SeraCare™ HIV p24 Antigen Mixed Titer Performance Panels

Description

For the evaluation of the sensitivity and specificity of HIV p24 antigen and antigen/antibody combination test systems

Specimens with reactivity ranging from weak to strong positive for HIV p24 antigen by commercially available assays; samples were chosen to provide a broad range of reactivity, from early seroconversion (with no or low detectable antibody) to later infection (with high antibody titer)

• Two negative specimens are included

• Extensive array of panels helps labs maintain the highest standards for assay validation, regulatory compliance and method development
• Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing reagent assay/platform performance, sensitivity and specificity to be independently challenged
• Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing
• Enables labs to evaluate, monitor and troubleshoot test and staff performance
• Minimizes down time and accelerates validation and verification of new test methods, reagent systems and platforms

• Rigorously tested and characterized using highest-quality test methods
• Comprehensive test results provided with each panel; quantified against international standards when available
• Long-term stability and availability
• SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

These materials have not been treated and should be considered biohazardous. Some panel members were found positive by tests for HIV Ag and/or anti-HIV-1. The units that make up this panel were found negative for HBsAg and anti-HCV. This does not ensure the absence of these or other human pathogens. Do not pipette by mouth. Do not smoke, eat or drink in areas where specimens are handled. These materials should be disposed of in a manner that will inactivate pathogenic agents.

Specifications

• Certifications/Compliance: ISO 9000 13485
• Content And Storage: -65°C to -80°C
• Format: Panel
• Type: HIV p24 Antigen Mixed Titer Performance Panel
• Includes: Set of 25 specimens with reactivity ranging from weak to strong positive for HIV p24 antigen
• Intended Use: Evaluating sensitivity and specificity of HIV p24 Antigen and Antigen/Antibody combination test system using well characterized specimens, to provide comprehensive data for comparative analysis
• Quantity: 25 x 1.5 mL