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SeraCare™ ACCURUN™ Nucleic Acid Multi-Analyte Positive Controls
Independent controls for nucleic acid testing
Manufacturer: SeraCare™ 20200105
Alert:
Use the Centers for Disease Control (CDC) recommended universal precautions for handling ACCURUN. Do not pipette by mouth; do not smoke, eat or drink in areas where specimens are being handled. Clean any spillage by immediately wiping up with 0.5% sodium hypochlorite solution. Dispose of all specimens, controls and materials used in testing as though they contain infectious agents.
To prevent formation of potentially explosive compounds due to reactions of sodium azide and copper or lead pipes, flush waste lines with large quantities of water.
Description
- An independent, easy-to-use, fully-characterized, multi-analyte positive control for multiplex or standard NAT donor screening or patient monitoring
Formulated for use with in vitro diagnostic test methods that detect HIV-1 RNA, HCV RNA and HBV DNA
- ACCURUN 345 Series 150 is prepared by diluting separate stocks of known titers of HIV-1 RNA, HCV RNA and HBV DNA with defibrinated plasma
- Formulated to low concentration levels of HIV-1 RNA, HCV RNA and HBV DNA; challenge assay performance near limit of detection
- Specifically formulated for manual and automated assay platforms to help monitor both assay and instrument integrity
- Human plasma based controls mimic patient samples
- Monitor all aspects of sample testing, from sample lysis and extraction through PCR amplifiction and detection
- Independent controls meet compliance requirements of regulatory agencies and professional organizations
- Liquid, ready-to-use - no reconstitution or special handling required
- Extended shelf life means efficiency for labs, allowing assay performance to be monitored with same lot over an extended period of time
- All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards
- Routine use of independent controls helps monitor day-to-day test variability, lot-to-lot variability and staff performance
Specifications
| ACCURUN™ 345 Multi-analyte Positive Control | |
| Defibrinated Plasma | |
| IVD, CE, HC | |
| Detect HIV-1 RNA, HCV RNA and HBV DNA, for research use only |
| Vial | |
| HIV-1 RNA, HCV RNA, HBV DNA | |
| 5 x 4mL |
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