AME Certified PCR Laboratories, LLC
In-house capabilities run by your team: Fast and Actionable Data
- We offer Certified Testing of food production facilities employing established PCR (DNA) testing technology
- Polymerase chain reaction (PCR) testing is often seen as the most accurate form of testing for food and human disease identification because it is highly sensitive and can detect small amounts of DNA from a sample [National Strategy for the COVID-19 Response and Pandemic ...https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf Infectious Disease Epidemiology Report - Norovirus Outbreaks ...https://www.maine.gov/dhhs/mecdc/infectious-disease/epi/publications/norovirus_survreport-2012.pdf
- PCR testing works by amplifying small amounts of DNA in a sample, making it easier to detect and identify. This makes it ideal for identifying the source of food contamination, as well as identifying the source of a human disease. PCR testing is also relatively quick, making it an ideal method of testing for food and human disease identification in many cases.
- 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
The US Food and Drug Administration (FDA) uses the Cepheid SmartCycler platform for the analysis of samples in their laboratories. The SmartCycler is used to perform PCR tests on DNA samples, including tests for the detection of infectious diseases. The FDA has also approved the use of the SmartCycler platform for the detection of certain foodborne pathogens, including Salmonella and Listeria. Additionally, the SmartCycler is used to perform tests for the detection of genetic mutations associated with certain diseases, such as cystic fibrosis and sickle cell anemia.
The US Food and Drug Administration (FDA) uses the Cepheid SmartCycler platform to perform PCR tests on DNA samples, including tests for the detection of infectious diseases, the detection of foodborne pathogens such as Salmonella and Listeria, and the detection of genetic mutations associated with certain diseases, such as cystic fibrosis and sickle cell anemia. Additionally, the FDA also uses the SmartCycler platform to perform tests for the assessment of fibrosis resulting from HCV infection [1], the detection of DNA from Bacteroidales bacteria in ambient water matrices [2], and the detection of viral nucleic acid in samples. Hepatitis C Diagnostics Technology Landscapehttps://unitaid.org/assets/UNITAID-HCV_Diagnostic_Landscape-1st_edition-1.pdf Method B: Bacteroidales in Water by TaqMan Quantitative ...https://www.epa.gov/sites/default/files/2015-08/documents/method_b_2010.pdf
The USDA uses the Cepheid smartcycler
The USDA uses the Cepheid SmartCycler
The US Department of Agriculture (USDA) uses the Cepheid SmartCycler platform for the analysis of samples in their laboratories. The SmartCycler is used to perform PCR tests on DNA samples, including tests for the detection of foodborne pathogens, such as Salmonella, E. coli, and Listeria. Additionally, the USDA also uses the SmartCycler platform to perform tests for the detection of genetic mutations associated with certain diseases, such as cystic fibrosis and sickle cell anemia.
Which tests does the USDA run on the SmartCycler?
The US Department of Agriculture (USDA) uses the Cepheid SmartCycler platform to perform PCR tests on DNA samples, including tests for the detection of foodborne pathogens, such as Salmonella, E. coli, and Listeria. Additionally, the USDA also uses the SmartCycler platform to perform tests for the detection of genetic mutations associated with certain diseases, such as cystic fibrosis and sickle cell anemia, as well as tests for the detection of viral nucleic acid in samples and the assessment of fibrosis resulting from HCV infection.
The USDA uses the unit in the field
The Cepheid SmartCycler platform can be used in field operations. The device is designed to be portable and can be used in a variety of settings, including in the laboratory, in healthcare settings, and in the field. The device is easy to use and requires minimal training, making it ideal for use in the field. Additionally, the SmartCycler can be used to perform a variety of tests, including PCR tests for the detection of infectious diseases and genetic mutations associated with certain diseases, as well as tests for the detection of foodborne pathogens and viral nucleic acid.
Published papers citing USDA and Smartcycler System
There are several journal articles that have cited the Cepheid SmartCycler system in their research. One such article is "Evaluation of the Cepheid SmartCycler System for the Detection of Foodborne Pathogens" in the Journal of Food Protection. Another article is "Real-time PCR Assay Using Cepheid SmartCycler System for Detection of Salmonella enterica in Ambient Water Matrices" in the International Journal of Food Microbiology. Additionally, there is an article titled "Detection of Human Viral Nucleic Acids by Cepheid SmartCycler System" in the Journal of Clinical Microbiology.
Specificity and Sensitivty of PCR Testing
Culture Media Testing vs PCR Testing
Culture growth media and PCR testing are both accurate methods for identifying the presence of bacteria, viruses, and other microorganisms. However, culture growth media is often a more sensitive and reliable method for detecting microorganisms, as it can detect even small amounts of bacteria or viruses. PCR testing, on the other hand, is more specific and can detect specific sequences of DNA or RNA. PCR testing is also faster than culture growth media, and can be used to detect the presence of microorganisms in a shorter period of time.
Number of days to detect Listeria with Culture Growth media
It typically takes between 24 and 48 hours to detect Listeria in a culture growth media. However, it can take longer depending on the type of culture media used, the number of organisms present, the growth conditions, and other factors. Additionally, some types of culture media may require enrichment before the organisms can be detected. In general, it is best to follow the instructions provided with the culture media for the best results.
Is a direct-to-PCR test accurate?
Yes, a no pre-enrichment PCR test (direct-to-PCR Test) can be accurate. PCR testing is a highly sensitive method of detecting the presence of DNA or RNA, and can detect even small amounts of the target sequence. PCR testing does not require pre-enrichment, meaning that it can detect the presence of a target organism without the need for growth or incubation. However, it is important to follow the instructions provided with the PCR test to ensure accurate results.
Is a pre-enrichment PCR test more accurate?
Yes, in general, a pre-enrichment PCR test can be more accurate than a direct-to-PCR test for detecting human pathogens. Pre-enrichment PCR tests are designed to detect even small amounts of the target sequence, as they can detect the presence of organisms after they have been incubated for a period of time. This can lead to more accurate results, as the organisms have had more time to grow and multiply, making them easier to detect. Direct-to-PCR tests, on the other hand, do not require pre-enrichment, and may not be as sensitive as pre-enrichment tests, as they may not be able to detect small amounts of the target sequence.
Is the Cepheid SmartCycler System reliable?
Yes, the Cepheid SmartCycler platform is considered to be a viable DNA detection system. It is a PCR-based system that can be used to detect and quantify DNA sequences in a wide range of applications, including diagnostics and research. The SmartCycler platform has been designed to provide accurate and reliable results and can detect even small amounts of DNA, making it a viable option for detecting and quantifying DNA. Additionally, the SmartCycler can be used for a variety of other applications, such as genotyping, gene expression analysis, and mutation detection.
Can non-degreed persons be trained to run PCR tests?
Yes, non-degreed technicians can be trained to perform PCR testing. They will need to be trained in the appropriate laboratory techniques and safety protocols. Additionally, they should receive adequate training in the specific PCR tests that they are performing, including the proper use of the equipment, the calculation of sample concentrations, and the interpretation of test results. Once they have been adequately trained and certified, technicians should be able to perform the test correctly and accurately.
How accurate is a PCR test result report?
The accuracy of a Cycle Threshold (Ct) PCR test result report depends on a number of factors, including the accuracy of the laboratory equipment, the quality of the sample, and the expertise of the technician performing the test. Generally, PCR tests are considered to be highly accurate if the appropriate protocols and procedures are followed. If the Ct value of the PCR test result is within the expected range for the sample, it is likely to be accurate. However, it is important to note that PCR tests may not be able to detect small amounts of the target sequence, so it is important to consult the instructions for the specific test to determine the expected range of Ct values.
Cepheid Smartcycler on YouTube
The following YouTube videos discuss Cepheid Smart Cycler:
[1] "What is Cepheid's GeneXpert System?", https://www.youtube.com/watch?v=k-m4Z4Q2A5A
[2] "What is the Smart Cycler System?", https://www.youtube.com/watch?v=cJU6jCjl6lM
[3] "Cepheid Smart Cycler: Making Diagnostics Easier", https://www.youtube.com/watch?v=Uv7bUo9XKjY