Serum Phosphoric Acid COVID-19 Neutralizing Ag Rapid Test Kit Sample Buffer

Sample Requirements

1.A sample of serum, plasma, or whole blood collected.
2.The precipitates and suspended solids in the samples may affect the experimental results, so they need to be removed by centrifugation.
3.Anticoagulant therapy: heparin, EDTA and sodium citrate are not important.
4.Blood collection should be carried out by professional medical personnel.
Serum / plasma tests are recommended.
Whole blood samples from patients can also be used for rapid testing in emergency or special situations.
5.Serum and plasma samples should not be stored for more than 8 hours at room temperature.
They're right there.
It can be stored at 2-8 degrees Celsius for 5 days and below-20 degrees Celsius for 6 months, but avoid repeated freeze-thaw cycles.
Whole blood samples cannot be frozen and must be stored at 2 ℃ to 8 ℃ for 48 hours.

Test Method

Please read the instructions carefully before testing.
Restore all reagents to room temperature at room temperature.
1.Remove the test card from the test package for use within 1 hour.
2.Add a sample of 20 μ L (serum, plasma or whole blood) to the loading hole of the test card, then add 2 drops (about 60 μ L) of the sample buffer to start the timing.
3.The results were read after the reaction at room temperature for 10 ~ 15 minutes.
The result is invalid after 20 minutes.

Interpretation of Test Results

Figure used to judge the result of test card:
1. Invalid result: the quality management line (c) does not respond and needs to be retested.
2. Negative result: red band is displayed on the test line (t line), the color above the baseline (r line), the color of the quality control line (C line), and the color of the baseline (r line).
With or without red (R) on the reference line, and the test result is less than 3 (R) on the reference line.

Limitation of Test Method

1. The kit is only used for qualitative detection and invitro assisted diagnosis.
2. Confirm that appropriate equivalent samples are added for the test. Too large or too small sample size may produce inaccurate results.
3. Hemolytic, lipid blood, jaundice or contaminated samples may affect the test results, so these samples should be avoided.
4. The test results of this reagent are only for clinical reference and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease must be made after a comprehensive evaluation of all clinical and examination results.

Product Performance Indicators

​

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.

1.2Interfering substances: in the 2019 ncov and ab test procedures, the following concentrations were added to the samples to assess potential interference. The results show that various interfering substances will not interfere with the detection results of the reagent.

2. Clinical trial: when using commercial 2019 ncov IgG AB test reagent (gold colloid method) as control reagent, 120 positive samples and 300 negative samples were selected for the trial. The results are summarized as follows.

Precautions

1. This product is only used for invitro diagnosis.
2. This product is disposable and cannot be reused.
3. Please pay attention to the experimental operation in strict accordance with the instructions of the reagent before operation.
4. Avoid experiments under harsh environmental conditions (including 84 disinfectant, sodium hypochlorite, acid, alkali, acetaldehyde and other high concentration corrosive gases and dust). The disinfection of the laboratory should be carried out after the experiment.
5. All samples and used reagents will be regarded as potentially infectious substances and treated in accordance with local regulations.
6. The reagent shall be used within the validity period indicated on the packing box. The test card should be used as soon as possible after being removed from the aluminum foil bag to prevent moisture.

Logo interpretation

	Do not re-use		Store at 2℃～30℃
	Consult instructions for use		In vitro diagnostic medical device
	Batch code		Use-by date
	Keep dry		Keep away from sunlight
	Authorized representative in the European Community		Manufacturer

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.

Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

Company profile