VeriSure® Triplex Control

The VeriSure® Triplex HIV-1/HCV/HBV External Quality Control was developed for use with qualitative assays for the detection of human immunodeficiency virus type 1 (HIV-1) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA, respectively. The VeriSure® Triplex HIV-1/HCV/HBV EQC is intended to provide a means of estimating accuracy, and has the potential for detecting systematic deviations of nucleic acid test procedures for the qualitative determination of HIV-1 RNA, HCV RNA and/or HBV DNA. This product is for in-vitro diagnostic use only.

Procedure

The VeriSure® Triplex HIV-1/HCV/HBV EQC has been designed to maintain quality assurance and for the purpose of assessing assay performance of nucleic acid based HIV-1 RNA, HCV RNA and/or HBV DNA tests. The reagent has been formulated to ensure stability of the final product.

Interpretation of Results

Each lot of Positive EQC is designed to produce a reactive result within the appropriate COBAS AmpliScreen Test. The VeriSure® Triplex HIV-1/HCV/HBV EQC should be analyzed in the same manner as a specimen, according to the appropriate qualitative assay package insert.

The VeriSure® Triplex HIV-1/HCV/HBV EQC contains 15ppm ProClin® as preservatives

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Description Catalog Number
Positive Control HIV-1/HCV/HBV
(50 vials, 1 mL each)
96-0030

Each control is filled into sterile polypropylene vials with screw caps.

VeriSure® Triplex HIV-1/HCV/HBV EQCs are shipped frozen on dry ice.

Storage Instructions

The VeriSure® Triplex HIV-1/HCV/HBV External Quality Control is stable when stored at -15°C to -80°C. Discard any unused material after use. Any Controls that appear cloudy or contain precipitates after thawing should be discarded. Once thawed, the VeriSure® Triplex HIV-1/HCV/HBV External Quality Control is stable for up to 5 days if stored at 2°C to 8°C. Do not use this product beyond the expiration date printed on the vial label.