COVID Neutralizing Antibody Rapid Test Kit
COVID Antibody Test Neutralizing Antibody Rapid Test Kit
COVID-19 Antibody Test Neutralizing Ab Rapid Test is use Lateral flow immunochromatographic assays for detection of SARS-COV-2 neutralizing antibody (NAb), which can be used to determine the immunity status after infection or vaccination.
PRINCIPLE
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) is for detection antibodies to SARS-CoV-2 or its vaccines. The cell surface receptor angiotensin converting enzyme-2 (ACE2) are coated in the test line region and the recombinant receptor-binding domain (RBD) conjugated with the indicate particles. During testing, if there are SARS-CoV-2 neutralizing antibodies in the specimen, it would react with the protein RBD-particle conjugate and not react with the pre-coated protein ACE2. The mixture then migrates upward on the membrane chromatographically by capillary action and would not captured by the pre-coated antigen.
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) contains protein RBD-coated particles. The protein ACE2 are coated in the test line region
Feature
A. Blood test: serum, plasma , whole blood and fingertip blood all are avaliable.
B. Small specimens are required. Serum, plasma 10ul or whole blood 20ul is enough.
C. Rapid immunity evaluation with 10 mins.
Authorized certifications for Neutralizing AB Antibodies rapid test
CE Approved
China’s white list approved Neutralizing Antibody Rapid Tes
Test Procedure
Reader of Result
LIMITATIONS
1. The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) is for in vitro diagnostic use only. This test should be used for the detection of neutralizing antibodies to SARS-CoV-2 or its vaccines in whole blood, serum, or plasma.
2. The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) will only indicate the presence of neutralizing SARS-CoV-2 antibodies in the specimen and should not be used as the sole criterion for the antibody titer detection method.
3. In the recovered patients, the titer of SARS-CoV-2 neutral antibodies concentrations may be above detectable levels. The positive of this assay could not be considered as a successful vaccination program.
4. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
5. Results from immunosuppressed patients should be interpreted with caution.
6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
PRECISION
Intra-Assay
Within-run precision has been determined by using 15 replicates of two specimens: a negative, and a spiked RBD antibody positive (5ug/mL). The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same two specimens: a negative, and a positive. Three different lots of the SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) have been tested using these specimens. The specimens were correctly identified >99% of the time.
CAUTIONS
1.For in-vitro diagnostic use only.
2.Must not use kit beyond the expiration date.
3.Do not mix components from kits with different lot number.
4.Avoid microbial contamination of reagents.
5.Use the test as soon as possible after opening to protect it from moisture.