Testing Guidance for SARS-CoV-2 Variants of Concern

Introduction:

Since the isolation and identification of the original Wuhan SARS-CoV-2 over a year ago, many strains have emerged. During April and May 2020, a notable mutation in the SARS-CoV-2 genome, D614G, led to the emergence of the predominate strain found in the second and third surge of COVID-19 cases in the United States. In December 2020, a new strain, variant B.1.1.7, was detected and felt to be responsible for the dramatic increase in COVID-19 in the United Kingdom since October 2020. Around the same time, another strain, variant B.1.135, was also detected in South Africa and quickly became the predominate strain causing their COVID-19 cases. A third strain, P.1, was detected during January 2021 in Japan during routine screening of travelers from Brazil. All three of these variants have been identified in the United States. More variants have been identified since then, including B.1.427, B.1.429, B.1.525, B.1.526. Currently, variants B.1.1.7, B.1.147, B.1.149, B.1.525, and B.1.526 have been detected in Montana.

The Centers for Disease Control and Prevention classifies the variants in the following manner:

1. Variant of interest: A variant with specific genetic markers that have been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, reduced efficacy of treatments, potential diagnostic impact, or predicted increase in transmissibility or disease severity. These variants include B.1.525, B.1.526, and P.2. 2. Variant of concern: A variant for which there is evidence of an increase in transmissibility, more severe disease (increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures. Please see the following table for the current list of variants of concern. 3. Variant of high consequence: A variant of high consequence has clear evidence that prevention measures or medical countermeasures have significantly reduced effectiveness relative to previously circulating variants. Currently, there are no variants that are known to meet this classification.

April 14, 2021

Current Variants of Concern (VOC) According to CDC: Variant Origin Mutations Transmissibilit Disease Convalescent Monoclonal y severity and post- antibody vaccination sera activity neutralization B.1.1.7 United D614G, ~50% increase Increased Minimal Minimal Kingdom N501Y, reduction impact A570D, P681H B.1.135 South D614G, ~50% increase ? Reduced Moderate Africa N501Y, impact E484K, K417N P.1 Japan/Brazi D614G, ? ? Reduced Moderate l N501Y, impact E484K, K417N B.1.427 California D614G, ~20% increase ? Moderate Significant L452G reduction impact B.1.429 California D614G, ~20% increase ? Moderate Significant S13I, reduction impact W152C, L452R Adapted from https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant- surveillance/variant-info.html

Recommended pretest screening questions for symptomatic persons to help identify possible case of COVID-19 due to VOC:

1. Did you recently travel outside of Billings and/or Montana? If yes, where? a. Persons who recently traveled to the following counties in Montana should be considered for testing for VOC: Beaverhead, Cascade, Flathead, Gallatin, Glacier, Hill, Jefferson, Liberty, Madison, Missoula, Park, Phillips, Ravalli, Roosevelt, Valley. b. Persons who recently traveled to the following states (higher prevalence of B.1.1.7) should be considered for testing for VOC: California, Colorado, Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, Ohio, and Pennsylvania. 2. Have you had COVID-19? If yes, when were you diagnosed? a. Persons who had a positive SARS-CoV-2 test (RT-PCR or antigen) of at least 45 days prior to current presentation should be considered for testing for VOC. 3. Have you received the COVID-19 vaccine? If yes, which one and how many doses have you received? When did you receive the last dose of the COVID-19 vaccine? a. Persons who are fully vaccinated, i.e., at least 14 days after receiving both doses of the Pfizer-BioNTech or Moderna vaccine or one dose of the Janssen vaccine, should be considered for testing for VOC.

April 14, 2021

After you suspect someone who may have infection with a VOC, you should:

 Collect two (2) specimens. Nasopharyngeal swab is preferable.  If local SARS-CoV-2 testing is readily available, o Confirm COVID-19 diagnosis using one of specimen swabs. o If positive, send the second specimen swab to the Montana Public Health Laboratory. Please make sure the specimen you are planning to send is placed in the appropriate swab and transport medium for RT-PCR testing. o On the accompanying order form, indicate that you want the sample to be screened for a possible variant of concern.  If SARS-CoV-2 testing is not readily available, o Send both swabs directly to the Montana Public Health Laboratory. Ensure that the specimens you are sending are on the appropriate swab and transport medium for RT- PCR testing. o On the accompanying order form, indicate that you want the sample to be screened for a possible variant of concern, if the COVID-19 test is positive.

Management:

 Persons with suspected infection with VOC should be managed the same way as with all cases of COVID-19.  If monoclonal antibody therapy is being considered, either casirivimab/imdevimab (REGN- COV) or bamlanivimab/etesivimab should be used.  The effectiveness of steroids, remdesivir, or tocilizumab is not affected by infections due to any of the VOC.

April 14, 2021