Aug
17
Written by:
Emily Sherman
8/17/2010 8:16 AM
If you have an autoimmune, infectious, or other disease, researchers need your help. Donate plasma and receive $400/donation for your time. Visit www.idonateplasma.com for details.
|
Source PDF: http://www.seracare.com/Portals/0/Papers/Tech%20Bulletin%20901_r18.pdf
SeraCare Technical Bulletin 0901: Multi-Analyte Controls
US Toll Free 800.676.1881 508.244.6400 Fax 508.634.3394 www.seracare.com info@seracare.com
AQS1139-01-109
For more information or to place an order, contact SeraCare customer service at 800.676.1881 or visit our eCatalog at www.seracarecatalog.com
Q: Why is there a wide range of ACCURUN® 1 multi-analyte control products?
A:Because test methods with similar sensitivity for anti-HIV and other analytes produce different results with controls. In the development of anti-HIV assays, manufacturers use different approaches to formulate a test that will detect an HIV-infected individual’s immune response.
Among the differences:
• Antigens: viral lysate, synthetic or
recombinant proteins, a combination
• Sample dilution
• Conjugates
• Assay conditions: temperature, incubation time, etc. Test kits are also designed to optimize detection of early antibodies, which generally have lower antigen affinity than antibodies produced later in the immune response.
Our research and development showed clearly that one control cannot meet the specifications of all anti-HIV assays.
A control that provided a consistent low positive result with one test method was so low that it was frequently negative with another method, or so high that it couldn’t really be considered a low positive control with a third method. Yet, all three of these tests could be similar in their ability to detect early seroconversion in patient samples, a required characteristic for anti-HIV test methods. To monitor test methods over time, across kit lots and in different laboratories, independent controls for antibody tests must be made in large batches or lots, often by diluting a pool of high titer samples with antibody negative plasma. Pools of high-titer samples will contain a mixture of mostly later, high-affinity antibodies to multiple antigenic sites or epitopes.
Since test kits have different mixtures of epitopes or antigenic sites, their responses to a single formulation of a control such as ACCURUN 1 will differ.
This phenomenon could be observed in any test that yields a single response (signal or specimen absorbance to cutoff ratio or s/co) for a group of molecular entities, and antibody tests or serologies are themost common example of this category.
The ACCURUN 1 series was formulated specifically for different test methods or automated instrument systems, to provide a low positive control for each analyte/method/ instrument combination.
Table 1: SeraCare Multi-Analyte Control Products
As shown below, a wide variety ofmulti-analyte control products were developed because SeraCare research clearly showed that one control will notmeet the specifications of all anti-HIV assays.
Platform/ Analyte Product* Target Assays** IVD/CE Fill Size Cat No
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Abbott Prism® IVD, CE 12 x 3.5 mL A001-2408-P
Anti-HBc, Anti-HCV, HBsAg Series 2400
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Abbott Prism® IVD, CE 12 x 3.5 mL A001-2508-P
Anti-HBc, Anti-HCV, HBsAg Series 2500
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Abbott AxSYM®, IVD, CE 3 x 5 mL A001-2603-P
Anti-HBc, Anti-HCV, HBsAg, Series 2600 Abbott AxSYM®Plus 12 x 3.5 mL A001-2608-P
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Sanofi Diagnostics IVD, CE 3 x 5 mL A001-3003-P
Anti-HBc, Anti-HCV, HBsAg, Series 3000 GENSCREEN®
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 bioMerieux VIDAS® IVD, CE 3 x 5 mL A001-4003-P
Anti-HBc, Anti-HCV, HBsAg, Series 4000 HIV DUO ULTRA
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Murex EIA IVD, CE 3 x 5 mL A001-4103-P
Anti-HBc, Anti-HCV, HBsAg, Series 4100
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Bio-Rad Genetic IVD 3 x 5 mL A001-4403-P
Anti-HBc, Anti-HCV, HBsAg, Series 4400 Systems™ EIA 12 x 3.5 mL A001-4408-P
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Abbott EIA IVD, CE 1 x 5 mL A001-5101-P
Anti-HBc, Anti-HCV, HBsAg, Series 5100 3 x 5 mL A001-5103-P
Anti-CMV 12 x 3.5 mL A001-5108-P
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Roche Elecsys® IVD, CE 6 x 3.5 mL A001-5605-P
Anti-HBc, Anti-HCV, HBsAg, Series 5600
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Dade Behring Enzygnost® IVD, CE 3 x 5 mL A001-8103-P
Anti-HBc, Anti-HCV, HBsAg, Series 8100 12 x 3.5 mL A001-8108-P
Anti-CMV
Anti-HIV-1/2, Anti-HTLV I/II, ACCURUN 1 Abbott HIVAB® IVD, CE 1 x 5 mL A001-1001-N
Anti-HBc, Anti-HCV, HBsAg, Negative 12 x 3.5 mL A001-1008-N
Anti-CMV, HIV-1 Ag, Control
Anti-Syphilis
* Many products have been tested on multiple platforms. Please inquire
** Based on Anti-HIV-1/2 target assay IVD For in vitro diagnostic use
CE Complies with EU standards