This document provides a summary of the work experience and qualifications of Venkatakrishna Shyamala, Ph.D. It outlines her extensive experience in molecular diagnostics and blood testing spanning over 30 years, including roles leading research and development teams at multiple biotech companies. Her areas of expertise include assay development, scientific affairs, and evaluating nucleic acid testing technologies.

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Venkatakrishna Shyamala, Ph. D.
Research Diagnostics, Inc.
Consultant, Molecular Diagnostics and Blood Testing (>30 years Biotech experience)
E-mail: vshyamala@netscape.net ; Web Contact: http://www.linkedin.com/in/vshyamala
Country of Citizenship: United States of America
RESEARCH AND WORK EXPERIENCE
Independent Consultant
10/2008 To Present
Consultant, Molecular in vitro Diagnostics, Blood Screening and Molecular Biology
 Consultant – Research Diagnostics, Inc. India; Reuters Insight Expert, Zintro Expert
 Novartis Vaccines and Diagnostics, Scientific Affairs (2011-2014)
 CLSI Area committee for Molecular Methods-Observer; subcommittee participant for “Point-of- Care Testing for Infectious Diseases”, “Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine” and “Microarrays for diagnosis and Monitoring of Infectious Diseases”.
 CLSI publications: MM01 (2012)- Molecular Methods for Clinical Genetics and Oncology testing 3rd Ed.; MM19 (2011) Establishing Molecular Testing in Clinical Laboratory Environments; MM09 (2010) Quantitative Molecular Methods for Infectious Diseases 2nd Ed.
At Innovative Biosensors, Inc., Rockville, Maryland
7/2007 To 10/2008
Senior Vice President, Research and Development; Clinical Diagnostics on CANARYTM platform, Next generation technologies
 1 patent
 Leading a team of 10 scientists tasked to facilitate developing and launching Diagnostics assays for MRSA, Chlamydia trachomatis and Group B Streptococcus; Feasibility evaluation of Next Generation technologies.
 Initiated Pilot Clinical trial studies at Indiana University and UM Shock Trauma Center for the CANARYTM-MRSA assay and CANARYTM-Chlamydia assays.
 3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the Engineering department at Univ of Maryland at College Park.
At Digene Corporation, Gaithersburg, Maryland
3/2006 To 7/2007
Director; Assay Development, Next Generation Platform Technologies for Nucleic Acid Detections of HPV, CT and NG
 Leading a team of 14 scientists tasked to facilitate development of Next Generation assay for Chlamydia trachomatis and Neisseria gonorrhoea.
 Completed Analytical Sensitivity comparison of commercially available nucleic acid detection assays including Roche, GenProbe, and Abbott for 16 serovars of CT with Digene Hybrid CaptureR, Digene Isothermal and Digene Helicase Dependent Amplification assays.
Chiron Corporation 1990-2006
At Chiron Corporation-Blood Testing Division, Emeryville, California
6/2004 To 3/2006
Associate Director; Research Leader of the Next Generation Platform Technologies for Nucleic Acid Detections of HBV, HCV, WNV, Parvo B19 and HAV for Blood Screening.
5 publications, 9 presentations at Scientific conferences.
 Leading a team of 3 scientists and several research associates to quickly evaluate and identify the best amongst 10 Nucleic acid isolation technologies in the newly assigned project.
Established collaborations with 8 companies and tested in-house, novel amplification-detection technologies.
Have been a liaison as assay development expert to other departments, affiliates and customers in the existing and new product related questions.
year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration with Univ of Arizona.
4/2000 To 6/2004
Senior Scientist-Associate Director; Research Leader and Project Team Leader of the PCR based Alternative NAT assays for HBV, HCV and WNV for Blood Screening.
5 publications, 4 patents, 27 presentations at Scientific conferences.
Led and managed assay development teams for HBV, HCV and WNV Tests; research and development activities, including optimizations of assay reagents and test system, and transfer of product to Reference Testing Laboratories.

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Worked in liaison with Validation, Statistics, Marketing/Business Development, Regulatory- Clinical affairs & Scientific affairs to design and execute Market evaluations, Registration studies.
Identified, negotiated and placed the Confirmatory Alternative assays for HBV and WNV in the GMP qualified Bayer Reference and Testing Laboratories (BRTL), and the HCV assay at Blood Systems Research Institute (BSRI).
Played a key role in IND and BLA submissions of Procleix-Duplex (HCV) and Procleix-Ultrio (HBV) in confirming the Clinical trial positives. Key role in IND submission of Procleix-WNV assay. Helped the Regulatory Affairs to review the Clinical report for Procleix-Ultrio for CE Mark and FDA submission and approval.
Participated in several Coded studies offered by US and Canadian Blood banks, CBER (USA), QCMD (UK), ISS & EQA (Italy) and VQC (Netherlands) for HCV, HBV and WNV Qualitative and Quantitative assays. Publication and presentation of these data, resulting in numerous collaborations.
Interfaced with Chiron Legal department to research on competitor marketed HIV and HCV assay reagents.
At Chiron Corporation -Technologies Division, Emeryville, CA
1/1996 To 10/2000
Principal Scientist, Coordinated the efforts of scientists from various disciplines including chemistry, high-through put screening and phage display to examine the effect of ligand dimerization on receptor activation. Generated cell lines overexpressing recombinant and chimeric receptor. Set up ligand binding and signaling assays for high through-put screening. Identified novel orphan receptors, and determined their expression profile.
6/1994 To 1/1996
Research Scientist. Analyzed signaling by tumor necrosis factor receptors I and II. Identified kinase interacting proteins by the yeast two hybrid system.
Identified novel, alternatively spliced endothelin B receptor. Defined features of IL-8 to interact and signal with IL-8 receptors 1 and 2. Defined signaling molecules for IL-8 receptors.
Identified and isolated several novel orphan seven transmembrane receptors.
6/1990 To 6/1994
Research Biochemist, Identified conserved sequences in the 5’ and 3’ region of Hepatitis C viral RNA. Developed an internal standard RNA for RT-PCR based quantitation of hepatitis C viral RNA in tissue samples. Examined the translational control by the untranslated 5’ end of HCV RNA.
Post-Doctoral Experience
1986-1990
Visiting Scientist Department of Biochemistry, University of California at Berkeley, CA.
Developed PCR based methods for gene analysis. Studied structure-function relationship of the bacterial histidine permease and recombination events.
1984-1986
1983-1984
1979-1983
Scientist. Pacific Presbyterian Hospital, San Francisco, CA.
Post Doctoral Fellow (with Dr. J. Inselburg). Dartmouth College, Hanover, NH.
Post Doctoral Fellow (with Dr. H. W. Dickerman) NY State Department of Health Albany, NY.
EDUCATION
1973-1979
Ph.D., Department of Biochemistry, Indian Institute of Science, Bangalore, India.
Thesis: Effect of starvation on rat liver organelles.
AREAS OF EXPERTISE
Background
Ph.D. in Biochemistry and Molecular Biology
Assay Development and Technical
Evaluated Nucleic Acid Testing (NAT) technologies, extensive virology and bacteriology experience, Primer/probe designs and NAT assay development; Strong troubleshooting skills and innovative thinking; Novel NAT detection methods, cDNA library screening, molecular cloning, sequencing and expression.
Scientific Affairs
Developed and maintained contacts with key external opinion leaders, clinical investigators, and other key customers in blood screening and diagnostic field; Marketing study designs; Authored several original publications; Presented scientific data at numerous professional conferences; Solid

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knowledge and experience on assay development and product improvements; Critical data analysis and interpretation. Recruited subject experts to IBI Scientific Advisory Board, monthly progress presentations to Board members, procured NSF-MASINT and NIH grant.
Other Areas
Reviewed Clinical trial data for IND and BLA preparation and submission; B round financing of $12 million for IBI; IRB procurement to initiate pilot MRSA clinical studies
EXTRA MURAL FUNDING
2008-2010
3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the Engineering department at Univ of Maryland at College Park.
2003-2007
2007-2008
year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration with Univ of Arizona.
Invited reviewer by NSF for the Ohio State interdisciplinary grant.
SELECTED PUBLICATIONS
Patents Issued
1. C. Cote, Q.-X. Zheng, V. Shyamala, T. Hazel: Methods and Systems for Detecting Methicillin- Resistant Staphylococcus (2008) PCT/US09/43143
2. V. Shyamala, S. Pichuantes and S. Nguyen: Methods and Reagents for Detecting Hantavirus (2005) WO 2008/008444 A2
3. S. Pichuantes, and V. Shyamala: Diagnostic assays for Parvovirus B19 (2002) WO 03/002753 A2; US 6,936,442 (2005).
4. V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of Hepatitis A viral RNA (2003) WO2003/106641.
5. V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of West Nile viral RNA (2002) WO2004/055159 A2; US 7,132,233 B2.
Original Papers
Since 1989
1. V. Shyamala (2014) Nucleic acid technology (NAT) testing for blood screening: Impact of Individual donation and minipool NAT testing on Analytical sensitivity, Screening sensitivity and Clinical sensitivity. ISBT Science Series. In press.
2. V. Shyamala (2014) Transfusion transmitted infections in Thalassemics: Need for reappraisal of blood screening strategy in India. Transfusion Medicine. 2,79-88.
3. V. Shyamala (2014) Factors in Enhancing blood safety by Nucleic Acid Technology Testing for Human Immunodeficiency virus, Hepatitis C virus and Hepatitis B virus. Asian J. Trans. Sci. 8, 13-18.
4. V. Shyamala, T. Sandison and J. A. Holmberg (2014) Individual Donation Nucleic Acid Technology testing to minimize Human Immunodeficiency virus-1, Hepatitis C virus and Hepatitis B virus Transfusion Transmitted Infections. Asian J. Trans. Sci. 8, 68.
5. R. Emmadi, J.B. Boonyaratanakornkit, R. Selvarangan, V. Shyamala, B. L. Zimmer, L. Williams, B. Bryant, T. Schutzbank, M. M. Schoonmaker, J. A. Amos Wilson, L. Hall, P. Pancholi and K. Bernard (2011) Molecular methods and platforms for infectious diseases testing. A review of FDA approved and cleared assays. J. Mol. Diagnostics 13, 583-604.
6. S. Kleinman, S. Glynn, T.-H. Lee, L. Tobler, L. Montalvo, D. Todd, J. Kiss, V. Shyamala, M. Busch (2007) Prevalence and quantitation of Parvovirus B19 DNA levels in blood donors using a sensitive PCR screening assay. Transfusion 47, 1756-1764.
7. M. Busch , S. Caglioti, G. Robertson, J. McAuley, L. Tobler , H. Kamel, J. Linnen, V. Shyamala, P. Tomasulo, and S. Kleinman (2005) Screening the blood supply for West Nile Virus RNA by nucleic acid amplification testing. New Engl. J. Med. 353, 460-467.
8. M. P. Busch, L.H. Tobler, J. Saldanha, S. Caglioti, V. Shyamala, J. Linnen, J. Gallarda, B. Phelps, R. Smith, and S. H. Kleinman (2005) Analytical and Clinical Sensitivity of First Generation West Nile Virus RNA Screening and Confirmatory Assays. Transfusion 45, 492- 499.
9. A. Cox, D. M. Netski, T. Mosburger, S.G. Sherman, S. Strathdee, D. Ompad, D. Vlahov, V. Shyamala, D. Chien, S. C. Ray and D. Thomas (2005) Prospective evaluation of community- acquired acute hepatitis C. Clin. Infect. Dis. 40, 951-958.
10. L. H. Tobler, C. Bianco, S. A. Glynn, G. B. Schreiber, B. J. Dille, H. E. Prince, R. S. Lanciotti,

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J. M. Linnen, J. Galarda, V. Shyamala, D. Smith, S. H. Kleinman and M. P. Busch (2005) Detection of West Nile Virus (WNV) RNA and antibody in frozen plasma components recalled from the 2002 peak epidemic. Transfusion 45, 480-486.
11. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Madriaga, D. Chien and B. Phelps (2004) Assessment of the Target-Capture PCR Hepatitis B Virus (HBV) DNA Quantitative Assay and Comparison with Commercial HBV DNA Quantitative Assays. J. Clin. Microbiol. 42, 5199-5204.
12. G. Pisani, K. Cristiano, J. Saldanha, M. Wirz, G. M. Bisso, C. Mele, G. Gentili and the EQA Participants. (2004) External quality assessment for the detection of blood-borne viruses in plasma by nucleic acid amplification technology: the first human immunodeficiency virus and hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study (HCV EQA/5). Vox Sanguinis 87, 91-95.
13. V. Shyamala, J. Cottrell, P. Arcangel, D. Madriaga, J. Linnen, B. Phelps, and D. Chien (2004) Detection and quantitation of HBV DNA in the WHO International standard for HIV-1 RNA. J. Virol. Meth. 118, 69-72.
14. C. Gentili, G. Pisani, J. Saldhana, K. Cristiano, Wirz, G. M. Bisso, C. Mele, and the EQA participants. (2003) High proficiency in detecting the six major hepatitis C virus genotypes of laboratories involved in testing plasma by nucleic acid amplification technology. Vox Sanguinis 85, 114-116.
15. J.-P. Allain, D. Candotti, K. Soldan, F. Sarkodie, B. Phelps, C. Giachetti, V. Shyamala, F. Yeboah, M. Anokwa, S. Owusu-Ofori, and O. Opare-Sem (2003) The risk of hepatitis B virus infection by transfusion in Kumasi, Ghana. Blood 101, 2419-2425.
16. H. Khoja, G. Wang, C.-T. Lee Ng, J. Tucker, T. Brown, and V. Shyamala (2000) Cloning of CCRL1, an orphan seven transmembrane receptor related to chemokine receptors, expressed abundantly in the heart. Gene 246, 229-238.
17. M.D. Ballinger, V. Shyamala, L. D. Forrest, M. Deuter-Reinhard, L.V. Doyle, J. X. Wang, L. Panganiban-Lustan, J. R. Stratton JR, G. Apell, J. A. Winter, M. V. Doyle, S. Rosenberg, W.M. Kavanaugh (1999). Semirational design of a potent, artificial agonist of fibroblast growth factor receptors. Nat. Biotechnol. 17, 1199-1204.
18. V. Shyamala, H. Khoja, M. L. Anderson, J.-X. Wang, H. Cen, and W. M. Kavanaugh (1999) High-throughput screening for ligand-induced c-fos mRNA expression by branched DNA assay in chinese hamster ovary cells. Anal. Biochem. 266, 140-147.
19. V. Shyamala, and H. Khoja (1998) Interleukin-8 receptors R1 and R2 activate mitogen- activated protein kinases and induce c-fos, independent of Ras and Raf-1 in chinese hamster ovary cells. Biochemistry 37, 15918-15924.
20. V. Shyamala, H. Khoja, and M. Moghadam (1998) Inhibition of adenylyl cyclase by  chemokines IL-8 and GRO- in chinese hamster ovary cells expressing R1 and R2 receptors. J. Interferon Cytokine Res. 18, 235-239.
21. C. Caudai, M. G. Padula, I. Bastianoni, P. E. Valensin, V. Shyamala, J. Han, C. A. Boggiano, P. Almi (1998) Antibody testing and RT-PCR in hepatitis C virus (HCV) infection: HCV-RNA detection in PBMC of plasma viremia-negative HCV-seropositive persons. Infection 26, 151- 154.
22. C. Reinhard, B. Shamoon, V. Shyamala, and L. T. Williams (1997) Tumor Necrosis factor alpha induced activation of c-jun N-terminal kinase is mediated by TRAF2. EMBO J. 16,1080- 1092.
23. M. E. Wernette-Hammond, V. Shyamala, M. A. Siani, C. A. Gallegos,, P. H. Feucht, J. Abbott, G. Reza-Lapointe, M. Moghadam, H. Khoja, J. Zakel, and P. Tekamp-Olson (1996) Receptor recognition and specificity of interleukin-8 is determined by residues that cluster near a surface- accessible hydrophobic pocket. J. Biol. Chem. 271, 8228-8235.
24. V. Shyamala, T. H. M. Moulthrop, J. Stratton-Thomas, and P. Tekamp-Olson (1994) Two distinct human endothelin B receptors generated by alternative splicing from a single gene. Cell. Mol. Biol. Res. 40, 285-296.
25. F. Damacco, D. Sansonno, J. H. Han, V. Shyamala, V. Cornacchiulo, A. R. Iacobelli, G. Lauletta, and R. Rizzi (1994) Natural interferon-alpha versus its combination with 6-methyl- prednisolone in the therapy of type II mixed cryoglobulinemia: a long-term, randomized, controlled study. Blood 84, 3336-3343.

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26. L. J. van Doorn, V. Shyamala, J. H. Han, and G. E. Kleter (1994) HCV RNA detection in heparinized blood by direct genomic RNA capture onto paramagnetic particles. J. Virol. Meth. 48, 339-341.
27. S. Magrin, A. Craxi, C. Fabiano, G. Florentino, L. Marino, P. Almasio, G. B. Pinzello, U. Palazzo, M. Vitale, A. Maggio, G. Bucca, F. Gianguzza, V. Shyamala, J. H. Han, and L. Pagliaro (1992) Serum hepatitis virus (HCV)-RNA and response to alpha-interferon in anti- HCV positive chronic hepatitis. J. Med. Virol. 38, 200-206.
28. J. H. Han, V. Shyamala, K. H. Richman, M. J. Brauer, B. Irvine, M. S. Urdea, P. Tekamp- Olson, G. Kuo, Q.-L. Choo, and M. Houghton (1991) Characterization of the terminal regions of hepatitis C viral RNA: Identification of conserved sequences in the 5' untranslated region and poly(A) tails at the 3' end. Proc. Natl. Acad. Sci. USA 88, 1711-1715.
29. A. J. Weiner, C. Christopherson, J. Eric Hall, F. Bonino, G. Saracco, K. Crawford, C. D. Marion, K. A. Crawford, V. Shyamala, T. Miyamura, J. McHutchinson, T. Cuypers and M. Houghton (1991) Sequence variation in hepatitis C viral isolates. J. Hepatology 13, 6-14.
30. R. V. Webster, J. C. Craig, V. Shyamala, G. C. Kirby, and D. C. Warhurst (1991) Antimalarial activity of optical isomers of quinacrine dihydrochloride against chloroquine-sensitive and - resistant plasmodium falciparum in vitro. Biochem. Pharmacol. 42, S225-S227
31. V. Shyamala, V. Baichwal, E. Beall, and G. F.-L. Ames (1991) Structure-function analysis of the histidine permease and comparison with cystic fibrosis mutations. J. Biol. Chem. 266, 18714-18719.
32. R. E. Kerppola, V. Shyamala, P. Klebba, G. F.-L. Ames (1991) The membrane-bound proteins of periplasmic permeases form a complex. Identification of the histidine permease HisQMP complex. J. Biol. Chem. 266, 9857-9865.
33. V. Shyamala, and G. F.-L. Ames (1991) Use of exonuclease for rapid polymerase-chain- reaction-based in vitro mutagenesis. Gene 97, 1-6.
34. V. Shyamala, E. Schneider, and G. F. L. Ames (1990) Tandem chromosomal duplications: Role of REP sequences in the recombination event at the join-point. EMBO J. 9, 939-946.
35. V. Shyamala, and G. F.-L. Ames (1989) Genome walking by single-specific-primer polymerase chain reaction: SSP-PCR. Gene 84, 1-8.
36. V. Shyamala, and G. F.-L. Ames (1989) Amplification of bacterial genomic DNA by the polymerase chain reaction and direct sequencing after asymmetric amplification: application to the study of periplasmic permeases. J. Bacteriol. 171, 1602-1608.
Selected Invited Articles
1. V. Shyamala, and G. F.-L. Ames (1993) Genome walking by Single-Specific Primer Polymerase Chain Reaction, in Methods in Enzymol. Vol. 217 Part H, pp 436-446. Ed. R. Wu.
2. V. Shyamala, and G. F.-L. Ames (1993) Single-Specific Primer Polymerase Chain Reaction and Gene walking, in PCR protocols Current methods and applications, Vol. 15, pp 339-348. Ed. B. White
3. A. J. Weiner, V. Shyamala, J. Eric Hall, M. Houghton, and J. Han (1992) Application of polymerase chain reaction to hepatitis C virus research and diagnostics, in Diagnosis of human viruses by polymerase chain reaction technology. pp 86-100.
Conference Presentations
2000-2012
65th Annual AABB meeting, 2012, 6th -9th October, Boston MA
1. K. Chatterjee, V. Shyamala. Procleix Ultrio Plus Assay Evaluation Experience for Indian donor population. Transfusion 52, 218A, SP434
32nd Congress of the ISBT, 2012, 7th-12th July, Cancun, Mexico
2. V. Shyamala, Karnataka State Government, Bangalore Medical Systems. Public Private Partnership for Statewide consolidation and Centralized Individual Donation Nucleic Acid Testing in India: Karnataka State Experience. Vox Sanguinis 103, 81.
40th Annual Oakridge Conference, 2008, 17th -18th April San Jose, CA
3. F. Benahmed, J. Simpson, N. Chakraborty, I. Mielzynska, K. Modarress, T. Hazel, V. Shyamala A rapid, sensitive, specific assay for the detection of Chlamaydia trachomatis in urine by the CANARYR assay.
59th Annual AABB meeting, 2006, 21st -24th October, Miami Beach, FL
4. Y.-L. Fong, D. Madriaga, V. Shyamala, J. Cottrell, R. Lewis, L. Eudey, G. Crutcher, N. Lelie, A. Heaton, B. Phelps, D. Chien. Evaluation of Analytical Sensitivity of Chiron Target Capture

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HBV DNA Assay for HBV Detection, and Comparison with NGI SuperQuantTM HBV DNA Assay. Transfusion 46, 96.
5. S. Kleinman, T. H. Lee, L. Montalvo, L. H. Tobler, S. A. Glynn, D. S. Todd, V. Shyamala, D. Madriaga, J. E. Kiss, M. P. Busch. Prevalence and Quantitation of Parvovirus B19 DNA Levels in Blood Donors Using a Sensitive PCR Screening Assay. Transfusion 46, 37.
25th Annual meeting of American Society of Virology, 2006, 15th -19th July, Madison, WI
6. V. Shyamala, B. Hjelle, D. Madriaga, H. Huang, S. Nguyen, D. Chien, B. Phelps, S. Pichuantes. Multiplex detection and quantitation of six subtypes of Hantavirus RNA. Abstract W53-1, p210.
58th Annual AABB meeting, 2005, 15th -18th October, Seattle, WA
7. J. Cline, C. Deza, R. Cory, A. Garcia, M. Lewis, A. Broulik, M. Deras, V. Shyamala, S. Pichuantes, C. Giachetti, J. M. Linnen. Stability of WNV Viral RNA from tissue culture and blood donor samples in stored blood. Transfusion 45, 149.
8. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B. Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison study. Transfusion 45, 151.
9. S. Nguyen, V. Shyamala, H. Huang, D. Madriaga, M. Badgett, J. Hedges, C. WalkerPeach, D. Chien, B. Phelps, S. Pichuantes. Cloning of West Nile virus internal control and nucleotide fragments spanning the full-length viral genome for production of stable RNA standards. Transfusion 45, 151.
2005 National conference on West Nile Virus, 8th -9th February, San Jose, CA
10. S. Cagliotti, G. F. Robertson, J. McAuley, S. H. Kleinman, L. H. Tobler, H. Kamel, J. M. Linnen, V. Shyamala, P. A. Tomasulo, M. P. Busch. Screening the blood supply for West Nile Virus RNA by nucleic acid amplification testing.
11. M. P. Busch, L. H. Tobler, J. McAuley, J. M. Linnen, V. Shyamala, G. F. Robertson, D. J. Wright, S. H. Kleinman, S. Cagliotti. West Nile virus RNA dynamics and antibody evolution based on Follow-up of viremic blood donors.
12. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B. Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison study.
57th Annual AABB meeting, 2004, 23rd -26h October, Baltimore, MD
13. V. Shyamala, D. Madriaga, S. Pichuantes, B. Jaitner, D. Chien and B. Phelps. Performance characteristics of the Validated and Improved qualitative and quantitative Target-Capture PCR
WNV NAT assays. Transfusion 44, 140.
14. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Chien, B. Phelps. Performance characteristics of the qualitative and quantitative Target-Capture PCR HBV NAT assay. Transfusion 44, 85.
15. V. Shyamala, J. Cottrell, D. Madriaga, P. Arcangel, M. Hartman, K. Gasuad, D. Chien, B. Phelps. Quantitation of commercially available nucleic acid amplification Run controls, and Standards by Target-Capture PCR assay. Transfusion 44, 91.
16. M. Busch, L. Tobler, J. McAuley, J. Linnen, V. Shyamala, G. Robertson, D. Wright, S. Kleinman, S. Cagliotti. West Nile Virus RNA dynamics and anttibody evolution based on follow-up of viremic blood donors. Transfusion 44, 2.
17. J. Cline, M. Lewis, W. Wu, S. Miller, A. Broulik, J. Savage, V. Shyamala, M. Cass, C. Giachetti, J.M. Linnen. Gen-Probe Alternative WNV assay: A TMA-based confirmatory assay for West Nile Virus. Transfusion 44, 138.
28th congress of the ISBT meeting, 2004, 10th-15th July, Edinburgh, UK.
18. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H. Huang, A. Medina-Selby, D. Coit, D. Chien B. Phelps. Performance characteristics of the qualitative and quantitative Target-Capture PCR WNV NAT assay. Vox Sanguinis, 87, 26.
19. L. H. Tobler, H. Prince, G. Hafner, B. Dille, R. A. Gutierrez, W. Andrews, C. Harrington, V. Shyamala, J. McAuley, V. Winkelman, S. Cagliotti, M. P. Busch. Relative performance of four West Nile Virus antibody assays in viremic blood donor specimens. Vox Sanguinis, 87, 65.
XII APISBT, 2003 15th –18th November, New Delhi, India
20. V. Shyamala, P. Arcangel, D. Madriaga, D. Chien, and B. Phelps. Detection and Quantitation of HCV RNA by Bead capture-TaqMan technology.
56th Annual AABB meeting, 2003, 1st-4th November, San Diego, CA

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21. V. Shyamala, J.Cottrell, P. Archangel, D. Coit, A. Medina-Selby, C. McCoin, J. Turczyn, D. Chien and B. Phelps. Validation Of Alternative NAT HBV Assay: A Highly Sensitive PCR Based Assay For HBV DNA. Transfusion. 43, 125.
22. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H. Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Detection and Quantitation of West Nile Virus RNA by the Alternative NAT WNV Assay. Transfusion. 43, 128.
23. B. Jaitner, V. Shyamala, S. Nguyen, H. Huang, Y-L Fong, D. Chien, B. Phelps, S. Pichuantes. Propagation, quantitation, and inactivation of West Nile Virus to support nucleic acid and IgM assay development. Transfusion. 43, 128.
24. V. Shyamala, P. Arcangel, D. Madriaga, J. Cottrell, J. Linnen, D. Chien, B. Phelps. Compatibility of ProcleixR-West Nile Virus (WNV) assay in various anticoagulants. Transfusion. 43, 129.
10th EPFA/NIBSC workshop & SoGAT meeting, 2003, 3rd-4th July, Langen, Germany
25. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H. Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Use of quantitative NAT assay to correlate West Nile Virus titration bioassasy (pfu/ml) with genomic copy numbers (geq/mL).
55th Annual AABB meeting, 2002, 26th-29th Oct. Orlando, FL
26. S. Pichuantes, V. Shyamala, H. Huang, S. Nguyen, D. Madriaga, D. Chien, B. Phelps. Identification and characterization of nucleic acid positive sera from Indonesian and Chilean patients with acute hepatitis A infections. Transfusion, 42, 90.
27. V. Shyamala, D. Madriaga, J. Cottrell, S. Pichuantes, D. Chien, B. Phelps. Development of a Parvovirus B19 nucleic acid quantitative confirmatory assay for use in blood donor screening. Transfusion, 42, 90.
27th congress of the ISBT meeting, 2002, 24th-28th August, Vancouver, Canada.
28. V. Shyamala, P. Arcangel, J. Cottrell, J. Linnen, C. Giachetti, D. Chien, B. Phelps. Performance characteristics of hepatitis B virus DNA confirmatory assay for ProcleixR triplex assay. Vox Sanguinis, 83, 183.
29. V. Shyamala, D. Madriaga, S. Pichuantes, D. Chien, B. Phelps. Performance characteristics of PCR based Parvovirus B19 nucleic acid testing confirmatory assay for the ProcleixR Parvovirus B19/Hepatitis A virus assay. Vox Sanguinis, 83, 44.
30. S. Pichuantes, H. Huang, S. Nguyen, A. Gaggerro, M. Pena, C. Larranaga, V. Shyamala, D. Madriaga, D. Chien, B. Phelps. Identification and characterization of parvovirus B19 from Chilean clinical specimens. Vox Sanguinis, 83, 54.
31. J. Linnen, A. Umali, A. Broulik, D. Kolk, J. Dockter, S. McDonough, V. Shyamala, J. Cottrell, P. Arcangel, L. Mimms and C. Giachetti. Effect of donor mini-pool size on closure of the HBV detection window: A comparison of Triplex TMA to surface antigen detection. Vox Sanguinis, 83, 42.
11th Regional Western Pacific Congress of ISBT, 2001, 10th-13th Nov. Shanghai, China.
32. J. Linnen, M. Ho-Sing-Loy, M. Miyano, V. Shyamala, D. Kolk, A. Broulik, A. Menez, A. Vaughn, E. Peterson, D. Chien, B. Phelps, L. Mimms, C. Giachetti. Performance of the Chiron ProcleixR Triplex Assay for simultaneous detection of HIV-1, HCV and HBV.
54th Annual AABB meeting, 2001, 13th-17th Oct. San Antonio, TX.
33. J. Linnen, M. Ho-Sing-Lloy, M. Miyano, D. Kolk, A. Menez, A. Vaughn, E. Peterson, V. Shyamala, P. Arcangel, D. Chien, B. Phelps. Performance of the TMA Triplex Assay which simultaneously detects HIV-1, HCV and HBV nucleic acid. Transfusion, 41, 82.
34. L. H. Tobler, J. M. Vargo, K. M. Smith, D. Hirschkorn, J. Heitman, C. Degula, V. Shyamala, D. Chien, B. Phelps, L. Mimms, M.P.Busch. Sensitivity and Specificity of an HCV supplemental NAT assay. Transfusion, 41, 83.
35. V. Shyamala, S. Brentano, M. Batranina, S. Pichuantes, D. Madriaga, D. Chien, B. Phelps. Detection of Parvovirus in human plasma samples by Nucleic Acid Amplification Technology (NAT) Transfusion, 41, 86.
VIIth European congress of the ISBT meeting, 2001,15th-18th July, Paris, France
36. V. Shyamala, D. Chien, S. Nguyen, N. Lagwinski, D. Madriaga, P. Carmichael, B. Phelps. J. Heitman, D. Hirschkorn, L. Tobler, and M. Busch. Development and Evaluation of Alternative NAT assay: a highly sensitive RT-PCR based diagnostic assay for HCV RNA.

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37. S. Pichuantes, H. Huang, S. Nguyen, V. Shyamala, D. Madriaga, D. Chien and B. Phelps. PCR amplification, cloning, DNA sequencing and quantitation of parvovirus B19 from human IgM positive sera.
AACC meeting, 2000, 16th-18th Nov, Anaheim, CA.
38. V. Shyamala, D. Madriaga, D. Chien and B. Phelps. A highly sensitive, TMA and PCR dual amplification assay for the detection of Hepatitis C viral RNA molecules.