Only at UCSF: the next generation of diagnostic tests.

The UCSF Clinical Microbiology Laboratory offers validated DNA/RNA mNGS testsfrom cerebrospinal fluid and DNA mNGS tests from plasma in our CLIA-certified laboratory. Results are interpreted by laboratory physicians, and consultation services are available upon request.

The UCSF Department of Laboratory Medicine oversees the Clinical Laboratories, which offer advanced testing methods to institutional clients. See our lab manual for additional information and services.

Clinical Test Performance

The validation of the mNGS test involved rigorous studies to assess performance metrics, including limits of detection, sensitivity, specificity, precision, interference, matrix effect, stability, and clinical accuracy. The mNGS test for pathogen detection from CSF was found to have a sensitivity of 86.1% and specificity of 97.9%. In a follow-up study published November 2024 in Nature Medicine, we analyzed the 7-year performance of clinical CSF mNGS testing of 4,828 samples from June 2016 to April 2023. A pathogen was detected in 697 (14.4%) of 4,828 samples. Among 220 infectious diagnoses made from 1,053 UCSF patients, 48 (21.8%) were identified by mNGS alone. The sensitivity, specificity and accuracy of mNGS testing for CNS infections were 63.1% (86% for diagnoses made by CSF direct detection testing), 99.6% and 92.9%, respectively.

 

Clinical Microbiology Lab

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