Points to consider

  • COVID-19 should be tested for in people with COVID-19 symptoms or those having close contact with someone who has COVID-19.
  • Performing serial screening tests at the point of care provides rapid results, which can identify people with COVID-19 who are symptom-free and slow the spread of SARS-CoV-2. When they are high, Community Levels in COVID-19 are especially important.
  • Testing for SARS-CoVID-2 is conducted in a variety of settings, and healthcare providers, public health authorities, and those in charge of organizing and implementing testing should consider context, such as the prevalence of SARS-CoV-2 in the population being tested as well as the person being tested (signs, symptoms, close contacts).
  • Viral tests for the SARS-CoVID-2 do not depend on a person’s vaccination status.
  • As more information about SARS-CoVID-2 infections and COVID-19 becomes available, changes may be made to this guidance.

Stopping the spread of COVID-19, the virus that causes SARS-CoV-2, should have a testing infrastructure, which must be robust and responsive.

Overview of the different types of testing available for the detection of SARS-CoV-2 infection

The overview covers testing for diagnosis and screening to prevent the virus from spreading by individuals who have no symptoms

  • Testing health equity.
  • Selecting the test.
  • Interpreting results in vaccine recipients.
  • Examining specific settings (i.e., secondary school areas, business areas, non-healthcare environments, correctional facilities, and detention centers)

We intend to make this information available for healthcare providers, public health professionals, and those planning and organizing testing outside the healthcare setting, such as schools, workplaces and congregate housing. There is also information for the general public on SARS-CoV-2 testing.

Tests to Consider

An integrated approach to reducing the spread of SARS-CoVID-2 could include testing to track symptoms and contact information, including SARS-CoVID-2 testing. As a result of the combination of these strategies, those infected with SARS-CoVID-2 can be identified, and measures can be made to stop the spread of the virus.

Testing individuals should receive clear recommendations regarding their results.

  • Name and manufacturer of the test, the test type, test purposes, the test specifications, its limitations, who will be responsible for paying for the test, how it will be done or performed, and how/when people will be getting the results the test.
  • What do the results mean, which steps should be taken after a negative/positive result, the difference between screening for workplace purposes and screening for medical purposes, who will be receiving the test results, how they can be used, and the consequences if someone declines to test themselves.

Testing for SARS-CoV-2 and vaccination

Viral tests’ results of SARS-CoVID-2 (nucleic acid amplification tests or antigen) are not affected if a person has received a COVID-19 vaccine. A positive serologic (antibody) test for spike protein IgM/IgG could indicate past infection or vaccination with the Pfizer-BioNTech, Moderna, and Johnson & Johnson COVID-19 vaccines. Each of these vaccines uses spiked SARS-CoV-2 proteins to stimulate an immune response. Tests to assess immunity to SARS-CoV-2 following vaccination with COVID-19 or to assess the vaccination need in non-vaccinated individuals are not recommended. The use of a specific antibody test evaluating IgG/IgM antibodies to the nucleocapsid protein is recommended to determine whether a vaccinated individual has previously been infected (e.g., for public health surveillance or the diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) or Multisystem Inflammatory Syndrome in Adults (MIS-A)). 

An assessment of the performance of 10 rapid antigen tests for SARS-CoV-2

We collected 9 different brands of competing products (1) Indicaid, (2) Panbio, (3) Hotgen, (4) AESKU, (5) FlowFlex, (6) BGI YHLO, (7) Jinwofu, (8) Wondfu, (9) Hecin (herein after named a, b, c, d, e ,f, g ,h, i), and performed sensitivity verification, detection performance verification for variant strains, and specificity verification on them.

At the same time, the exact same validation was carried out on the SARS-CoV-2 Rapid Antigen Test produced by Medriva to compare the performance of these SARS-CoV-2 Antigen Rapid test Cassettes. The verification results indicate that in overall highest sensitivity, highest detection of omicron & delta strains, and highest specificity verification indeed is the Medriva COVID-19 Rapid Antigen Test.

Sensitivity verification

Test 10 different brands of SARS-CoV-2 Antigen Rapid test cassettes by diluting the inactivated virus culture solution with extraction buffer. Add 65 mL of sample. During interpretation, record the results and dilution ratios. Until all reagent brands are undetectable, the concentration is high to low.

Below are the results from the tests on the most sensitive SARS-CoV-2 Antigen Rapid test cassette brands, brands “D” and Medriva.

Detection performance verification for variant strains

With extraction buffer, dilution ratios for inactivated virus cultures of Delta and Omicron variant strains are 1:10000, 1:20000, 1:40000, and 1:80000. After testing ten brands of SARS-CoV-2 Antigen Rapid test cassettes with diluted samples, we recorded the results and dilution ratios at the corresponding interpretation time.

According to the results below, the best test brands for the mutant strains Delta and Omicron are brands “a,“d,” and “Medriva”.

Specificity verification

For specificity verification, we collected nine brands of SARS-CoV-2 Antigen Rapid test cassettes, along with the “Medriva” brand SARS-CoV-2 Antigen Rapid test cassette we produced. The next step was to confirm the negative status of 50 subjects by PCR twice in a row. SARS-CoV-2 Antigen Rapid Test cassettes were used to validate nasal swab samples from these subjects

In the results below, brand ‘b,” “c” “e”, “f”, “h”, “i”, and brand ‘Medriva’ were found to have better specificity than brand “b”, “c”, “e”, “f”, and “h”.

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