PeliSpy Pro HCV Control

The PeliSpy Pro HCV RNA External Quality Control (EQC) is intended for use with the Procleix HIV-1/HCV Screening and Discriminatory Assays and no other HCV assay for the detection of hepatitis C virus (HCV) RNA in human plasma from donations of whole blood and blood components for transfusion. The PeliSpy Pro HCV 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 HCV RNA. This product is for In Vitro Diagnostic Use and is CE marked.

This product is only available outside the United States.

Principles of the Procedure

The PeliSpy Pro HCV 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 HCV 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 HCV 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 HCV 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 HCV RNA positive human serum or plasma diluted in defibrinated, delipidized normal human plasma.

The defibrinated, delipidized normal human plasma used in the production of the PeliSpy Pro HCV 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 HCV RNA EQC contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.

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Description	Catalog Number
HCV POS (+) HCV RNA Positive (10 vials, 1.4 mL each)	96-4601

The PeliSpy® Pro HCV 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 HCV RNA EQC is stable for up to 5 days if stored at 2°C to 8°C.