AME Certified PCR Laboratories, LLC
Featuring the SmartCycler DNA Analyzer
- We offer Certified Testing of food production facilities employing established PCR (DNA) testing technology
- Absolutely the most efficient testing station mobilization in the food production vertical
- AME can support your current program or develop a cutting-edge testing programs
- Validate current program control points
- On-site training for your team members with certification available
- AME provides parts, equipment, accessories and maintains SmartCycler I and II thermocycler units
PCR LABORATORY TESTING
- We can support your facility to sample test your samples at our lab
- Certificate of Analysis (COA) delivered within 24-48 hours
- Environmental and Water sampling
- Affordable, dependable results
- Assistance with developing and certifying an in-house lab testing st
- We can build or advise on your Environmental Safety Program
IN-HOUSE testing station SETUP
- AME is prepared to set up a lab in your facility so you can conduct your own testing with your own team members
- We are prepared to lease the necessary equipment, provide all consumables, train your team members, and certify your staff members to collect and run test samples in international quality standards.
Leasing AND REPAIR OF Cepheid SMARTCYCLER DNA analyzerS
- Cepheid Smartcycler DNA Analyzer
- 2.0d software availabile
- Customized PC System Pre-Loaded with SmartCycler Software
LLNL/CEPHEID SMARTCYCLER DEVELOPMENT
Technology originally developed by Lawrence Livermore National Laboratories (LLNL)
Confirmatory diagnostic methods utilizing polymerase chain reaction (PCR) methodologies in tandem with innovative, state-of-the-art biosensor technologies.
Blakely, William & Brooks, Antone & Lofts, Richard & Schans, Govert & Voisin, Philippe. (2002). Overview of Low-Level Radiation Exposure Assessment: Biodosimetry. Military medicine. 167. 20-4. 10.1093/milmed/167.suppl_1.20.
Cepheid's battery-operated. notebook Smart Cycler, partially funded by U.S. Army Medical Research Institute of Infectious Diseases, which performs nucleic extraction and PCR assay in an integrated handheld device.. A schematic of a handheld biosensor, which is based on an optical waveguide design that detects changes in the relative refractive index of multiple biomatrix antibody/antigen complexes. The Sunnyvale company Cepheid, for example, used Lab technology to develop the Smart Cycler DNA testing system, which has been beneficial to the nation's anti-terrorism efforts. The system was part of the Livermore/LANL jointly developed Biological Aerosol Sentry and Information System (BASIS).
Michael L. Perdue "Molecular Diagnostics in an Insecure World," Avian Diseases 47(s3), 1063-1068, (1 September 2003). https://doi.org/10.1637/0005-2086-47.s3.1063
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Block I began fielding in 2006. JBAIDS is a fully integrated in vitro diagnostic system composed of the JBAIDS instrument with laptop computer, software, freeze-dried reagent assays and sample preparation protocols for isolating target DNA from whole blood, blood culture, or direct culture. The JBAIDS instrument, using Polymerase Chain Reaction (PCR) technology, is a portable thermocycler and real-time fluorimeter
https://irp.fas.org/threat/cbdp2007.pdf
Journal for the Association for Laboratory Automation. Volume 3, No.6, December 1998
https://journals.sagepub.com/doi/pdf/10.1177/221106829800300604
Cepheid Technology & US Food & Drug Administration
FDA's Mobile Laboratories
Mobile laboratories help FDA save time and quickly test food and drugs for contaminants.
April 8, 2009; Nogales, AZ – Working on-site with samples collected by FDA consumer safety officers from produce shipments crossing the border, an FDA mobile lab analyst tests for Salmonella and E. coli. Mobile laboratories help FDA quickly test food and drugs for contaminants. When not deployed, the mobile labs are stationed at FDA's Jefferson, Arkansas Regional Laboratory. Learn more at www.fda.gov
https://www.flickr.com/photos/fdaphotos/albums/72157625637329385
SmartCycler on-board the International Space Station
Cepheid SmartCycler on the ISS
ISS047e066248 (04/19/2016)
NASA astronaut and Expedition 47 flight engineer Jeff Williams works with the Wet Lab RNA SmartCycler on-board the International Space Station. Wetlab RNA SmartCycler is a research platform for conducting real-time quantitative gene expression analysis aboard the ISS. The system enables spaceflight genomic studies involving a wide variety of biospecimen types in the unique microgravity environment of space.
Gene Expression Analysis in a Microgravity Environment
https://ntrs.nasa.gov/citations/20150018249
https://www.flickr.com/photos/nasa2explore/25941659244/in/photolist-FwnMuY/
Toward biotechnology in space: High-throughput instruments for in situ biological research beyond Earth
Validation of the International Space Station Smart Sample Concentrator for Microbial Monitoring of Low Biomass Water Samples
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7566613/
WetLab-2 employs a standard method of measuring gene expression called Quantitative Polymerase Chain Reaction, or qPCR, which involves extracting certain types of ribonucleic acid (RNA) molecules from biological samples and then measuring the amounts extracted.
https://www.nasa.gov/mission_pages/station/research/news/wet_lab2
NASA astronaut and Expedition 47 Flight Engineer Jeff Williams works with the Wet Lab RNA SmartCycler on-board the International Space Station. Wetlab RNA SmartCycler is a research platform for conducting real-time quantitative gene expression analysis aboard the ISS. The system enables spaceflight genomic studies involving a wide variety of biospecimen types in the unique microgravity environment of space.
https://spaceref.com/space-stations/nasa-international-space-station-on-orbit-status-19-april-2016/
SmartCycler-based RT PCR Leishmania assay
RT PCR Leishmania assay
The Leishmania Diagnostics Laboratory at Walter Reed Army Institute of Research (WRAIR) of the US Army has utilized the College of American Pathologists-certified SmartCycler-based RT PCR Leishmania assay for diagnosis of cutaneous leishmaniasis cases in theater, and efforts are ongoing to obtain U.S. FDA licensure for this product (Wortmann et al. 2005). A rapid diagnostic assay to detect scrub typhus in humans is in development.
https://apps.dtic.mil/sti/pdfs/ADA502972.pdf
Wortmann, G., L. Hochberg, H.-H. Houng, C. Sweeney, M. Zapor, N. Aronson, P. Weina, and C.F. Ockenhouse. 2005. Rapid identification of Leishmania complexes by a real-time PCR assay. Am. J. Trop. Med. Hyg. 73: 999- 1004.
US FDA BAM Chapter 4A: Diarrheagenic Escherichia coli
Screening method for E. coli STEC and Serotype O157:H7 from Foods
Food samples may be screened for O157:H7 using ....the SmartCycler II.
Escherichia coli is one of the predominant species of facultative anaerobes in the human gut and usually harmless to the host; however, a group of pathogenic E. coli has emerged that causes diarrheal disease in humans. Referred to as Diarrheagenic E. coli or commonly as pathogenic E. coli, these groups are classified based on their unique virulence factors and can only be identified by these traits. Hence, analysis for pathogenic E. coli often requires that the isolates be first identified as E. coli before testing for virulence markers [Enterohemorrhagic Escherichia coli (EHEC)].
The real-time PCR assay configured for the SmartCycler II platform, is specific for the stx1 and stx2 genes and the +93 single nucleotide polymorphism in the uidA gene that encode for the β-D-glucuronidase (GUD) enzyme (11). The +93 SNP is highly conserved in O157:H7 and O157:H- strains that produce Stx and is an accurate identification marker for O157:H7 strains. The stx1 and stx2 markers on the real-time PCR assays also enabled the detection of other STEC strains, some of which are known human pathogens
https://www.fda.gov/food/laboratory-methods-food/bam-chapter-4a-diarrheagenic-escherichia-coli