A Rockville, Maryland, genetic testing lab that has been providing Montgomery County with saliva-based COVID-19 tests since late May has agreed to suspend its testing program upon an order from the state.
The state is calling into question over 17,000 tests carried out using supplies from AdvaGenix after a federal and state inspection “revealed pre-analytic deficiencies that may have affected sample integrity,” according to a news release from the Maryland Department of Health.
— Mike Ricci (@riccimike) August 14, 2020
Maryland Department of Health spokesman Charles Gischlar said in an email that “pre-analytic” refer to how the specimen is handled before being processed.
“The Centers for Medicare and Medicaid Services are preparing an official survey report and the facility will be required to develop a plan of correction subject to the approval of CMS,” Gischlar said.
Maryland Health Secretary Robert Neall issued an 8-point order Friday afternoon, banning AdvaGenix from carrying out COVID-19 testing until their suspension is lifted.
The lab is required to alert everyone it has tested that their results are “questionable,” and that they should consider getting retested.
The AdvaGenix tests account for about 8% of the county’s 251,000 COVID-19 tests carried out during the pandemic.
Montgomery County Executive Marc Elrich and Health Officer Dr. Travis Gayles announced Friday night that the county will continue to pursue new testing options.
The state agreed to provide Montgomery County with 5,000 new test kits per week via a different vendor, to make up for the lost testing capacity. The county has not yet said how it plans to take advantage of those tests.
Earlier Friday, a Montgomery County spokeswoman said those who had been tested at county facilities in the last two weeks, approximately 2,000 people, should be retested.
The news resulted in Montgomery County temporarily closing seven testing sites that had been scheduled to provide tests in the next week.
Clinice using AdvaGenix tests were held at the following locations in Montgomery County:
- PlumGar Recreation Center at 19561 Scenery Drive, Germantown
- Mid-County Community Recreatio Center at 2004 Queensguard Road, Silver Spring
- Silver Spring Community Center at 1 Veterans Place, Silver Spring
- Takoma Park Community Center at 7500 Maple Ave., Takoma Park
- Wheaton Library and Community Recreation Center at 11701 Georgia Ave., Silver Spring
- White Oak Community Recreation Center at 1700 April Lane, Silver Spring
WTOP’s efforts to reach AdvaGenix so far, in an effort to learn of the state’s specific concerns, have been unsuccessful.
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It’s not known if AdvaGenix is providing its saliva-based oral swab or saliva tests to other counties or other states.
Both Elrich and Gayles expressed concerns about the news during a call with reporters Thursday.
Elrich said the county decided to halt testing “out of an abundance of caution.”
Gayles said while the county waits to hear more from the state about what may be wrong with the tests, other testing options are being considered.
“We are working behind the scenes to re-purpose those sites, and also looking at other alternatives to be able to stand up and continue to offer testing in that setting until we get more specific results to be able to answer the questions [about the AdvaGenix tests],” Gayles said.
The county initiated its partnership with AdvaGenix in late May and has been able to significantly increase its testing numbers due to the ease of administering the saliva-based tests, which residents are able to self-administer.
The county announced Wednesday that it was canceling tests for Thursday. Then, a day later, it suspended testing until it could get more information from the state.
A county spokeswoman explained that testing sites that use nasal swabs are much more difficult to set up and manage since everyone working at the testing site needs to be outfitted with personal protective equipment, such as face shields, smocks, face coverings and gloves.
The county’s Department of Health and Human Services spokesperson Mary Anderson confirmed with WTOP that AdvaGenix tests have been exclusively used at county-administered sites recently.
If you have made an appointment to get a county-provided test within the next week, you should check your email for a cancellation notification, Anderson said.
The county-run testing locations listed below, along with the regularly scheduled sessions at White Oak Community Recreation Center (Tuesdays and Thursdays), have been suspended until further notice:
|8/14, 17, 19, 21||PlumGar Recreation Center||20002 Century Blvd. Germantown|
|8/15||Poolesville Baptist Church||17550 West Willard Rd. Poolesville|
|8/17||Wheaton Library and
Community Recreation Center
|11701 Georgia Ave. Silver Spring|
|8/17||Parking garage behind Regal Theater||19561 Scenery Dr. Germantown|
|8/18||Mid-County Community Recreation Center||2004 Queensguard Rd. Silver Spring|
|8/19||Lincoln Park Community Center||357 Frederick Rd. Rockville|
|8/20||Silver Spring Civic Building||1 Veterans Pl. Silver Spring|
WTOP’s Kate Ryan contributed to this report.