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07/27/2021 01:33 PM
Pennsylvania State Senate
https://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=S&SPick=20190&cosponId=31669
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Senate of Pennsylvania
Session of 2019 - 2020 Regular Session

MEMORANDUM

Posted: April 27, 2020 11:20 AM
From: Senator Andrew E. Dinniman
To: All Senate members
Subject: Antibody Testing
 
I am urging your consideration of co-sponsoring SB 1123. The bill simply adds to the duties of the Pennsylvania Department of Health (DoH) in the following way…”The Department of Health shall support the efforts of counties to initiate antibody point-of-contact testing, including the State health lab waivering or covering the needed Clinical Laboratory Improvement (CLIA) protocol”.
 
Pennsylvania can’t reopen and we can’t stop the spread of the Coronavirus without testing. Yet there is a severe shortage of materials necessary for nasal swab tests and a vaccine is at least a year away.
 
This is the problem facing Chester County and my district. It is the same that is facing your district. So, the Chester County Health Department started to review antibody tests in order to protect emergency responders and front-line workers.
 
A number of states and counties across the country were already using such tests. For example, Arizona is using antibody tests for 250,000 health care workers and first responders.
 
After much deliberation, the County selected a county-based biopharma company, which had point-of-contact tests with results in 15 to 20 minutes. After the County received approval from the DoH to use the tests for first responders, they were purchased with County funds. Almost two weeks later, the DoH put major barriers in the way and despite a plea from the County and myself to them and the Governor’s office, these barriers have not been removed.
 
Antibody tests are not used to determine if a person is contagious. They are used to determine if a person had the virus (even if they didn’t have symptoms) and have a degree of protection.
 
These tests can be used without FDA approval because of the Coronavirus emergency. This antibody test was tested for validity by LabCorp, a leading global clinical laboratory. The validity was 97%.
 
Because of DoH barriers with weeks of no testing, Advaite decided to submit the test for FDA Emergency Use Authorization (EUA), even though it didn’t have to. Advaite is optimistic, based on conversations with the FDA, that EUA approval will be granted.
 
No tests are perfect, but in the absence of statewide mass testing many counties, like Chester County, have health professionals and physicians doing due diligence to review appropriate tests. In this case, there is a Pennsylvania company that developed an antibody test that saves lives.
 
This bill requires the state DoH to assist and be supportive of these county and regional initiatives. If you agree, please sign on as a co-sponsor.