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AACC Releases New Guidance for POC Testing in Reproductive Health

NEW YORK – The American Association for Clinical Chemistry this week released updated guidance and recommendations for performing point-of-care tests for fertility and reproductive health.

The organization's original guidelines for point-of-care testing were published in 2007, but with the publication of new point-of-care testing studies, the original document needed to be updated, according to the new guidelines' authors. Instead of revising the entire guidance document, sections were prioritized for revision "to narrow the focus of the revision process and expedite publication of updated recommendations," they said. The first section was published in 2020 as the AACC Guidance Document on Management of POCT, and the newest section addresses the reproductive testing portion of the original document.

Among multiple recommendations, the organization said using only commercial test kits for premature rupture of membranes, or a patient's water breaking, isn't recommended without clinical signs that a patient's water has broken, such as leakage of amniotic fluid from the cervical opening. It added that results from the tests must be interpreted in the context of a patient's clinical presentation, but the authors also noted that multiple studies have shown that performance of commercial test kits is equal to or surpasses the performance of traditional testing methods.

Another recommendation involved the use of over-the-counter urine luteinizing hormone tests as predictors of ovulation. The organization said that the tests are accurate and reliable but noted that more studies are needed to understand the relationship between reproductive hormones and other factors affecting the menstrual cycle, such as body mass index, race, age, and environmental pollutants.

AACC also said that further study is necessary to determine the efficacy and usability of at-home ovulation prediction kits that use saliva or measure basal body temperature.

The organization said healthcare providers should consider using pregnancy point-of-care tests in situations where rapid diagnosis of pregnancy is necessary for treatment decisions, although blood laboratory pregnancy tests are the gold standard. The authors cited a scenario of a patient coming to the emergency department with unstable vital signs and symptoms indicating a ruptured ectopic pregnancy that could require surgery.

They noted, however, that urine point-of-care testing for pregnancy is limited to qualitative results and that the available quantitative whole-blood testing has limited reportable ranges.