API Urinalysis
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We recently received result from our API proficiency testing and a few of my sites failed on the Leukocyte Esterase. We use the Clinitek Status or Status + and Multistix 10SG. I am wondering if it is related to the lot number. They used lot 607044. Has anyone else noticed any issues with this particular lot number?
TIA!
Cindy
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Cindy, we utilize API as our PT provider as well but did not have any issues with our last two challenges for Leukocyte Esterase on the Clinitek Status. I reviewed our shipments tracking log of Multistix but we have never received the lot # you are referencing.
You could review your historical QC with this lot # and the previous lot # and see if the abnormal QC material had an overall change in the detection level (up or down). If you have another lot # of strips available, perform repeat testing. If you contact Siemens, their Technical Support has been very good in working with us. They may offer to send you a bottle of a new lot # to assist with your investigation. Are all of your sites utilizing the same lot # or were the failures limited to only those sites with the specific lot # in question?
Thank you for your response! I did have them test the samples again using a different lot number and they came back with the correct results. I had three sites fail with this analyte and two of them were using the same lot number. I may give Siemens a call to see if they can provide more information.
Cindy,
How long has the bottle been opened?
Note that after a long time, the Leukocyte turn pink after been exposed to air many times.
The manufacturer does dictate expiration date after opening, but when TJC came they told us
that we should write an expiration date even though the manufacturer does not state it in the insert.
Since then, all our bottles are marked with expiration date 90 days after opening.
I also trained the operators to check the color of the leukocyte pad before using.
Thank you Pet! I'm not sure how long the bottle of strips were opened for since they no longer have them. I was not aware the TJC had the recommendation of writing a new expiration date. I did talk with Siemens and the only thing they could recommend was making sure that the calibration bar was cleaned with DI water.
Cindy, I think the color of the color block if not white should give you an indication the bottle has been opened a while.