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Coronavirus | Medical Diagnostic Laboratories

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from a Single Specimen! </h2> <div class="intro_container"> <div class="cont_box"> <h3 class="box_title">Test No. 1134</h3> <p class="box_subtitle">CombiVid® Panel by Real-Time PCR</p> <ul class="lg_list"> <li>SARS-CoV-2 virus (COVID-19) by Real-Time Reverse Transcription PCR (CDC N1, N2, RP targets)£*</li> <li>Influenza A virus</li> <li>Influenza B virus*</li> </ul> <p class="box_subtitle">Available on Nasopharyngeal swab specimen collection submitted in a <strong class="oneswab" style="display: inline; white-space: nowrap">COVID-<em>One</em>Swab<sup>™</sup></strong> transport media vial specimen collection</p> <ul class="lg_list"> <li>Detect multiple respiratory pathogens from a single sample</li> <li>Assists in guiding triage, patient care, and treatment decisions to prevent further transmission</li> <li>Less discomfort for the patient compared to collecting a separate sample for each test</li> <li>Reduce the risk of exposure to healthcare workers gathering multiple specimens</li> <li>Conserves precious sampling &amp; testing resources by reducing the demand for important materials which may be in short supply</li> <li>Allows for ongoing flu surveillance while also testing for SARS-CoV-2</li> <li>High precision robotic accuracy</li> <li>High diagnostic sensitivity &amp; specificity</li> <li><strong>24 – 48 hour turnaround time</strong></li> </ul> </div> </div> <div class="intro_container"> <p class="intro_text">Coronavirus Disease 2019 (COVID-19) is an acute respiratory disease caused by a viral infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus, which has infected and caused deaths of over 4 million people worldwide, has rapidly escalated to pandemic status since it first appeared in Wuhan, China in December 2019. Additional cases have now been reported in the United States. An infection with coronavirus 229E, NL63, OC43, or HKU1 is not the same as a COVID-19. Patients with COVID-19 are evaluated and cared for differently than patients with common coronavirus diagnosis.</p> <div class="cont_box"> <h3 class="box_title">Test No. 1131</h3> <p class="box_subtitle">SARS-CoV-2 [COVID-19] by Reverse Transcription Real-Time PCR (CDC N1, N2, RP Targets) This assay has been authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA)*</p> <ul class="lg_list"> <li>Nasopharyngeal swab OR Oropharyngeal swab specimen collection submitted in a <strong>COVID-</strong><strong class="oneswab"><em>One</em>Swab<sup>™</sup></strong> transport media vial</li> <li><strong class="nasoswab"><em>Naso</em>Swab<sup>®</sup></strong> specimen collection for adult patients ONLY (may be self-collected on-site)</li> <li>Specimens should be refrigerated until ready for transport and shipped within 72 hours of collection</li> </ul> </div> <p class="intro_sub">*Not available in NY</p> </div> </section> <section class="faq"> <div onclick="toggleClass('.faq .expand:nth-child(1)', 'show')" class="expand"> <strong>What are the symptoms of COVID-19?</strong> <div class="scb"> <div class="box_wrap"> <div class="col"> <p>Common signs of infection may appear <strong>2-14 days after exposure</strong> and include:</p> </div> <div class="col"> <p>In severe cases, infection can cause:</p> </div> <div class="col"> <ul class="list"> <li>Fever</li> <li>Cough</li> <li>Shortness of breath &amp; breathing difficulties</li> </ul> </div> <div class="col"> <ul class="list"> <li>Pneumonia</li> <li>Severe acute respiratory syndrome</li> <li>Kidney failure</li> <li>Death</li> </ul> </div> <p class="box_desc">People with heart and lung disease, weakened immune systems, and older adults are at higher risk for lower respiratory tract illness.</p> </div> </div> </div> <div onclick="toggleClass('.faq .expand:nth-child(2)', 'show')" class="expand"> <strong>How is COVID-19 spread?</strong> <div class="scb"> <div class="box_wrap"> <p class="box_desc">This virus is spread person-to-person by someone who is currently sick with COVID-19 through:</p> <ul class="list"> <li>Respiratory droplets produced while coughing and sneezing</li> <li>Close personal contact (i.e., within about 6 feet)</li> <li>Touching or shaking hands</li> </ul> <p class="box_desc">It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not reported to be the primary way the virus spreads.</p> </div> </div> </div> <div onclick="toggleClass('.faq .expand:nth-child(3)', 'show')" class="expand"> <strong>How is COVID-19 diagnosed?</strong> <div class="scb"> <div class="box_wrap"> <p class="box_desc">Due to symptom overlap with other common viral infections, diagnosis on the basis of clinical symptoms alone is highly inaccurate. Patients who meet the testing criteria described by the <a href="https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html" target="_blank" class="underline">Centers for Disease Control and Prevention (CDC)</a> should undergo testing for SARS-CoV-2.</p> </div> </div> </div> <div onclick="toggleClass('.faq .expand:nth-child(4)', 'show')" class="expand"> <strong>What types of tests are available from MDL for COVID-19?</strong> <div class="scb"> <div class="box_wrap"> <p class="box_desc">MDL offers two types of testing for SARS-CoV-2 (COVID-19). Direct detection of SARS-CoV-2 viral genetic material using a highly sensitive molecular assay is available from MDL for nasopharyngeal, oropharyngeal, and mid-turbinate area swabs.</p> <h3 class="box_title _smaller">Test 1131 SARS-CoV-2 [COVID-19] by Reverse Transcription Real-Time PCR (CDC N1, N2, RP Targets)</h3> <ul class="list"> <li>This test has been approved by the New Jersey Department of Health in accordance with FDA EUA policy;</li> <li>This test has not been FDA cleared or approved; and</li> <li>This test has been submitted for authorization by the FDA under an EUA for use by authorized laboratories.</li> </ul> <p class="box_desc">Testing for IgM and IgG antibodies, produced by a patient’s immune system in response to the presence of SARS-CoV-2 virus, is available from MDL on serum specimens by ELISA. The presence of certain antibodies can indicate an immune response to SARS-CoV-2, whether symptoms developed from infection or the infection was asymptomatic.</p> </div> </div> </div> </section> <section class="forms"> <h2 class="intro_heading">Related Forms</h2> <div class="masonry"> <section class="rCat"> <h3>Test Requisition Forms</h3> <ul class="resource_links"> <li><a href="https://www.mdlab.com/forms/Coronavirus_Test_Req.pdf?v=1725266875" target="_blank">Coronavirus SARS-CoV-2 [COVID-19]</a></li> </ul> </section> <section class="rCat"> <h3>Specimen Collection and Packaging</h3> <ul class="resource_links"> <li><a href="https://www.mdlab.com/forms/Nasopharyngeal_Collection_Kit_Instructions.pdf?v=1701712423" target="_blank">Nasopharyngeal Instructions</a></li> <li><a href="https://www.mdlab.com/forms/Oropharyngeal_Collection_Kit_Instructions.pdf?v=1701712425" target="_blank">Oropharyngeal Instructions</a></li> <li><a href="https://www.mdlab.com/forms/Midturbinate_Collection_Kit_Instructions.pdf?v=1701712423" target="_blank">Mid-turbinate Specimen Collection instructions</a></li> </ul> </section> <section class="rCat"> <h3>Sample Result Report</h3> <ul class="resource_links"> <li><a href="https://www.mdlab.com/forms/Pos_COVID_Result.pdf?v=1718115837" target="_blank">Positive RT-PCR</a></li> <li><a href="https://www.mdlab.com/forms/NotDetected_COVID_Result.pdf?v=1718115839" target="_blank">Not Detected RT-PCR</a></li> <li><a href="https://www.mdlab.com/forms/Inconclusive_COVID_Result.pdf?v=1718115841" target="_blank">Inconclusive RT-PCR</a></li> <li><a href="https://www.mdlab.com/forms/Invalid_Covid_Result.pdf?v=1718115844" target="_blank">Invalid Report RT-PCR</a></li> </ul> </section> <section class="rCat"> <h3>Fact Sheet</h3> <ul class="resource_links"> <li><a href="https://www.mdlab.com/forms/EUA-CDC-nCoV-HCPFS2_WP_Providers.pdf?v=1701712407" target="_blank">For Health Care Providers</a></li> 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