I-Stat B-hCG

We are using BhCG cartridges in our I-stat analyzers. lately we are having an increase of indeterminate results. the  tests were repeated in the main lab and the results came out Negative.

Is someone experiencing the same problem or another issue with these cartridges?

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A qualitative interpretation of “Indeterminant” means the quantitative result was 5.0 – 25.0 IU/L.  We have our handheld display in the default setting, so we see both the quantitative and qualitative results.  Only 4 of 74 tests done last month were “Indeterminant”, and the quantitative results were 6.2 – 21.6.  These would have given a negative result using a serum pregnancy test (cut-off 25 IU/L).

Thank you Terry.

My concern is that our number of indeterminate results had never gone over 6%. right now, as today we have 8.27% of indeterminate results. Which according to our policy needs to be confirmed in the main lab. This is delaying patient care and of course turn around time.

I called Abbott and they are investigating the cartridges.

I appreciate any suggestions.

thank you.

 

Our validation studies showed that the quantitative results are consistent with our Laboratory over the reportable range of the test.  We do not require confirmation by the Lab.

This test is used by our OB Triage location to guide treatment decisions for patients who have a positive urine pregnancy test.

The lot numbers we were using in December are F18294 and F18320.

Terry,

Thank you for the information.

 

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