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Dear Colleagues,

I am trying to see if anyone (especially in Australia!) is having similar
problems to ourselves with low level TSH measurements on the Immulite
(original model). There seem to be two possibly unrelated problems.

Several months ago we noted an increase in the values of the results
determined at the low end of the assay. The number of samples we had with
results below the functional sensitivity (0.01 mIU/L) fell markedly
compared to previously. Samples from many patients with clear elevations of
free T4 and free T3 gave detectable TSH up to 0.1 mIU/L. Testing of these
samples on an AxSYM analyser gave undetectable TSH results. We have seen no
change in our internal QC or external QA but there are not many samples
down at these levels. This has occurred with lot numbers 293, 295, 296 and 297.

The apparently false positive TSH results mentioned in the paragraph above
generally give the same positive result when repeated or after serial
dilution (when multiplied by the dilution factor). However a subset of
samples with clearly positive results give a zero reading after a 1/2
dilution in buffer or TSH-free serum. For example a result of 0.1 becomes
<0.01 after a 1/2 dilution. We are completely uncertain as to the cause, or
the relationship of this phenomenon to the apparent upwards shift. We have
changed to a new tube types (BD SSTII and PSTII, not sure if these are in
the UK yet) but the timing does not fit exactly with the discovery of the
issue.

We are in active discussion about this with DPC.

Any thoughts welcome.

Graham

Dr Graham Jones
Staff Specialist in Chemical Pathology
St Vincent's Hospital, Sydney
Ph: (02) 8382-9160
Fax: (02) 8382-2489



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