Clinitek Pregnancy tests

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Hello,
Has anyone that is running pregnancy tests on the Clinitek (Clinitest) noticed an increase in Borderline results?
TYIA,
Reine

9 Replies

SHANEECE NORRIS

Wed Sep 10, 2025 at 10:43AM

Yes. Due to this ( and other issues) we have discontinued use and only use the Clinitek for Urinalysis. Went back to visual read

Alma Knudson

Wed Sep 10, 2025 at 11:40AM

I used it in the past in my previous organization but I changed to another product because its sensitivity is > 25 mIU/mL and there are products out there that is > 20 mIU/mL and it makes a lot of difference. The only benefit to Clinitest is its ability to be interface using the Clinitek but if you are manually entering the result in your EMR, its worth looking at those that is sensitive > 20 mIU/mL. I have all of my Cliniteks interface to our EMR but I did not use the pregnancy kit because of the lower sensitivity.

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
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Kari Echtenkamp

Wed Sep 10, 2025 at 11:49AM

My organization is in the process of trying to implement urine Hcg on our Clinitek devices for our outpatient sites. How are others handling the Borderline results? We were thinking of writing our policy to say staff can perform the test a 2nd time on the Clinitek and if the result is still borderline, then its equivalent to an "invalid" result and testing must be performed via another method (send urine to clinical lab or draw serum and send to clinical lab). Does anyone have Telcor QML for their Clinitek hcg tests? Do these borderline results come into your QML?

Karin Gehringer

Wed Sep 10, 2025 at 11:55AM

We had this exact problem a while ago with this method! The root cause was that staff were not hitting "Start" first and then loading the cassette. Please check that your SOP is written correctly and they're following it. Then do observed patient testing to ensure that staff are doing things in the right order. Turned out that they weren't. This resolved it for us!

Karin Gehringer

Wed Sep 10, 2025 at 12:00PM

hCG Do It Right chart.pdf

I recommend already having the urine drawn up into the pipette, then hit Start, and then dispensing the urine into the cassette.

Patsy Gunn

Wed Sep 10, 2025 at 12:22PM

at our facility we have used Clinitek preg for 5 years. We chart the borderline result - the clinician then orders a serum HCG. Out of 930 so far this year we have had 6 borderline (4 in january, 1 in feb and 1 in May). I too believe it is important to press start and then add sample - follow the IFU. These borderlines resulted in lab with quants of 5, 21, 3 and <1's - so some minimal HCG quant often detected in main lab. I have seen borderlines with quants of 14 and 12 several times through the years. The 4 in Jan are interesting as I have thought HMM may be lot issue?? Overall I have been very impressed with this test. There are virtually no false negatives which is what is needed for a screening test for preg. So nice to have autofiling and not have to police the input of the lto number, exp date and internal controls.

James Beck

Wed Sep 10, 2025 at 12:33PM

100% agree with Patsy's comments above. The value appreciated in having automated processing of results far outweighs an occasional borderline result, and also to her point, the real danger here is a false negative, not a false positive, and the method excels at that. In addition to operators observing the proper order of testing ("Start" button, then add sample), it is also worth mentioning that cleaning the white calibration bar (including drying it, so there is no water film), is often at the root of increased occurrences in borderline Clinitek results,

Sherilyn Solanick

Fri Sep 12, 2025 at 10:47AM

Many years ago I had the experience of a false negative reported on a manual read and the patient went to surgery. I agree with James and Patsy. Any borderlines are sent to the lab for quant.

Kate H

Wed Sep 17, 2025 at 9:29AM

We've had 3 indeterminants in the last week in our main lab (run by CLS, not as POC), all came back the same on repeat. Our UA lead thought it was weird and submitted them to the manufacturer.

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Clinitek Pregnancy tests