SARS-2 Antibody Test Covid 19 Neutraliazing AB Rapid Test Kit
Features for COVID Antibody Test kits Neutraliazing AB Rapid Test
A. Blood test, finger whole blood is feasible.
B. Detection of Limit: Cutoff：100ng/ml, Detection range：50~5000ng/ml
C. Small specimens are required. Serum, plasma 10ul or whole blood 20ul is enough.
Characteristics of rapid detection technology for colloidal gold
1. Convenient operation: the operation steps are sample, no special equipment is required, the sample does not need special processing, the test results can be directly interpreted with the naked eye, and there is no special skill requirement for the operator
2. Fast and quick: only 10-15 mins will produce results. While other methods such as ELISA require 1-2 hours， PCR takes longer.
3. Strong specificity: because the technology is mostly labeled with monoclonal anyibodies, it determined that it only detects a certain antigenic determinant, so it has very good specificity.
4. The sensitivity is accurate
5. Convenient to carry: since the colloidal gold labeling protein is a physical binding process, the binding is firm and rarely causes changes in protein activity. Therefore, the reagent is very stable and not affected by externnal factors such as temperature. It can be carried with you for monitoring at any time.
6. Safety and environmental protection: Compared with other detection methods, immune colloidal gold technology greatly simplifies the operation. No harmful substances such as radioisotopes and o-phenylenediamine are involved in the test, so it will neither harm the health of the operator nor pollute the environment. , Has the safety that can’t be compared with the detection methods such as radioisotope or enzyme label.
Authorized certifications for Neutralizing AB Antibodies rapid test
CE Approved
China’s white list approved Neutralizing Antibody Rapid Test
SPECIMEN COLLECTION AND PREPARATION
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) (Whole Blood/Serum/Plasma) can be performed using whole blood. Both Fingerstick Whole Blood and Venipuncture Whole Blood can be used.
To collect Fingerstick Whole Blood specimens:
• Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
• Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
• Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
• Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
• Add the specimen to the test device by using a dropper or micropipette measuring 10uL.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. For long term storage, specimens should be kept below -20°C.Whole blood collected by Fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than three times.
If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
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.