Blood Donor Testing and Screening
AcroMetrix® serology and nucleic acid controls and training panels assist in monitoring assay performance and operator training in laboratories conducting human plasma screening from blood donations. Laboratories using AcroMetrix® controls can improve the accuracy and efficiency of their lab tests, reduce repetitive testing due to control errors, and enhance troubleshooting ability. AcroMetrix® controls also assist laboratories in meeting quality and regulatory requirements while establishing traceability of results and providing material that help ensure consistent, accurate, and meaningful test results. The AcroMetrix® propriety formulations are consistent with the chemistry, platform, and sensitivity unique to each assay.
Nucleic Acid and Serology Testing Materials
- AcroMetrix® Blood Bank Nucleic Acid Test (BB NAT) positive and negative external quality controls are designed for use with qualitative NAT donor screening assays. Quality controls were developed for use with automated assay systems such as the Novartis PROCLEIX® ULTRIO® System. AcroMetrix® BB NAT RNA controls satisfy the appropriate CLIA requirements mandated in 42 CFR 493. For In Vitro Diagnostic Use.
- The AcroMetrix® Blood Bank Nucleic Acid Test (BB NAT) Triplex Positive Control is designed to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can assist in identifying increases in random or systematic error. For In Vitro Diagnostic Use. (Class I exempt.) Not intended for use in blood screening.
Benefits of AcroMetrix® Controls and Training Panels
- Enhance quality control and quality assurance in your testing lab
- Human plasma–based controls mimic patient samples in both manual and automated platforms and consist of intact virus or microorganisms
- Independent controls help 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 your lab and allows you to monitor assay performance with same lot over an extended period of time
For Your Research Applications
- AcroMetrix® PeliSpy™ Sero Controls, manufactured under cGMP and ISO 13485, are designed to monitor the performance of assays that detect HBsAg, anti-HBc, anti-HCV, anti–HIV-1, anti-CMV, and anti–HTLV-I. These quality controls simulate specimens and enable laboratories to assess the reliability of their test systems, establish assay precision, and detect systematic deviations in their assay technique. For Research Use Only. Not for use in diagnostic procedures.
- AcroMetrix® Training Panels are designed for operator qualification and assessment of performance of nucleic acid test procedures for the detection of pathogens. The training panels help ensure that nucleic acid testing procedures are properly validated and that test results are consistent across manufacturers, testing laboratories, operators, platforms, and assay formats. For Research Use Only. Not for use in diagnostic procedures.
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