PeliSpy Multi-Marker Run Controls
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 In Vitro Diagnostic Use and are CE marked.
Procedure
PeliSpy Multi-Marker Run reagents 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 establishing precision and has the potential for detecting 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.
| Description | Catalog Number |
|---|---|
| PeliSpy Multi-Marker run control Type 17 (10 vials, 5.0 mL) |
S2068 |
| PeliSpy Multi-Marker run control Type 26 (10 vials, 5.0 mL) |
S2109 |
| PeliSpy Multi-Marker run control Type 36 (10 vials, 5.0 mL) |
S2381 |
| PeliSpy Multi-Marker run control Type 38 (10 vials, 5.0 mL) |
S2404 |
| PeliSpy Multi-Marker run control Type 40 (10 vials, 5.0 mL) |
S2410 |
| PeliSpy Multi-Marker run control Type 41 (10 vials, 5.0 mL) |
S2413 |
Each reagent is filled into sterile 5 mL polypropylene vials with screw caps.
PeliSpy Multi-Marker Run Control reagents are shipped at room temperature.
Control availability varies with region.
Storage Instructions
PeliSpy Multi-Marker Run Control reagents should be stored at 2°C to 8°C to ensure highest quality. Once opened, any unused material should be discarded after 8 weeks.