VeriSure® Pro HBV DNA External Quality Control
The VeriSure® Pro HBV DNA External Quality Control (EQC) is intended for use with the Procleix® UltrioTM Assay and no other assay for the detection of hepatitis B virus (HBV) DNA in human plasma from donations of whole blood and blood components for transfusion. The VeriSure Pro HBV DNA External Quality Control is intended to provide a means of estimating precision and reproducibility of the Procleix Ultrio Assay and has the potential for detecting systematic deviations of the Procleix Ultrio Assay for the qualitative determination of HBV RNA. This product is for in-vitro diagnostic use.
Summary
Frequent testing of independent quality control samples such as VeriSure Pro HBV DNA EQC 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.
According to CLIA requirements (42 CFR 493), external quality controls should be included with every Procleix Ultrio Assay run where donor specimens are tested to screen the blood supply.
Principles of the Procedure
The VeriSure Pro HBV RNA EQC contains heat inactivated HBV DNA positive human serum or plasma diluted in preserved processed normal human plasma (NHP) and is supplied in single-use tubes. The reagents have been formulated to ensure stability of the final product.
Although the VeriSure Pro HBV RNA EQC does not have an assigned value, each lot is designed to produce a reactive result within a target range established by each testing laboratory. The VeriSure Pro HBV RNA EQC should be analyzed in the same manner as donor specimens, according to the Procleix Ultrio Assay package insert.
The VeriSure Pro HBV RNA EQC contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
| Description | Catalog Number |
|---|---|
| VeriSure® Pro HBV DNA Positive (10 vials, 1.4 mL each) |
96-3603 |
The VeriSure® Pro HBV RNA EQC is stable when stored at -20°C to -80°C. This control is designed for single use and excess material in each tube is to be appropriately discarded. Controls may removed from frozen storage and stored at 2°C to 8°C for up to 5 days or at room temperature (15°C to 30°C) for 24 hours prior to first use