Premature rupture of membranes (PROM) is a condition describing the rupture of chorioamniotic membrane during pregnancy, resulting in amniotic fluid leaks. It may occur at term, just before onset labour, or during the preterm period, meaning before the 37th week of gestation. Out of these types of ROM, preterm PROM has the greatest potential to cause serious complications such as neonatal sepsis, umbilical cord prolapses, and possibly fetal death. Thus, it is of great importance to detect amniotic fluid leaks as early as possible, for better management of preterm PROM.
Diagnosis of PROM can be through physical examination, or laboratory tests. Nitrazine test is one of the more common laboratory techniques that can be conducted as a point-of-care (POC) test. Nitrazine is a dye that can be impregnated into paper strips and used to test pH in vaginal fluid. A change in pH is a good indicator of PROM as normal vaginal pH is approximately between 4.5 and 6, while amniotic fluid has a higher pH range, between 7.1 and 7.3. If there is leakage of amniotic fluid, an increase of pH will be seen, and the Nitrazine strip will turn blue. It must be noted that interfering substances such as blood or semen can also falsely raise the pH of vaginal fluid, and there might be subjectivity in interpretation of colour changes as well.
Oneworld Accuracy has been offering the NITZ431 (Nitrazine) program for a number of years, and we will be adding a new format of this program starting in 2020. NITZ432 will be offered with three test events a year, with two samples provided per test event. The test event dates remain the same as the NITZ431 format, and each sample consist of 2mL of aqueous solution. The increased number of samples means we can provide a greater variety of samples to participants. This program can be ordered online by logging in to OASYS and accessing our online catalog or by contacting our Oneworld Accuracy Support team.