None listed
Conditions
Brief summary
This study aims to investigate the utility of the use of whole blood for point of care testing for B-hCG to rapidly differentiate pregnant and non-pregnant patients. This is important in time-critical conditions such as ruptured ectopic pregnancy. It would also expedite things in the situation where medical imaging involving ionising radiation is delayed until pregnancy can be excluded. The current testing options are a urine point of care test, or a serum sample sent to the pathology lab. The point of care test pack inserts state that whole blood cannot be used with them, but in practice they have been used that way and expedited decision-making. A convenience sample of female patients of reproductive age presenting to the Emergency Department who would typically have their pregnancy status checked, will be recruited to the study. A whole blood B-hCG (point of care), a urine B-hCG (point of care), and a serum sample for quantitative hCG will be tested. The blood sample will be sent to pathology for a quantitative serum B-hCG result, and will be used as the standard for comparison. A result of <1.2 units/L is a negative pregnancy test. The results from the urine and whole blood point of care tests will be compared against this, to determine their sensitivity and specificity in a separate analysis. The time taken to obtain a result from the point of care B-hCG testing using urine and whole blood will be compared against the time taken to obtain a result from the sample sent to the lab. We will then be able to compare the differences between length of time taken to obtain a urine or blood sample, and the differences between length of time taken to obtain test results for each of these samples.
Interventions
Comparison of time taken to obtain results from urine and whole blood testing using point of care B-hCG testing cartridges, and blood samples sent to the lab for serum testing.
Blood drawn from the patient will be sent to the lab for testing as per our usual practice. The time taken to obtain a result since the patient's presentation to the Emergency Department will be calculated. Three drops from that sample drawn will be tested using the bedside BhCG test cartridge, and the time taken to obtai
Comparison of time taken to obtain results from urine and whole blood testing using point of care B-hCG testing cartridges, and blood samples sent to the lab for serum testing. Blood drawn from the patient will be sent to the lab for testing as per our usual practice. The time taken to obtain a result since the patient's presentation to the Emergency Department will be calculated. Three drops from that sample drawn will be tested using the bedside BhCG test cartridge, and the time taken to obtain a result from that since the patient's presentation will be calculated. When the patient is able to provide a urine sample, the urine will be tested using the bedside BhCG test cartridge, and the time taken to obtain a result from that since the patient's presentation will be calculated. These times will then be compared to find which is the most efficient method to obtain a BhCG result, and if there is a difference depending on time of day of patient presentation. Clinicians are likely to be aware of the results from the urine and whole blood point of care tests, but only the lab serum B-hCG result will be used to determine patient care.
Sponsors
Mater Adult Hospital Brisbane Emergency Department
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Females of reproductive age (18-50) presenting to the Mater Adults Hospital Emergency Department Patients who will have their pregnancy status tested as part of their usual care given their presenting complaint
Exclusion criteria
Patients who do not consent or withdraw consent from the study.
Outcome results
None listed