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COVID-19 (SARS-CoV-2) Neutralizing Antibody Test Kit (Self-testing)

Sensitivity : 279/300×100%=93.0%

Specificity : 296/305×100%=97.0%

Brand:
DEEPBLUE

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COVID-19 (SARS-CoV-2) Neutralizing Antibody Test Kit

Product Detail

Intended use

This product is used for in vitro qualitative detection of COVID-19 (SARS-CoV-2) neutralizing antibodies in humanfingertip blood after vaccination. It is recommended to use this product for testing 21 days after completing all vaccination procedures.It is intended for personal use by untrained layman .

Test principle

This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFcC-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody.

Product advances

1.Pre-filled buffer solution, easier operation.
2.Passed the PEI evaluation.
3.Room temperature storage.
4.No need instrument, get results within 15 minutes.
5.Identify acute or early infection.
6.No reduction in sensitivity test against the Alpha, Beta, Delta, Gamma, Lambda, Omicron variant and so on.

Materials and Components

1.Instruction

2.Packaged test cassette
3.Disposable sampler

4.Buffer

5.Sterile Lancet

6.Alcohol Swab

7.Sterile Pad
8.Collection Bag
9.(Materials required but not provided)

Product Information

Specification	1pcs/box,5pcs/box,25pcs/box
Specimen	Serum,plasma,whole blood or fingertip blood
Storage	4-30℃

Test Procedure

Allow test device extraction reagent and specimens to equilibrate to room temperature(15 ~ 30 ℃） prior to testing.Please keep the temperature at 15 ~ 30 ℃ and the humidity at 20%-80% during the whole test.

1.Specimen Collection

（1）Wipe the fingertips with an Alcohol Swab

（2）Pull out the cap on the front end ofthe lancet. Use sterile lancet to gently press on the wiped area

（3）Squeeze out a sufficient amount of blood

（4）Pinch the bulb at the upper end of the disposable sampler, place the lower end vertically in the blood, and then slowly loosen the bulb. The blood must exceed the thin tube, asshown in the figure as an example.

2.Testing

（1）Add a drop of blood to the sample well(S).

（2）Break off the bottleneck of thebuffer solution and squeeze adrop of buffer solution into the sample hole. Start the timer.

3.Test Results

Read result at 15 minutes.Do not read results after 30minutes.

Clinical Performance

In the clinical study, a total of 605 clinical fingertip whole blood samples were collected, among which 300 cases were vaccinated and 305 cases were not vaccinated. The test results of 605 samples of experimental reagents are as follows:

Assessment reagent	Comparison method		Total (example)
Assessment reagent	Positive (case)	Negative (case)	Total (example)
Positive	279	21	300
Negative	9	296	305
Total	288	317	605