Selling CE Marked AG Diagnostic Reagent Neutralizing Antibody Test Kit

Description

Product Description

With vaccine invented, the number of people vaccinated is gradually increased in the world-wide range. On the other hand, due to the effectiveness of the vaccine and personal physique factor, it is unlikely to promise that each injection of vaccine is valid. Therefore, Singclean Neutralizing Antibody Rapid Test Kit is invented to test the vaccine injection is working or not. This product uses colloidal gold method to detect Neutralizing Antibody in human wholeblood, serum or plasma. The detection of Neutralizing Antibodies can help with vaccine development, plasma therapy and immunology study. However, it is worth noting that this test could only be a preliminary test, the confirmation should combine the result with other alternative detection method.
 

Features & Benefits

• Accurate: the product has a high accurate serology test for Neutralizing Antibodies detection

• Easy to administer and read results: no need for instrument or other equipment during the test

• Fast detection: the result appears in *0 minutes, can be used for testing on a massive scale.

• No specific storage requirement: room temperature (***0ºC)
  
  
   

  We also produce nasal swab, nasopharyngeal swab, saliva swab test kit and IgG/IgM antibody blood test kit for detection.

   

  Test result

  NEGATIVE:
  If only the C band is present, the absence of any burgundy color in the T band indicates that no Neutralizing Antibody is detected in the specimen. The result is negative.
  POSITIVE:
  In addition to the presence of C band, if T band is developed, the test indicates for the presence of Neutralizing Antibody in the specimen. The result is Neutralizing Antibody positive.
  INVALID:
  Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
  
  Limitations:
  1. A positive test result indicates that there are neutralizing antibodies in the sample, and a positive reaction can be generated after infection or injection of the vaccine. It needs to be analyzed based on the individual situation of the user.
  2. A positive neutralizing antibody test result only indicates that the tested person has neutralizing antibody in the blood, but it does not mean that the tested person will be protected from infection. Please pay attention to maintain personal protective measures in a crowded environment.
  3. A negative result only indicates that there is no neutralizing antibody that reaches the test concentration in the specimen, and other cellular immunity and mucosal immunity cannot be ruled out.
  4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should be made by a doctor after evaluating the results of other clinical and laboratory tests
  
  
  Warnings
  1. This test is only used to detect Neutralizing Antibodies and is not used to diagnose an active infection.
  2. Use fresh specimen whenever possible.
  3. Optimal assay performance requires strictly adherence to the assay procedure described in Instruction for use. Deviations may lead to aberrant results.
  4. All samples and reaction waste should be treated as the source of infection, and the operators should take necessary protective measures.

  Company Profile

  Hangzhou Singclean Medical Products Co., Ltd., established in ***3 with registered capital of RMB *0 million Yuan, is a national high and new technology enterprise. Singclean Medical manufacturing site covers the construction area of *7,**0 m2, including producing tract *3,**0 m2, class C cleanroom 2,**0 m2, class B cleanroom **0 m2, class A cleanroom *0 m2.

  Our main products include Cross-linked Sodium Hyaluronate GEL, Medical Sodium Hyaluronate Products, High-tech Hemostatic Products, and In-vitro Diagnostic Reagents Products.

  Singclean has fully established and strictly operated the quality management system for In-vitro Diagnostic Reagents Products, to ensure the company has the capability to consistently provide customer with products/services which meet the requirements of customer and regulatory, and is committed to continual improvement of the system so as to improve customer satisfaction.