National Genetics Institute (NGI) offers comprehensive plasma donor screening for the global plasma industry and screens millions of plasma donations a year for blood-borne infectious agents. Our full range of donor testing, including required supplemental and confirmatory testing, is tailored to meet the regulatory and quality requirements of the industry. Additionally, our test algorithm is designed to provide optimal efficiency and turn-around times for our customers, all while following the mandatory guidelines. NGI’s laboratory is Clinical Laboratory Improvement Amendments (CLIA) certified and registered with the US Food and Drug Administration (FDA) as well as the Austrian Agency for Health and Food Safety (AGES). Our medical and technical staff—including our medical director that is board-certified in blood banking and transfusion medicine—are available for technical consultations.
Our test menu includes 5 nucleic acid tests (NAT), and soon will include 3 viral marker tests (VMT) and all required ancillary tests. We will customize panels that best fit your company’s laboratory testing needs. NGI is leverages additional LabCorp FDA-registered specialty testing group sites to perform confirmatory and supplemental testing on donor samples, as well as non-donation testing such as donor re-entry, post exposure, and donor follow-up. We plan for our newly renovated, state-of-the-art, VMT laboratory will be FDA-registered and certified by the Clinical Laboratory Improvement Act (CLIA), as well as licensed in numerous states (including, but not limited to NY, CA, and FL), by the end of 2019. In addition, the laboratory maintains internal quality control programs and voluntarily participates in a number of external quality control programs.
Our Screening Services include:
NGI is focused on providing the very best in comprehensive plasma donor screening to support all the needs of the donor centers and global plasma therapeutics industry. Contact NGI to find out how we can develop customized solutions for your screening needs.
NGI is a leading provider of state-of-the-art, ultrasensitive, and high-throughput nucleic acid testing (NAT) screening services. A key advantage of our testing platform is the ability to robustly detect nucleic acid targets in pools of up to 512 specimens using highly sensitive and advanced multiplexed assays. Specimen pooling substantially reduces the cost of nucleic acid testing over systems that test a single sample at a time.
Specimen pools are generated using an automated liquid handling system and proprietary pooling algorithms. Master pools are tested and cleared if results are negative. Positive pools are resolved using proprietary algorithms and the suspected positive specimen(s) are tested individually to confirm the presence of the nucleic acid target.
The UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2, and HBV is the latest assay of NGI’s broad test menu and was developed solely by in-house scientific staff which tested over 1.5 million plasma donations during the validation efforts. The assay allows NGI to offer pharmaceutical clients significant benefits including reductions in plasma sample volumes, reduction in viral detection reagents, streamlined instrumentation footprint and lower instrument maintenance requirements. Importantly, the UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2, and HBV is approximately four-times more sensitive than previous NGI tests for the detection of HCV.
Our state-of-the-art viral marker testing laboratory is comprised of the latest FDA-cleared instrumentation and our test menu is guided by FDA source plasma regulations (CFR21 parts 610, 630, and 640) and applicable European Directives. The testing process is governed by current Good Manufacturing Practice (cGMP, CFR21.606), CLIA CFR42 part 493 regulations and other applicable statutory requirements.