NEWS DETAIL
Home » News » SARS-COV-2 ANTIGEN TEST KIT USER INSTRUCTION

SARS-COV-2 ANTIGEN TEST KIT USER INSTRUCTION

Views: 0     Author: Site Editor     Publish Time: 2022-04-07      Origin: Site

SARS-COV-2 ANTIGEN TEST KIT USER INSTRUCTION

Ⅰ. Product File

抗原检测卡2021.10.13_00抗原检测卡2021.10.13_01抗原检测卡2021.10.13_03抗原检测卡2021.10.13_04


Ⅱ. Instruction SOP 

QRI改3.10_00


Ⅲ. Video


Ⅳ. General question

1. Are antigens tests really reliable?

Without reaching the reliability of the best test to detect COVID so far with 99.9% reliability, the PCR test, our tests that detect the presence of antigens offer more than acceptable results. With 92.9% sensitivity and 99.6% specificity, our tests are almost as reliable as PCR, if performed within the first few days of the onset of symptoms.

2. What is the difference between a rapid antigens test and a rapid antibody test?

The antigens test is capable of detecting the presence of the virus, the antibody tests are not. The rapid antibody test and the ELISA test do not detect the virus but the immune reaction generated by our body against it, that is, they detect the antibodies produced against the virus by the person’s immune system. They are indirect proof that the disease is active or has been passed.

3. What are its advantages over the PCR test?

Speed: although we are currently the only laboratory that delivers the results of the PCR tests on the same day they are performed, undoubtedly the time to know the result of these tests is its greatest advantage. The results of the antigen tests are known within 15 minutes.

Simplicity: antigens tests do not require expensive reagents, robots, or qualified technical personnel for their results and although they can be performed in the same place of patient care, the World Health Organization does not recommend that they be done in places where they are not comply with the necessary biosecurity measures, both for the safety of whoever performs the test and for the risk of contamination of the sample.

Price: they are notably cheaper than the PCR tes.

Therefore, it appears that they could be done more frequently than PCR, and on a larger scale.

4. What is the sensitivity and specificity of your antigens test?

The sensitivity of our antigens tests is 95% and the specificity is 99.6%. The confidence intervals are: Sensitivity 82% – 99%; Specificity 98% – 100%. Test results are usually lower in asymptomatic people and, therefore, if in doubt, a PCR test should be performed.

Sensitivity is the ability of the antigens test to detect the disease and is calculated as the percentage of true positives over the total number of patients. For example, a sensitivity of 97% means that only 3 out of 100 samples have been diagnosed as negative (healthy people) when, in fact, they were from infected individuals (positive). This 3% indicates the percentage of the so-called “false negatives”.

Specificity is the ability of the antigens test to detect healthy individuals and is calculated as the percentage of true negatives over the total number of healthy individuals. For example, a sensitivity of 98% means that only 2 out of 100 samples have been diagnosed as positive (infected) when, in fact, they were from healthy people (negative). This 2% indicates the percentage of the so-called “false positives”.

5. How is the test done and when should it be done?

To carry out this immunochromatographic test, it is necessary to collect a nasopharyngeal sample, that is, from the nasal portion of the pharynx, with a sterile rayon swab, which will later be analyzed with the rapid detection kits for SARS-CoV-2.

The Rapid Antigens Test is indicated for people with symptoms in the first days of COVID-19 evolution, and for those asymptomatic who have had recent direct contact with a person who has tested positive.

6. What are antigens?

Definition of antigen: “substance that triggers the formation of antibodies and can cause an immune response”.

It is also defined as “antigen” any molecule that penetrates our body and that the defense mechanisms identify as foreign or unknown. Therefore, in this definition the types of antigens include any element that is part of a pathogen (a virus, a bacterium, a fungus), or any toxin, allergen, etc.

These molecular structures found on the surface of viruses are recognized by the immune system that triggers the production of antibodies. Antigens testing therefore detects these structures that are part of the outer envelope of the virus, that is, the virus proteins. However, when we perform a PCR test we are detecting the presence of the genetic material of the SARS-CoV-2 virus, RNA in this case.

7. Is the negative result valid for air travel?

The rapid antigens test is not valid for traveling to other countries, at the moment. The governments of many countries require a negative PCR. 

8. Should I combine it with any other tests for COVID-19?

When a person decides to undergo tests, especially if they are asymptomatic, it is advisable to do both types of tests, the antigens test (or the PCR test) together with another serology test that detects antibodies, either the ELISA test or the rapid test of antibodies. The combination will tell us what phase of the disease we are in. In the first days after infection, the antigens test will be positive and the serology could be negative; later it will be the other way around: the serologies will be positive and the antigens test or the PCR test will be negative.

On the other hand, if the antigens test is negative but the person has clear symptoms of COVID-19, it should be contrasted with a PCR test immediately.


QUICK LINKS
PRODUCTS
CONTACT US
Placeholder Image

   Telephone: 008651068501244

Placeholder Image

  Email: info@bioteke.cn 

Copyright BioTeke Corporation(wuxi) Co.,Ltd  |   苏ICP备18042459号-1