2019 NCOV Phosphate Ag Rapid Test Kit Colloidal Gold Antigen Test

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample affect the experimental results and must be removed by centrifugation.
Anticoagulant therapy Heparin, EDTA, sodium citrate are not important.
3. Blood collection is performed by a professional medical staff. Serum / plasma tests are recommended. The patient's entire blood sample can also be used for rapid testing in emergencies and special cases.
The storage time of serum and plasma samples at room temperature should not exceed 8 hours. They are there
It can be stored at 2-8 degrees Celsius, 5 days Celsius, and 6 months Celsius, but repeated freeze-thaw cycles should be avoided. Whole blood samples should not be frozen and should be stored at 2 ° C-8 ° C for at least 48 hours.

Test Method

Please read the instructions carefully before testing. Bring all reagents to room temperature.
1. Remove the test card from the packaging kit within an hour.
2. Add l sample (serum, plasma or whole blood) to the load hole, add 2 drops (about 60 drops) to the μ test card, start buffering the μ sample, and start time counting.
3. It reacts at room temperature for 10 to 15 minutes and gives a result, but after 20 minutes, no result is obtained.

Interpretation of Test Results

Test card result judgment sheet
1. Invalid result: Quality control line (c) is invalid and needs to be retested.
2. Negative result: Red stripes appear above or above the detection line (T line), baseline (R line), quality control line (C line) and baseline (R line).
3. Positive result: The red band on the test line (t), or the following red band on the test line (t), instead of the reference line (r), quality control line (c) and reference line (r).

Limitation of Test Method

1. The kit can be used not only for qualitative tests but also for in-vitro assisted diagnosis.
2. Put an appropriate amount of sample in advance and inspect. Results may be inaccurate if there are too many or too small samples.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be avoided as they can affect test results.
4. It should not be the sole basis for clinical trials and treatment. The final diagnosis of this disease should be made by comprehensively assessing the results of all clinical and experimental studies.

Product Performance Indicators

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1. Analysis of specificity

1.1 Cross reaction: evaluate the interference of the following type of antibody to the reagent and show no cross reaction.

1.2 Interfering substances: In the 2019 NCoV and AB test plans, the following concentrations will be added to the sample to assess potential interference. As a result, it was found that each interfering substance did not interfere with the detection result of the reagent.

2. Clinical study: 120 positive samples and 300 negative samples are selected using a commercially available 2020 ncov igg antibody detection reagent (colloidal gold method) as a control reagent. The results can be summarized as follows.

Precautions

1. This product is used only for in vitro diagnosis.
2. This product is a disposable product and cannot be collected.
3. Strictly follow the reagent instructions before surgery to perform the experiment.
4. Avoid experiments in harsh environmental conditions (84 disinfectants, sodium hypochlorite, environments containing corrosive gas and high concentrations of dust, such as acids, alkalis, acetaldehyde). Disinfect after the experiment.
5. Samples and reagents used are considered potential contagious substances and are treated according to local regulations.
6. Reagents should be used within the validity period of the outsourced label. The test card must be removed from the aluminum foil bag and used as soon as possible 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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