SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma), rapid chromatographic immunoassay
A rapid test for the qualitative detection of SARS-CoV-2 Neutralization Antibody in human whole blood, serum or plasma specimens.
For professional in vitro diagnostic use only.
The SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the cell surface receptor ACE2 in human whole blood, serum or plasma. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.
Results are for the detection of SARS-CoV-2 neutralization antibodies. Positive results indicate the presence of neutralization antibodies to SARS-CoV-2.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
All coronaviruses share similarities in the organization and expression of their genome, in which 16 nonstructural proteins (nsp1 through nsp16), encoded by open reading frame (ORF) 1a/b at the 5’ end, are followed by the structural proteins spike (S), envelope (E), membrane (M), and nucleocapsid (N), which are encoded by other ORFs at the 3’ end.1 The virus gains entry to the host cell through binding of the S protein receptor-binding domain (RBD) to the angiotensin-converting enzyme 2 (ACE2) receptor on target cells, particularly respiratory epithelial cells of the host. Upon infection with SARS-CoV-2, the host usually mounts an immune response against the virus by producing different types of antibodies in the blood.
A subset of these antibodies, which reduce viral infectivity by binding to the surface epitopes of viral particles and thereby blocking the entry of the virus to an infected cell, are defined as neutralizing antibodies (NAbs).
This test contains two key components: the recombinant SARS-CoV-2 RBD fragment , labeled by colloidal gold, as tracers; and the human ACE2 receptor protein (hACE2) , coated with cellulose nitrate membrane. When specimens are added to the sample pad, neutralizing antibodies, if present in the specimen, will bind to the RBD labeled colloidal gold and block the protein-protein interaction between RBD and hACE2. The unbound RBD labeled colloidal gold as well as any RBD labeled colloidal gold bound to non-neutralizing antibody will be captured on the test line. The control line acts as a procedural quality control.
The test contains recombinant SARS-CoV-2 RBD fragment coated particles as a detection reagent and human ACE2 receptor protein coated with cellulose nitrate membrane as a capture reagent.
1. This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after the expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use the test if the pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the collection, handling, storage and disposal of patient samples and the disposal of used kit contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after testing.
8. Please ensure that appropriate amounts of samples are used for testing. Too much or too little may lead to deviation of results.
9. The used test should be discarded according to local regulations.
10.Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Take out the test from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test on a flat and clean surface.
For Serum or Plasma specimen:
•Use a dropper: Hold the dropper vertically and transfer 2 drops of serum or plasma
(approximately 50uL) to the specimen well (S). Start the timer.
•Use a pipette: Transfer 50uL of serum or plasma to the specimen well(S), then
start the timer.
For Whole Blood specimen:
•Use a dropper: Hold the dropper vertically and transfer 3 drops of whole blood
(approximately 75uL) to the specimen well (S). Then add 1 drop of buffer
(approximately 40uL) and start the timer.
•Use a pipette: Transfer 75uL of whole blood to the specimen well(S), then add 1
drop of buffer (approximately 40uL) and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: One colored line appears in the control region (C) or two colored lines appear, color intensity of test region (T) is weaker than line in control region (C). Positive result indicates the detection of neutralization antibodies against SARS-CoV-2 in the sample.
NEGATIVE: Two colored lines appear. One colored line should be in the control region (C) and another colored line in the test region (T). The color intensity of test region (T) is equal to or stronger than control region (C).
Negative result indicates the neutralization antibody against SARS-CoV-2 was not in the sample.
INVALID: Control line fails to appear. Insufficient specimen or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
1. The test procedure and the interpretation of test result must be followed closely when testing for the presence of neutralization antibodies against SARS-CoV-2 in human whole blood, serum, or plasma. For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results.
2. The performance of the SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) was evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter the performance of the test.
3. The SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of neutralization antibodies against SARS-CoV-2 in human whole blood, serum, or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of neutralization antibodies against SARS-CoV-2 can be determined by this qualitative test.
4. The hematocrit level of the whole blood can affect the test results. Hematocrit level needs to be between 25% and 65% for accurate results.
5. The test will show negative results under the following conditions: The titer of the novel coronavirus antibodies in the sample is lower than the minimum detection limit of the test, or the neutralization antibody against SARS-CoV-2 has not appeared at the time of sample collection.
6. Results from immunosuppressed patients should be interpreted with caution.
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