HIV Antibody Testing Algorithm -
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Is the use of OraQuick rapid HIV test specified by the HPTN 035 protocol? If so, please provide an explanation as to why OraQuick is the recommended test and whether all HPTN 035 sites must include this test in their validations.
This continues to be a difficult and confusing issue. It is recognized that there are many very good rapid HIV tests available at HPTN sites. No specific rapid test manufacturers or brands are specified in the HPTN 035 protocol, however specific test kits will be listed in the study-specific procedures manual. More importantly, the US Food and Drug Administration (FDA) has required the HPTN 035 Protocol Team to specify the tests that will be used, and to provide in-country validation data for every test kit that will be used, even if the test is FDA-approved. The FDA wants to have a clear idea of the performance characteristics and manufacturing controls for all HIV tests that will be used in the study. Since HIV is the primary endpoint for HPTN 035, the FDA will not accept the use of tests for which they have no knowledge. The HPTN Network Lab will continue to determine ways to provide flexibility to the sites while also ensuring that acceptable rapid tests will always be available for use and satisfying the FDA with the rigor of our approach.
To date the HPTN 035 Protocol Team has specified that the OraSure OraQuick test and the Abbott Determine test (as well as the Bio-Rad Western blot test) will be used at all HPTN 035 sites, and has informed the FDA of this approach. As you may know, the FDA approved the Unigold rapid test in December 2003, and this test is available in Africa. Given potential kit supply problems, the Protocol Team is considering requesting that validation data be generated for all three of these rapid tests (Unigold, Determine, and OraQuick). Then, if any of the tests are not available, there are still two alternate tests that could be used for rapid testing. This was discussed during a recent HPTN 055 conference call, and 055 sites were instructed to validate all three of the rapid tests and any other tests they may want to validate at their sites. At a minimum, however, the OraQuick and Determine must be validated at all sites, as well as the Bio-Rad Western blot test.
The HPTN 035 Protocol Team must provide the FDA validation data for each
study site prior to the initiation of HPTN 035. If, upon review, the test
performance data look unacceptable (less than 99% sensitivity and/or less
than 99% specificity), the Protocol Team will need to reconsider whether any
one of the tests should be used.
The EIA test used at our site just got FDA approved. Can I use the
non-reactive samples determined by this kit prior to FDA approval for the
100 negative samples?
No. You can't be sure that it was the exact same manufacturing process used prior to FDA approval.
Do the HIV positive samples need to be confirmed by a FDA approved kit?
You must use a WB or IFA kit that is either FDA approved or one approved for use by your country’s regulatory body.
Why do I need two FDA approved rapid kits when I would only need one FDA approved EIA kit?
In our experience the rapid kits are not as sensitive as the FDA approved ELISA kits.
I cannot order any FDA approved kits in country? How should I proceed?
Work with your US university if you have one and have them ship the kits. If you do not have a US affiliate, contact the Network Lab.
I do not want to validate the FDA approved OraQuick kit but want to validate the approved MedMira kit? Is this acceptable?
Yes it is acceptable. You should always check with the protocol team as well.
If the protocol dictates a particular kit or kits, must I use those kits? What if I did not validate with those kits?
Yes. You should contact the protocol chair to see if it is really necessary.
Then you need to validate with those kits.
The OraQuick kit is licensed for whole blood and fingerprick yet I want to use plasma for my rapid kits. Do I need to validate the plasma on the OraQuick kit?
Yes, you need to validate with plasma.
I may not be able to import any of the FDA kits into my country, what should I do?
Check with the appropriate protocol team to see how they want you to proceed. If there are further issues, contact the NL. While it is possible your country may prohibit importation of FDA approved kits for diagnostic use in your country, it would seem likely they may allow importation for a comparison study. Check with the your regulatory authority.
Who is paying for FDA approved kits and/or the validation study?
Your HPTU site is paying for the kits and validation study.
What if the samples are run on two non FDA approved kits and are negative – are these considered negative samples?
You still must run them with an FDA approved ELISA kit or two FDA approved rapid kits.
My country validates the kits we can use – what should I do?
Provide the data to the NL for review so it can be determined how they were validated.
I have banked samples. Can I use the same patient sample over time or must I use multiple samples?
You cannot use the same patient. You must use samples from different people.
What if I have samples tested on one approved Rapid and one non approved rapid test?
These samples need to be tested on two FDA approved test so these can not be used as "negatives".
