PeliSpy Pro HIV-1 Control
The PeliSpy Pro HIV-1 RNA External Quality Control (EQC) is intended for use with the Procleix HIV-1/HCV Screening and Discriminatory Assays and no other HIV-1 assay for the detection of human immunodeficiency virus, type 1 (HIV-1) RNA in human plasma from donations of whole blood and blood components for transfusion. The PeliSpy Pro HIV-1 RNA External Quality Control is intended to provide a means of estimating precision and reproducibility of the Procleix HIV-1/HCV Screening and Discriminatory Assays and has the potential for detecting systematic deviations of the Procleix HIV-1/HCV assay for the qualitative determination of HIV-1 RNA. This product is for In Vitro Diagnostic Use and is CE marked.
This product is available only outside of the United States.
Principles of the Procedure
The PeliSpy Pro HIV-1 RNA EQC has been designed to maintain quality assurance and for the purpose of assessing assay performance of the Procleix HIV-1/HCV Screening and Discriminatory Assays. The PeliSpy Pro HIV-1 RNA EQC contains preserved processed human plasma and is supplied in single-use tubes. The reagents have been formulated to ensure stability of the final product.
Although the PeliSpy Pro HIV-1 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 PeliSpy Pro HIV-1 RNA EQC should be analyzed in the same manner as donor specimens, according to the Procleix HIV-1/HCV Screening and Discriminatory Assay package inserts.
Product Description
Heat-inactivated HIV-1 grown in culture and diluted in defibrinated, delipidized normal human plasma.
The defibrinated, delipidized normal human plasma used in the production of the PeliSpy Pro HIV-1 RNA EQC was previously tested and found to be negative for HBV DNA, HCV RNA, HIV-1 RNA, West Nile Virus (WNV) RNA, antibodies to HIV-1 and HIV-2, HBsAg, antibodies to HCV and antibodies to HTLV I-II.
The PeliSpy Pro HIV-1 RNA EQC contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.
| Description | Catalog Number |
|---|---|
| HIV-1 POS (+) HIV-1 RNA Positive (10 vials, 1.4 mL each) |
96-4602 |
The PeliSpy® Pro HIV-1 RNA EQC is stable when stored at -15°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 PeliSpy® Pro HIV-1 RNA EQC is stable for up to 5 days if stored at 2°C to 8°C.