Frequent Asked Questions (FAQs) for the Upcoming HIV RNA Assay Platform Switch at AIDS Clinical Trial Network (ACTN) International Laboratories
Click here to open a printer-friendly version of these FAQs.
Q: Which labs are required to install the Abbott m2000 System?
Laboratories are currently required to have an Abbott m2000 system installed and validated if they are interested in doing HIV RNA testing for all new protocols in which RNA is a primary endpoint going forward.
Q: When will the AIDS Clinical Trial Network (ACTN) International Laboratories (IL) have their Abbott m2000 System platforms installed and how will this process work?
A:
· The international Laboratories (IL) will have their Abbott m2000 System installation completed by October 2009 per the signed Memorandum of Understanding (MOU) between the AIDS Clinical Trial Networks and Abbott Molecular Inc. Laboratories should refer to the MOU in order to establish an agreement with Abbott. If you have not received a copy of the MOU, please contact your PNL.
· The installation plan has been designed according to a laboratory priority list provided to Abbott Molecular Inc. by the networks and it is expected that the m2000 System installations for all the International Laboratories will be completed by October 2009.
· Abbott Molecular Inc. will contact each laboratory according to the priority list provided.
· Each Network will follow up with Abbott Molecular Inc. and their laboratories to make sure a date has been assigned for the m2000 System installation.
· The IL will obtain the new instrument and the staff will be trained by the manufacturer (Abbott Molecular Inc. or its international service proxy).
· Abbott will provide training for a minimum of two (2) operators per laboratory prior to completion of equipment installation. A site specific training plan with training venues will be mutually agreed upon, prepared and planned by the Networks coordinator and the Abbott program manager based on geography, location, language and installation schedule. Abbott will further provide follow-up support training, coaching, re-training, re-certification of trained staff and training for up to two (2) new operators per laboratory per year.
Q: What is the validation procedure for the Abbott m2000 System?
A:
· The IL must perform a validation comparing their current HIV RNA platform against the Abbott m2000 platform using the VQA Secondary Validation Plan.
· The IL must validate either the automated or manual extraction methods for the Abbott m2000 assay depending on the extraction method selected by the laboratory.
· The IL needs to initiate communication with the VQA ASAP. Please contact the VQA to start the validation process and to get the necessary assistance.
· Validation of the Abbott m2000 manual method of sample processing is a component of the VQA secondary validation panel.
· Abbott will support the DAIDS VQA secondary validation algorithm at each laboratory and provide up to three (3) Abbott RealTime HIV-1 reagent kits (96 tests/kit, a total of 288 tests) to compare the Abbott RealTime HIV-1 viral load test with the Roche assay used at each site.
· The IL needs to have the m2000 System validation results reviewed by both the VQA and the respective Primary Network Laboratory (PNL).
· The IL is required to be prequalified for the new HIV RNA assay by the VQA and must participate in the VQA Proficiency Testing Program in order to start analyzing clinical samples. The IL must successfully pass the prequalification panel and the first 5-member panel with a score of C to begin protocol testing with the Abbott m2000 platform.
o All laboratories must have their systems up and running by the end of October 2009 and complete their system validated by January 1, 2010.
Q: Where is Abbott’s technical support for my laboratory?
A: Click here to open a printer-friendly table of Abbott contacts by country.
Q: Can a laboratory switch platform within an existing protocol?
A: Absolutely, NOT. Continue using the current HIV RNA platform until the protocol is completed.
Q: Will it be possible for an International laboratory to run the Abbott m2000 System in parallel with Roche within a protocol?
A: The labs should not run Abbott in parallel with Roche within a protocol.
Q: How will the Abbott m2000 HIV RNA assay kits and reagents be ordered?
A: An Abbott representative will arrange a standing order with each laboratory.
Q: When can an International laboratory begin to report protocol results using the Abbott m2000 System?
A: When the laboratory is VQA certified in the Abbott m2000 System.
Q: What does the Abbott MOU mean for my laboratory?
A: Abbott will provide installation, service, maintenance, training and on-going support for an Abbott m2000rt System as lease for $50.00 per test kit.
Q: What is the timeline for new International protocols to use the Abbott m2000 System.
A: By the last quarter of 2009.
Q: Can a laboratory establish an agreement independently from the MOU).
A: Yes. Laboratories have the option to negotiate a different agreement directly with Abbott depending on their testing utilization. They can purchase the whole m2000 system (m2000rt and m2000sp) or purchase any part of the system and receive a different test kit price.
Q: If I choose not to acquire the Abbott m2000 System, what do I do?
A: Where the Abbott m2000 System is protocol specified, testing must be performed at another DAIDS approved (VQA certified) laboratory that uses the Abbott m2000 System.
Q: What will happen to the protocols that have Roche Monitor 1.5 as the HIV RNA assay?
A: Laboratories must continue using the Roche Monitor 1.5 platform until the protocol is completed.
Q: How much longer will the Roche Monitor 1.5 kits and support be provided to the International labs?
A: Roche will continue to manufacture the Roche Monitor 1.5 kits until 2011; however, a sufficient number of kits will be held in reserve to allow for completion of protocols that use this assay (anticipated to extend into the year 2013).
Please direct any questions to your Primary Network Laboratory (PNL) who will address your question appropriately:
Click here to see a list of laboratories by PNL.
Updated 08/31/2009