FAQ – PRO•Mcomplete™  

Q: Does the specimen collection have to be taken using a speculum?

A: No, the specimen collection can be taken with or without a speculum.

Q: Once the swab has been placed in the extraction buffer how long is the sample good for?

A: The sample is good for 6 hours at room temperature.  This is ideal for locations that are running the test in the laboratory as it’s sufficient time to get the sample to the laboratory.

Q: Can the PRO·Mcomplete™ be used in the presence of blood?

A: Yes, the PRO·Mcompletesample can contain up to 2% of blood, making it a robust test in the presence of blood. (See IFU for details). You would not use this test in the case of a heavy bleed but certainly in cases of a previous bleed or blood present.  Too high a concentration of blood (generally >10% of sample) can lead to a false positive result.

Q: Can the PRO·Mcomplete™ be used in the presence of interfering substances?

A: Yes, the PRO·Mcomplete™ can be used in the presence of blood, semen, urine, vaginal mucus, and hygiene products.  Only blood at higher concentrations had an effect and could lead to a false positive result.

Q: Can I use the PRO·Mcomplete™ following a vaginal ultrasound with lubricant?

A: Technically the answer is yes.  However, we recommend that the PRO·Mcomplete™ test be performed prior to the ultrasound.  This would eliminate concern that the remaining lubricant in the vagina could affect how much vaginal fluid the swab absorbs.

Q: What is the advantage of measuring 2 proteins and on two distinct lines?

A: Adding AFP increases the sensitivity of IFGBP-1 alone. By providing the proteins on 2 separate lines the test provides more clinical information on which to help base a diagnosis.  Further, AFP is more stable than IGFBP-1 and thus can be detected longer after ROM.

Q: Should I base a PROM diagnosis on the PRO·Mcomplete™ results alone?

A: No, there is still no universally accepted single test on which to base a PROM diagnosis.  PRO·Mcomplete™ results should be used in conjunction with clinical indications of rupture of fetal membranes.

Q: Does PRO·Mcomplete™ meet POC and Laboratory accreditation requirements?

A:Yes, each cassette has an internal control line to ensure that the user has applied the sufficient specimen volume and the correct procedure has been followed. The test should be repeated if the control line does not appear. 

There is an external positive control available, and the negative control can be achieved by opening a pouch and adding 3 drops of the extraction buffer to the cassette. 

For new users, it is recommended that Quality Control be performed on a per box basis so that the user can become familiar with the product and interpreting the results. After which, the standard Q.C. regiment should be performed on a per LOT basis.
Further, training Education Power Points are available.