COVID- 19 Laboratory Testing
CSI Laboratories’ Coronavirus (COVID-19) SARS-CoV-2 testing is available using a real-time reverse transcription polymerase chain reaction (RT-PCR) assay pursuant to the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for diagnostic testing in CLIA-certified laboratories. The test detects the presence of SARS-CoV-2.
Specimens should be collected with appropriate infection control procedures using appropriate personal protective equipment.
Accepted Sample Collection:
- Nasal swab
- Nasopharyngeal swab
- Oropharyngeal swab
Accepted Swabs (in appropriate media):
- Synthetic, flocked swabs
- Do NOT send dry swabs, wood shaft swabs, calcium-alginate tip swabs or swabs with preservatives
Accepted Transport Media
- Any universal transport media (UTM), viral transport media (VTM) or sterile saline in 1 mL or 3mL volume
List price for SARS-CoV-2 by PCR is $100.
Request COVID-19 Virus Testing
If you are a healthcare provider or administrator interested in using CSI Laboratories for COVID-19 testing, please provide your contact information and someone will reach out to you soon. Alternately, you may email firstname.lastname@example.org or call 800-459-1185. Please note that our COVID-19 testing services are not available to individual clinicians or patients but rather to healthcare institutions.
Frequently Asked Questions
CSI Laboratories provides molecular-based laboratory developed tests for detection of nucleic acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test). The test uses a real-time reverse transcription polymerase chain reaction (RT-PCR) to detect genetic information and indicate active infection with the virus that causes COVID-19.The RT-PCR technique is a high-sensitivity, high-accuracy test due to its ability to analyze alterations of gene expression levels. Our COVID-19 testing is provided under the guidance of Kevin Goudy, PhD, D(ABMLI), Director of Molecular Diagnostics.
IS CSI LABORATORIES APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) TO CONDUCT COVID-19 SARS-COV-2 LABORATORY TESTING?
Yes, CSI Laboratories has been approved by the Food and Drug Administration (FDA) under the Emergency Use Authorization (EUA), Section 564 of the Federal Food, Drug, and Cosmetic Act(the Act) (21 U.S.C. §360bbb-3) to provide Molecular LDT COVID-19 Authorized Tests. View FDA approval letter.
Currently, CSI does have some capacity to take on additional testing, but we are prioritizing current hospital clients first. If additional capacity is available, we will take on new hospital clients. Please contact us to inquire about availability. During the call, we will discuss volumes so we know how much capacity to reserve and allow us to continue to meet our turnaround time commitments.
CSI returns test results within 24-48 hours. Our ability to meet these turnaround times is based on partnership with current and new clients to understand expected testing volume so lab resources are not overcommitted.
Per the CDC, if specimens will ship without delay, store specimens at 2-8°C and ship overnight on ice pack. If a delay in shipping will result in receipt at CSI Laboratories of more than 72 hours after collection, store specimens at -70°C or below and ship overnight on dry ice. Additional useful and detailed information on packing, shipping, and transporting specimens can be found at Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Download our quick reference guide for shipping COVID-19 samples.