection of suspected SARS-CoV-2 nucleic acid negative cases, or is used in coordination with nucleic acid detection in the diagnosis of
suspected cases. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.
Test principle
The neutralization antibody test uses immunochromatography. The test card contains:1) colloidal gold-labeled recombinant novel coronavirus S-RBD antigen, refering control and quality control antibody gold markers; 2) tow
detection lines (T1 and T2) and one quality Control line (C line) of nitrocellulose membrane. The T line is immobilized with anti-human IgG for detecting novel coronavirus neutralizing antibody and the C line is immobilized with a
quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains Novel
coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The immune complex will be captured by the anti- human IgG antibody immobilized on the membrane to form a
purple-red T line, showing that the novel coronavirus Neutralizing antibody is positive. The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears. If
the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.
The IgG test is based on the principle of colloidal gold immunochromatography to quaitatively detect the new coronavirus SARS-CoV-2 IgG antibody in serum, plasma or whole blood samples.
When the SARS-CoV-2 IgG level in the specimen is at or above the target cutoff (the detection limit of the test), the antibody bound to the antigen-dye conjugate are captured by anti-human IgG immobilized in the Test Region (T)
of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 IgG level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the
device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.
Main composition
- Test card
- Disposable alcohol cotton pad
- Disposable blood collection needle
- Diluent
Storage conditions and validity
1.Store at 2℃～40℃，the validity period is tentatively set for 24 months.
2.After opening the aluminum foil bag, the test card should be used as soon as possible within 30 minutes. The sample diluent should be capped immediately after opening and placed in a cool place. Please use it within the valid period.
