Detail
Features
● Efficient: get the result within 15 minutes
● Accuracy: with 95.83% sensitivity and 99.99% specificity.
● Easy to use: 3 steps get the results without extra equipment.
Technical Parameter
|
Applicable Scope |
Professionals |
|
Packing Specification |
1 test/kit, 5 tests/kit， 10 tests/kits, 20 tests/kit, 30 tests/kit, 50 tests/kit |
|
Storage Conditions and Expiration Date |
Stored at 2~30℃, and is valid provisionally for 24 months. Once open the pouch, the test should be used within 30min. |
|
CATALOGUE NUMBER |
CG9081-1T，CG9081-5T，CG9081-20T，CG9081-30T，CG9081-50T. |
|
Certification |
CE1434 |
|
Turnaround time |
15~20 mins |
|
Specimens |
Nasopharyngeal Swabs, Oropharyngeal Swabs, Anterior Nasal Swab and Saliva. |
|
Stability |
Stable for 24 months at 2°C to 30°C |
Main Components
|
Serial number |
Component |
Composition |
Specification and quantity |
||||
|
1 test/kit |
5 tests/kit |
20 tests/kit |
30 tests/kit |
50 tests/kit |
|||
|
1 |
Test Cassette |
NC membrane, RBD protein, ACE2 protein, anti-chicken IgY, chicken IgY |
1 |
5 |
20 |
30 |
50 |
|
2 |
Sample diluent |
PBS buffer |
1 |
||||
|
3 |
Disinfection cotton |
/ |
1 |
5 |
20 |
30 |
50 |
|
4 |
Blood collection needle |
/ |
1 |
5 |
20 |
30 |
50 |
|
5 |
Quantitative capillary blood collection vessel |
/ |
1 |
5 |
20 |
30 |
50 |
Test Procedure
1) Take out the test cassette from the sealed pouch, lay it flat and make a mark.
2) Serum/plasma sample: add 10ul serum/plasma to the sample hole of the test cassette, and then add 70ul (4 drops) sample diluent to the sample hole of the test cassette.
Whole blood sample: Use the matching 20ul quantitative capillary tube to draw whole blood (capillary or venous) sample, add it to the sample hole of the test cassette, and then add 70ul (4 drops) sample diluent to the sample hole.
3) Start the timer, wait for colored lines to appear. Interpret the test results at 15 minutes. Do not read results after 20 minutes.
FAQ
The SARS-CoV-2 Neutralization Antibody Rapid Test Cassette is based on the principle of lateral flow Latex immunoassay and use the immunochromatography-sandwich method to detect the neutralization antibodies in the sample.
RBD protein and anti-chicken IgY antibody are coated on the test line (T line) and quality control line (C line) of the NC membrane, conjugation pad contains red latex microspheres labeled proteins (RBD protein and chicken IgY protein).
If the sample contains SARS-CoV-2 neutralization antibodies, it forms a complex with the red latex microspheres labeled antigen (RBD of the S1 spike antigen). The complex moves forward under the action of chromatography and captured by the coated RBD protein at the test line (T line) and develops color, indicating a positive result, The color of the band is positively correlated with the titer of neutralization antibody.
If the sample does not contain SARS-CoV-2 neutralization antibody, the red latex microspheres labeled RBD can’t be captured by the coated RBD protein at the test line (T line) and, no color develops at test line(T), indicating a negative result.
Regardless of whether the sample contains neutralization antibody or not, the red latex microspheres labeled quality control chicken IgY antigen on the conjugation pad will bind to the coated Anti-chicken IgY antibody at the C line and develop color.
They are 3 results we might get: Positive (with C & T line); Negative (with C line, without T line); and Invalid (without C line).
1. Positive: Colored bands appear at both test line (T) and control line (C), faint color. Faint colored line(s) in the test region(s) should be considered as positive.
2. Negative: Colored band appears at control line (C) only，it is suggested that there is no neutralization antibody against SARS-CoV-2 in the sample, or content of neutralization antibody is lower than the detection limit of the kit.
3. Invalid: Absence of colored band at control line (C), it is recommended to retest with a new test cassette.
They are 2 ways we can detected this situations: NAAT and Antigen.
(Comes from CDC of Los Angeles)
