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MDxHealth COVID-19 NP Swab PCR Active Infection Test
MDxHealth now offers a diagnostic swab test for COVID-19, using Quidel’s Lyra® Direct SARS-CoV-2 Assay, which is authorized for use with respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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MDxHealth is a leader in molecular diagnostics with a proven track record to identify, develop, validate and deliver molecular diagnostic assays. We endeavor to stay at the cutting edge of molecular diagnostics by continuously exploring and developing new and improved clinically relevant products, approaches and techniques. MDxHealth now offers a diagnostic swab test for COVID-19, using Quidel’s Lyra® Direct SARS-CoV-2 Assay, which is authorized for use with samples collected from individuals who are suspected of COVID-19 by their healthcare provider.
MDxHealth’s COVID-19 PCR test has not been FDA cleared or approved. Use of the Quidel Lyra Direct SARS-CoV-2 Assay has been authorized by FDA under an Emergency Use Authorization (EUA) and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Laboratories within the United States and its territories are required to report SARS-CoV-2 test results to the appropriate public health authorities.
A positive result indicates that viral RNA from SARS-CoV-2 was detected, the patient is infected with the novel coronavirus, and presumed to be highly contagious. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
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