Quidel Sofia Urine hCG test results

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Has anyone encountered discrepant urine hCG test results using the Quidel Sofia Instrument?


We use the Sofia for hCG in our Amb Surg areas and within the past year we have had 6 false positive results (5 at one location and 1 at another). When the test is repeated on the same or another instrument the test result is negative. Blood hCG tests are negative also.


I have contacted Quidel for each issue and have replaced the instrument, test kit lot#, added a UPS and had a specialist come in to observe the operators. After all of this yesterday we got another false positive result.


Although Quidel has been very helpful and has worked up each incident they cannot explain the discrepancy in results.


 If anyone has had a similar experience can you please reply to this discussion or email me personally.


Thanks in advance for your help.


Linda Bourke


Westchester Medical Center


Linda.Bourke@wmchealth.org

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Not familiar with errors with the Quidel instrument per se, but I know we have experienced (plus I have also read similar posts on this page) regarding errors like this with Siemens Clinitek STATUS.  False positives that either do not confirm on repeat testing or do not confirm with serum tests.


 


While it's sort of good to hear the problem isn't limited to just Clinitek devices, it's distressing that such a simple test is encountering these type issues.

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linda bourke
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