Aug
11
Written by:
Emily Sherman
8/11/2010 11:22 AM
SeraCare Life Sciences Develops New Diagnostic Control Products for Sexually Transmitted Infections
Molecular diagnostic controls optimized for commercial nucleic acid testing platforms
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MILFORD, Mass., Aug 05, 2010 (BUSINESS WIRE) --
SeraCare Life Sciences, Inc. (NASDAQ: SRLS) today announced that the Company has developed a new series of controls in its ACCURUN portfolio to monitor and validate molecular diagnostic test performance for detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). Through collaboration with instrument and reagent manufacturers, SeraCare has optimized the ACCURUN 341 Nucleic Acid Positive controls specifically for use with the three most popular assays currently on the market; the Gen-Probe APTIMA Combo 2(R) Assay, the Roche COBAS(R) AMPLICOR CT/NG Test, and the Becton, Dickinson BD ProbeTec(TM) ET System.
"SeraCare has again set itself apart from other controls suppliers by offering whole cell, independent controls that challenge test kit reagents, analyzers and test procedures to achieve high quality standards," said Susan Vogt, President and CEO of SeraCare. "The use of assay specific controls ensures optimal diagnostic performance. In addition, the controls for the Gen-Probe and BD assays are packaged in platform-compatible vials which can be placed directly on the manufacturers' automated test platforms, minimizing processing time and the risk of adventitious contamination. We believe this suite of controls offers clinical diagnostic laboratories the means to ensure high quality and achieve new standards in testing for sexually transmitted infections."
The ACCURUN 341 Nucleic Acid Positive controls for CT/NG are derived from cultured Chlamydia trachomatis and Neisseria gonorrhoeae and closely simulate an actual patient sample, challenging every stage of the assay from sample extraction through amplification and detection. ACCURUN controls are rigorously tested and manufactured in ISO 9001 and 13485 certified facilities. SeraCare's complete catalog of diagnostic controls, plasma-derived reagents and molecular biomarkers is available online at www.seracarecatalog.com.
About SeraCare Life Sciences, Inc.:
SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics. The Company's innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking and contract research services. SeraCare's quality systems, scientific expertise and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry.
Forward-Looking Statements:
This press release contains disclosures that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about SeraCare Life Sciences, Inc. ("SeraCare" or the "Company"). All statements regarding our expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budget, projected costs or cost savings, capital expenditures, competitive positions, growth opportunities for existing products or products under development, plans and objectives of management for future operations and markets for stock are forward-looking statements. In addition, forward-looking statements include statements in which we use words such as "expect," "believe," "anticipate," "intend," or similar expressions. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, we cannot assure you that these expectations will prove to have been correct, and actual results may differ materially from those reflected in the forward-looking statements. Factors that could cause our actual results to differ from the expectations reflected in the forward-looking statements in this press release include, but are not limited to, failure to maintain proper inventory levels, availability of financing, reductions or terminations of government or other contracts, interruption in our supply of products or raw materials, actions of SeraCare's competitors and changes in the regulatory environment. Many of these factors are beyond our ability to control or predict.
SOURCE: SeraCare Life Sciences, Inc. http://www.seracare.com/InvestorCenter/PressReleases/tabid/124/Default.aspx
SeraCare Life Sciences, Inc.Gregory A. Gould, 508-244-6400Chief Financial OfficerorMacDougall Biomedical CommunicationsSarah Cavanaugh, 781-235-3060
Neisseria gonorrhoeae Wiki
Neisseria gonorrhoeae, also known as gonococci (plural), or gonococcus (singular), is a species of Gram-negative coffee bean-shaped diplococci bacteria responsible for the sexually transmitted infection gonorrhea.[1]
N. gonorrhoea was first described by Albert Neisser in 1879.
[edit] Microbiology
Neisseria are fastidious Gram-negative cocci that require nutrient supplementation to grow in laboratory cultures. Specifically, they grow on chocolate agar with carbon dioxide. These cocci are facultatively intracellular and typically appear in pairs (diplococci), in the shape of coffee beans. Of the eleven species of Neisseria that colonize humans, only two are pathogens. N. gonorrhoeae is the causative agent of gonorrhoea and is transmitted via sexual contact.[2]
Neisseria is usually isolated on Thayer-Martin agar—an agar plate containing antibiotics (Vancomycin, Colistin, Nystatin, and SXT) and nutrients that facilitate the growth of Neisseria species while inhibiting the growth of contaminating bacteria and fungi. Further testing to differentiate the species includes testing for oxidase (all clinically relevant Neisseria show a positive reaction) and the carbohydrates maltose, sucrose, and glucose test in which N. gonorrhoeae will only oxidize (that is, utilize) the glucose.
N. gonorrhoeae are non-motile and possess a type IV pilus to adhere to surfaces. The type IV pilus operates mechanistically similar to a grappling hook. The pilus extends from the pole of the cell and attaches to a substrate which signals the pilus to retract, dragging the cell forward. N. gonorrhoeae are able to pull 100,000 times their own weight and it has been claimed that the pili used to do so are the strongest biological motor known to date, exerting one nanonewton.[3]
[edit] Disease
Symptoms of infection with N. gonorrhoeae differ depending on the site of infection.
Infection of the genitals can result in a purulent (or pus-like) discharge from the genitals which may be foul smelling. Symptoms may include inflammation, redness, swelling, dysuria and a burning sensation during urination.
N. gonorrhoeae can also cause conjunctivitis, pharyngitis, proctitis or urethritis, prostatitis and orchitis.
Conjunctivitis is common in neonates, and silver nitrate or antibiotics are often applied to their eyes as a preventive measure against gonorrhoea. Neonatal gonorrheal conjunctivitis is contracted when the infant is exposed to N. gonorrhoeae in the birth canal and can lead to corneal scarring or perforation, resulting in blindness in the neonate.
Disseminated N. gonorrhoeae infections can occur, resulting in endocarditis, meningitis or gonococcal dermatitis-arthritis syndrome. Dermatitis-arthritis syndrome presents with arthralgia, tenosynovitis and painless non-pruritic (non-itchy) dermatitis.
Infection of the genitals in females with N. gonorrhoeae can result in pelvic inflammatory disease if left untreated, which can result in infertility. Pelvic inflammatory disease results if N. gonorrhoeae travels into the pelvic peritoneum (via the cervix, endometrium and fallopian tubes).
[edit] Treatment and Prevention
If N. gonorrhoeae is resistant to the penicillin family of antibiotics, then ceftriaxone (a third-generation cephalosporin) is often used. Sexual partners should also be notified and treated.
Patients should also be tested for other sexually transmitted infections, especially Chlamydia infections, since co-infection is frequent.
Transmission can be reduced by the usage of condoms during intercourse and oral sex and limiting sexual partners.
[edit] See also
[edit] References
[edit] External links
Chlamydia trachomatis Wiki
Chlamydia trachomatis, an obligate intracellular human pathogen, is one of three bacterial species in the genus Chlamydia.[1] C. trachomatis is Gram-indeterminate (i.e., cannot be stained with the Gram stain); structurally the organism is Gram-negative.[2] Identified in 1907, C. trachomatis was the first chlamydial agent discovered in humans.[3]
C. trachomatis includes three human biovars: trachoma (serovars A, B, Ba or C), urethritis (serovars D-K), and lymphogranuloma venereum (LGV, serovars L1, 2 and 3).[4] Many, but not all, C. trachomatis strains have an extrachromosomal plasmid.[5][edit] Identification
Chlamydia species are readily identified and distinguished from other chlamydial species using DNA-based tests.
Most strains of C. trachomatis are recognized by monoclonal antibodies (mAbs) to epitopes in the VS4 region of MOMP.[6] However, these mAbs may also cross-react with two other Chlamydia species, C. suis and C. muridarum.
[edit] Life cycle
[edit] Clinical significance
C. trachomatis is an obligate intracellular pathogen (i.e. the bacterium lives within human cells) and can cause numerous disease states in both men and women.[1] Both sexes can display urethritis, proctitis (rectal disease and bleeding), trachoma, and infertility. The bacterium can cause prostatitis and epididymitis in men. In women, cervicitis, pelvic inflammatory disease (PID), ectopic pregnancy, and acute or chronic pelvic pain are frequent complications. C. trachomatis is also an important neonatal pathogen, where it can lead to infections of the eye (trachoma) and pulmonary complications.
[edit] Treatment
C. trachomatis may be treated with any of several antibiotics: azithromycin, erythromycin or doxycycline/tetracycline.[7]
[edit] See also
[edit] References
- ^ a b Ryan KJ, Ray CG (editors) (2004). Sherris Medical Microbiology (4th ed.). McGraw Hill. pp. 463–70. ISBN 0838585299.
- ^ Kenyon College - Dept. of Biology (2006-08-15). "Chlamydia". MicrobeWiki. http://microbewiki.kenyon.edu/index.php/Chlamydia. Retrieved 2008-10-27.
- ^ Budai I (March 2007). "Chlamydia trachomatis: milestones in clinical and microbiological diagnostics in the last hundred years: a review". Acta microbiologica et immunologica Hungarica 54 (1): 5–22. doi:10.1556/AMicr.54.2007.1.2. PMID 17523388.
- ^ Fredlund H, Falk L, Jurstrand M, Unemo M (2004). "Molecular genetic methods for diagnosis and characterisation of Chlamydia trachomatis and Neisseria gonorrhoeae: impact on epidemiological surveillance and interventions". APMIS : acta pathologica, microbiologica, et immunologica Scandinavica 112 (11-12): 771–84. doi:10.1111/j.1600-0463.2004.apm11211-1205.x. PMID 15638837. http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=0903-4641&date=2004&volume=112&issue=11-12&spage=771.
- ^ Carlson JH, Whitmire WM, Crane DD, et al. (June 2008). "The Chlamydia trachomatis plasmid is a transcriptional regulator of chromosomal genes and a virulence factor". Infection and immunity 76 (6): 2273–83. doi:10.1128/IAI.00102-08. PMID 18347045. PMC 2423098. http://iai.asm.org/cgi/pmidlookup?view=long&pmid=18347045.
- ^ Ortiz L, Angevine M, Kim SK, Watkins D, DeMars R (2000). "T-cell epitopes in variable segments of Chlamydia trachomatis major outer membrane protein elicit serovar-specific immune responses in infected humans". Infect. Immun. 68 (3): 1719–23. doi:10.1128/IAI.68.3.1719-1723.2000. PMID 10678996.
- ^ Chlamydia Information
[edit] External links