omation mbers - Society for Laboratory Automation and Screening
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omation mbers - Society for Laboratory Automation and Screening

omation mbers - Society for Laboratory Automation and Screening omation mbers - Society for Laboratory Automation and Screening

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10:30 am Wednesday, February 4 Clinical – Molecular Diagnostic Room C1 Guido Baechler Roche Molecular Systems 4300 Hacienda Drive Pleasanton, California 94566 guido.baechler@roche.com NAT Automation – Enabling Transformation of Molecular Technology From Research to IVD Today, nucleic acid testing (NAT) is mainly performed in highly technical labs. Less than 6.5% of the hospital based clinical diagnostic labs worldwide perform NAT. Some of the key factors that prevent a wider utilization of NAT technology include the highly technical skill level required, the need for additional, dedicated laboratory space and the need to acquire additional equipment. Appropriate automation will serve to overcome the technical hurdles while helping to solve the economic hurdles for wider utilization of NAT in the marketplace.“NAT Automation – Enabling transformation of molecular technology from Research to IVD” will introduce you to the current market trends in NAT testing, outline key economic drivers and the opportunity for automation. The presentation will focus on the laboratory requirements needed to perform NAT testing and how Roche Diagnostics has overcome the challenges of automation to enable a wider utilization of the NAT technology. 11:00 am Wednesday, February 4 Clinical – Molecular Diagnostic Room C1 Hasnah Hamdan Quest Diagnostics Nichols Institute 33608 Ortega Highway San Juan Capistrano, California 92690 hamdanh@questdiagnostics.com High Throughput Molecular Infectious Diseases Tests in the Routine Clinical Laboratory Environment Molecular tests for infectious diseases require extraction and amplification of nucleic acid and detection of amplified products. Numerous factors must be considered when automating nucleic acid tests (NATs) for the clinical laboratory: types of infectious agents, types of specimens, handling and exposure to infectious material, contamination control, and use of different amplification methods. Currently, only a few NATs have been FDA cleared for infectious diseases. Moreover, these tests are either not automated or only semi-automated. Most existing automation systems for infectious disease NATs are for the amplification and detection processes; limited automation is available for nucleic acid extraction, which is the most labor-intensive and challenging of all the processes in NATs. Some solutions for automating NATs for the infectious disease laboratory will be presented. 112

11:30 am Wednesday, February 4 Clinical – Molecular Diagnostic Room C1 Jeffrey Allen Gen-Probe, Inc. 10210 Genetic Center Drive San Diego, California 92121 jeffa@gen-probe.com Process Control With Automated NAAT Systems Molecular diagnostic assays entering the clinical laboratory are rapidly increasing in number. However clinical laboratories are experiencing an ever increasing shortage of highly skilled personnel necessary to run these molecular methods which require significant “hands-on” technique. Automation of nucleic acid amplification testing (NAAT) offers a solution that simultaneously addresses both increasing testing volume and acute labor shortage. Yet automation alone is insufficient to address the concerns facing the clinical lab or blood testing facility. For many laboratories, the quality of the results, i.e., “process control” particularly for NAAT assays, has taken on greater importance than overall sample through-put. New systems for molecular testing must not only save labor, but have design features incorporated which provide system performance “checks” throughout the process. While many clinical chemistry analyzers can determine if sufficient sample volume is present in the primary tube, next generation platforms must confirm sufficient sample was transferred to the reaction vessel. Molecular techniques compound the technical challenges in implementing process control, to help ensure quality results, due to the extreme sensitivities inherent with NAAT and the resulting potential for contamination. Gen-Probe, Incorporated is currently developing the TIGRIS DTS system which is the first system that not only automates NAAT procedures, but also provides extensive process control design features (such as: “Reagent Dispense Verification”), that confirm the assay result integrity. Both hardware and software design features will be reviewed to illustrate how process control can be implemented with systems capable of detecting less than 100 copies of nucleic acid target sequence in a clinical sample. 12:00 pm Wednesday, February 4 Clinical – Molecular Diagnostic Room C1 Zhili Lin Pediatrix Screening, Inc. 90 Emerson Lane, Suite 1403 Bridgeville, Pennsylvania 15017 zlin@neogenscreening.com 113 Co-Author(s) Joseph G. Suzow Jamie M. Fontaine Edwin W. Naylor Primary DNA-based Newborn Screening of Sickle Cell Disease and Hemoglobinopathy For a population-based newborn screening program, challenges exist in using technological advances to improve the quality and efficiency of the existing screening program and to develop new diagnostic capabilities. A newly developed genotyping method for screening of common mutations within the beta-globin gene is described here. This genotyping system consists of three major components: an automation system for high throughput DNA extraction and PCR setup, a conventional thermal cycler, and a LightTyper instrument for post-PCR melting temperature analysis. Briefly, genomic DNA is extracted from dried blood on a filter paper using the common chemicals methanol and Tris buffer. Genetic fragments of interest are amplified by asymmetric PCR. Fluorescent labeled probes are added during PCR setup, which eliminates the need for any post-PCR sample handling process. Melting temperature analysis is achieved through fluorescent resonance energy transfer (FRET) reaction using the LightTyper instrument. The assay is designed to simultaneously detect three common beta-globin mutations, S(A173T), C(G172A), and E(G232A), and can identify any of the eight possible genotypes in a single reaction: AA, AE, EE, AS, SC, SS, AC, and CC (A represents wild type allele). The method was validated with a large number of samples in both a retrospective and parallel study. Results were compared to those obtained by isoelectric focusing electrophoresis. The accuracy of this genotyping method is greater than 99%. PODIUM ABSTRACTS

10:30 am Wednesday, February 4 Clinical – Molecular Diagnostic Room C1<br />

Guido Baechler<br />

Roche Molecular Systems<br />

4300 Hacienda Drive<br />

Pleasanton, Cali<strong>for</strong>nia 94566<br />

guido.baechler@roche.com<br />

NAT Aut<strong>omation</strong> – Enabling Trans<strong>for</strong>mation of Molecular Technology From Research to IVD<br />

Today, nucleic acid testing (NAT) is mainly per<strong>for</strong>med in highly technical labs. Less than 6.5% of the hospital based<br />

clinical diagnostic labs worldwide per<strong>for</strong>m NAT. Some of the key factors that prevent a wider utilization of NAT<br />

technology include the highly technical skill level required, the need <strong>for</strong> additional, dedicated laboratory space <strong>and</strong><br />

the need to acquire additional equipment. Appropriate aut<strong>omation</strong> will serve to overcome the technical hurdles<br />

while helping to solve the economic hurdles <strong>for</strong> wider utilization of NAT in the marketplace.“NAT Aut<strong>omation</strong> –<br />

Enabling trans<strong>for</strong>mation of molecular technology from Research to IVD” will introduce you to the current market<br />

trends in NAT testing, outline key economic drivers <strong>and</strong> the opportunity <strong>for</strong> aut<strong>omation</strong>. The presentation will focus<br />

on the laboratory requirements needed to per<strong>for</strong>m NAT testing <strong>and</strong> how Roche Diagnostics has overcome the<br />

challenges of aut<strong>omation</strong> to enable a wider utilization of the NAT technology.<br />

11:00 am Wednesday, February 4 Clinical – Molecular Diagnostic Room C1<br />

Hasnah Hamdan<br />

Quest Diagnostics Nichols Institute<br />

33608 Ortega Highway<br />

San Juan Capistrano, Cali<strong>for</strong>nia 92690<br />

hamdanh@questdiagnostics.com<br />

High Throughput Molecular Infectious Diseases Tests in the Routine Clinical <strong>Laboratory</strong><br />

Environment<br />

Molecular tests <strong>for</strong> infectious diseases require extraction <strong>and</strong> amplification of nucleic acid <strong>and</strong> detection of<br />

amplified products. Numerous factors must be considered when automating nucleic acid tests (NATs) <strong>for</strong> the<br />

clinical laboratory: types of infectious agents, types of specimens, h<strong>and</strong>ling <strong>and</strong> exposure to infectious material,<br />

contamination control, <strong>and</strong> use of different amplification methods. Currently, only a few NATs have been FDA<br />

cleared <strong>for</strong> infectious diseases. Moreover, these tests are either not automated or only semi-automated. Most<br />

existing aut<strong>omation</strong> systems <strong>for</strong> infectious disease NATs are <strong>for</strong> the amplification <strong>and</strong> detection processes; limited<br />

aut<strong>omation</strong> is available <strong>for</strong> nucleic acid extraction, which is the most labor-intensive <strong>and</strong> challenging of all the<br />

processes in NATs. Some solutions <strong>for</strong> automating NATs <strong>for</strong> the infectious disease laboratory will be presented.<br />

112

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