Background Distinguishing bacterial, viral, or other etiologies of acute illness is diagnostically challenging with significant implications for appropriate antimicrobial use. Host gene-expression offers a promising approach although no clinically useful tests have yet been developed to accomplish this. Here, Qvella’s FAST™ HR process was developed to quantify previously identified host gene-expression signatures in whole blood in <45 minutes. Methods Whole blood was collected from 128 human subjects (mean age 47, range 18-88) with clinically adjudicated, microbiologically confirmed viral infection, bacterial infection, non-infectious illness, or healthy controls. Stabilized mRNA was released from cleaned and stabilized RNA-surfactant complexes using e-lysisTM, an electrical process providing a qRT-PCR-ready sample. Threshold cycle values (CT) for 10 host response targets were normalized to HPRT1 expression, a control mRNA. The transcripts in the signature were specifically chosen to discriminate viral from non-viral infection (bacterial, non-infectious illness, or healthy). Classification accuracy was determined using cross-validated sparse logistic regression. Results Reproducibility of mRNA quantification was within 1 cycle as compared to the difference seen between subjects with viral vs. non-viral infection (up to 5.0 normalized CT difference). Classification of 128 subjects into viral or non-viral etiologies demonstrated 90.6% overall accuracy compared to 82.0% for procalcitonin (p=0.06). FASTTM HR achieved rapid and accurate measurement of the host response to viral infection in less than 45 minutes. Conclusions These results demonstrate the ability to translate host gene expression signatures to clinical platforms for use in patients with suspected infection.
Background: Prostate cancer is a leading cause of morbidity and mortality in our male population, thus screening initiatives will help to improve outcomes. The current screening marker, total prostate-specific antigen (PSA), is not prostate cancer specific. The development of percentage free PSA (%FPSA) has largely improved the detection of prostate cancer.Objectives: To assess the performance of %FPSA ratio at the 25% cut-off and its ability to distinguish between prostate cancer and benign prostatic lesions.Methods: This was a retrospective study conducted on male patients with total prostate-specific antigen values 10 ng/ml and with prostate histology results. Male patients with total prostate-specific antigen between 4 and 10 ng/ml had their free prostate-specific antigen determined together with the calculation of the free prostate-specific antigen ratio. The ratio was then correlated with prostate histology results to determine the presence of prostate cancer at the cut-off ratio of 25%.Results: Prostate cancer was detected in 28 (21.37%) patients out of the total population of 131. Ninety-two patients had a FPSA ratio of 25%, 22 (22.8%) of whom were found to have prostate cancer. Notably the sensitivity and specificity were found to be 86% and 27% respectively, with a positive predictive of value of 21% at this cut-off.Conclusions: The study demonstrates a %FPSA ratio of 25% not to be a good discriminator between prostatic cancerous and benign lesions. It is thus recommended that a prostate biopsy should be done based on clinical examination findings rather than the level of total prostate specific antigen from 0–10 ng/ml or %FPSA ratio.
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