SPECIAL NOTICE
B -- Ocular Toxoplasmosis Study Tests and Data
- Notice Date
- 6/2/2008
- Notice Type
- Special Notice
- NAICS
- 621112
— Offices of Physicians, Mental Health Specialists
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 00HCVHBC-2008-56278
- Archive Date
- 6/10/2008
- Point of Contact
- Linda M Young, Phone: (770) 488-2655
- E-Mail Address
-
lml3@cdc.gov
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Palo Alto Medical Foundation, Toxoplasma Serology Laboratory, 795 El Camino Real, Palo Alto, CA, 94301-2302, for an ocular toxoplasmosis study to determine the proportion of patients with toxoplasmic chorioretinitis who are infected post-natally (versus congenitally). The background for this study is as follows: Toxoplasma gondii is considered the most common etiologic agent of posterior uveitis in the United States (approximately 25%) and worldwide (up to 85%) [1, 2]. Toxoplasmic chorioretinitis can result in significant visual disturbances including clinically significant relapses and blindness [3-6]. Active chorioretinal lesions may result from congenital or postnatally acquired infection. In both of these situations, lesions may occur during the acute stage of the infection or as a relapse of the latent (chronic) phase of the infection. Retinal scars (asymptomatic latent infection) can be serendipitously observed on a routine ophthalmological exam or during the evaluation of other ocular pathology. Thus, ocular toxoplasmosis can occur in the setting of five different clinical scenarios: 1) chorioretinitis can be discovered at birth in a newborn congenitally infected with the parasite; 2) chorioretinitis may not be evident at birth but reactivation of congenital disease can occur later in life, usually between the ages of 10 to 30 years; 3) chorioretinitis can be manifested in association of an acute post-natally acquired infection. We and others have reported that this presentation usually occurs in individuals older than 50 years of age [7, 8]; 4) reactivation of a previous post-natally acquired infection; 5) an asymptomatic scar is incidentally discovered in a routine eye exam. In the first four clinical scenarios treatment may be indicated particularly when lesions threaten the macula or central vision whereas in patients without symptoms drug therapy is not offered. For many years the traditional view and teaching has been that the vast majority of patients with ocular toxoplasmosis were infected congenitally (clinical scenarios 1 and 2, see above) [1, 2]. Recently, investigators from Europe and the United States have reported a significant number of patients with eye disease associated with infection acquired post-natally, either accompanying the acute infection or reactivating a latent infection (clinical scenarios 3 and 4, see above) [7, 8]. T. gondii can occur in nature in three distinct genetic lineages (types I to III) which may identify clinically relevant biological differences. Type I or type I/III atypical strains appear to be responsible for most of the ocular disease reported in the literature [9, 10]. Recently, the CDC laboratory has optimized a novel technique that would allow to establish whether a patient is infected with type II vs type I/III strain of the parasite using only a serum sample [11]. A study attempting to establish how much of the ocular disease caused by T. gondii is due to the post-natal acquisition of the infection vs congenital and the type of parasite strain affecting acutely infected patients in the United States has not been attempted so far. Distinguishing between post-natally acquired vs congenital infection has major implications in establishing national priorities for disease prevention. [References: 1. Holland GN, O'Connor GR, Belfort Jr. R and Remington JS. Toxoplasmosis. In: Pepose JS, Holland GN and Wilhelmus KR, eds. Ocular Infection and Immunity. St. Louis: Mosby Yearbook Inc., 1996:1183-1223. 2. Holland GN. Ocular toxoplasmosis: a global reassessment. Part I: epidemiology and course of disease. Am J Ophthalmol 2003;136:973-88. 3. Soheilian M, Sadoughi MM, Ghajarnia M, et al. Prospective Randomized Trial of Trimethoprim/Sulfamethoxazole versus Pyrimethamine and Sulfadiazine in the Treatment of Ocular Toxoplasmosis. Ophthalmology 2005. 4. Blaise P, Comhaire Y and Rakic JM. Giant macular hole as an atypical consequence of a toxoplasmic chorioretinitis. Arch Ophthalmol 2005;123:863-4. 5. Okhravi N, Jones CD, Carroll N, Adamson P, Luthert P and Lightman S. Use of PCR to diagnose Toxoplasma gondii chorioretinitis in eyes with severe vitritis. Clin Experiment Ophthalmol 2005;33:184-7. 6. Holland GN. Ocular toxoplasmosis: a global reassessment. Part II: disease manifestations and management. Am J Ophthalmol 2004;137:1-17. 7. Couvreur J, Thulliez P. Acquired toxoplasmosis with ocular or neurologic involvement. Presse Med 1996;25:438-442. 8. Montoya JG, Remington JS. Toxoplasmic chorioretinitis in the setting of acute acquired toxoplasmosis. Clin Infect Dis 1996;23:277-282. 9. Vallochi AL, Muccioli C, Martins MC, Silveira C, Belfort R, Jr. and Rizzo LV. The genotype of Toxoplasma gondii strains causing ocular toxoplasmosis in humans in Brazil. Am J Ophthalmol 2005;139:350-1. 10. Grigg ME, Ganatra J, Boothroyd JC and Margolis TP. Unusual abundance of atypical strains associated with human ocular toxoplasmosis. J Infect Dis 2001;184:633-9. 11. Kong JT, Grigg ME, Uyetake L, Parmley S and Boothroyd JC. Serotyping of Toxoplasma gondii infections in humans using synthetic peptides. J Infect Dis 2003;187:1484-95.] The main aim of this study is to determine the proportion of patients with toxoplasmic chorioretinitis who present to different ophthalmology clinics or centers across the United States as a result of a post-natally acquired acute infection. The secondary purposes are as follows: 1. To establish whether important geographical differences exist in the United States in terms of proportion of patients presenting with ocular toxoplasmosis as a result of post-natally acquired disease. 2. To determine whether patients with ocular disease as a result of a recently acquired infection are parasitemic as measured by polymerase chain reaction. 3. To determine the serotype of the strain of T. gondii affecting patients in the United States with toxoplasmic chorioretinitis in the setting of acute infection. The scope of work is as follows: Patients will be identified with T. gondii-associated ocular disease at the participating centers. The vendor will perform anti-Toxoplasma IgM and IgG antibody testing, and for those sera with positive anti-Toxoplasma IgM and IgG antibodies perform the full Toxoplasma testing panel, which includes the dye test (if not done previously), avidity test, IgE ELISA, IgA ELISA, and differential agglutination (AC/HS). For serum samples that are anti-Toxoplasma IgG and IgM positive the vendor will perform (or subcontract to perform) a series of peptide-specific serologic tests to determine if the infection is due to genetic types 1 and 3, or type 2 T. gondii. Also for serum samples that are anti-Toxoplasma IgG and IgM positive, the vendor will perform polymerase chain reaction testing on whole blood to determine if patients are parasitemic. These data will then be entered into computer software, which shall be provided to CDC, and periodic summary reports will be made to CDC. Task to be performed in this requirement are as follows: 1. Collaborate with the CDC on the study design and data collection instrument. 2. On an annual basis, request renewal of human subjects board approval from all involved study sites. Forward letter of renewal to the CDC IRB annually or as required by the CDC IRB. 3. Perform anti-Toxoplasma IgM and IgG antibody testing on samples from at least 50 additional persons with ocular toxoplasmosis (in addition to the 100 persons in the FY07 contract), and for those sera with positive anti-Toxoplasma IgM and IgG antibodies perform the full Toxoplasma testing panel, which includes the dye test (if not done previously), avidity test, IgE ELISA, IgA ELISA, and differential agglutination (AC/HS). Also, for serum samples that are anti-Toxoplasma IgG and IgM positive the vendor will perform (or subcontract to perform) a series of peptide-specific serologic tests to determine the genetic types of T. gondii, and perform polymerase chain reaction testing for T. gondii. The estimated period of performance is nineteen months. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=65036adb8847adda0fcf93a44c38461f&tab=core&_cview=1)
- Place of Performance
- Address: 795 El Camino Real, Palo Alto, California, 94301-2302, United States
- Zip Code: 94301-2302
- Zip Code: 94301-2302
- Record
- SN01584941-W 20080604/080602220414-65036adb8847adda0fcf93a44c38461f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |