AACC has issued a new guidance document with expert recommendations for performing point-of-care tests for fertility and reproductive health. As the use of point-of-care testing rises in these fields, this guidance is intended to ensure that patients and their babies fully benefit from it.
Point-of-care tests are clinical tests that are performed near the patient instead of in a central lab. Due to their convenience and rapid turnaround times, these tests can help patients to get treatment much faster than traditional tests.
As a result, the use of point-of-care testing has risen steadily in all areas of healthcare. In the fertility and reproductive health fields in particular, it is now used for everything from predicting ovulation and diagnosing pregnancy to managing premature rupture of membranes (PROM)—also known as a patient’s water breaking—and high-risk deliveries. However, when point-of-care tests are used inappropriately or performed incorrectly, this can lead to unnecessary follow-up tests and procedures and can even put the patient’s health at risk or lead to death. As just one example of this, FDA has reported infant deaths as a result of PROM test misuse.
AACC has updated guidance that it originally published in 2007 to inform healthcare professionals of the most current best practices for point-of-care testing in reproductive medicine. Highlights of the key recommendations from this document are as follows:
- Testing for PROM using commercial kits alone is not recommended without clinical signs that a patient’s water has broken. Additionally, results from these tests must be interpreted in the context of a patient’s clinical presentation to prevent patient harm.
- Urine luteinizing hormone tests are accurate and reliable predictors of ovulation. These tests can improve the likelihood of conception among healthy fertile women and can also be used to time certain assisted reproduction procedures. However, further study is still needed to determine the efficacy of at-home ovulation prediction kits that use saliva or measure basal body temperature.
- While blood laboratory pregnancy tests are the gold standard, healthcare providers should consider using pregnancy point-of-care tests in situations where rapid diagnosis of pregnancy is needed for treatment decisions. One such scenario is if a patient presents to the emergency department with unstable vital signs and symptoms indicative of a ruptured ectopic pregnancy that might require surgery.
“Point-of-care testing is growing in popularity as a means of delivering faster turnaround time of test results closer to the patient,” say the guidance document authors Drs. James H. Nichols, Mahesheema Ali, John I. Anetor, Li-Sheng Chen, Yu Chen, Sean Collins, Saswati Das, Sridevi Devaraj, Lei Fu, Brad S. Karon, Heba Kary, Robert D. Nerenz, Alex J. Rai, Zahra Shajani-Yi, Vinita Thakur, Sihe Wang, Hoi-Ying Elsie Yu, and Lindsey E. Zamora.
“Guidance is needed for optimizing the implementation of [point-of-care testing] in patient care. This guidance document revises previous recommendations and offers best practices for the use of [point-of-care testing] in fertility and reproductive health,” they added.