Validity Of Point of Care Pregnancy Testing in the ED Using Serum From Whole Blood Collected At Bedside Linh T Le, M.D. PGY III Division of Emergency Medicine Saint Louis University, School of Medicine

Disclaimer We would like to thank Sekisui Diagnostics for their donation of the pregnancy test assays. There was no monetary funding from the company for the study.

Study Team Authors and Co-Investigators Preeti Dalawari, MD, MSPH Kamal Gursahani, MD, MBA Eric Lee, MD Katrina Wade, MD We would like to acknowledge: ED nursing staff, attendings, residents and medical students

Background POCT urine pregnancy Most common practice Urine can be unobtainable, take time Serum hCG laboratory test Increased cost Prolonged time POCT serum pregnancy Easy to perform May be faster in certain situations NOT a CLIA waive test

Study Objectives 1.Demonstrate validity of POCT serum pregnancy to the current standard of care: POCT urine pregnancy test Serum hCG qualitative/quantitative laboratory test Obvious ultrasound evidence of IUP 2.Compare the tests metrics to see if there is a difference

Hypotheses 1.We hypothesized that POCT serum pregnancy test can be as reliable as the POCT urine pregnancy test and serum hCG laboratory test. 2.We also hypothesized that POCT serum pregnancy test may be more efficient in certain clinical scenarios

Study Design IRB approved, single site cross sectional study at Saint Louis University Hospital All enrolled patients signed informed consent and HIPPA forms All of the samples were tested via POCT serum (study test) and a standard of care test

Study Design  Blood sample obtained from patient in a tube with no anticoagulants/additives  Sample was placed up right allow to separate by gravity for >20 mins  Both the POCT urine and serum samples were applied to the OSOM hCG Combo Test Sensitivity ›20 mIU/mL Urine ›10 mIU/mL Serum Timing ›3 minutes for urine ›5 minutes for serum

Study Design Estimated pregnancy prevalence of 8% in the study population A sample size of 210 subjects is needed to achieve 80% power at a 5% alpha level using a two-sided equivalence test of correlated proportions

Preliminary Results  76 patients enrolled thus far  Mean age: 28.4  Standard deviation 7.5  22% of the patients were pregnant.

Preliminary Results POCT serum compared to POCT urine  100% sensitivity and 100% specificity POCT serum compared to laboratory serum hCG  100% sensitivity and 100% specificity POCT serum compared to bedside ultrasound  100% sensitivity and 100% specificity

Preliminary Results Time of test order to time of results POCT urine –Average time: 51 minutes –Standard deviation: 42 minutes POCT serum –Average time: 97 minutes –Standard deviation: 47 minutes

Limitations May not be true representation of the ED care timeline as consent has be to obtained prior to using patient’s already collected blood – this may increased the “order to result” time for POCT serum test

Limitations Limited by using only the OSOM hCG Combo Test, it is possible that different manufacturer’s assays may have different results

Conclusion POCT pregnancy test using OSOM hCG Combo Test can be done reliably using serum blood at the bedside

References Davies S, Byrn F, Cole LA. Human chorionic gonadotropin testing for early pregnancy viability and complications. Clin Lab Med Jun;23(2):257-64, vii. Fromm C, Likourezos A, Haines L, Khan AN, Williams J, Berezow J. Substituting Whole Blood for Urine in a Bedside Pregnancy Test. J Emerg Med., 2011 Aug 27. Habboushe JP, Walker G. Novel use of a urine pregnancy test using whole blood. Am J Emerg Med Sep;29(7):840.e3-4. Epub 2010 Aug 13. Lee-Lewandrowski E, Corboy D, Lewandrowski K, Sinclair J, McDermot S, Benzer TI. Implementation of a point-of- care satellite laboratory in the emergency department of an academic medical center. Impact on test turnaround time and patient emergency department length of stay. Arch Pathol Lab Med Apr;127(4): Lewandrowski K. How the clinical laboratory and the emergency department can work together to move patients through quickly. Clin Leadersh Manag Rev May-Jun;18(3): Lazarenko GC, Dobson C, Enokson R, Brant R. Accuracy and speed of urine pregnancy tests done in the emergency department: a prospective study. CJEM Oct;3(4): Cole LA, Ladner DG. Background hCG in non-pregnant individuals: need for more sensitive point-of-care and over- the-counter pregnancy tests. Clin Biochem Feb;42(3): Epub 2008 Oct 2. Plerhoples W, Zwemer FL Jr, Bazarian J. Point of care pregnancy testing provides staff satisfaction but does not change ED length of stay. Am J Emerg Med Oct;22(6): Von Lode P, Rainaho J, Pettersson K. Quantitative, wide-range, 5-minute point-of-care immunoassay for total human chorionic gonadotropin in whole blood. Clin Chem Jun;50(6): Epub 2004 Apr 8.

QUESTIONS