Special Edition - CHAD Connection Oct 27

This is a short special edition of the CHAD Connection. Primarily, we wanted to share some deep-dive work we have been doing to help you (and ourselves!) make sense of all of the COVID-19 testing modes and methods. With many new COVID-19 tests that rolled out with emergency use authorization, and more coming each week, it is starting to become somewhat confusing! To explain the various testing options available, the difference in types of specimens collected, and some common terms used when discussing COVID-19 testing, I dusted off my clinical laboratory science shoes and put together a document that outlines just that. I am happy to answer any questions that arise on the COVID-19 testing.

Vaccines are also a huge focus for us at CHAD, including understanding the state plans as they are being developed, providing input and feedback from health centers and tracking all of the administrative elements from payment to data collection to vaccine handling. Lori Dumke provides several updates for you in the area of vaccines.

Finally, we thought we would use this special edition to share some updates from the ever-changing world of COVID-19 grants, including new Provider Relief Fund guidance and new guidelines for the South Dakota CARES Act small business grants.

Our next regular CHAD Connection is next week Thursday!

With so much news and information on the COVID-19 pandemic, it is easy to get lost in a sea of technical terminology relating to the virus and the laboratory testing to diagnose the infection. CHAD has developed a document highlighting the different types of testing available, the different types of samples used for testing, and some definitions of terms used when COVID-19 testing is being discussed. You can access the full document, Understanding the Basics of COVID-19 Testing, here, but here are some of the main points.

PCR Testing
The most accurate and reliable test method to date is the Reverse Transcription - Polymerase Chain Reaction (RT-PCR) test performed in both the North Dakota and South Dakota State Public Health Laboratories. Another type of PCR testing – rapid PCR testing – is also available and is being done in smaller laboratory settings on the Abbott ID Now instrument, and more recently, on the Cepheid GeneXpert instrument. All PCR testing is also referred to as molecular testing.

RT-PCR testing offers a very high accuracy level, with a sensitivity and specificity of >99%. Sensitivity is a measure of how likely a sample containing the virus that causes COVID-19 will test positive. The greater the sensitivity of a test, the less likely there will be false-negative results. Similarly, specificity is a measure of how likely a sample that does not contain the virus is to test negative. The greater the specificity of a test, the less likely there will be false-positive results. The RT-PCR testing that is done requires time for the sample to go through amplification of viral DNA, which makes it possible to detect positive tests from samples with only a small amount of virus.

Rapid PCR instruments offer the benefit of being authorized for use in smaller, less complex laboratories. They can produce results in as few as 15 minutes but are slightly more likely to produce a false-negative result, with sensitivity studies ranging from low to mid-90 percent.

Antigen Testing
Antigen testing is another type of test available to diagnose COVID-19. Some antigen testing is done using a small laboratory instrument, and some are done solely with a test kit that does not require an instrument. Antigen testing is relatively inexpensive and offers a fast turn-around-time for results. These tests can also be performed in any licensed laboratory. This table highlights some of the specifications of the antigen tests that are currently authorized for emergency use for the detection of SARS-CoV-2.

Antigen tests may be performed with the understanding that all or some negative tests can be followed up with a confirmatory RT-PCR test. If even a small percent of antigen tests yield a false negative result, there would still be a tremendous improvement in isolating infected patients.

Antibody Testing
The last type of test relating to COVID-19 is the antibody test. This is also referred to as a serology test because the antibodies are found in blood serum. This test uses a blood sample, and it does not diagnose an active infection; rather, a positive antibody test indicates that the patient has recovered from an active infection, and their body has had an immune reaction to the virus.

For more information on laboratory testing for COVID-19, differences in specimen type, and the type of swab used for specimen collection, see the full document on Understanding the Basics of COVID-19 Testing.

2020 is coming to an end, but COVID-19 is not. There is substantial speculation about the timing of a COVID-19 vaccine, and CHAD is following the progress closely. As of now, it appears that there will be a vaccination ready for emergency use by the end of 2020. There are still many questions that need to be addressed, including how were COVID-19 vaccines developed so quickly? How can I be sure the vaccine is safe for my patients and me? Who will get the vaccine first? Several upcoming local and national meetings will bring people up to date with the COVID-19 vaccine news.

Advisory Committee on Immunization Practices Meeting
The Centers for Disease Control and Prevention’s (CDC) advisory committee on immunization practices (ACIP) holds three meetings each year to review scientific data and vote on vaccine recommendations. The October meeting will include COVID-19 vaccine updates. This meeting is open to the public in listen-only mode. Find more information here and the agenda here.

Friday, October 30
8:00 am - 2:45 pm MT/ 9:00 am - 3:45 pm CT
To join the meeting, visit this page at the time of the meeting. No registration is required.

South Dakota
The South Dakota Department of Health (SDDOH) has submitted its COVID-19 vaccination state plan to the Centers for Disease Control and Prevention (CDC) for review. They have stated that they will publish the plan on their website once the review is complete.

The SDDOH is also starting weekly meetings for key stakeholders about the state vaccination plan and will utilize the state epi listserv for invites. Sign up for the state epi listserv here.

South Dakota Department of Health COVID-19 Mass Vaccination Planning
Tuesday, October 27 (Occurs weekly on Tuesdays thru March 2021)
12:00 pm MT/ 1:00 pm CT
Meeting link or call (669) 900 9128
Meeting ID: 845 2763 1820
Passcode: 719500

North Dakota
The North Dakota Department of Health has submitted their COVID-19 vaccination state plan to the CDC for review and has published the draft on its website for the public here.

SARS-CoV-2: Virology to Vaccine - What YOU Need to Know
Join Dr. Paul Carson, MD, FACP, NDSU professor of practice and medical director of the NDSU Center for Immunization Research and Education, as he addresses the vaccine development and approval process. All health care professionals and the public are invited. No registration is required, and the program is free.

Thursday, October 29
11:00 am MT/ 12:00 pm CT
Click here for Zoom link
A recording will be available at a later date on the NDDOH website.

On October 22, the Department of Health and Human Services (HHS) announced that it is amending the reporting instructions to increase flexibility around how providers can apply provider relief fund (PRF) money toward lost revenues attributable to coronavirus. After reimbursing health care-related expenses attributable to coronavirus unreimbursed by other sources, providers may use remaining PRF funds to cover any lost revenue measured as a negative change in actual year-over-year revenue from patient care-related sources

In essence, this change removes the September 19 reporting requirement and rolls the instructions back to the guidance issued in June. Applications are still being accepted for Phase 3 of the PRF. Applications may be submitted here until November 6.