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.

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.

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.

The present invention provides a novel virus-like particle expression vector pTMSCA2C, which is constructed as follows: firstly, using plasmid pTrcHis-MS2 as a starting vector and mutating the base T at position 5 of the gene sequence of MS2 bacteriophage 19mer packaging site on the plasmid pTrcHis-MS2 into C through genetic mutation technologies to obtain a plasmid pTMSC; then, mutating valine which is a amino acid corresponding to the initiation codon on the plasmid pTMSC for encoding the maturase protein of MS2 bacteriophage into methionine to obtain a plasmid pTMSCA; and finally, the gene sequence coding wild type MS2 bacteriophage coat protein, after the removal of the terminator, is linked in series with the gene sequence coding MS2 bacteriophage coat protein comprising histidine-tag which is from a pseudovirus vector pTrcMS, and the gene sequence obtained after linking in series is linked to the plasmid pTMSCA to give pTMSCA2C. When the virus-like particle is prepared by using the expression vector pTMSCA2C of the present invention, the yield and purity of the virus-like particle may be improved while the workload for preparation of virus-like particles may be greatly reduced.