Nitrazine pH versus ROM Plus

WE have switched to Amnisure ROM about 6-7 years ago.  It was not hard to convince the doctor that this test is more specific  than the Nitrazine pH test.  
We were using Prolab Amniotest ( NItrazine pH in a stick) for  more than 8-10 years. 
Amnisure is more costly but we  did not have as many  false positives as the Nitrazine pH 

We switched from Nitazine pH to Clinical Innovations ROM about 3 years ago.
We were challenged to make the change away from the "Gold Standard" of nitrazine testing which was how it described to us by the physicians.  We had a number of meetings with them including the Lab Director to review the differences: more sensitive, more specific, less contamination problems. 

After we made the change we needed to review with some of the physicians that the test was a screen and not diagnostic, still needed to review the whole clinical picture.  The test is so sensitive that it will pick up the smallest leak and report a positive,  This is something that some women occasionally do as they get closer to their delivery date, leak a little and then it stops.  The vendor came in and reviewed the test with the staff at different facilities a couple times within the first year.

I work at a women's hospital and would suggest that you do not do away with your nitrazine testing.  The ROM testing kits are not made to be a stand alone test.
The physician is to use other clinical information in the decision as we all know, there can be false positives and negatives in any test method.
"The FDA has received information that indicates healthcare providers may be relying solely on ROM test results when making critical patient management decisions, despite manufacturers’ labeling instructions that ROM tests should not be used on their own to independently assess whether a ROM has occurred. The FDA reviewed these devices through its premarket clearance pathway and concurred with the manufacturers’ labeling recommendations warning providers to not use these tests independently."https://www.fda.gov/news-events/press-announcements/fda-alerts-healthcare-providers-women-about-risks-associated-improper-use-rupture-membranes-tests.  The nitrazine test can be another "tool" a physician can use in decision making.

The nitrazine test is also not made to be a stand alone test, it is also less specific, less sensitive and has more interfering substances.  Physicians using the ROM as a sole decision maker is an educational issue.

There is the potential argument to be made that the ROM test kits are TOO sensitive, or at least from what the physicians are use to when comparing to the nitrazine test.  But then again, it is a screening test and its better to error on the side of caution.

Thank you all for your input, much valued!

Hello,

This is a late reply, but our hospital OB Triage group uses an algorithm that relies on nitrazine, ROM+ and fern testing.

Patsy,   We had paper document for the Amniotest QC.  with Lot# Expiration date, results, etc. 
I am glad we do not have to do this test anymore. 

Thomas Nichols- would you be willing to share that algorithm?  Thanks!

Protocol and Flow Chart for Amnio, Fern and ROM.docx

Colleen Chiappa - see attached.  I included some snips from the clinical protocol to support the flow chart.