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Patient's samples used as antisera

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Hi there! I am wondering if any of you use patient's plasma (antibody positive) as antisera. Does FDA require results of viral testing before you can use any patient sample as in house reagent? 

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Certainly, within the UK, using a patient's sample as antisera frowned upon, but there are occasions when the specificity is so rare that you have no option other than to use the patient's sample.

I am not thinking of something like an anti-k (such a specificity is rare enough, but it is possible to obtain an example through a commercial source, but specificities that are even rarer, such as our anti-DOLG (anti-Do8) that, as far as I know, is unique to one individual in the world, and if we didn't use her sample, there would be no anti-DOLG!

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Thanks Malcolm, our goal is just to save on cost. So, we are aliquoting patient's plasma, positive for anti-K, for example and give it a 1 year expiration date. This, we use for our 0.2M DTT quality control instead of the commercially available anti-K. Does anyone know if this practice is regulated by FDA or CLIA? I actually don't see any but I just want to confirm because FDA is so strict on patient's specimens and may require trackable viral results record if these specimens are to be stored as in house reagents. Not so sure though. Thanks in advance for all your inputs.

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A few points, but first, a disclaimer: I am not an expert in FDA or CLIA regulations.

I suspect that many labs are using some form of a "home-brew" reagents. The number of internal controls required by various regulatory agencies increases by the day. Add the large number of "competencies" necessary for all the staff and one has to use what is available.

Personally, I don't think viral testing should really be an issue (although it would be nice to know) - you're not preparing this stuff for distribution/sale to other facilities; the "treat all materials as potentially infectious" mentality and Universal Precautions approach should cover you.

The absence of an expiration date is probably better that assigning an arbitrary one (you have no stability data). In your application, you have a in-built control - it either works or it doesn't (I'm presuming you test the untreated [positive result] and the treated cells [negative result]?).

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I will use a patient's specimen to screen units.  When I find compatible ones I will type using the FDA approved reagents.  This is especially helpful to screen for higher incidence neg units (c, Fy, Jk, Ss).  I think that if you are using it as a sole source to screen you could be in dire straits if you missed something.

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