VeriSure ® Pro WNV RNA
The VeriSure ® Pro WNV RNA External Quality Controls (EQCs) is intended for use with the ProcleixWNV Assay for the detection of West Nile Virus RNA (WNV RNA) in human plasma from donations of whole blood and blood components for transfusion. The VeriSure ® Pro WNV RNA External Quality Controls are intended to provide a means of estimating precision and reproducibility of the Procleix WNV Assay and have the potential for detecting systematic deviations of Procleix WNV Assay for the qualitative determination of WNV RNA. This product is for InVitro Diagnostic use.
The VeriSure ® Pro WNV RNA EQCs are designed to monitor assay performance. Frequent testing of independent quality control samples provides the analyst with a means of monitoring the performance of laboratory assays. Routine use of controls enables laboratories to monitor day-to-day test variation, lot-to- lot performance of test kits, and operator variation, and can assist in identifying increases in random or systematic error. The VeriSure ® Pro WNV RNA EQCs may be used to satisfy the appropriate CLIA requirements mandated in 42 CFR 493.
Procedure
Each lot of VeriSure ® Pro WNV RNA Positive EQC is designed to produce a reactive result within a target range established by the laboratory. Each lot of VeriSure ® Pro WNV RNA Negative EQC is designed to produce a nonreactive result within a target range established by each laboratory. VeriSure ® Pro WNV RNA EQCs should be analyzed in the same manner as donor specimens, according to the Procleix WNV Assay package inserts.
Product Description
West Nile Virus, grown in culture, inactivated, and diluted in defibrinated, delipidized normal human plasma (NHP).
The defibrinated, delipidized normal human plasma used in the production of the VeriSure ® Pro WNV RNA Positive EQC was previously tested and found to be negative for WNV RNA, HBV DNA, HCV RNA, HIV-1 RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and HTLV I-II.
Each VeriSure ® Pro WNV RNA EQC contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
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Kit Configuration
| Description | Catalog Number |
|---|---|
| VeriSure® Pro WNV RNA Positive (10 vials, 1.4 mL each) |
96-0500 |
| VeriSure® Pro WNV RNA Negative (10 vials, 1.4 mL each) |
96-0600 |
| VeriSure® Pro WNV RNA Positive & Negative (30 positive vials, 30 negative vials, 1.4 mL each) |
96-0700 |
Storage Instructions
The VeriSure ® Pro WNV RNA EQCs are stable when stored at -20°C to -80°C. Discard any unused material after use. Any EQC that appears cloudy or contains precipitates after thawing should be discarded. Once thawed, the VeriSure ® Pro WNV RNA EQCs are stable for up to 5 days if stored at 2°C to 8°C, and up to 24 hours if stored at room temperature (15° to 30°C). Do not use this product beyond the expiration date printed on the tube label.
