PeliSpy Pro HBV Control
The PeliSpy Pro HBV DNA External Quality Control (EQC) is intended for use with the Procleix Assay System for the detection of hepatitis B virus (HBV) DNA in human plasma from donations of whole blood and blood components for transfusion. This product is for In Vitro Diagnostic Use and is CE marked.
This product is only available outside the United States and Canada.
Summary and Explanation
The PeliSpy Pro HBV DNA EQC is designed to monitor performance of the Procleix® Assay System for the detection of Hepatitis B virus (HBV) DNA. Frequent testing of independent quality control samples provides the analyst with a means of monitoring the performance of this assay. Routine use of controls enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, as well as assist in identifying increases in random or systematic error.
Product Description
The PeliSpy Pro HBV DNA EQC has been designed to maintain quality assurance and for the purpose of assessing assay performance of the Procleix Assay System for the detection of HBV DNA.
This EQC contains HBV DNA positive human serum or plasma diluted in defibrinated, delipidized normal human plasma (NHP). The NHP used in production of the PeliSpy Pro HBV DNA EQC was previously tested and found to be negative for HBV DNA, HCV RNA, HIV-1 RNA, West Nile Virus RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and antibodies to HTLV I-II.
The PeliSpy Pro HBV DNA EQC contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
Control Configurations
| Description | Catalog Number |
|---|---|
| PeliSpy Pro HBV DNA EQC (10 vials, 1.4 mL each) |
96-4603 |
The PeliSpy Pro HBV DNA EQC is stable when stored at -15°C to -80°C. Discard any unused material after use.