PeliSpy Multi-Marker Run Controls (U.S.)

PeliSpy Multi-Marker Run Controls are intended for use in assessing the performance of immunoassay test procedures for the qualitative determination of HBsAg, anti-HIV, anti-HBc, anti-HCV, anti-HTLV-I and anti-HTLV-I/II. These products are for Research Use Only, not for use in diagnostic procedures.

Procedure

PeliSpy Multi-Marker Run Controls are designed to closely simulate unknown specimens used in routine testing. Therefore, these reagents can be used with any test procedure designed for detecting HBsAg, anti-HIV, anti-HBc, anti-HCV, anti-HTLV-I and anti-HTLV-II in human serum or plasma.

Interpretation of Results

This product is designed as a means for assessing precision and can help detect systematic deviations of the assay technique. As such, users should develop their own assay ranges for PeliSpy Multi-Marker using replicate assays in their own assay systems. The results may be used as a guideline for assessing further assay performance, since values falling outside the user determined range may be indicative of unsatisfactory test performance caused by reagents, instruments or operators.

Product Description

The Positive Reagent is derived from human plasma positive for HBsAg, anti-HIV, anti-HBc, anti-HCV, or anti-HTLV-I/II. All positive plasmas were inactivated using a validated method and blended in the appropriate portions to provide a positive reagent.

Each control contains Thimerosal as a preservative.

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Description	Catalog Number
PeliSpy Multi-Marker Type 39 (10 vials, 5.0 mL)	S2406
PeliSpy Multi-Marker Type 17 (10 vials, 5.0 mL)	S2407
PeliSpy Multi-Marker Type 36 (10 vials, 5.0 mL)	S2408
PeliSpy Multi-Marker Negative Control (10 vials, 5.0 mL)	S2409

Each control is filled into sterile 5 mL polypropylene vials with screw caps.

PeliSpy Multi-Marker Run Controls are shipped at room temperature.

Control availability varies with region.