In September, AACC issued new guidance for point-of-care testing (POCT) for fertility and reproductive health. This new document replaces previous guidance set out in 2007 and incorporates advancements in knowledge about the accuracy of these kinds of tests. It also addresses the fact that usage, acceptance, and even preference for this technology is surging.
“Point-of-care tests can be a powerful tool to help patients and their babies across reproductive and fertility medicine. They can help people better understand their menstrual and ovulation cycles, whether they’re trying to conceive or avoiding pregnancy,” said James H. Nichols, PhD, DABCC, FADLM, professor of pathology, microbiology, and immunology at the Vanderbilt University Medical Center, and editor of the updated guidance. “But if point-of-care tests are used incorrectly or inappropriately, they can lead to unnecessary treatment or put a patient’s life at risk. We hope these guidelines can help guide clinicians on the best way to use these kinds of tests.”
The guidance was developed by a committee of experts with interest and experience in POC and laboratory testing. The committee members created clinical questions related to the use of POCT in the assessment of ovulation, pregnancy, premature rupture of membranes (PROM), and evaluation of fetal distress. They then surveyed peer-reviewed literature that could address each clinical question, including publications on test performance, sensitivity, and potential interferences. They also reviewed guidance documents from other professional organizations such as American College of Obstetrics and Gynecology.
The new AACC guidance is also written with increased use, acceptance, and trust of POCT in mind, as patients have gotten used to doing things like testing for SARS-CoV-2 in a clinic or home setting.
“Point-of-care testing is popular because it’s convenient and easy to use. In some cases, it’s accessible directly by the patient,” said Zahra Shajani-Yi, PhD, DABCC, FADLM, NRCC-CC, technical director of chemistry for Labcorp’s San Diego regional laboratory and national codiscipline director of routine and esoteric immunoassays, and coauthor on the new guidance. “As that use has increased, it is incredibly important to know in what situations point-of-care testing should be used, and what these tests’ limitations are.”
That applies to POCT both in and outside of reproductive health.
THREE AREAS TO WATCH IN THE UPDATED GUIDANCE
Authors of the new guidance highlighted three key areas that have been updated and that laboratory medicine professionals should discuss with clinicians:
Testing for PROM. PROM is defined as rupturing of the amniotic sac prior to the onset of labor. It complicates 2%−3% of pregnancies in the U.S. and increases the risk of preterm birth, which is why POCT could be useful in helping clinicians to accurately diagnose PROM and deliver swift care. However, the new AACC guidance cautions that using commercial kits for PROM alone is not recommended without clinical signs that a patient’s water has broken, such as leakage of amniotic fluid from the cervical opening. “There needs to be clinical context, not just a test alone,” said Shajani-Yi.
The updated AACC guidancealso includes tables on the effectiveness of different POC PROM tests with respect to different clinical diagnostic criteria. “Having something like that is very useful for clinicians,” she added.
Use of urine luteinizing hormone tests for ovulation. Authors of the new guidance found that home tests accurately and reliably predict ovulation and can improve the likelihood of conception among healthy fertile women. These tests also can be used to time certain assisted reproduction procedures.
In addition, the guidance covers how POCT can pinpoint the day of ovulation, which may vary greatly between patients. For example, the average menstrual cycle is 22 to 37 days, with ovulation occurring at any point from day 8 to 26.
“These guidelines have been updated with new studies to show this range, and can be used in discussion about where point-of-care testing can be useful,” said Shajani-Yi. “Having this information demonstrates some of the nuances and background on how these tests should be used.”
Use of pregnancy POCT. While laboratory pregnancy tests are the gold standard in determining pregnancy, the new guidance urges healthcare providers to consider using pregnancy POCT in situations where rapid diagnosis is needed for timely treatment decisions. For example, if a patient presents to the emergency department with unstable vital signs and symptoms of a ruptured ectopic pregnancy that might require surgery, a POC pregnancy test can give a result in minutes.
“We focused on the use of point-of-care testing in emergency management because time can really make a difference in these scenarios,” said Nichols. POC pregnancy tests can also ensure that any procedures that are potentially dangerous to a fetus, such as X-rays, are not performed on patients who could be pregnant, no matter what they came to the emergency department for. This is also why the new guidance should be shared not just with clinicians focusing on fertility and reproductive health, but also with emergency medicine healthcare professionals, he added.
POCT ON THE UPSWING ACROSS MEDICINE
The new AACC guidelines are especially important in a healthcare world where POCT has become more popular, and even expected, because of the pandemic. If someone is comfortable testing themselves for SARS-CoV-2 at home, they will be comfortable self-administering other kinds of tests.
And it’s just the start, said Nichols. “There will absolutely be more. This is not the end. We see requests for testing on the rise, and spreading out of the hospital into the community, so I think this is certainly an up-and-coming field.”
That’s especially true in reproductive and fertility medicine. According to the market research company Technavio, the fertility testing device market share is expected to increase to $153.91 million by 2026, with an annual growth rate of 5.73%. Technavio considered ovulation predictor kits, fertility monitors, and male fertility testing devices in their report. And these devices represent just a piece of the expected POCT pie. By 2028, the global POC market is expected to reach $65 billion, according to Research and Markets.
Nichols predicts that the next big wave of innovation will be molecular diagnostics. “With COVID, testing has moved outside of the hospital and microbiology laboratory and into the community,” he said. “We’re using it in the emergency department, in clinics, and patients are using SARS-CoV-2 antigen tests in their homes. We’re trusting those home diagnostics more.”
The trust with home tests has changed for both patients and physicians. “Before, when you walked into your physician and said my home pregnancy test is positive, they immediately redid it because they didn’t trust it,” he said. “Now if you walk in and say, ‘My COVID test was positive,’ they believe patients and the test and don’t necessarily redo it.”
Shajani-Yi said that this increased use and popularity of POCT means that guidelines like these and others from AACC will become even more critical to ensure the best patient care in the future. “It’s really important that we continue to publish guidelines that clearly review the current literature and describe the clinical use benefits and limitations and nuances of each method,” she said.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +Twitter: @byJenAMiller