2019 NCoV Coronavirus Neutralizing Antibody Rapid Test Immunochromatography BfArm

Keep it at 2℃ ~ 30℃ for 12 months.
The validity period of the aluminum foil bag is 1h after unpacking.
Batch number of products: see label for details.
Expiry date of products: see label for details.

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the samples may affect the experimental results and should be removed by centrifugation.
3. Anticoagulants: The use of heparin, EDTA and sodium citrate anticoagulants has no significant effect.
4. Blood collection should be carried out by professional medical personnel. It is recommended to give priority to serum/plasma detection. In emergency or special circumstances, whole blood samples of patients can also be used for rapid detection.
5. Serum and plasma samples should not be stored at room temperature for more than 8 hours, and can be stored for 5 days at 2℃ ~ 8℃, and for 6 months below -20℃, but avoid repeated freezing and thawing. Whole blood samples shall not be frozen and stored at 2℃ ~ 8℃ for no more than 48 hours.

Test Method

Read the instruction manual carefully before testing. Please restore all reagents to room temperature before testing, and the testing should be carried out at room temperature.
1. Take out the test card from the packaged reagent bag and use it within 1 hour.
2. Drop 20μL sample (serum, plasma or whole blood) into the sample adding hole of the test card, then drop 2 drops (about 60μL) of sample buffer, and start timing.
3. Read the results when reacting for 10 ~ 15 minutes at room temperature. The reading result is invalid after 20 minutes.

Interpretation of Test Results

Figure for judging test card results:
1. Invalid result: there is no reaction line in the quality control line (C line), and the test is invalid, so the experiment should be repeated.
2. Negative result: the detection line (T line) appears red band, and the color development is higher than or equal to that of the control line (R line), and the quality control line (C line) and the control line (R line) develop color.
3. Positive results: there is no red band in the detection line (T line) or red band in the detection line (T line), but the color development is lower than that of the control line (R line), and the quality control line (C line) and the control line (R line).

Limitation of Test Method

1.This kit is a qualitative test, and is only used for auxiliary diagnosis in vitro.
2. Please make sure that an appropriate amount of samples are added for testing. Too much or too little sample may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect the test results, so these samples should be avoided.
4. The test results of this reagent are for clinical reference only, and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

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1. Analysis of specificity
1.1 Cross-reaction: The interference of the following types of antibodies was evaluated with reagents, and the results showed that there was no cross-reaction.

1.2 Interfering substances: The following substances were added to the samples with specified concentrations, and their potential interference in the neutralization antibody test project of novel coronavirus (2019-nCoV) was evaluated. The results show that various interfering substances will not interfere with the detection results of this reagent.

2. Clinical research: Using the novel coronavirus (2019-nCoV)IgG antibody detection reagent (colloidal gold method) as the contrast reagent, 120 positive samples and 300 negative samples were selected for detection respectively, and the results are summarized as follows:

Precautions

1. This product is only used for in vitro diagnosis.

2. This product is disposable and cannot be recycled after use.

3. Read the instruction manual carefully before operation, and carry out experimental operation in strict accordance with the reagent instruction manual.

4. Avoid the harsh environment (such as the environment containing high-concentration corrosive gases and dust such as 84 disinfectant, sodium hypochlorite, acid, alkali or acetaldehyde). Laboratory disinfection should be carried out after the experiment.

5. All samples and used reagents should be regarded as potentially infectious substances, and should be disposed of in accordance with local regulations when discarded.

6. Please use the reagent within the validity period marked on the outer packaging, and use the test card as soon as possible after taking it out of the aluminum foil bag to prevent moisture.

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Basic Information

ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD

Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA

Tel:+86-371-55016575

Email:zosbio@zosbio.com

Web:www.zosbio.com

SUNGO Europe B.V.

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