EZ1 DSP Virus Kit

High analytical sensitivity with lower detection limits

The EZ1 DSP Virus Kit provides simultaneous purification of viral nucleic acids and bacterial DNA from human serum, plasma, CSF, urine, whole blood, stool, transport media, respiratory samples, and dried swab. Efficient purification of viral RNA and DNA results in sensitive analytical detection in polymerase chain reaction (PCR), as demonstrated using CE-IVD-marked artus PCR Kits for detection of CMV DNA (see table "Detection limit of CMV DNA using the EZ1 DSP Virus system and artus CMV PCR Kits") and HBV DNA (see table "Detection limit of HBV DNA using the EZ1 DSP Virus system and artus HBV PCR Kits") on a variety of real-time thermal cyclers.

Linear yields of highly pure viral DNA and RNA

Purification of viral nucleic acids provides linear yields, allowing accurate quantitative analysis for both high and low viral titers. Purified viral nucleic acids give high-performance results in sensitive diagnostic assays, even when starting material contains elevated levels of endogenous inhibitors, demonstrating the robustness of the purification procedure (see table "Robust purification procedure provides unparalleled removal of inhibitors").

Exclusion of sample carryover

High process reliability is critical for clinical laboratories that purify nucleic acids for routine testing. Lack of sample-to-sample carryover is a prerequisite for reliable results. To evaluate the risk of sample-to-sample carryover during and between runs, the EZ1 DSP Virus procedure was subjected to rigorous testing using an alternating checkerboard setup of negative and highly positive (1.0 x 10⁸ IU/ml) parvovirus B19 DNA samples. All of the highly positive samples were detected positive using the CE-IVD-marked artus Parvo B19 RG PCR Kit. All negative samples, in the checkerboard runs and the all-negative runs, were unresponsive (see table "Cross-contamination test setup and C_T values for detection of parvovirus B19 DNA"). This demonstrates that the EZ1 DSP Virus procedure provides no sample carryover under these conditions.

Automated sample preparation enables efficient, standardized purification of nucleic acids. The EZ1 Advanced and the EZ1 Advanced XL enable purification of nucleic acids using proven magnetic-particle technology for use in routine in vitro diagnostic applications. Reagent production is subjected to stringent quality control assuring reliable and robust performance. An easy-to-use instrument, prefilled and sealed reagent cartridges, and simple protocol selection and worktable setup help to prevent handling errors and allow the system to be operated by anyone — from the novice to the expert. Manual handling of potentially infectious samples is minimized, ensuring safety to the user and reliable processing of samples. Purified viral DNA and RNA are ready to use in sensitive downstream diagnostic assays based on enzymatic amplification, such as PCR and reverse transcriptase PCR (RT-PCR) for viral load monitoring.

The EZ1 Advanced or the EZ1 Advanced XL in combination with the proven EZ1 DSP Virus Kit enables purification of viral nucleic acids and bacterial DNA from 1–6 (EZ1 Advanced) or 1–14 (EZ1 Advanced XL) samples of human serum, plasma, CSF, urine, whole blood, stool, transport media, respiratory samples, and dried swabs. All processing steps are performed by the instrument, from piercing the reagent cartridge to elution of highly pure nucleic acids. The innovative design of the instrument means that the pipet tips function as separation chambers, increasing the efficiency of magnetic purification and eliminating the need for centrifugation steps. The streamlined procedure provides robust walkaway purification of nucleic acids with minimal hands-on time.

In combination with the EZ1 Advanced DSP Virus Card and the EZ1 Advanced or the the EZ1 Advanced XL DSP Virus Card and the EZ1 Advanced XL, the EZ1 DSP Virus Kit provides a fully automated procedure for simultaneous purification of viral nucleic acids and bacterial DNA from human serum, plasma, CSF, urine, whole blood, stool, transport media, respiratory samples, and dried swabs. Viral nucleic acids purified using the EZ1 DSP Virus Kit are ready to use in downstream diagnostic assays based on enzymatic amplification, such as PCR and RT-PCR.