Analytical sensitivity of four commonly used hCG point of care devices

• Published in: Clinical biochemistry Vol. 48; no. 6; pp. 448 - 452
• Main Authors: Kamer, Sandy M., Foley, Kevin F., Schmidt, Robert L., Greene, Dina N.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2015
• Subjects: Analytical sensitivity; Chorionic Gonadotropin - urine; False negative; False Negative Reactions; Female; Human chorionic gonadotropin (hCG); Humans; Limit of detection; Point of care (POC); Point-of-Care Systems; Pregnancy; Pregnancy Tests - standards; ROC Curve; Limit of detection; Analytical sensitivity; Human chorionic gonadotropin (hCG); False negative; Point of care (POC)
• ISSN: 0009-9120; 1873-2933
• DOI: 10.1016/j.clinbiochem.2014.12.015

Point of care (POC) hCG assays are often used to rule-out pregnancy and therefore diagnostic sensitivity, especially at low concentrations of hCG, is important. There are very few studies in the literature that seek to verify the claimed analytical sensitivity of hCG POC devices. The analytical sensitivity of four commonly used hCG POC devices (Alere hCG Combo Cassette, ICON 20 hCG, OSOM hCG Combo Test, and Sure-Vue Serum/Urine hCG-STAT) was challenged using urine samples (n=50) selected based on quantitative hCG concentrations. The majority of these specimens (n=40) had an hCG concentration between 20 and 200U/L. Each specimen/device combination was reviewed by three individuals. Statistical calculations were performed using Stata 12. The analytical sensitivity of the OSOM was significantly lower inferior than that of the other POC devices. There was no significant difference in the sensitivity of the Alere, ICON 20 and Sure-Vue devices. There was no significant difference in the individual interpretation of the hCG POC results. All hCG POC devices evaluated in this study were susceptible to false negative results at low concentrations of urine hCG. Laboratorians and clinicians should be aware that there are limitations when using urine hCG POC devices to rule out early pregnancy. •The analytical sensitivity of four hCG POC devices was evaluated.•All devices evaluated were susceptible to false negative results.•The OSOM had the poorest analytical sensitivity.