VeriSure® Pro Negative RNA (HIV-1/HCV) External Quality Control

Intended Use

The VeriSure® Pro Negative RNA (HIV-1/HCV) 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 human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA in human plasma from donations of whole blood and blood components for transfusion. The VeriSure® Pro Negative RNA (HIV-1/HCV) 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 and HCV RNA. This product is for in-vitro diagnostic use only

Summary and Explanation

The VeriSure® Pro Negative RNA (HIV-1/HCV) EQC is 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 Negative RNA (HIV-1/HCV) 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 VeriSure® Pro Negative RNA (HIV-1/HCV) 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 VeriSure® Pro Negative RNA (HIV-1/HCV) EQC DOES NOT HAVE AN ASSIGNED VALUE, each lot is designed to produce a non-reactive result within a target range established by each testing laboratory. The VeriSure® Pro Negative RNA (HIV-1/HCV) EQC should be analyzed in the same manner as donor specimens, according to the Procleix HIV-1/HCV Screening and Discriminatory Assay package inserts.

Negative RNA (HIV-1/HCV) Positive External Quality Control: Defibrinated, delipidized normal human plasma. The defibrinated, delipidized normal human plasma used in the production of the VeriSure® Pro Negative RNA (HIV-1/HCV) 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 VeriSure® Pro Negative RNA (HIV-1/HCV) EQC contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.

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Description	Catalog Number
Negative RNA (HIV-1/HCV) (10 vials, 1.4 mL each)	96-3600