SOLICITATION NOTICE
B -- Microscopic Scoring of Human Lymphocyte Micronucleus Assay
- Notice Date
- 6/15/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Acquisition and Assistance Field Branch (Pittsburgh), Post Office Box 18070 Cochrans Mill Road, Pittsburgh, PA, 15236-0070, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-000HCCGB-2007-44302
- Response Due
- 6/30/2007
- Archive Date
- 7/15/2007
- Description
- CDC, NIOSH, Cincinnati Research Laboratory intend to issue a request for quotation (RFQ) to obtain Microscopic Scoring of Human Lymphocyte Micronucleus Assay BACKGROUND As a part of the recent NIOSH project ?Determination of Antineoplastic Drug Exposure in Health Care Workers? field studies were conducted from March to October 2006. The goals of the project were to determine worker potential exposure to antineoplastic drugs by various methodologies including worker reported use and environmental and biological sampling. For biological sampling, urine was collected for measurement of antineoplastic drugs and blood collected for various cytogenetic assays including the COMET and lymphocyte micronucleus assay. Whole blood samples were collected from each participant, and shipped to Taft Laboratories in Cincinnati, Ohio. Lymphocyte cytokinesis-block cultures were initiated and cytoslides were prepared for microscopic scoring. The results of scoring will be used to assess exposure of individuals to antineoplastic drugs by noting the presence of cellular morphologic and structural features characteristic of antineoplastic exposure. Scoring and enumeration of micronuclei in human lymphocytes is a research function. Micronucleus (MN) levels may vary in humans due to dietary exposure, age, sex and smoking. The presence of micronuclei and nucleoplasmic bridges has no clinical relevance, and their presence is not used medically to indicate health status. Two levels of Micronucleus (MN) analyses in human lymphocytes are available: 1) "Classic" Fenech approach, which includes MN scoring in 1000 bi-nucleated cells and establishing a nuclear division index (NDI) in 500 cells to assess proliferation as described in Fenech et. al. 2000 (Mutation Research 445:81-95) and Fenech et.al. 2003 (Mutation Research 534:65-75.) 2) "State of the Art - Cytome Assay" is a more advanced approach, also suggested by Fenech and validated by the International Committee on Micronucleus Assay (http://www.humn.org), includes scoring for MN in 1000 binucleated cells (at least 1000 binucleated cells are scored, or 500 from each replicate culture), a replicative index, as well as nucleoplasmic bridges (in binucleated cells) and other endpoints related to genetic damage, cell death and proliferation (nuclear buds, apoptotic cells, and necrotic cells) as fully described in Fenech et. al. 2006 (Mutation Research 600:58-66.) The research goals described in the Research Project: Determination of Antineoplastic Drug Exposure in Health Care Workers will be served best if scoring services are conducted at the second level ?State of the Art ? Cytome Assay? as described above. For reward of contract the vendor is required to provide scoring services at the second level of analysis. PURPOSE The purpose of this contract is to obtain microscopic scoring of cytoslides prepared from human lymphocyte cytokinesis-block cultures and receive documentation of the results of this microscopic analysis. SCOPE OF WORK The vendor shall provide all labor, materials and equipment to complete the tasks outlined below. Scoring of cytoslides from each participant shall be conducted using cytoslides provided by NIOSH that have been prepared from replicate cultures. The vendor shall score 1000 binucleated lymphocytes: 500 cells from culture A and 500 from culture B. With only two exceptions NIOSH will provide a total of four cytoslides; two slides prepared from each replicate culture per study participant. While at least two slides must be viewed, initial scoring of slides indicate in many instances three to four slides will be needed to score 1000 binucleated cells. The vendor will be required to return all cytoslides provided by NIOSH upon completion of services by Federal Express or other appropriate shipping and delivery service, and include an inventory of all slides returned. Slides shall be returned in several shipments as received from NIOSH. TASK TO BE PERFORMED The vendor shall perform the following minimum task: A. Perform microscopic scoring of cytoslides provided by NIOSH at the first or ?Classic? level by: 1. Scoring or enumerating micronuclei present in 1000 binuclear lymphocytes using the scoring criteria established by the Human Micronucleus Project, Fenech et.al. 2003 (Mutation Research 600:58-66.) 2. Establish a Nuclear Division Index (NDI) by enumerating 500 mono-, bi-, tri- and tetranucleated cells. NDI = [M1 + 2(M2) +3(M3) + 4(M4)] / N Where M1- M4 represent the number of cells with one to four nuclei and N is the total number of cells counted (500). The vendor shall score 250 cells from each replicate culture. 3. Provide an estimate of experimental variation and the effect of scorer bias as described in Fenech 2000 in which estimates are based upon results from duplicate cultures and preparation of a total of four cytoslides. With two exceptions four cytoslides have been prepared for each participant. B. The vendor providing scoring services at the preferred ?State of the Art ? Cytome Assay? shall include additional cytological end points as described in Fenech 2006: 1. Scoring or enumeration of binucleated cells containing nucleoplasmic bridges. 2. Enumerate mononuclear cells containing one or more micronuclei. 3. Enumerate binuclear cells containing nuclei with nuclear buds. 4. Enumerate apoptotic and necrotic cells in 500 cells. 5. Establish a Nuclear Division Cytotoxicity Index by enumerating 500 mono-, bi-, tri- and tetranucleated cells and using the formula: NDCI = [Ap + Nec + M1 + 2(M2) +3(M3) + 4(M4)] / N* Where Ap = number of apoptotic cells, Nec = number of necrotic cells and N* = the total number of cells scored (viable and non-viable). 6. Provide an estimate of experimental variation and effect of scorer bias as described above in item A.3. C. The vendor shall provide on a Scoring Sheet for each participant assay the following information. Score Sheets for ?Classic? assays will include the following information: 1. Code Number of each slide. 2. The number of slides examined to score 1000 binuclear cells. 3. Number of binuclear cells scored. 4. The distribution of binuclear cells with 0, 1, 2, 3 or more micronuclei in 1000 binuclear cells. 5. Total number of micronuclei in binuclear cells. 6. The frequency of micronuclei in 1000 binuclear cells. 7. The frequency of micronucleated binuclear cells in 1000 binucleated cells. 8. The proportion of mono-, bi-, tri- and tetranucleated cells in 500 viable cells. 9. The frequency of binucleated cells in a total of 500 viable cells. 10. The Nuclear Division Index 11. Coefficient of variation for duplicate estimates of the above parameters. Score Sheets for ?State of the Art ? Cytome Assays? shall provide the additional information: 1. The proportion of binucleated cells containing nucleoplasmic bridges. 2. The proportion of mononucleated cells containing one or more micronuclei. 3. The proportion of binucleated cells containing nuclei with nuclear buds. 4. The proportion of cells undergoing apoptosis or necrosis in 500 cells. 5. The Nuclear Division Cytotoxicity Index. 6. Coefficient of variation for duplicate estimates of the above parameters. NIOSH FURNISHED MATERIALS NIOSH shall provide 481 Wright?s stained and cover-slipped cytoslides prepared from 121 human lymphocyte cytokinesis-block cultures and full cytoside inventory packed into standard microslide boxes for use by vendor to provide scoring services. Boxes will be shipped by Federal Express Standard Ground Service in several shipments. MINIMUM VENDOR QUALIFICATIONS IN ORDER TO BE CONSIDERED FOR AWARD OF PURCHASE ORDER, VENDORS ARE REQUIRED TO SUBMIT DOCUMENTATION WITH THEIR CAPIBILITIES ADDRESSING NIOSH MINUMUM VENDOR QUALIFICATIONS. AWARD OF PURCHASE ORDER SHALL BE MADE TO THE LOWEST QUOTER THAT MEETS NIOSH?S MINIMUM VENDOR REQUIREMENTS. 1. The vendor shall be familiar with NIOSH programs and policies relevant to government research data, provided materials, study-participant specimen chain of custody procedures and applicable HSRB regulations as evidenced by prior work. 2. The vendor shall have expertise in conduct of the Human Lymphocyte Cytokinesis- Block Assay with assurance and quality control procedures consistent with the Intenational Programme Chemical Safety (IPCS) Guidelines for Monitoring Genotoxic Effects of Carcinogens in Humans. This can be evidenced by providing such information as prior studies that the laboratory has participated in, copies of standard operating procedures, and CLIA certification status. 3. The vendor shall appoint a Liaison or Contract Officer to provide such information as deemed necessary by NIOSH to assure timely completion of services as described above. 4. The prefered vendor will be one who can perform the State of the Art ? Cytome Assay level within a 6-month time period from the award date and show appropriate technical and quality assurance/control expertise in the methodology as evidenced by such information as participation in prior studies, copies of standard operating procedures, quality control assurance programs, and CLIA certification. The acquisition is being processed under FAR part 13, Simplified Acquisition Procedures, with an estimated value of less than $100,000. The entire scope of work will be addressed in the solicitation package (RFQ) number 000HCCGB-2007-44302 available on or about June 30, 2007. Qualified organizations are encouraged to submit a capabilities statement which addresses the requirements and contains material in sufficient detail to allow the CDC to determine if the party can perform this requirement. Capabilities are to be received in the contracting office no later than fifteen (15) days from the date of this announcement. Responses shall contain no more than 10 pages total. Submit written information to: Margaret L. Mooney, 626 Cochrans Mill Road, PO Box 18070, Pittsburgh, Pa. 15236-0070, or responses may be submitted electronically to Margaret Mooney at zia3@cdc.gov. All vendors must be registered in the Central Contractor Registry (CCR) prior to award of a federal contract. Vendors may register at www.ccr.gov.
- Place of Performance
- Address: NIOSH Robert A Taft Laboratories, 4676 Columbia Parkway, Cincinnati, OH
- Zip Code: 45226-1922
- Country: UNITED STATES
- Zip Code: 45226-1922
- Record
- SN01319941-W 20070617/070615220552 (fbodaily.com)
- Source
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