Wren Laboratories COVID-19 PCR Test
Wren Laboratories LLC’s CLIA-certified testing center is approved to process and test COVID-19 patient samples using an FDA Emergency Use Authorization (EUA) approved test system for COVID-19 testing (Quant Studio 7 RT PCR – Viral Isolation QIAamp Viral RNA Mini Kit, N1/N3 CDC primers for respiratory specimens).
PCR Assay Overview
The Wren Laboratories COVID-19 PCR Test is a Real-time Quantitative-PCR Diagnostic Assay intended for the detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs collected from individuals who may have contracted the virus. Testing is limited to the Clinical Testing Facility at Wren Laboratories which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
The test was validated on 60 positive and 60 negative specimens representing nasopharyngeal (NP) swabs and found to have 100% accuracy with a lower limit of detection of 5 copies/µl.
Results are indicative for the detection and identification of SARS-CoV-2 RNA.
- A positive result is indicative of active infection with SARS-CoV-2 but does not rule out bacterial infection or co-infection with other viruses.
- SARS-CoV-2 nucleic acids (mRNA of the virus) can persist following clearance of active viral replication.
- We are required to report all positive results to the appropriate public health authorities.
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient treatment or other patient management decisions.
- Negative results must be combined with clinical observations, patient history, and epidemiological information.
We do accept third party clinical swab samples for testing.
The cost of our COVID 19 Test is $125.00 per test.
Sample Collection and Shipping
- Specimens should be collected by trained personnel in accordance with manufacturer guidelines and in accordance with FDA approved collection devices (FAQs on Diagnostic Testing for SARS-CoV-2).
- This test has currently been validated for use with respiratory swab samples. For a list of approved swabs, please visit FDA FAQ (Q: I am having trouble obtaining...).
- VTM, UTM, M4, M5, M6, saline, and MTM are acceptable transport media types.
- Acceptable specimens should be transported in accordance with guidelines established by the Centers for Disease Control and Prevention:
- Refrigerate all samples at 2-8℃ prior to and during transport within 24 hrs.
- If the specimen is to be submitted greater than 24 hrs post collection, freeze the specimens at -20℃ or below and then ship on dry ice.
- Ship as a Category B (UN3373 - Biological Substances).
- Specimen collection guidance is available here.
- Samples should be shipped to the following address:
- Wren Laboratories LLC
- 688 East Main Street Branford, CT 06405
We accept individually labeled tubes each with two patient identifiers per CLIA protocol.
Alternative options should be discussed with Wren Labs prior to transmission.
- Tube with swab.
- Patient ID and/or Name or DOB.
- Requisition. Click this link to download the Wren COVID-19 requisition.
- Please provide at least 150-300µL of media in the tubes for processing.
- Due to regulations, sample tube and requisition MUST include 2 identifiers.
COVID-19 Testing Fact Sheets:
Contact and License Information
Wren Laboratories LLC
688 East Main Street
Branford, CT 06406
Telephone: (203) 208-3464
Fax: (203) 648-9988
CLIA ID: 07D2083188
CL #: 0996
Laboratory Director: Mark Kidd Ph.D., DABCC (203-208-4180)
Laboratory Manager: Alexandra Kitz, Ph.D.
Medical Consultant: Irvin Modlin, M.D., Ph.D., D.Sc.