International Product: The QuikCheck™ fFN Test

The QuikCheck fFN Test is not approved for sales and marketing in the U.S. or licensed for sale in Canada.

The QuikCheck Fetal Fibronectin Test is a simple, reliable test that determines the risk of preterm birth. The 10-minute, one-step, visual test consists of a sterile polyester-tipped applicator, fetal fibronectin test strip, and sample extraction buffer. The clinical use of fetal fibronectin in supported by over 120 peer-reviewed publications.

Interpreting test results

• A positive (+) patient result will appear as two lines: a test line and a control line. The presence of a very light test line should be interpreted as a positive result.

  

• A negative (-) patient result will appear as one distinct line: a control line.

  

• The absence of a distinct control line should be interpreted as an invalid result.

  

For accurate patient results

• Specimens should be obtained prior to digital examination or manipulation of the cervix. Manipulations of the cervix within 24 hours of collection may lead to false positive results.
• Care must be taken not to contaminate cervicovaginal fluid with topical agents such as lubricants, disinfectants, or creams (e.g. K-Y® Jelly lubricant), Betadine® disinfectant, Monistat® cream, hexachlorophene). These substances may interfere with the specimen collection process and/or the antibody-antigen reaction of the QuikCheck fFN Test.
• Precaution should be taken when the patient has had sexual intercourse within 24 hours as this can cause false positive results. However, even when a patient reports having had intercourse in the previous 24 hours, a negative fetal fibronectin test result is valid.
• Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested.