Abstract: Urine drug testing (UDT) is an important laboratory tool utilized in various healthcare settings to identify drug or toxic exposures. It has wide clinical applications, including but not limited to detecting substance misuse, monitoring treatment effectiveness and compliance, and identifying substances in affected patients. Depending on the clinical care setting and patient population, the UDT service model and practice are important decisions by the clinical laboratory to meet the needs of the healthcare providers. In addition, clinical laboratories must appreciate the testing process and unique aspects of this toxicology test, from specimen collection and integrity, testing methods, to the result reporting and interpretation. Each phase has specific quality requirements to ensure the accuracy and appropriate interpretation of results. This review aims to summarize the preanalytical, analytical, and postanalytical considerations of clinical laboratories when implementing the test or providing support to clinicians in point-of-care settings. To bring awareness of the limitations inherent to different analytical methodologies, this review discusses important considerations and presents the current gaps, opportunities, and recommendations for quality improvement and standardization. This article may serve as a framework for clinical laboratory directors and other laboratory professionals to review their current provision of UDT and provide recommendations on various important aspects when considering changes to the test service models to meet their local clinical needs, including when introducing new test methods. It may also help physicians and healthcare providers appreciate the complexities of UDT and recognize the challenges in clinical interpretation.
AACC Guidance Document on the Use of Point-of-Care Testing in Fertility and Reproduction
Abstract Background The AACC Academy revised the reproductive testing section of the Laboratory Medicine Practice Guidelines: Evidence-Based Practice for Point-of-Care Testing (POCT) published in 2007. Methods A panel of Academy members with expertise in POCT and laboratory medicine was formed to develop guidance for the use of POCT in reproductive health, specifically ovulation, pregnancy, premature rupture of membranes (PROM), and high-risk deliveries. The committee was supplemented with clinicians having Emergency Medicine and Obstetrics/Gynecology training. Results Key recommendations include the following. First, urine luteinizing hormone (LH) tests are accurate and reliable predictors of ovulation. Studies have shown that the use of ovulation predicting kits may improve the likelihood of conception among healthy fertile women seeking pregnancy. Urinary LH point-of-care testing demonstrates a comparable performance among other ovulation monitoring methods for timing intrauterine insemination and confirming sufficient ovulation induction before oocyte retrieval during in vitro fertilization. Second, pregnancy POCT should be considered in clinical situations where rapid diagnosis of pregnancy is needed for treatment decisions, and laboratory analysis cannot meet the required turnaround time. Third, PROM testing using commercial kits alone is not recommended without clinical signs of rupture of membranes, such as leakage of amniotic fluid from the cervical opening. Finally, fetal scalp lactate is used more than fetal scalp pH for fetal acidosis due to higher success rate and low volume of sample required. Conclusions This revision of the AACC Academy POCT guidelines provides recommendations for best practice use of POCT in fertility and reproduction.