Urine hCG on the Clinitek Status +
Looking into discrepant urine hCG results on our Clinitek Status + analyzers in our Emergency Room...
We had one false negative on a women in which fetal heartbeats were detected. Urine hCG in lab was positive. Quantitative hCG was >10,000.
About a week later we had two false positives. Patient 1 had a positive hCG in the ER on Saturday. She called back to state she had taken 3 at home pregnancy tests and all were negative. Returned to ER today and both urine hCG and quantitative hCG were negative. Patient 2 also had a positive urine hCG in ER. At that time they were questioning the validity of the results so they sent it to lab and it was negative.
I'm thinking this might be a cassette lot issue. Anyone have any suggestions? Siemens is essentially saying it is user error, which I question.
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James - in my investigation the instrument was powered off and on multiple times and never produced an error code or anything to indicate that there was something wrong with the test table. We also cleaned the calibration bar weekly and let it air dry as recommended. Unfortunately, cleaning weekly did not prevent our discrepant results. The test table was cleaned 5 days before our discrepant results were discovered.
Anyone have any suggestions on alternatives? Definitely on the market for a new platform!
Melissa - There is a new rapid blood-based hCG lateral flow test on the market today produced by a company called NOWDiagnostics. If you are interested, my email is morgan.peterson@nowdx.com and I would be happy to share more information with you. The test operates on a few drops of blood (capillary/or venous whole blood, plasma, or serum) so it will not be susceptible to false positive or negatives in the way that urine tests are. It also detects pregnancy down to 10 mIU/mL.