Emergency Use Authorization (EUA) SUMMARY ALPHADx SARS-COV-2 RT-PCR Test
July 20, 2023
The ALPHADx SARS-COV-2 RT-PCR Test by AlphaDERA Labs is a specialized diagnostic tool with Emergency Use Authorization (EUA) from the FDA. Located at 15355 W. Vantage Pkwy., Suite 195, Houston, TX 77032, AlphaDERA Labs is CLIA-certified and authorized to perform high-complexity tests.
The test is designed for qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and mid-turbinate nasal swab specimens. It's intended for use in individuals suspected of having COVID-19 by their healthcare provider. Results can identify the presence of SARS-CoV-2 RNA but should be corroborated with other clinical and diagnostic information to determine a patient's infection status. Positive results do not exclude the possibility of other infections.
Negative results should not be the sole basis for patient management decisions and must be considered alongside clinical observations, patient history, and epidemiological data.
Use of the ALPHADx SARS-COV-2 RT-PCR Test is restricted to qualified clinical laboratory personnel trained in real-time RT-PCR and in vitro diagnostic procedures. This test is available only under the FDA's Emergency Use Authorization. All test results must be reported to the appropriate public health authorities.
AlphaDERA Labs - Precision in Diagnostics, Trusted by Professionals
AlphaDERA Labs is a certified name when it comes to clinical lab testing and diagnostic services. Since our inception in 2018, we have been at the forefront of innovation, delivering accurate and reliable results and helping professionals, individuals, and communities make informed health decisions. Our commitment to excellence has positioned us as a trusted partner in the field of laboratory services.
