[Product Name ]

SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography- sandwich method).

[Model and Specification ]

[Intended Use ]

The SARS-CoV-2 Neutralizing Antibody Test Kit can be used for in-vitro qualitative detection of SARS-CoV-2 neutralizing antibody in human serum, plasma or whole blood samples, which can be used to assess the levels of neutralizing antibodies produced in the body after vaccination or infection with novel coronaviruses (COVID-19).

SARS-CoV-2 is a new acute respiratory infectious disease and has become a major public health event in the world. The main sources of infection are patients with new coronavirus infections and asymptomatic infections, which are contagious during the incubation period and are highly contagious within 5 days of onset. Fever, dry cough, fatigue as the main clinical manifestations. Some patients have first symptoms such as loss of smell, loss of taste, etc., and a few patients have symptoms such as nasal congestion, runny nose, sore throat, conjunctivitis, myocardial pain and diarrhea.

SARS-CoV-2 belongs to the [3 genus coronavirus, with envelopes, round or oval particles, and a diameter of 60 to 140nm. 4 essential genes for nucleoprotein(N), viral envelope (E), matrix protein(M), and puncture protein(S)4 structural proteins and RNA-dependent RNA polymerase (RdRp). The nuclearprotein(N)encased in the RNA genome forms the nuclear shell, surrounded by a viral envelope(E), which is encased with proteins such as matrix protein(M) and puncture protein(S). The protrusion protein enters the cell by binding angiotensin-converting enzyme 2 (ACE-2).

SARS-CoV-2 Neutralizing Antibody is a kind of antibody that can specifically identify the neutralizing site of the antigen on the surface of the virus, can organize the virus to invade cell reproduction, protect the cell from attack, has a real antiviral effect, is the index to evaluate the immune effect of the vaccine.

[Test Principle ]

This kit is based on the principle of latex immunochromatography - sandwich method to detect the neutralizing antibodies in the sample.

RBD protein is coated on the test line (T line) and anti-chicken IgY antibody on the quality control line (C line) of the test card. The sample pad of the test card contains RBD-ACE2 protein complex to bind non-neutral antibodies against RBD in the sample. The binding pad contains RBD labeled with red latex microsphere and chicken IgY labeled with red latex microsphere.

When the RBD protein labeled with latex microspheres combined with novel coronavirus neutralizing antibody in the sample to form a complex, the neutralizing antibody on the complex combined with RBD coated on T line to form T line. The color of the band is positively correlated with the titer of neutralizing antibody. Under normal circumstances, the quality control line should be colored to indicate that the test is effective.

[Reagents and Materials Provided ]

[Materials Required but not Provided ]

Timer, Personal protective equipment: such as protective gloves, medical mask, goggles and lab coat Biohazard container.

[Storage and Stability ]

Store at temperature of 4-30 ° C(39.2-86 ° F) in a dry shady place. Avoid direct sunlight. Do not freeze the kit or its components, 18 months of shelf life (Production date to expiration date).

This product must be used in 1h at room temperature 20 to 30°C and relative humidity between 30% and 50% after opening the inner package.

[Sample Requirements ]

1. This kit is suitable for testing human serum, plasma and whole blood (including fingertip blood). Samples are collected and processed with conventional methods.

2. Fingertip blood samples should be used immediately. Other samples can be stored at 2-8°C for 24 hours, 15~25°C for 8 hours, or at/below -20°C for 1 month.

3. Samples with severe hemolysis, excessive lipid or turbidity, or samples with high level of bilirubin should not be used.

4. Samples should be fully restored to room temperature (15~25°C) before detection. Once frozen, samples should be thawed one time only. The samples must be mixed thoroughly after thawing, by low speed vortex or gently inverting, then centrifuged at >10,000 rpm for at least 5 minutes to remove particulate matter prior to testing to ensure consistency of the results.

[Test Procedure ]

Please read the instruction manual carefully before testing. Samples to be tested, test cards, sample diluents and other testing materials should be balanced to room temperature 15 minutes in advance, and the test should be carried out at room temperature.

1. Open the bag, take out the test card, lay it flat and mark it.

2. Take 15pL serum/plasma with transfer pipette, or 25pL whole blood/fingertip blood with matched capillary pipette.

3.1 test / kit and 5 tests / kit: Add 1 dropper of diluent vertically to the sample well.

25 tests / kit: Pinch both sides of black cover and gently pull it up to open the cover. Add 4 drops of diluent (about 70pL) vertically to the sample well.

4. Interpretation results in 15 minutes.

① Remove the protectivecap of the lancet;  ② Place the end face of the lancet on the fingertip, and click the tail of the lancet; ③ Place the used lancet in the waste cylinder,

[Interpretation of Results]

Positive: Colored bands appear at both test line (T) and control line (C), compare the color depth of the T-line with colorimetric card to estimate the content of neutralizing antibodies in the sample, if the T-line color depth is equal or greater than the color of C1 in the colorimetric card, the test result is positive.

Negative: Colored band appears at control line (C) only, or the T-line color depth is weaker than the color of C1 in the colorimetric card; It is suggested that there is no neutralizing antibody against novel coronavirus (SARS-CoV-2) in the sample, or content of neutralizing antibody is lower than the detection limit of the detection kit.

Invalid: Absence of colored band at control line (C), it is recommended to retest with a new test card.

[Test Limitations ]

1. This product is only used for the professional qualitative detection of neutralizing antibody in human serum, plasma, and whole blood samples.

2. Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.

3. In the early stage of virus infection or vaccination, the content of neutralizing antibodies in human body is always too low to be detected immediately. For this kind of samples, the results may be negative, so it is recommended to wait for 2 weeks after complete vaccination.

1. Due to individual differences, abnormal detection results may occur, this product is only intended for the initial screening test. The deter mination of vaccination effect should be made in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence.

[Warnings and Precautions 】

1. For in vitro diagnostic use only.

2. The instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All users have to read the instruction prior to performing a test.

3. Using fresh samples and avoiding to use samples infected with bacteria, hemolysis, jaundice or hyperlipidemia.

4. Do not use the kit if opened, damaged, or expired, keep test card sealed in its foil pouch before use.

5. To avoid cross-contamination, do not reuse the capillary blood collection vessel or lancet.

6. Avoid splashing or aerosol formation of specimen and buffer.

7. Do not mix or interchange different specimens.

8. Do not dilute the collected swab with any solution except for the provided extraction buffer.

9. Inadequate or inappropriate sample collection, storage, and trans port may cause false test results.

10. Samples with invalid results must be retested.

11. Clean up spills thoroughly using an appropriate disinfectant.

12. Do not store the test kit in direct sunlight.

13. Avoid breathing dust/fume/gas/mist/vapors/spray.

14. Contaminated work clothing should not be allowed out of the workplace.

15. Dispose of contents/container to an approved waste disposal plant

16. All human material should be considered potentially infectious.

No high dose hook effect was observed when tested with up to a concentration of 1.5x105.0 TCID50/mL of SARS-CoV2 virus.

【Description of Symbols 】

	Manufacturer		Temperature limit
	In vitro diagnostic medical device		Batch code
	Catalogue number		Consult instructions for use
	Do not re-use		M Date of manufacture
	Keep away from sunlight		Caution
	Biological risks		Keep dry
	Do not use if package is damaged		Contains sufficient for <x> tests
	Sterilized using ethylene oxide		Sterilized using irradiation
	Use-by date		Do not resterilize

Name: Nanjing Leading Medical Technology Co.f Ltd.

Add: Unit 408-410, Block C6, 9 Xian Lin Da Xue Wei Di

Rd, Xian Lin Community, Qi Xia District, Nanjing City, Jiangsu Province, China

Tel: +86 (25) 8967 4295

E-mail: postmaster@njliding.com

Website: www.njliding.com

Name: Share Info GmbH

Add: Heerdter Lohweg 83, 40549 Dusseldorf

Tel: 0049 1795 6665 08

Dimdi Code: DE/0000049303

Version 1.0

Preparation date: 07/12/2021