In 2001, National Genetics Institute received FDA approval for an in-house developed ultrasensitive and high throughput UltraQual® nucleic acid testing platform using proprietary methods that eliminate distorting variables inherent to nucleic-acid amplification and detection. This breakthrough enabled the ultrasensitive detection of nucleic acids in individual samples or pools of hundreds (100s) of individual plasma samples providing significant cost advantages over systems that test a single sample at a time. Today we offer a next generation UltraQual 2.0 assay platform that offers enhanced performance and turn-around-times, including ultra-sensitive nucleic acid detection.
In addition to NAT testing, in May 2018, NGI received FDA Biologics License Application (BLA) approval for the UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV. This new innovative assay enables the simultaneous and sensitive detection of four viral targets (HCV, HIV-1, HIV-2 and HBV) in a single sample. Coupled with NGI’s proprietary process of testing 512 sample pools, the new UltraQual® Multiplex PCR Assay provides enhanced throughput, exceptional turn-around times and significant value to the plasma fractionation industry to support the development of therapeutics such as IgG and various clotting factors. NGI will soon be offering comprehensive plasma donor testing including viral marker testing (VMT) and ancillary testing services.
Specimen Accessioning and Pooling
Specimens are accessioned into our laboratory information system. For testing involving specimen pooling, master and primary pools are generated using an automated liquid handling system according to proprietary pooling algorithms.
Nucleic Acid Extraction and Amplification
Ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) from plasma are isolated using a ChemagicTM 360 or a ChemagicTM MSM I nucleic acid extractor. Specific sequence regions are amplified by a highly efficient and proprietary procedures.
Nucleic Acid Detection
Amplified nucleic acids are either endpoint detected using a BioPlex® 200 Instrument (Luminex® technology) or detected in real-time using a Roche LightCycler® 480 Instrument. These state-of-the-art procedures significantly enhance turn-around times.
Positive Pool Resolution and Individual Specimen Confirmation
For testing involving specimen pooling, individual positive specimen(s) are identified according to FDA approved-pooling algorithms. As a final confirmation, the suspected positive specimen(s) is tested individually to detect the presence of the nucleic acid target.
Viral Marker Testing
NGI’s newly renovated laboratory utilizes state-of-the-art equipment and testing solutions, and was established to provide the full spectrum of plasma screening services in order to meet the growing needs of our plasma partners. Our testing methodologies are CE marked and FDA-cleared and approved, as appropriate, for plasma donor screening.
Customized Plasma Testing Solutions
NGI offers customizable test solutions that best fit your company’s individual needs. For example, NGI develops detailed client specific quality agreements, electronic data transfer agreements, and results reporting to appropriate state specific and national (e.g. National Donor Deferral Registry –NDDR) standards. As a part of the LabCorp® Specialty Testing Group, NGI has full access to the vast resources of our parent company and its subsidiaries to offer end-to-end laboratory testing solutions for the global plasma industry.
Luminex® is a registered trademark of Luminex Corporation
Bioplex® 200 is a registered trademark of Bio-Rad
LightCycler® is a registered trademark of Roche
ChemagicTM is a trademark of PerkinElmer Chemagen