Thank you for visiting the Concierge Pediatrics of Houston Testing Verification page. If you have used the QR code on the PCR result form we have provided, you will be directed to this page as verification of the authenticity of the PCR test performed.
This patient’s PCR test was conducted at our facility located at 550 Westcott St, Houston, TX 77007, on the date specified on the patient result form. The test was performed by a licensed medical professional under the supervision of the Laboratory Director, Dr. Kathrym España. The results of the test are specified on the laboratory report provided by the patient.
Concierge Pediatrics of Houston is a CLIA-accredited laboratory. Our CLIA number is 45D2107756.
If you require further verification of a specific traveler’s PCR results please contact us at 832-940-2262 or via email at firstname.lastname@example.org.
Device: Accula SARS-CoV-2 Test
Company: Mesa Biotech Inc.
Indication: The Accula™ SARS-CoV-2 Test performed on the Accula Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider. On March 23, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Accula SARS-Cov-2 Test for the qualitative detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). Emergency use of this test is limited to authorized laboratories using the Accula Dock or Silaris Dock.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.