NIH GUIDE, Volume 26, Number 19, June 6, 1997




P.T. 34


  Immune System Disorders 



National Institute of Dental Research


The National Institute of Dental Research (NIDR) is conducting a

market survey to determine the availability and potential technical

capability of small businesses; the applicable SIC code is 8731 and

the size standard is 500 employees.  The NIDR has a requirement to

develop methods and assay for selected immunological and viral

characteristics in the saliva and serum of members of a cohort of HIV

positive U.S. military personnel.  The Contractor will test

approximately 2000 serum and 2000 saliva samples (to be supplied by

the Government) for total IgG, IgM, and IgA; HIV-specific IgG, IgM,

and IgA; nonspecific immune factors (lactoferrin, lysozyme and

lactoperoxidase); levels of secretory leukocyte protease inhibitor;

quantitative HIV virions; and infectivity of human peripheral blood

mononuclear cells (PBMC).  Special features of this project are the

large number of samples and the need for the development of

procedures to apply to saliva as the matrix and to conserve volume of

specimen as much as possible.  Subsequent to the assaying of the

samples, the laboratory findings will be linked to the demographic,

medical, behavioral, oral examination and follow-up data available on

this cohort.  This project will entail two phases.  Phase I will

consist of all activities undertaken prior to commencement of

production assays.  During Phase I the contractor will develop, test,

and prepare the final protocol for the study, including plans for

quality control, for approval by the NIDR. Phase II will include

performing the assays on the serum and saliva.  The Government

estimates that three years with a total of 19,200 hours will be

required to carry out the study.  It is estimated that 2000

professional, 1400 technical, and 3000 support hours (6400 hours

total) will be required in each of the three years.  General

objectives include the following:  1. To quantify in all saliva and

serum samples (a) total IgM, IgA (IgA1 and IgA2) and IgG; (b) HIV-

specific IgM, IgA (IgA1 and IgA2) and IgG, including nonspecific

immune factors including SLPI, mucins, lactoferrin, lysozyme and

lactoperoxidase, as well as HIV-1 viral load as measured by culture

and nucleic acid detection HIV (RNA PCR).  2. To characterize the

phenotype of HIV-1 isolated from saliva and blood according to

syncytium-inducing ability (SI vs NSI), cell tropism (macrophage vs T

cell), replication kinetics and strain variability.  Specific

technical requirements include the following:  1. SPECIMEN

MANAGEMENT:  (a) Maintain and update at all times, an electronic

receipt and control system that keeps track of all specimens received

and returned at all times; (b) Ensure proper disposal of specimen

containers; (c) Ensure proper handling of specimens to prevent

degradation and to ensure proper infection control; (d) Return unused

specimens to a repository designated by NIDR in the Washington, DC,

metropolitan area.  2. DEVELOPMENT OF ASSAYS:  Due to the presence of

proteinases, inhibitors, bacteria, and other biological variables in

saliva, preliminary experiments are required to assess the best

method of viral detection and/or culture of virus in these

preparations (e.g., centrifuged vs uncentrifuged; cell vs

supernatant). Assays must be standardized to enable direct comparison

and correlations between saliva specimens (cells and saliva) and

blood specimens for HIV and other parameters.  Specifically, the

contractor must use the following techniques for the listed assays:

quantitative HIV RNA PCR assessment for plasma, use of specified

commercially available assays may require adjustment for saliva


Total and HIV-specific immunoglobulins; use ELISA techniques for

total and HIV-specific immunoglobulins IgM, IgA (IgA1 and IgA2) and

IgG; additional assays may include neutralizing antibodies and

antibody dependent cellular cytotoxicity (ADCC); (b) HIV-viral load;

HIV RNA PCR assay (quantitative RT-PCR or another commercially

available method); use cell microculture techniques for PBMC and

saliva pellet cell associated HIV; use p24 antigen ELISA on serum and

saliva supernatant to assess HIV levels; in situ hybridization from

smears of cells; (c) Non-specific immune factors; (d) Syncytia-

inducing ability:  Use cell microculture techniques to determine

cell-associated syncytia inducing (SI) HIV phenotypes and non-

syncytia inducing (NSI) macrophage tropism (isolates from saliva cell

pellet); and (e) Replication kinetics and heteroduplex mobility assay





This is NOT a Request for Proposal; there is no solicitation.  The

Government is not committed to award a contract pursuant to this

announcement.  Responses should not include cost or pricing

information.  Sources believing they have the required capabilities

to undertake this project should submit four copies of the requested

material addressing experience and capabilities by 4:00 P.M., local

time, on June 16, 1997.  The requested material shall be submitted to

the following:


Marilyn R. Zuckerman

Contracts Management Section

National Institute of Dental Research

45 Center Drive, Room 4AN-44J MSC 6402

Bethesda, MD  20892-6402



Return to 1997 Index

Return to NIH Guide Main Index

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.