COVID 19 Mutations Negatively Impact Effectiveness of Detection Tests

COVID 19 Mutations Negatively Impact Effectiveness of Detection Tests

During the last year, the SARS-CoV-2 virus has mutated multiple times, resulting in the circulation of several COVID-19 variants that have different genetic sequences than the original strain. Since these COVID 19 mutation variants have different characteristics, certain COVID-19 tests may not be as effective in detecting the virus or its variants. The affected tests include molecular, antigen, and serology tests (FDA, 2021).

A test’s performance may be impacted by the variant’s sequence, the test’s design, and how widespread the variant is in the public. Here are several molecular tests that the FDA pointed out and the possible impact on each:

• Accula SARS-CoV-2 Test (Mesa Biotech, Inc.): The variant’s impact is minor, but the FDA alerted providers out of caution.
• Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.): Certain mutations may affect the test’s sensitivities for select targets, but overall sensitivity should not decrease; this may affect interpretation of test results.
• TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.): Certain mutations may affect the test’s sensitivities for select targets, but overall sensitivity should not decrease; this may affect interpretation of test results..
• Xpert Xpress SARS-CoV-2 (Cepheid): Certain mutations may affect the test’s sensitivities for select targets, but overall sensitivity should not decrease; this may affect interpretation of test results..
• Xpert Xpress SARS-CoV-2 DoD (Cepheid): Certain mutations may affect the test’s sensitivities for select targets, but overall sensitivity should not decrease; this may affect interpretation of test results..
• Xpert Omni SARS-CoV-2 (Cepheid): Certain mutations may affect the test’s sensitivities for select targets, but overall sensitivity should not decrease; this may affect interpretation of test results..

Additional Information

Review the full description of the variants’ effects and recommendations for providers on the FDA website. Follow the YES COVID-19 Resource Center for more developments, and visit the YES COVID-19 Training page to learn how to code the Coronavirus and related tests and treatments.

Get the latest COVID-19 medical coding training. This covers the new ICD-10-CM/PCS codes, FAQ advice, treatments, vaccines. The courses also other CMS-targeted COVID-19 training topics. You can also follow our COVID-19 Resource Center for additional updates.