APPLIED SCIENCES
Founded in 2007, BioGX’s core focus included the development of molecular diagnostics panels for Food Safety, Water Quality and Pharmaceutical Quality Control. Since then, the company has established itself as a leader in this field, holding one of the largest portfolios of infectious disease panels worldwide.
WATER QUALITY
The BioGX Sample-Ready™ technology, one-tube reagent approach is available for ruminant and porcine origin confirmation for food, pharmaceutical and drinking water safety.
Cattle Feed Contamination
BioGX offers a unique reagent that detects ruminant DNA (bovine, caprine, and ovine) in cattle feed. This reagent has been independently evaluated using very strict performance criteria and was recently converted to the BioGX Sample-Ready™ lyophilized format. The reagent is now utilized as part of an official method in many government laboratories, including the US FDA. Note: this reagent has only been validated on the Cepheid SmartCycler II.
BioGX Ruminant DNA Panel
YLM Ruminant DNA Dual Probe, IAC.
Product #204-0003
Duplex panel
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Background and Pubs
Background
The US FDA and many regulatory agencies outside of the USA have implemented a ban on the use of most mammalian protein in feeds for ruminant animals in order to prevent the establishment and spread of BSE through animal feed.
Publication Reference
Development of a Multiplex Real-Time PCR Assay for the Detection of Ruminant DNA
Authors: Ekins, Jason1; Peters, Sharla M.1; Jones, Yolanda L.1; Swaim, Heidi1; Ha, Tai2; La Neve, Fabio3; Civera, Tiziana3; Blackstone, George4; Vickery, Michael C.L.4; Marion, Bill4; Myers, Michael J.1; Yancy, Haile F.5
Source: Journal of Food Protection®, Volume 75, Number 6, June 2012 , pp. 1107-1112(6) Publisher: International Association for Food Protection
Affiliations: 1: U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, 8401 Muirkirk Road, Laurel, Maryland 20708, USA 2: Nebraska Department of Agriculture, 301 Centennial Mall South, Lincoln, Nebraska 68508, USA 3: Department of Animal Pathology, Faculty of Veterinary Medicine, University of Torino, via Leonardo da Vinci 44, 10095 Grugliasco, Torino, Italy 4: BioGX, Inc., 1500 1st Avenue North, Unit # 34, Birmingham, Alabama 35203, USA 5: U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, 8401 Muirkirk Road, Laurel, Maryland 20708, USA. haile.yancy@fda.hhs.gov
Abstract: The U.S. Food and Drug Administration (FDA) has previously validated a real-time PCR-based assay that is currently being used by the FDA and several state laboratories as the official screening method. Due to several shortcomings to the assay, a multiplex real-time PCR assay (MRTA) to detect three ruminant species (bovine, caprine, and ovine) was developed using a lyophilized bead design. The assay contained two primer or probe sets: a “ruminant” set to detect bovine-, caprine-, and ovine-derived materials and a second set to serve as an internal PCR control, formatted using a lyophilized bead design. Performance of the assay was evaluated against stringent acceptance criteria developed by the FDA’s Center for Veterinary Medicine’s Office of Research. The MRTA for the detection of ruminant DNA passed the stringent acceptance criteria for specificity, sensitivity, and selectivity. The assay met sensitivity and reproducibility requirements by detecting 30 of 30 complete feed samples fortified with meals at 0.1% (wt/wt) rendered material from each of the three ruminant species. The MRTA demonstrated 100% selectivity (0.0% false positives) for negative controls throughout the assessment period. The assay showed ruggedness in both sample selection and reagent preparation. Second and third analyst trials confirmed the quality of the written standard operating procedure with consistency of results. An external laboratory participating in a peer-verification trial demonstrated 100% specificity in identifying bovine meat and bone meal, while exhibiting a 0.03% rate of false positives. The assay demonstrated equal levels of sensitivity and reproducibility compared with the FDA’s current validated real-time PCR assay. The assay detected three prohibited species in less than 1.5 h of total assay time, a significant improvement over the current real-time assay. These results demonstrated this assay’s suitability for routine regulatory use both as a primary screening tool and as a confirmatory analysis.
Shellfish Testing
BioGX offers Internal Amplification Control (IAC) DNA for use with multiplex PCR tests (including FDA Vibrio parahaemolyticus testing). This product may be adapted for use on any real-time PCR instrument platform. This product is shipped frozen in liquid format.
BioGX Internal Amplification Control (IAC) DNA
BioGX Internal Amplification Control (IAC) DNA -1,000 reactions
Product # 760-0001 (1,000 reactions)
Packaging: 1000 reactions* [250 reactions/tube; 4 tubes]
* estimated when properly diluted and utilized to a concentration to produce a Ct of approx. 20 in qPCR.
BioGX Internal Amplification Control (IAC) DNA -250 reactions
Product # 760-0001 (250 reactions)
Packaging: 250 reactions* [250 reactions/tube; 1 tube]
* estimated when properly diluted and utilized to a concentration to produce a Ct of approx. 20 in qPCR.
Produce Analysis
BioGX offers Produce Analysis assays that may be adapted to virtually any real-time PCR instrument platform. Most reagents are available Sample-Ready™ lyophilized. Just add water, sample and start run.
To address customer needs, BioGX offers customization of formulations that include:
- Number of reactions per tube range from 1-60.
- Packaging formats can designed to fit customer needs.
- Instrument designations customized to meet the analysis needs of our customers.
BioGX Multiplex Panels
Campylobacter, Shigella, Salmonella, IAC.
Product #202-0032
4-plex panel
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Meat Analysis
BioGX offers Meat Analysis assays that may be adapted to virtually any real-time PCR instrument platform. Most reagents are available Sample-Ready™ lyophilized. Just add water, sample and start run.
To address customer needs, BioGX offers customization of formulations that include:
- Number of reactions per tube range from 1-60.
- Packaging formats can designed to fit customer needs.
- Instrument designations customized to meet the analysis needs of our customers.
Please Note: Reagents listed below without part numbers are available for custom order Individually or in Multiplexed combinations.
- Avian Influenza
- Norovirus GI/GII
- Campylobacter
- Legionella
- Mycoplasma
- Pseudomonas aeruginosa
- Shigella
- Vibrio parahaemolyticus (tl, tdh, trh)
- Vibrio vulnificus
BioGX Multiplex Panels
E. coli stx1, stx2, O157:H7 (proprietary BioGX target), IAC.
Product #202-0023
4-plex panel
Packaging: 48 Sample-Ready™ reagents [1 reaction/tube, 16 tubes/pouch, 3 pouches]
E. coli stx1, stx2, eae (intimin), IAC.
Product #202-0024
4-plex panel
Packaging: 48 Sample-Ready™ reagents [1 reaction/tube, 16 tubes/pouch, 3 pouches]
E. coli stx1/stx2 (combined in same channel), eae (intimin), O157:H7 (proprietary BioGX target), IAC.
Product #202-0030
4-plex panel
Packaging: 48 Sample-Ready™ reagents [1 reaction/tube, 16 tubes/pouch, 3 pouches]
Campylobacter, Shigella, Salmonella, IAC.
Product #202-0032
4-plex panel
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
BioGX Single Target Reagents
E. coli species plus IAC.
Product #201-0025ic
Duplex panel
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Listeria species plus IAC.
Product #202-0003
Duplex panel
Standard Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Listeria monocytogenes plus IAC.
Product #202-0033
Duplex panel
Standard Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Drinking Water
BioGX offers Drinking Water assays that may be adapted to virtually any real-time PCR instrument platform. Most reagents are available Sample-Ready™ lyophilized. Just add water, sample and start run.
To address customer needs, BioGX offers customization of formulations that include:
- Number of reactions per tube range from 1 – 60
- Packaging formats can be designed to fit customer needs
- Instrument designations customized to meet the analysis needs of our customers
Drinking Water Analysis
Total Coliform plus IAC
Product #201-0030
Contains one pouch each of 201-0030A and 201-0030B. Each pouch contains 10 tubes of 5 reactions each. To be used in parallel for 50 samples. Tests for Total Coliform (bdg gene of Citrobacter freundii, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, and Klebsiella oxytoca) and includes an internal amplification control (IAC)
Source Tracking
BioGX offers Source Tracking assays that may be adapted to virtually any real-time PCR instrument platform. Most reagents are available Sample-Ready™ lyophilized. Just add water, sample and start run.
To address customer needs, BioGX offers customization of formulations that include:
- Number of reactions per tube range from 1 – 60
- Packaging formats can be designed to fit customer needs
- Instrument designations customized to meet the analysis needs of our customers
Sewage Effluent Monitoring
Sewage Effluent Monitoring Description E. coli Species, no IAC.
Product #201-0025
Quantitative analysis
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
SKETA (Salmon Sperm Target), no IAC.
Product #201-0027
Quantitative calibrator
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Bacteroides spp. (available for custom order)
Custom order only
Recreational Water Analysis
BioGX offers Recreational Water Analysis assays that may be adapted to virtually any real-time PCR instrument platform. Most reagents are available Sample-Ready™ lyophilized. Just add water, sample and start run.
To address customer needs, BioGX offers customization of formulations that include:
- Number of reactions per tube range from 1 – 60
- Packaging formats can be designed to fit customer needs
- Instrument designations customized to meet the analysis needs of our customers
BioGX Beach Testing – Saltwater
Total Enterococcus, no IAC.
Product #201-0024*
Quantitative analysis
Packaging: 48 Sample-Ready™ reagents [8 reactions/tube, 6 tubes/pouch]
SKETA (Salmon Sperm Target), no IAC.
Product #201-0027
Quantitative calibrator
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Norovirus GI, GII, IAC.
Product #202-0011
Triplex panel
Packaging: 48 Sample-Ready™ reagents [16 reactions/tube, 3 tubes/pouch]
BioGX Beach Testing – Freshwater
E. coli Species, no IAC.
Product #201-0025
Quantitative analysis
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
SKETA (Salmon Sperm Target), no IAC.
Product #201-0027
Quantitative calibrator
Packaging: 48 Sample-Ready™ reagents [4 reactions/tube, 12 tubes/pouch]
Norovirus GI, GII, IAC.
Product #202-0011
Triplex panel
Packaging: 48 Sample-Ready™ reagents [16 reactions/tube, 3 tubes/pouch]
Heparin Contamination
This novel real-time PCR-based reagent detects ruminant (bovine, caprine, and ovine) and porcine origin DNA. The US FDA recently released a protocol utilizing this reagent to identify ruminant DNA in pig-derived crude heparin. It has been independently evaluated using very strict performance criteria and was recently converted to BioGX’s easy to use Sample-Ready™ format. Note: this reagent has only been validated on the Cepheid SmartCycler II. Please Note: Due to the innovative nature of our products, new reagents are frequently being brought online. Please check our site regularly for the latest updates. BioGX Ruminant and Porcine DNA Panel
Ruminant DNA, Porcine DNA, IAC. Product #204-0002 4-plex panel (3 channels) Packaging: 48 Sample-Ready™ reagents [4 reactions per tube, 12 tubes per pouch]
Ruminant and Porcine DNA Panel Development Information
FDA Protocol Background
Visit the FDA’s site for the complete FDA protocol Background
FDA considers the presence of any non-porcine origin material (especially ruminant material) in heparin to render that drug adulterated. According to FDA, “the control of the animal origin of crude heparin is important to ensure the safety of drugs and devices that contain heparin and to protect public health.
Publication Reference
Development of a Multiplex Real-Time PCR Assay for the Detection of Ruminant DNA in Raw Materials used for Monitoring Crude Heparin for Quality
Authors: Sharla M. Peters1, Yolanda L. Jones1, Frank Perrella2, Tai Ha3, and Haile F. Yancy1
Affiliations: 1U. S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, 8401 Muirkirk Road, Laurel, Maryland 20708, USA. 2U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, Silver Spring, MD 20993, USA. 3Nebraska Department of Agriculture, 301 Centennial Mall South, Lincoln, Nebraska 68508, USA.
Abstract: A real-time PCR assay was developed for the determination of ruminant material in porcine-derived crude heparin products. The assay consists of a bead format with lyophilized primers and probe sets that identify ruminant (bovine, ovine, caprine) and porcine material and also contain an internal amplification control. The assay was verified by two analysts: the first located at the FDA and the second at an independent State laboratory. Performance of the assay was evaluated against stringent acceptance criteria developed by the U.S. FDA’s Center for Veterinary Medicine’s Office of Research. The heparin Multiplex Real-Time Assay (hMRTA) for the detection of ruminant DNA in porcine crude heparin passed the stringent acceptance criteria for specificity, sensitivity, and selectivity. The assay met sensitivity and reproducibility requirements previously established by the multiplex real-time PCR assay (MRTA) for detection of ruminant animal material in feed. The hMRTA, when used in porcine crude heparin, exhibited 98% sensitivity, 98% true positives, 2% false negatives. This multiplex PCR-based assay detects three ruminant species, verifies porcine origin and could be used as a screening tool or as a confirmatory assay. It is capable of providing additional assurances of crude heparin quality and will help to identify and control the species origin of the heparin supply. The control of the animal origin of crude heparin is important to ensure the safety of drugs and devices that contain heparin and to protect public health.
Please also refer to FDA’s Draft Guidance for Industry, titled: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality. CLICK HERE for link to document.
Ruminant and Porcine Origin Information
This novel real-time PCR-based reagents detects ruminant (bovine, caprine, and ovine) and porcine origin DNA. The US FDA recently released a protocol utilizing this reagent to identify ruminant DNA in pig-derived crude heparin. It has been independently evaluated using very strict performance criteria and was recently converted to BioGX’s easy to use Sample-Ready™ format.
BioGX Ruminant and Porcine DNA Panel
Ruminant DNA, Porcine DNA, IAC.
Product 204-0002
4-plex panel (3 channels)
Packaging: 48 Sample-Ready™ reagents [4 reactions per tube, 12 tubes per pouch]
Instrumentation: Currently validated only on the Cepheid SmartCycler II
FDA Protocol Background
Visit the FDA’s website for complete protocol Background
FDA considers the presence of any non-porcine origin material (especially ruminant material) in heparin to render that drug adulterated. According to FDA, “the control of the animal origin of crude heparin is important to ensure the safety of drugs and devices that contain heparin and to protect public health.
Publication Reference
Development of a Multiplex Real-Time PCR Assay for the Detection of Ruminant DNA in Raw Materials used for Monitoring Crude Heparin for Quality
Authors: Sharla M. Peters1, Yolanda L. Jones1, Frank Perrella2, Tai Ha3, and Haile F. Yancy1
Affiliations: 1U. S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, 8401 Muirkirk Road, Laurel, Maryland 20708, USA. 2U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, Silver Spring, MD 20993, USA. 3Nebraska Department of Agriculture, 301 Centennial Mall South, Lincoln, Nebraska 68508, USA.
Abstract: A real-time PCR assay was developed for the determination of ruminant material in porcine-derived crude heparin products. The assay consists of a bead format with lyophilized primers and probe sets that identify ruminant (bovine, ovine, caprine) and porcine material and also contain an internal amplification control. The assay was verified by two analysts: the first located at the FDA and the second at an independent State laboratory. Performance of the assay was evaluated against stringent acceptance criteria developed by the U.S. FDA’s Center for Veterinary Medicine’s Office of Research. The heparin Multiplex Real-Time Assay (hMRTA) for the detection of ruminant DNA in porcine crude heparin passed the stringent acceptance criteria for specificity, sensitivity, and selectivity. The assay met sensitivity and reproducibility requirements previously established by the multiplex real-time PCR assay (MRTA) for detection of ruminant animal material in feed. The hMRTA, when used in porcine crude heparin, exhibited 98% sensitivity, 98% true positives, 2% false negatives. This multiplex PCR-based assay detects three ruminant species, verifies porcine origin and could be used as a screening tool or as a confirmatory assay. It is capable of providing additional assurances of crude heparin quality and will help to identify and control the species origin of the heparin supply. The control of the animal origin of crude heparin is important to ensure the safety of drugs and devices that contain heparin and to protect public health.
Please also refer to FDA’s Draft Guidance for Industry, titled: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality. CLICK HERE for link to document.
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