We make a fair number of random donor platelets and are trying to decide how to test them. We have a BactAlert system available to us, and think this is the way to go. Anyone have a validation plan in place for this? How about dipsticks or glucometers for testing pools of random donors?

Fortunately we stopped making random donor platelets a few years ago.

I was under the impression that both the Pall BDS and BacT/ALERT systems recommend testing each product rather than a pool. Does anyone know if this is based on some regulation or recommendation?

It seems to me that bacterial testing with its complexity and costs, will be the death knell of random platelets, except under the most unusual circumstances.

The logistics, confound me.

We are trying to validate a protocol using a small pH meter (minilab). We are a large facility and make a large number of random platelets. We would prefer not to have to do 100% leukoreduction.

Even when a licensed method for bacterial detection of random donor platelets is avaialble, I heard that each product will still have to be leukoreduced. Has anyone heard any similar news? :?:

The two methods that will likely get FDA approval first, Pall eBDS and BacT/ALERT will probably always have to be done on leukoreduced products. They both measure oxygen consumption or CO2 production of bacteria present. WBC's consume oxygen and produce CO2, so if they are present in the sample they will cause a false positive.

I think Pall is in the process of trying to validate the storage of random donor platelets that have been pooled using a sterile connection device. If we could pool, leukoreduce then test for bacteria it would be much easier to deal with random platelets.

has anyone heard if Veriax had its product for bacterial detection (bd) approved by the FDA? The product was introduced at AABB- San Diego (2004).

It would have helping in standardizing the bd testing at the issuing time for transfusion services. (Not particularly confortable with the pH and glucose dipstick testing/bandaid).

We had implemented 100% leukoreduction of whole blood (aka random) platelets in Pall RCPL bags prior to bacterial testing, so we implemented Pall BDS testing on these components. We produce and test between 100 and 160 platelets per day. This system works well for us.

We've been asked to participate in studies of pool, test and store, which we're doing, but the logistics are quite challenging, and we feel best suited for a transfusion service, not a blood center.

No doubt, implementation of 7 day platelet processes will significantly impact current practices.

We use the Pall BDS analyzer for platelet bacterial detection. I would shy away from pooling random donor platelets and then testing them for one simple reason. If a pool were to be positive and it was a pool of, let's say, six random platelets, how do you know what unit had bacteria in it? Do you then want to quarantine and culture every other product that was made? I know I don't want to do that. Also it may save time but how long will a pooled platelet be good for in your facility? With our current methods and equipment our pools are only good for four hours.

We make a fair number of random donor platelets and are trying to decide how to test them. We have a BactAlert system available to us, and think this is the way to go. Anyone have a validation plan in place for this? How about dipsticks or glucometers for testing pools of random donors?

I have validated the Multistix 10 SG for both glucose and pH. Correlation studies were performed with the Olympus AU640 for glucose and the GEM Premier 3000 for pH. Tewelve random donors were used as a control group After correlation studies were performed, four units were inoculated with 10 ^7 colony forming units (CFU) with Staph A, Staph E, Strep B, and Escherhia coli. The Multistix 10 SG demonstrated a sensitivity of =/> 10^5 CFU/mL.

This sounds hard, but if you have a Micro department with a Densitometer they can handle the cultures for you and you can correlate the data. Time measurements used in this study were 0, 18, 24, and 36 hours.

I don't think random donor platelets are going away form institutions with neonatal units. The lattest thing on the horizon is Pre-Pooled Platelets from the Blood Supplier. They would take care of the bacterial testing and these units have the same expiration as PSD units. Not FDA approved yet.

The BactAlert system, in my opinion, would not be the way to go. Random donors must be tested before they are pooled. You would spend a lot of time and money using this system. The dipstick method has worked well for me, although, I know some institutions that are using a pH meter.

Hope this helps and if you would like further information please email me.

MWL

Hi Everyone,

I'm opening up this thread again...what is everyone using for bacterial testing of random donor platelets now? We're not having much luck passing the survey by measuring the glucose and ph with Multistix Urine Dipsticks. Of course we hardly ever get randoms anymore so I can't justify a huge expense with lots of training. Anyone have a method they can recommend?

Thanks,

Becky

We opted to pool paltelets using the Pall Acrodose Plus. Once pooled You can test the pool and not the individual platelets with the eBDS system.

We used the pH meter in the past, on individual platelets and the rate of false positive was too high.

You can also test a pool of leukoreduced platelets using the BacT/ALERT. We don't make random platelets, but I'm sure that a bioMerieux representative would be glad to help you.

Heather -

Good thing we don't have to vote for who is cuter.....your daughter or your son.....it would be a tough contest! Cute!!!

Donna

Heather -

Good thing we don't have to vote for who is cuter.....your daughter or your son.....it would be a tough contest! Cute!!!

Donna

I'd go along with that - in trumps.

:D:D:D:D

Awe, thanks you guys :-). I'm quite fond of them both...although the little guy doesn't let me get much sleep at night.