Singclean High Accuracy AG Diagnostic Neutralizing Antibody Test Device CE Approved

• Customization: Available
• Type: IVD Reagent
• Certificate: CE
• Application: Infectious Disease Test
• Specimens: Blood Sampling
• Quality Guarantee Period: 2 Years
• Feature 1: Fast Results in 10 Minutes
• Feature 2: High Sensitivity and Specificity
• Feature 3: Factory Price
• Transport Package: Box or Carton
• Specification: 1 test/box; 20 test/box; 50 test/box; 100 test/box
• Trademark: Singclean
• Origin: China
• HS Code: 3002150050
• Production Capacity: 1000000/Week

Product Description

Neutralizing Antibody Rapid Test Kit

Intended Use
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.

Product Information

Product Name	Neutralizing Antibody Test Kit
Test Type	Antibody Test
Test Principle	Colloidal Gold Method
Sample Type	Whole blood/Serum/Plasma
Sample Volume	1 Drop
Qualitative/Quantitative	Qualitative
Test Time	10 mins
Operation Temperature	15-30°C
Storage Temperature	4-30°C
Shelf Life (Unopened)	2 years

Features
•Accurate serology test for Neutralizing Antibodies detection
•Easy to administer and read results
•Results ready in 10 minutes
•Enable testing on a massive scale
•Affordable, no need for instrument, highly portable
•For healthcare workers use only

Packing

Test Procedures

INTERPRETATION OF RESULTS
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no virus
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
virus Neutralizing Antibody in the specimen. The result is virus 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.

Warnings
1. This test is only used to detect the C-19 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.

Limitations
1. A positive test result indicates that there are C-19 neutralizing antibodies in the sample, and a
positive reaction can be generated after infection with the C-19 or injection of the C-19 vaccine.
It needs to be analyzed based on the individual situation of the user.
2. A positive C-19 neutralizing antibody test result only indicates that the tested person has neutralizing
antibody of C-19 in the blood, but it does not mean that the tested person will be protected from the
C-19 infection. Please pay attention to maintain personal protective measures in a crowded environment.
3. A negative result only indicates that there is no C-19 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.