Background:
Currently, a standard value is assigned for hematocrit (hct) in hemoglobin (Hb) concentrations when measuring biomarkers in assays. Our method is to estimate the hct fraction in an individual's whole blood first, and then adjust the measured concentrations of the one or more biomarkers, based on the estimated hct fraction. Performing these adjustments is a significant improvement that eliminates biosensor reagent bias by calculating true concentration yields. An advantage of estimating hct values, in whole blood serum, provides the supplementary ability to screen for the predisposition or presence of one or more specific Hb variants to identify certain blood disorders such as sickle cell anemia (Hb S).
Applications:
- Improved diagnostic assay in newborn screening for Hb measurement. Suitable for use in multiplexed affinity assays such as a multiplexed bead-based affinity assay, a multiplexed electroluminescence affinity assay, a multiplexed chemiluminescence affinity assay or an immunoassay
- Supplementary method for determining one or more biomarkers in a blood sample by measuring concentration of Hb and Hb variants A, F, S, E and C.
- Beneficial in veterinary applications to accurately measure concentrations of one or more biomarkers in non-human patients, including primates, or domestic animals such as farm animals and pets, including dogs and cats.
Advantages:
- Accurate method for determining hct fraction in serum whole blood for multiplexed affinity assays and immunoassay
- Eliminates biosensor reagent bias
- Maximizes assay function to concurrently screen for predisposition or presence of one or more specific Hb variants that can be used to identify certain blood disorders such as sickle cell anemia.
- True measurement of Hb in extract serves as positive control to rule out machine or operator error
State of Development:
Early research stage of development.
Patents:
PCT US2009/46947
The Inventors:
Kenneth Pass, Ph.D.
For 28 years Dr. Kenneth Pass was director of the NYS Newborn Screening Program. During that time he introduced screening for biotinidase deficiency, congenital adrenal hyperplasia, and Krabbe disease. The NY program was the first to use a call-in system by which physicians could obtain test results on any day at any time, the first to provide a portion of the specimen form for the mother to facilitate acquisition of test results, the first to implement HIV testing of all newborns, and the first to test for the LSDs. He has published over 80 peer reviewed papers, eight book chapters, and delivered lectures all over the world on many different aspects of NBS. With funding from NICHD he has developed multiplex assays that screen for CH/CF/CAH (5-plex), SCID (2-plex), and autism (7-plex), all using a single 3 mm spot. Currently his laboratory is developing a multiplex assay for hemoglobin variants that can be added to each of the above, thereby allowing calculation of the hematocrit and normalization of test results.
Barbara Lindau-Shepard, Ph.D.
Publications:
Pass, Kenneth A., and Lindau-Shepard, Barbara A. Newborn Screening for Cystic Fibrosis by Use of a Multiplex Immunoassay. March 2010, Clinical Chemistry 56:3, 445–450.
Contact:
Diane L. Borghoff, B.S., M.S.
Marketing & Licensing Associate – Intellectual Property
Health Research, Inc.
150 Broadway – Suite 560, Menands, New York 12204-2719 U.S.A.
Phone 518-431-1213 Fax 518-431-1234
E-mail: DLB22@healthresearch.org Website: www.healthresearch.org
