False Positive Urine Pregnancy Tests - SURE-Vue Urine kits

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Hello
Has anyone had any problems with false positive urine pregnancy tests using the SURE-VUE Urine hCG kits? This is across multiple lot numbers and deliveries starting back in August until recently. I have a number of cases open with Abbott regarding this issue.
Although the kits are branded Fisher they are manufactured by Abbott as are the Cardinal Urine hCG kits...........so if there are problems with the Cardinal kits, I would be interested in seeing if there are issues with this kit also.

Will probably be replacing the kits for our organization....looking at OSMO Ultra kits as they are manufactured by Sekisui. I'd like to hear from anyone using this product.
Thank you

5 Replies

Lucy Messick

Thu Oct 24, 2024 at 10:36AM

Following this discussion as we have had three false positives with the Beckman Coulter Icon 25 within the last month. Provider followed up with all three patients and neither of them have the conditions that would cause a false positive according to the package insert. Contacted the manufacturer but they provided no additional information. I am wondering if this is the beginning of an issue as there was an adverse event reported on the Icon 20 test fairly recently.

Kari Echtenkamp

Thu Oct 24, 2024 at 10:48AM

Following the discussion. My organization has used the StanBio QuPID urine pregnancy test for the 8 years I've been in POC and we haven't had any issues. I would recommend that brand if you're looking to switch.

Amanda Reeves

Thu Oct 24, 2024 at 11:39AM

We had an issue with Medline hCG COMBO+ Pregnancy tests earlier this year. False positives across multiple lot numbers and shipments. We switched to OSOM hCG Combo Test back in February and haven't had any issues so far.

Amanda Casavant

Thu Oct 24, 2024 at 12:11PM

Pulled the CAP list of urine pregnancy tests so we can choose kits with good peer group data.
The following kits from various companies (called tech support numbers listed on package inserts and all went to Abbott Rapid Diagnostics, and all have same package insert information bibliography, performance characteristics, etc.

Sure-vue Urine hCG
Cardinal hCG Cassette Rapid test
McKesson Medi-Lab Performance Combo
Beckman Coulter ICON25 hCG has the same package insert but the tech support # goes to Hemocue.

Sophia Margaret Spartman

Thu Oct 24, 2024 at 2:47PM

Following this discussion. We are having the same issue this week with the Mckesson Consult HCG kit which is produced by Abbott. I just got done opening an investigation on this kit with Abbott today.

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Topic	Replies	Views	Participants	Last Reply
False Positive Urine Pregnancy Tests - SURE-Vue Urine kits Amanda Casavant about 5 hours ago	5	142	+ 2 more	Amanda Casavant about 1 hour ago
Future Diagnostics IOPTH Test System-Import Issue Catherine Acklen 1 day ago	6	190	+ 1 more	Catherine Acklen about 6 hours ago
CLIA Lab Director Site Visit Form/Checklist Lori Pattison 3 days ago	0	254		Lori Pattison

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False Positive Urine Pregnancy Tests - SURE-Vue Urine kits