After being held up by FDA in Cincinnatti, Delaware receives it’s COVID-19 test kits

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On Saturday, the Division of Public Health (DPH) Lab received a shipment of 5,000 rapid test kits from Pinnacle BioLabs. DPH’s order had been held for days in Cincinnati by the Food and Drug Administration.

Smyrna (DE): The kits, which use blood drawn by a finger stick instead of collecting a nasal swab to obtain a result, will be used primarily to test health care workers, first responders, and residents of long-term care facilities where outbreaks are suspected. Results can be provided in 5 to 15 minutes.

The Department of Health (DPH) tested the 10 first responders and health care personnel on Sunday. All 10 individuals were negative. DPH advised them they could return to their life-saving jobs, while continuing to follow precautionary measures such as continued self-monitoring for symptoms and wearing a mask. These individuals had all come into contact with a person confirmed to have COVID-19, but were asymptomatic.

This test does not replace the PCR tests but can complement them with the right application. The results can help doctors determine whether to reduce quarantine time and return these individuals sooner to their life-saving jobs., according to a release from DPH.

Test results are available in just 5 minutes for positive test results and 15 minutes for negative test results.

Delaware is one of the first states in the nation to perform this type of testing for first responders and health care providers. The goal is to expand rapid testing access in the future, under the proper applications, as tests becomes more readily available.

According to it’s website, “The Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test® Clinical Pack contains 25 test cassettes, buffer solution. The test may be performed using whole blood, serum or plasma and results are available in 15 minutes. Pinnacle BioLabs informed the FDA of intent to file Emergency Use Authorization and has began shipping kits to end users.”

The FDA Approved the Rapid COVID-19 Test Kits for Medical Professionals, First Responders, and Law Enforcement. The tests detects IgG and IgM antibodies to SARS-CoV-2 in human blood. The Covid Care Rapid Test has a 91% Clinical Sensitivity rating, and a 99% Clinical Specifity rating.

Medical professionals are adamant just how critical it is to have access to rapid, point of care testing, that is both simple and affordable. PCR testing technology takes multiple days to yield results and is not a scalable or an affordable solution to answering the extent of community and worldwide COVID-19 testing needs.

The COVID Care testing kits are FDA Approved under the Emergency Use Act and come from Pinnacle BioLabs, an FDA registered laboratory in Tennessee. They are manufactured in an ISO-13485 Certified Facility. The kits have undergone significant preliminary clinical testing and the results are in. COVID Care tests return results with Diagnostic Specificity higher than 90%!

Testing with the COVID Care test is easy and resembles the tests diabetics use to test their blood sugar. Simply “prick” a finger with the included lance, drip 2 drops of blood into the included testing cassette, drip 2 drops of testing solution into the cassette, and wait approximately 5 minutes for results. Interpreting results is a very straightforward process.

Starting Monday, the Division of Public Health will begin a new collaboration with the United Way of Delaware to better triage incoming calls related to COVID-19. Anyone with a question about COVID-19 should call Delaware 2-1-1, 1-800-560-3372, 7-1-1 for individuals with a hearing impairment, or text your ZIP code to 898-211. Delaware 2-1-1 has increased its hours, added operators, and now is available seven days a week.

The Division of Public Health asks any Delaware health care, long-term care, residential, or other high-risk facility with questions or concerns to email: DPH_PAC@delaware.gov or call the DPH Call Center at 1-866-408-1899 and press ext. 2.

Widespread community transmission is occurring throughout the state, which means COVID-19 is actively circulating in the community. If you are sick with any of the following symptoms, stay home: fever, cough, shortness of breath, sore throat, muscle fatigue, or digestive symptoms such as vomiting, diarrhea, abdominal pain or lack of appetite. If you are sick and need essential supplies, ask someone else to go to the grocery store or the pharmacy to get what you need.

If you think you have been exposed to someone with COVID-19, or have symptoms of illness, make sure to distance yourself from others, particularly vulnerable populations. Older adults and people of any age with serious underlying medical conditions – including serious heart conditions, chronic lung conditions, including moderate to severe asthma, severe obesity and those who are immunocompromised, including through cancer treatment – might be at higher risk for severe illness from COVID-19.

Statewide testing at standing health facility testing sites require a physician’s order or prescription to be tested (*Bayhealth patients will be pre-screened via phone without needing to see a provider first). These are not walk-in testing sites. Those without a primary care provider can call the DPH Call Center Line at 1-866-408-1899. Individuals awaiting test results, should wait to hear back from their medical provider. The DPH Call Center does not have test results.

Questions can also be submitted by email at DPHCall@delaware.gov.

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