SARS-CoV-2 RT-PCR Testing Service

On 23 June, 2023, the Arizona Molecular Clinical Core ended its SARS-CoV-2 (COVID) PCR testing service as part of UofA's Test All Test Smart initiative. The AZClinCore clinically validated its COVID PCR test early in the pandemic (18 April 2020) as a Laboratory Developed test (LDT) and began offering services to UofA personnel and students on 17 June 2020. Initially testing only NP swabs, in January 2021, the AZClinCore began offering a Saline Gargle test which was later made available for TakeAway testing, greatly increasing the laboratory's capacity to process samples. At its maximum capacity, the AZClinCore processed and reported 2,893 results in a single day (29 January 2021). Over the 3 years of providing COVID testing services, the dedicated and talented technologists at the AZClinCore processed a total 258,397 clinical PCR tests for the UofA community.

If you are associated with the University of Arizona and would like to request a COVID-19 test, please make an appointment with:

 Campus Health Services

CLINICAL UTILITY 

Detection of SARS-CoV-2 viral RNA in clinical specimens. Detection of viral RNA not only aids in the diagnosis of illness but also provides epidemiological and surveillance information.

Results are for the identification of 2019-nCoV RNA. The 2019-nCoV RNA is generally detectable in upper and lower respiratory specimens during infection. Positive results are indicative of active infection with 2019-nCoV but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Criteria for Patient Testing 

Individuals who meet 2019-nCoV clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with 2019-nCoV infection, contact with a probable or confirmed 2019-nCoV case, history of travel to geographic locations where 2019-nCoV cases were detected, or other epidemiologic links for which 2019-nCoV testing may be indicated as part of a public health investigation).

Specimen Requirements 

Sample Type: Nasopharyngeal (NP) swabs in VTM.
Volume: variable

Sample Type: Saline Oral rinse ("SG" Saline-Gargle specimen)
Collected with: 0.90% sodium chloride solution (AddiPak® 5ml sterile single use tubes, product no. 200-59; Teleflex LLC). Volume: 4–8 mL
Collection protocol follows a 5 second ‘swish’ followed by a 10 second ‘gargle’, repeated 3 times before transferring to a sterile collection tube.

Acceptable Specimens:

Per AZClinCore policy, nucleic acid specimens are accepted if the nucleic acid isolation occurred in a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or the CMS. Such samples will be processed, however, samples still must meet test-specific quality metrics and a successful outcome may not be guaranteed.

Specimen Storage:

• Specimens must be received in tightly sealed containers with no external spillage
• Specimens can be stored at 2–8°C for up to 72 hours after collection
• If a delay in processing is expected, store specimens at -20°C or lower
• Extracted nucleic acid should be stored at -70°C or lower
• SG specimens have been determined to generate equivocal results up to 10 days after collection when stored refrigerated

Turnaround Time

Results returned 24–48 hours from receipt of the specimen by AZClinCore, based on business hours of the laboratory: Monday through Friday, 9am–5pm Arizona Time. STAT services are available; contact the laboratory for more information.

PURPOSE OR PRINCIPLE

This test is intended to be performed on respiratory specimens collected from individuals who meet Centers for Disease Control and Prevention (CDC) clinical and/or epidemiological criteria for COVID-19 testing. CDC COVID-19 criteria for testing on human specimens are available at CDC's webpage Information for Healthcare Professionals: Coronavirus Disease 2019 (COVID-19) (https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html).

Methodology and Additional Details

The oligonucleotide primers and probes for detection of 2019-nCoV were selected from a region of the virus nucleocapsid (N) gene specific to SARS-CoV-2. This CDC marker (N1) is designed for specific detection of the 2019-nCoV. An additional primer/probe set to detect the human RNase P gene (RP) in control samples and clinical specimens is also included in the panel. Through Direct PCR of the patient saline oral rinse specimen ("SG" Saline-Gargle specimen), RNA is reverse transcribed to cDNA and subsequently amplified using 1-Step RT-qPCR and cycled in an Applied Biosystems 7900HT Real-Time PCR System.

Limit of Detection

This assay is reliable between 150–300 viral copies/reaction, or 30–60 viral copies/µl of sample.

FDA Comments

This test was developed and its analytical performance characteristics have been determined by the Arizona Molecular Clinical Core. It has not been cleared or approved by FDA. This assay was developed as a Laboratory-Developed Test and has been validated pursuant to the CLIA regulations and is used for clinical purposes.