Our Response to
COVID-19 is the disease caused by a novel coronavirus, SARS-CoV-2 that was first identified in Wuhan, China in late 2019. Since then, COVID-19 has been declared a pandemic, and as of August 9, 2020 there were over 5 million confirmed cases in the United States. Unfortunately, COVID-19 is a highly contagious disease transmitted through respiratory droplets, has a long incubation period of 2 to 14 days and infected individuals may be contagious when asymptomatic or before symptoms develop. Thus, testing is an important tool to identify patients who may be contagious so that they may be isolated and for the purpose of contact tracing.
Unfortunately, there is no “easy button” when it comes to COVID-19 testing. COVID-19 testing is detecting viral RNA or viral antigen; thus, sampling requires swabbing areas where the virus is present. Appropriate PPE is needed by the health care worker (HCW) performing the swab and shortages of PPE have impeded the testing process. Initially, nasopharyngeal (NP) swabs were recommended, though more recently, mid-turbinate swabs are acceptable. Mid-turbinate swabs may cause less patient discomfort and are generally preferred by patients.
Once collected, tests are sent to either a reference lab or processed using a point of care testing system. Examples of reference labs include government laboratories such as the CDC, state labs, or private laboratories such as LabCorp or Quest Diagnostics. At reference labs, samples can be processed in batches up to several hundred samples on the same machine cycle. During surges, the sheer number of tests outnumbered the testing capacity resulting in delays of days to even weeks. Shortages of supplies such as pipettes and reagents can further contribute to the backlog of testing. Providers working in a large medical group or hospital system may have access to an in-house lab with a facility point of care test. The advantage of an in-house lab is decreased transport time, which may save 1-2 days off the overall processing time.
Reference labs use molecular tests or RT-PCR (reverse transcriptase-polymerase chain reaction), and the sensitivity of these tests is generally above 90%, with high specificity. Since there are over 100+ high complexity COVID-19 tests that have an EUA, it is advised to contact your laboratory provider for specific performance data.
There are currently 6 CLIA-waived point of care tests that have received an EUA from the FDA. These portable testing platforms are well suited for the ambulatory clinic and deliver real time results. Of the 6 tests, 4 detect SARS-CoV-2 nucleic acid and 2 detect SARS-CoV-2 surface antigen proteins. Initial data suggested that antigen tests are not as sensitive as nucleic acid tests, but recent studies have demonstrated comparable sensitivity to PCR if the test is performed within 5 days after the onset of patient symptoms.
Clinicians are cautioned not to choose testing solely based on test sensitivity and specificity data. Sensitivity and specificity help a clinician decide which test to use for any particular disease, but these test characteristics are particular to the test and depend on the engineering behind how the test result is obtained. For COVID-19 tests, the sensitivity and specificity are based on small numbers of test samples and manufacturer’s data not independently confirmed by the FDA. There are publications in the literature that report widely different sensitivity values, with some claiming that the sensitivity of an individual test is grossly overestimated.
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DUC is committed to providing local families and employers the most reliable and fastest result COVID-19 diagnostic testing available. This rapid molecular ID NOW test, along with the associated antibody testing provides the best possible comfort level for you. This testing provides you the results you need, today. CALL: (201) 464-9431
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For COVID & Most Reasons You See a Dr.
If you are seeking an evaluation and treatment for COVID or any other illness or injury and it is inconvenient for you to visit DUC for any reason, you can get the assistance you need through a virtual visit. We are available for you to receive the medical professional help you need from the safety of your home.
CALL: (201) 464-9431