|Sample Type::||Saliva||Key Words:||Saliva Antigen Rapid Test Kit|
|Using::||Self Test||Detection:||Nucleocapsid Protein Antigen From 2019 NCoV|
2019 NCoV Diagnostic Rapid Test Kit,
Individual Diagnostic Rapid Test Kit,
Individual rapid diagnostic test kits
2019nCov Ag Rapid Test Kit
What are Neutralizing Antibodies
Not all the antibodies are neutralizing. Non-neutralizing antibodies, or binding antibodies, are able to bind to viral antigens but do not block viral infection. Binding antibodies can flag the viral antigen to trigger immune responses but the presence of binding antibodies does not reflect the level of immunity. Neutralizing antibodies (NAbs) are antibodies that not only bind to viral antigens, but also block viral infection. The presence of NAb can be used to evaluate immunity status after infection or vaccination.
Similar to many infectious diseases, neutralizing antibodies can help to inhibit SARS-CoV-2 replication, which means the level of neutralizing antibody correlates to the immunity of future SARS-CoV-2 infections. A rapid detection of neutralizing antibodies can help with vaccine development, plasma therapy, and immunology study.
Rapid immunity evaluation within 25 mins.
Proved by clinical evaluation with subjects who received vaccine.
Compatible with serum, plasma, whole blood, and fingertip blood.
Compatible with optical reading device for POC.
2019-nCoV RBD Antibody Rapid Test is an immunochromatographic assay for rapid, qualitative detection of the novel coronaviruses (2019-nCoV) spike protein receptor-binding domain (RBD) antibodies in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen.
The Test is used to monitor the presence of 2019-nCoV RBD antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus.
2019-nCoV RBD Antibody Rapid Test can be used to assess vaccine efficacy after vaccination or whether 2019-nCoV RBD antibodies are produced in human body after infection with novel coronavirus.
For in vitro diagnostic use only.
For professional use only.
SUMMARY AND EXPLANATION
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.
The genome of coronavirus encodes four structural proteins, namely Nucleoprotein, small membrane protein, membrane protein and Spike protein (S protein). The virus receptor-binding domain (RBD) is an important domain in Spike protein and is the main structural domains for inducing neutralizing antibodies and T-cell immune responses. The viral spike protein binds the host receptor angiotensin-converting enzyme 2 (ACE2) via the receptor-binding domain (RBD), and thus is believed to be a major target to block viral entry. Neutralizing antibodies that had receptor binding motif of RBD compete strongly with human ACE2.
PRINCIPLE OF THE TEST
2019-nCoV RBD Antibody Rapid Test is based on the principle of double antigen sandwich immunoassay for determination of 2019-nCoV RBD antibodies in human whole blood, serum and plasma specimen.
During detection, When the 2019-nCoV RBD antibodies level in the specimen is at or above the detection limit of the test, the RBD antibodies bound to the colloidal gold labeled 2019-nCoV recombinant antigen and form an immune complex which are captured by RBD immobilized in the Test Region (T) of the nitrocellulose membrane, and this produces a colored test band that indicates a positive result. When the 2019-nCoV RBD antibodies level is zero or below the detection limit, there is no 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.
MATERIALS AND COMPONENTS
Note: The components in different batches of the kit cannot be mixed.
Materials may require but not provided
- Transfer pipette
STORAGE AND STABILITY
- Store at 2°C - 30°C in the sealed pouch up to the expiration date printed on the package, forbidden to store under 2°C and avoid using expired products.
- The test cassette is used within 15 minutes after taking out from the foil envelope. Buffer solution are re-capped in time after use.
- MFD date and EXP date: marked on the label. The product will be expired after 24 months
The test can be performed with fingerstick whole blood, venous whole blood, serum and plasma.
For Fingerstick Whole Blood:
1. Clean the area to be lanced with an alcohol pad. Allow the finger to dry thoroughly.
2. Use a sterile lancet, puncture the skin just off the center of the finger pad. Apply gentle pressure beside the point of the puncture. Wipe away the first drop of blood.
3. Collect a fingerstick whole blood specimen using a blood collection tube with suitable anticoagulant (containing EDTA or Heparin). Other anticoagulants have not been validated and may give incorrect result.
4. If blood flow is inadequate, the subject’s finger may have to be gently massaged at the finger base to produce several droplets of sufficient volume.
5. Draw 20μL of fingerstick whole blood from the blood collection tube with the disposable dropper. Whole blood specimen collected by fingerstick should be tested immediately.
For Venous Whole Blood:
1. According to standard venous blood collection procedure, collect a venipuncture whole blood specimen using a blood collection tube with suitable anticoagulant (containing EDTA or Heparin). Other anticoagulants have not been validated and may give incorrect result.
KEY TO SYMBOLS USED
|Materials Included||Test Cassette|
|Instructions for Use||Date of|
|Consult Instructions||Do Not Reuse|
|Store at 2°C~30°C||Catalogue Number|
|Expiration Date||Keep away from Sunlight|
|Manufacturer||Tests per Kit|
|Lot Number||In Vitro Diagnostic Medical Device|
|Guangzhou Decheng Biotechnology Co., LTD|
|Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu District, 510000, Guangzhou P.R.China|
|CMC Medical Devices & Drugs S.L.|
|C/ Horacio Lengo Nº 18, CP 29006,|