CENTRAL LABORATORY FOR VIRAL ACTIVATION TRANSFUSION STUDY

NIH GUIDE, Volume 23, Number 6, February 11, 1994



RFP AVAILABLE:  NHLBI-HB-94-11



P.T.





Keywords:



National Heart, Lung, and Blood Institute



The National Heart, Lung, and Blood Institute issued Request for

Proposals (RFP) NHLBI-HB-94-11, on January 28, 1994, and proposal

will be due approximately eight weeks thereafter. It is anticipated

that a three-year contract will be awarded on or about September 30,

1994.  The contractor will serve as the Central Laboratory for a

multicenter clinical trial designed to determine if viral activation

in HIV-1 infected individuals is associated with blood transfusion.

It is anticipated that approximately 330 patients will be tested and

followed over a period of two years.  The Principal Investigator must

be on-site and have expertise in clinical pathology or transfusion

medicine.  Responsibilities of the central laboratory will include,

but are not limited to, the following:  (1) participate as a member

of the Steering Committee in finalizing the details of the protocol

and in completing the manual of operations; (2) develop procedures

for the collection of blood samples and their processing, temporary

storage and delivery to the Central Laboratory; (3) perform tests

using the polymerase chain reaction (PCR) technology to quantitate

the amount of CMV and HIV-1 present in peripheral blood mononuclear

cells, quantitative culture of CMV and HIV-1 and other tests such as

lymphocyte subsets and p24 relating to viral activation; (4) develop

and implement collection procedures for the laboratory data; (5)

utilize a computerized system to enter and edit the results from the

blood tests and blind duplicates on a regular basis and transmit test

results electronically to the Coordinating Center in an acceptable

format; (6) assure standardization of all blood tests within the

Central Laboratory and have an ongoing quality control program to

assess and control within run and between run variability, accuracy,

precision, and limits for each analyte; (7) store aliquots from each

participating clinical center for the purpose of case-control or

other special studies under conditions appropriate to prevent analyte

degradation; and (8) contribute to the analysis and reporting of

trial data.



INQUIRIES



Requests for copies of the RFP must include three self-addressed

mailing labels and are to be directed to:



Lynda A. Bindseil

BDR Contracts Section

National, Heart, Lung, and Blood Institute

7550 Wisconsin Avenue

Federal Building, Room 610

Bethesda, MD  20892



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