We bring rapid antigen COVID-19 testing to community based organizations (CBOs), schools, camps, after school programs, and other organizations serving children and their families in the San Francisco Bay Area. In the future, as COVID-19 wanes, we plan to diversify our health offerings to include further clinical and mental health services.
We're concerned about the growing mental and physical health challenges facing youth in San Francisco as we start to reopen programs and learning sites. We want to support efforts to create safety and trust through care.
We are financed by private contributions. We have received testing supplies from SFDPH for use in K-12 school communities. We offer our services for free to CBOs that serve high needs youth.
Safer Together is certified as a clinical laboratory, with a CLIA Certificate of Waiver that lets us offer any medical testing that is approved as CLIA-waived under the supervision of a prescribing doctor. The FDA has issued Emergency Use Authorization and CLIA-waived status for all COVID-19 tests that Safer Together administers.
Our prescribing doctor is Yvette Wild, MD, a pediatric gastroenterologist at UCSF.
The Clinical Laboratory Improvement Amendments (CLIA) program ensures quality laboratory testing in the United States. The Centers for Medicare & Medicaid Services (CMS) regulate all laboratory testing (except research) performed on humans in the U.S. through CLIA.
There are four types of CLIA Certifications, with a CLIA Certificate of Waiver being issued to laboratories that only perform waived tests. Waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer's applications for test system waiver.
All COVID-19 tests that Safer Together administers have an FDA Emergency Use Authorization that categorizes them as waived tests.
As a CLIA laboratory with a Certificate of Waiver, we follow all regulatory requirements set out by the CDC, CMS, and California Department of Public Health (CDPH). For schools within San Francisco, we also follow all local regulations and guidelines set out by SFDPH. Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing is provided by the CDC.
Staff are trained on the obligations and regulatory requirements governed by our CLIA Certificate of Waiver, maintaining HIPAA compliance, patient interaction and sample handling, proper test administration, and proper usage of personal protective equipment. Our training program incorporates pre-work that includes videos and reading, a hands-on training session for test administration and workflow, and follow-up certification quizzes.
Safer Together is represented by Morrison Foerster (MoFo) pro bono. We have received guidance from their experts in corporate law, contracts, and health care, amongst other practice areas. We have medical liability and other professional and business liability insurance coverage.
Safer Together works with our partners and can provide services to meet their needs and comfort level. We can provide an end-to-end solution where we show up with trained personnel and all materials and take care of testing for you at a frequency that works for your organization. Alternatively, if you would like to take some of this effort in house, we can train your employees or volunteers to meet HIPAA requirements and assist with administering tests properly. We can also provide consulting services for you to run a rapid antigen testing operation yourselves.
Rapid antigen tests work in 15 minutes using a frontal nasal swab specimen and a low complexity, lateral flow test. This type of test runs a liquid sample along a surface with reactive molecules and detects fragments of proteins of the SARS-CoV-2 virus. Lateral flow tests are common diagnostic tests, such as over the counter pregnancy tests.
The Abbott BinaxNOW test was used in a UCSF research study where it had a sensitivity of 93.3% and a specificity of 99.9%. The high specificity means that this test is unlikely to give false positive results. The sensitivity means that the test may miss some individuals who don’t have a viral load that is high enough to be detected by a rapid test. Rapid tests flag most infectious cases (even asymptomatic cases!), but negative results don’t rule out infection.
Yes, we offer follow-up PCR testing. Polymerase Chain Reactions (PCR) are considered the gold standard in COVID-19 testing because of their high sensitivity and are often required as a confirmatory test. Typical costs can be $100 per test or more and turnaround time is often days long, instead of minutes. PCR testing detects RNA (or genetic material) that is specific to the virus. These tests can detect the virus within days of infection, even at low viral loads. However, they can also detect the low level presence of virus long after a person has quarantined and after they are no longer contagious, so should not be used to confirm whether a person remains infectious.
Rapid antigen testing detects protein fragments of the coronavirus, so the virus needs to reach sufficient levels to be detected. These tests are good at detecting viral loads that correspond with a person’s period of infectiousness. In a recent UCSF study, rapid antigen tests were able to detect individuals that had recently been infected, even before they started showing symptoms. Given the low cost and quick result turnaround, rapid tests are best used for frequent screening. They are also the best choice for confirming a person is no longer infectious after they have undergone quarantine.