CONTROLS FOR NUCLEIC ACID ASSAYS

摘要

The present invention features a method and kit for isolating microvesicles or extracting microvesicle nucleic acids from a biological sample by using a control particle. The present invention provides control particles that are viruses or virus-like particles, such as bacteriophages, that contain control nucleic acids that can be detected to assess the accuracy, reliability, and efficiency of the microvesicle isolation or nucleic acid extraction steps. The methods described herein may further comprise the analysis of the presence, absence, or level of at least one biomarker associated with a disease or medical condition for diagnosing, prognosing, or monitoring the disease or medical condition.

主权项

1. A method for isolating microvesicles and microvesicle nucleic acids from a biological sample comprising:
a. adding a known quantity of control particles comprising a control nucleic acid to the biological sample; b. isolating a fraction, wherein said fraction comprises microvesicles and the control particles; c. extracting nucleic acids from the microvesicle fraction, d. calculating the amount of control particles recovered; and e. determining that the amount of control particles calculated in step (d) is within a predetermined range of values.