Rapid Antigen Tests

Luobofield Medical works since 2020 directly with RAT manufacturers and successfully supplied Governments and retailers worldwide. Our own QA/QC team in PR China ensures that the quality we ship is good. See more information about our main brands we sell below.

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Genrui SARS-CoV-2 antigen test kit (colloidal gold)

Genrui Biotech Inc. was established in 2004 and is the only product supplier in China that provides human and veterinary IVD total solutions. Their products have been exported to over 110 countries. Quality Genrui SARS-CoV-2 antigen test kit (colloidal gold) is an immunochromatographic assay for rapid and qualitative test of N protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen detection in nasal swabs. This test is applicable to all individuals suspected of being infected by SARS-CoV-2. The test will be used to assist in the diagnosis of the coronavirus infectious disease (COVID-19) caused by SARS-CoV-2. The test kit is simple, safe, effective and intended for self-testing, which is suitable for individuals to use in non-laboratory settings like homes, offices, schools, sports stadiums, airports, etc. Click here for Genrui’s documents and certificates.

Boson Rapid SARS-CoV-2 antigen test card

Xiamen Boson Biotech Co., Ltd., as a specialist of in vitro diagnostic kits founded in 2001, develops and manufactures high-quality point of care and other immunoassay kits for the worldwide market.

Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection.

Click here for Boson’s documents and certificates.

Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2

It happens that RAT’s will give a false positive result. The U.S. Food and Drug Administration (FDA) has been alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. 

In this article we will summarize the highlights of this FDA article which is related to Rapid Antigen Tests for home use as well. Most important is to read the user manual carefully before using a RAT. 

Main reasons for false positive, or false negative are:

  • For example, the package insert for tests include instructions for handling of the test cartridge/card, such as ensuring it is not stored open prior to use.  If the test components are not stored properly, this can affect the performance of the test.
  • The package insert for tests also includes instructions about reading the test results, including the appropriate time to read the results.  Reading the test before or after the specified time could result in false positive or false negative results.
  • Be aware that processing multiple specimens in batch mode may make it more challenging to ensure the correct incubation time for each specimen. 
  • Be careful to minimize the risks of cross-contamination
  • Prevalence is a measure of disease that allows us to determine a person’s likelihood of having a disease. Therefore, the number of prevalent cases is the total number of cases of disease existing in a population. Remember that positive predictive value (PPV) varies with disease prevalence when interpreting results from diagnostic tests. PPV is the percent of positive test results that are true positives. As disease prevalence decreases, the percent of test results that are false positives increase.
    • For example, a test with 98% specificity would have a PPV of just over 80% in a population with 10% prevalence, meaning 20 out of 100 positive results would be false positives.
    • The same test would only have a PPV of approximately 30% in a population with 1% prevalence, meaning 70 out of 100 positive results would be false positives.  This means that, in a population with 1% prevalence, only 30% of individuals with positive test results actually have the disease.
    • At 0.1% prevalence, the PPV would only be 4%, meaning that 96 out of 100 positive results would be false positives.

It happens that RAT’s will give a false positive result. The U.S. Food and Drug Administration (FDA) has been alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. 

In this article we will summarize the highlights of this FDA article which is related to Rapid Antigen Tests for home use as well. Most important is to read the user manual carefully before using a RAT. 

Main reasons for false positive, or false negative are:

For example, the package insert for tests include instructions for handling of the test cartridge/card, such as ensuring it is not stored open prior to use.  If the test components are not stored properly, this can affect the performance of the test.

The package insert for tests also includes instructions about reading the test results, including the appropriate time to read the results.  Reading the test before or after the specified time could result in false positive or false negative results.

Be aware that processing multiple specimens in batch mode may make it more challenging to ensure the correct incubation time for each specimen. 

Be careful to minimize the risks of cross-contamination

Prevalence is a measure of disease that allows us to determine a person’s likelihood of having a disease. Therefore, the number of prevalent cases is the total number of cases of disease existing in a population. Remember that positive predictive value (PPV) varies with disease prevalence when interpreting results from diagnostic tests. PPV is the percent of positive test results that are true positives. As disease prevalence decreases, the percent of test results that are false positives increase.

For example, a test with 98% specificity would have a PPV of just over 80% in a population with 10% prevalence, meaning 20 out of 100 positive results would be false positives.

The same test would only have a PPV of approximately 30% in a population with 1% prevalence, meaning 70 out of 100 positive results would be false positives.  This means that, in a population with 1% prevalence, only 30% of individuals with positive test results actually have the disease.

At 0.1% prevalence, the PPV would only be 4%, meaning that 96 out of 100 positive results would be false positives.

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