Test Data

The below reports are the data provided to us that shows the extensive testing that has been done by the manufacturer and 3rd parties to ensure the test results are as accurate as possible:

OnSite COVID-19 IgG/IgM Rapid Test Performance Over Time, after Onset of Symptoms

The OnSite COVID-19 IgG/IgM is designed to specifically detect IgG or IgM antibodies in human serum, plasma, and whole blood, as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior SARS-COV-2 infection. The result does not provide answers to whether the individual has an acute infection.  A confirmative test is required to diagnose acute infection.

Both in-house and outside evaluation studies of the OnSite COVID-19 IgG/IgM Rapid Test was conducted in multiple countries, and they consistently show high antibody detection rate on specimens collected after 2-3 weeks from the first demonstration of symptoms (see table 1 below).

Table 1: Summary of results of multiple evaluation studies in different countries

These results are in agreement with USA FDA latest guidelines on the application of serological tests: identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The OnSite COVID-19 IgG/IgM Rapid Test features:

1) a low complicity test method, that can be used by health care providers with minimal training,

2) no need for instruments or electricity,

3) results in 10-15 minutes,

4) multiple specimen types, including fingertip capillary blood.

Therefore, this test is suited for the following scenarios:

  • Testing at clinics and labs for individual screening of patients who are suspected of COVID-19 exposure, or have shown symptoms
  • Employee testing before returning to work
  • Screening for professionals with close proximity to coworkers and customers, such as airline, restaurant, cruise or sea freight workers, or military personnel.
  • Education institutions testing faculty, staff, and students before returning to the classroom.

reference: https://ctkbiotech.com/2020/05/15/understanding-the-intended-use-of-ctks-onsite-covid-19-igg-igm-rapid-test/