Chemistry: analytical and immunological testing – Nuclear magnetic resonance – electron spin resonance or other...
Reexamination Certificate
2007-07-17
2007-07-17
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Nuclear magnetic resonance, electron spin resonance or other...
C436S086000, C702S022000, C702S023000, C702S027000
Reexamination Certificate
active
11231109
ABSTRACT:
A method for interpreting data that is produced after a group of amino acids and acylcarnitines are derivatized from blood spots taken from newborn babies and scanned by a tandem mass spectrometer. Concentration levels of each metabolite, which are directly proportional to the butyl ester fragment after derivatization, are compared to threshold flags for determining a significance of any deviation of the metabolite relative to the flag threshold. The threshold flags are diagnostic limits to the data retrieved from each blood spot. The data includes metabolite concentrations and molar ratios of metabolites with other metabolites. Samples are labeled normal for a disease if the concentration of any of the metabolite concentrations or molar ratio concentration do not deviate from the flag threshold, but, in contrast, the sample must be further evaluated if a value is elevated or deficient to some degree. Thus, as each metabolite fragments at a different mass to charge value (m/z), corresponding data is compared to the respective flag thresholds for determining a next course of action that must be taken to ultimately assist a physician in the diagnosis of a genetic disorder such as hypermethionemia resulting from an elevation or deficiency of the metabolite particular for that disorder.
REFERENCES:
patent: 4224031 (1980-09-01), Mee et al.
patent: 5072115 (1991-12-01), Zhou
patent: 5206508 (1993-04-01), Alderice et al.
patent: 5251126 (1993-10-01), Kahn et al.
patent: 5252489 (1993-10-01), Macri
patent: 5316917 (1994-05-01), Roe
patent: 5352891 (1994-10-01), Monning et al.
patent: 5365426 (1994-11-01), Siegel et al.
patent: 5453613 (1995-09-01), Gray et al.
patent: 5538897 (1996-07-01), Yates et al.
patent: 5545895 (1996-08-01), Wright et al.
patent: 5629210 (1997-05-01), Hercules et al.
patent: 5878746 (1999-03-01), Lemelson et al.
patent: 6258605 (2001-07-01), Chace
patent: 6335369 (2002-01-01), Cavazza
patent: 6429230 (2002-08-01), Cavazza
patent: 6455321 (2002-09-01), Chace
patent: 6653349 (2003-11-01), Cavazza
patent: 6696492 (2004-02-01), Cavazza
patent: 6696493 (2004-02-01), Cavazza
C.G. Costa, et al., “Quantitative Analysis of Plasma Acylcarnitines Using Gas Chromatography Chemical Ionization Mass Fragmentometry,” Journal of Lipid Research, vol. 38, pp. 173-182 (1997).
Y. Shigematsu, et al., “Modifications in Electrospray Tandem Mass Spectrometry for a Neonatal-Screening Pilot Study in Japan,” Journal of Chromatography B, vol. 731, pp. 97-103 (1999).
K. Heinig, et al., “Determination of Carnitine and Acylcarnitines in Biological Samples by Capillary Electrophoresis-Mass Spectrometry,” Journal of Chromatography B, vol. 735, pp. 171-188 (1999).
B.M. Kelly et al., “Electrospray Mass Spectra of Medium-Chain and Long-Chain Acylcarnitines,” Organic Mass Spectrometry, vol. 27, pp. 924-926 (1992).
M.S. Rashed, et al., “Inborn Errors of Metabolism Diagnosed in Sudden Death Cases by Acylcarnitine Analysis of Postmortem Bile,” Clinical Chemistry, vol. 41 (8), pp. 1109-1114 (1995).
J.A. Montgomery, et al., “Measurement of Urinary Free and Acylcarnitines: Quantitative Acylcarnitine Profiling in Normal Humans and in Several Patients with Metabolic Errors,” Analytical Biochemistry, vol. 176 (1), pp. 85-95 (1989).
Chemical Abstract, vol. 128, No. 19, p. 323, Abstract No. 228108p (1998), F. Inoue, et al., “Analysis of Dried Blood Spots by Electrospray Mass Spectrometry,” Bull. Kyoto Univ. Educ., Ser. B, vol. 91, pp. 15-22 (1997).
Chemical Abstract, vol. 123, No. 19, p. 508 , Abstract No. 250402y (1995), M.S. Rashed, et al., “Diagnosis of Inborn Errors of Metabolism from Blood Spots by Acylcarnitines and Amino Acids Profiling Using Automated Electrospray Tandem Mass Spectrometry,” Pediatr. Res., vol. 38(3), pp. 324-331 (1995).
Chemical Abstract, vol. 124, No. 5, p. 608, Abstract No. 49898s (1996), N. Terada, et al., “Amino Acids and Acylcarnitines Analysis by ESLMS/MS” Nippon Iyo Masu Supekutoru Gakkai Koenshu, vol. 20, pp. 39-44 (1995).
Chemical Abstract, vol. 120, No. 13, p. 536, Abstract No. 157900n (1994), M.S. Rashed, et al., “Electrospray Tandem Mass Spectrometry in the Diagnosis of Organic Acidemas,” Rapid Commun. Mass Spectrom., vol. 8(1), pp. 129-133 (1994).
Rashed, et al., “Screening blood spots for inborn errors of metabolism by electrospray tandem mass spectrometry with a microplate batch process and a computer algorithm for automated flagging of abnormal profiles,” Clinical Chem., vol. 43:7, pp. 1129-1141, (1997).
Nada, M., et al., “Investigation of Beta-Oxidation Intermediates in Normal MCAD-Deficient Human Fibroblasts Using Tandem Mass Spectrometry,” Biochemical and Molecular Med., vol. 54, No. 1, pp. 59-66 (1995).
Chace, D., “Used of phenylalnine-to-tyrosine ratio determined by tandem mass spec . . . ,” Clin. Chem., vol. 44:12 (1998).
Abdenur, J., et al., Diagnosis of Isovaleric Acidaemia by Tandem Mass Spectrometry: False Positive Result due to Pivaloyl Carnitine in a Newborn Screening Programme; J. Inher. Metab. Dis., vol. 21, pp. 624-630 (1998).
Abdenur, J., et al., “MCAD Deficiency: Acylcarnitines (AC) by Tandem Mass Spectrometry (MS-MS) are Useful to Monitor Dietary Treatment,” Adv. Exp. Med. Biol., vol. 466, pp. 353-363 (1999).
Albers, S., et al., “Detection of Neonatal Carnitine Palmitoyltransferase II Deficiency by Expanded Newborn Screening with Tandem Mass Spectrometry,” Pediatrics 2001; 107:E103.
Barns, R., et al., “Carnitine in Dried Blood Spots: A Method Suitable for Neonatal Screening,” Clin. Chim. Acta, vol. 197, pp. 27-33 (1991).
Chace, D., et al, “Errors Caused by the Use of D,L-octanoly Carnitine for Blood-Spot Calibrators,” Clin. Chem. vol. 47, pp. 758-760 (2001).
Clayton, P., et al, “Screening for Medium Chain Acyl-coA Dehydrogenase Deficiency using Electrospray Ionisation Tandem Mass Spectrometry,” Arch. Dis. Child, vol. 79, pp. 109-115 (1998).
Gaskell, S., et al., “Differentation of Isomeric Acylcarnitines using Tandem Mass Spectroemtry,” Anal. Chem., vol. 58, pp. 2801-2805 (1986).
Gempel, K., et al., “Adult Carnitine Palmitoyltranferase II Deficiency: Detection of Characteristic Carnitine Esters in Serum by Tandem Mass Spectrometry,” J. Inherit. Metab. Dis., vol. 22, pp. 941-942 (1999).
Johnson, A., et al., “The Use of Automated Electrospray Ionization Tandem MS for the Diagnosis of Inborn Errors of Metabolism from Dried Blood Spots,” Biochem. Soc. Trans., vol. 24, pp. 932-938 (1996).
Johnson, D., “Inaccurate Measure of Free Carnitine by the Electrospray Tandem Mass Spectrometry Screening Methods for Blood Spots,” J. Inher. Metab. Dis., vol. 22, pp. 201-202 (1999).
Kodo, N., et al., “Quantitative Assay of Free and Total Carnitine using Tandem Mass Spectrometry,” Clin. Chim. Acta, vol. 186, pp. 383-390 (1989).
Liberato, D., et al., “Analysis of Acylcarnitines in Human Metabolic Disease by Thermospray Liquid Chromatography/Mass Spectrometry,” Burlingame A.A. Castagnoli N., editors, Mass Spectrometry in the Health and Life Sciences, Amsterdam, NL; Elsevier Science Publishers, pp. 333-348 (1958).
Millington, D., et al., “Application of Fast Atom Bombardment with Tandem Mass Spectrometry and Liquid Chromatography/Mass Spectrometry to the Analysis of Acylcarnitines in Human Urine, Blood and Tissue,” Anal. Biochem., vol. 180, pp. 331-339 (1989).
Millington, D., et al., “Tandem Mass Spectrometry: A New Method for Acylcarnitines Profiling with Potential for Neonatal Screening for Inborn Errors of Metabolism,” J. Inher. Dis., vol. 13, pp. 321-324 (1990).
Stevens, R., et al., “Assay for Free and Total Carnitine in Human Plasma Using Tandem Mass Specrtrometry,” Clin. Chem., vol. 46, pp. 727-729 (2000).
Vreken, P., et al., “Quantitative Plasma Acylcarnitine Analysis Using Electrospray Ta
Choate Hall and Stewart LLP
Herschbach Jarrell Brenda
Lyon Charles E.
Pediatrix Screening, Inc.
Warden Jill
LandOfFree
Method for interpreting tandem mass spectrometry data for... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for interpreting tandem mass spectrometry data for..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for interpreting tandem mass spectrometry data for... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3741099