Abstract

Khadija Shukaili62285*

Objective: Point-of-care pregnancy testing is widely used in emergency departments. Three prior studies demonstrated the accuracy of whole blood compared with urine in bedside pregnancy tests. Our study demonstrates the accuracy of the available point-ofcare kit, which differs from previous studies. The primary aim of this study was to assess the sensitivity, specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV) of whole blood in bedside pregnancy tests at three levels of serum beta hCG (5, 10, and 25 mIU/mL). The secondary aim was to get the reading time difference using whole blood versus laboratory serum human Chorionic Gonadotropin (hCG).

Materials and methods: Healthy females of 12-50 years old who required a pregnancy test for diagnostic studies or treatment were included in the study. A triage nurse or phlebotomist drew 5 ml of blood from the patients who met the inclusion criteria. A few drops were applied to an SD bioline bedside hCG test. The results were read after five minutes, and the laboratory technician processed the remaining blood. The nurse who read the SD bioline hCG whole blood tests and the laboratory technician who processed the quantitative serum hCG tests were blinded to each other, and the reading time was recorded for both methods. The SD bioline hCG whole blood test results were compared according to three quantitative serum hCG levels (5, 10, and 25 mIU/mL).

Results: Of the 278 patients in the study, 130 patients (47%) had a serum hCG level of ≥ 5 mIU/mL, 125(44%) had a serum hCG level ≥ 10 mIU/mL, and 123(44%) had a serum hCG level ≥ 25 mIU/mL. The sensitivity and negative predictive values were  90% and 91.93%, respectively, at serum hCG levels ≥ 5 mIU/mL. At serum hCG levels ≥ 25 mIU/mL, the sensitivity and negative predictive values  were  95.12% and 96.27%, respectively. The specificity and positive predictive value were 100% at serum hCG levels of 5, 10, and 25 mIU/mL. Our study showed a time savings of 70 minutes with the use of whole blood compared with laboratory serum hCG, with a p-value <0.05.

Conclusion: The SD bioline hCG whole blood test can rapidly detect early pregnancy with high sensitivity, specificity, NPV, and a PPV with threshold of 10 mIU/ mL.