QIAsymphony DSP Virus/Pathogen Kit

Yes. The QIAsymphony DSP Virus/Pathogen Kits are designated “For In Vitro Diagnostic Use”. It is the user’s responsibility to validate system performance for any procedures used in their laboratory that are not covered by the QIAGEN performance evaluation studies. The system performance has been established in performance evaluation studies purifying viral DNA and RNA from human serum, plasma, or cerebrospinal fluid (CSF), and purifying viral DNA and RNA, as well as bacterial DNA, from respiratory and urogenital samples. To minimize the risk of a negative impact on the diagnostic results, adequate controls for downstream applications should be used. For further validation, the guidelines of the International Conference on Harmonisation of Technical Requirements (ICH) in ICH Q2 R(1) Validation of Analytical Procedures: Text and Methodology are recommended. Any diagnostic results that are generated must be interpreted in conjunction with other clinical or laboratory findings.

Plasma, serum, and CSF samples can be processed using the QIAsymphony DSP Virus/Pathogen cellfree protocols. Respiratory samples (sputum, BAL, aspirates, dried swabs, transport media), and urogenital samples (urine, urogenital swabs, transport media) can be processed using the pathogen complex protocols.

For all cellfree and complex protocols, an eluate volume of 60 µl, 85 µl, or 110 µl can be selected. These are the minimum accessible volumes of eluate in the final elution tube. The initial elution volumes, which have to be used for the internal control, as well as titer calculations, are 90 µl, 115 µl, and 140 µl.

Pretreatment can improve the nucleic acid extraction for some sample types. Viscous samples (e.g., sputum, respiratory aspirates) might require liquefaction to enable pipetting. Performance may be improved for Gram positive bacteria by pretreatment with lysozyme. Pretreatment protocols are provided in the QIAsymphony DSP Virus/Pathogen Handbook.

The QIAsymphony DSP Virus/Pathogen Mini kit can be used to process 192 samples (96 per reagent cartridge). The Midi kit can be used to process 96 samples (48 per reagent cartridge) using the Cellfree1000, Complex800, and the Complex800_OBL protocols. The Midi Kit can also be used to process 144 samples (72 per reagent cartridge) using the Cellfree500, Complex400, and the Complex400_OBL protocols.

The sample volume depends on the QIAsymphony DSP Virus/Pathogen protocols:

• Cellfree200 — 200 µl
• Cellfree500 — 500 µl
• Cellfree1000 — 1000 µl
• Complex200 and Complex200_OBL — 200 µl
• Complex400 and Complex400_OBL — 400 µl
• Complex800 and Complex800_OBL — 800 µl

Sample material can be stored at 2–8°C for up to 6 h. For longer storage, samples should be kept at –20°C or –70°C.

No. The use of internal controls is not mandatory, but is strongly recommended. When using internal controls, they are added to the carrier RNA mixture (total volume of the mixture must be 120 µl).