Notices

Limitations:

  • The UCSC SARS-CoV-2 Multiplex qPCR Assay is for the qualitative detection of SARS-CoV-2 (also known as 2019-nCoV), the infectious agent that causes COVID-19.

  • Performance of the UCSC SARS-CoV-2 Multiplex qPCR Assay has been established using nasopharyngeal swabs, administered by a medical professional. A side-by-side comparison has shown that the performance of the assay is comparable using anterior nares specimens collected by a medical professional.

  • Negative results do not preclude SARS-CoV-2 (2019-nCoV) infection and should not be used as the sole basis for treatment or other patient management decisions. Optimum specimen types and timing for peak viral levels during infections caused by SARS-CoV-2 (2019-nCoV) have not been determined. Collection of multiple specimens (types and time points) from the same patient may be necessary to detect the virus.

  • A false negative result may occur if a specimen is collected, transported or handled incorrectly. False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate numbers of organisms are present in the specimen.

  • Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely to occur when disease prevalence is high. False positive test results are more likely when prevalence is moderate to low.

  • If the virus mutates in the rRT-PCR target region, SARS-CoV-2 (2019-nCoV) may not be detected or may be detected less predictably. Inhibitors or other types of interference may produce a false negative result.

  • Test performance can be affected because the epidemiology and clinical spectrum of infection caused by SARS-CoV-2 (2019-nCoV) is not fully known. Specifically, it may not be known at this time what are optimum types of specimens to collect. Furthermore, it may not be fully known when these specimens are most likely to contain levels of viral RNA that can be readily detected during the course of infection.

  • Detection of viral RNA may not indicate the presence of infectious virus or that SARS-CoV-2 (2019-nCoV) is the causative agent for clinical symptoms.

  • The performance of this test has not been established for monitoring treatment of SARS-CoV-2 (2019-nCoV) infection.

  • The performance of this test has not been established for screening of blood or blood products for the presence of SARS-CoV-2 (2019-nCoV).

  • This test cannot rule-out diseases caused by other bacterial or viral pathogens.

Disclaimers:

This test was developed and validated by the UCSC Molecular Diagnostic Laboratory (MDL) specifically to detect SARS-CoV-2.

This test has been approved by our Clinical Laboratory Improvement Amendments (CLIA)-certified lab director and has been validated under CLIA by successfully comparing its performance to a Food and Drug Administration (FDA) Emergency Use Authorized test and in accordance with FDA guidelines for molecular diagnostic tests performed in a single high-complexity CLIA laboratory such as ours.

The FDA does not currently require review of SARS-CoV-2 laboratory developed tests and therefore our test has not been evaluated by the FDA.

To learn more about the UCSC Molecular Diagnostic lab, this test, or the test validation process please visit the UCSC MDL website at https://sites.google.com/ucsc.edu/molecular-diagnostic-lab.