Request for Proposal: Supplemental HIV-Nucleic Acid Amplification/ HIV-2 Testing Evaluation
Proposal Due Date: August 19, 2010
Submit to: Kelly Wroblewski, APHL Manager of HIV, Hepatitis, STD and TB Programs
Summary: The Association of Public Health Laboratories (APHL), in cooperation with the Centers for
Disease Control and Prevention (CDC), is seeking to contract with state and/or local public health
laboratories to conduct supplemental nucleic acid amplification testing (NAAT) and Multispot testing on
specimens that are repeatedly reactive by HIV-1/HIV-2 enzyme immunoassay (EIA) and either negative
or indeterminate by western blot (WB). The data will identify the proportion of these specimens that
are resolved by the assays listed above and will aid in the evaluation of alternative HIV testing
algorithms possibly leading to improved identification of persons recently infected with HIV-1 or
infected with HIV-2.
Background: The HIV laboratory testing algorithm has not been significantly updated since its inception
in 1989 despite the development of new testing technologies. Advances include tests with greater
sensitivity during early and acute infection like NAAT and that differentiate HIV-1 from HIV-2. However,
supplemental testing with NAAT or an HIV-1/2 discriminatory assay is not regularly conducted under
current laboratory testing algorithms.
CDC and APHL continue to work towards updating the HIV laboratory testing algorithm to better screen
for early infection and HIV-2. More data are needed to evaluate new algorithms. The data collected
from these specimens will validate newly proposed HIV testing recommendations.
Request for Proposal: APHL and CDC are seeking one or two state or local public health laboratory
partners to conduct supplemental NAAT and Multispot HIV-1/HIV-2 differentiation testing for this
evaluation. The selected laboratory(s) will receive de-identified serum or plasma remnant specimens
that have previously tested repeatedly reactive by EIA and either negative or indeterminate on WB. The
partner laboratory will test each specimen using a HIV-1/HIV-2 discriminatory test (e.g. the Multispot
HIV-1/HIV-2 Rapid Test) and a NAAT. The total number of specimens included in the evaluation is
expected to be between 600 and 700 but this number is subject to change slightly.
Data generated in the study will be submitted electronically on a standardized results worksheet to
APHL. Testing sites will have the option to collaborate on a publication(s) using the data compiled.
The contracted laboratory will receive:
i.
A detailed study protocol
ii.
Deidentified serum or plasma remnant specimens that meet the study criteria
iii.
Funding for the purchase of test kits and consumables as well as support of laboratory
personnel and facilities. Selected testing sites will be paid $125 per specimen receiving both
NAAT and Multispot and $100 per specimen receiving NAAT only. A portion of the funds will be
distributed upfront to defray start-up costs.
iv.
The contracted laboratory will be responsible for:
i.
ii.
iii.
iv.
v.
Receiving specimens from other public health laboratories and notifying APHL of specimens
received.
Conducting supplemental HIV-1 NAAT and discriminatory HIV-1/HIV-2 (Mulstispot) testing.
Ensuring that corresponding data is collected and recorded in accordance with the study
protocol.
Providing the equipment and supplies necessary to conduct the required testing.
Providing experienced personnel to perform the required testing.
Award Mechanism: Contract with the Association of Public Health Laboratories (APHL)
Term of Project: From date of contract signing through completion of testing extending no later than
June 30, 2011. This contract will not be renewable and no extensions will be granted.
Requirements/Evaluation Criteria: The contracted laboratory should currently have the capability to
perform HIV-1 NAAT and Multispot. Laboratories that are interested in participating in this evaluation
are asked to submit a proposal. Proposals should include the following information:
i.
ii.
iii.
iv.
v.
vi.
Specific type of HIV-1 NAAT and HIV-1/HIV-2 discriminatory assays preformed in your laboratory
Length of time each assay type has been in use in your laboratory.
Experience of the personnel conducting and supervising the testing with each assay type.
Approximate number of specimens tested using each assay type per year.
Number of specimens your laboratory has the capacity to test within the term of the project.
Any other information about your laboratory that you think may be relevant to the project.
Awards Expected: One to two awards totaling $80,000-$112,000. Recipients will be notified by
September 8, 2010.
Additional Information and Deadlines for Proposal Submission: For additional information on this
project including detailed objectives, the scope of the work, deliverables, proposal content and length,
and evaluation criteria, please contact Kelly Wroblewski at APHL (kelly.wroblewski@aphl.org; 8515
Georgia Ave Suite 700, Silver Spring, MD 20910; telephone 240-485-2728; fax 240.485.2700). Proposals
must be received at APHL, attention Kelly Wroblewski, by close of business on August 19, 2010.