None listed
Conditions
Brief summary
Anecdotally, whole blood can be used on point of care cartridges for rapid determination of a patient's pregnancy status. Early identification of pregnancy status is important in the case of females of reproductive age with abdominal pain, as the possibility of a pregnancy (including an ectopic pregnancy) can be quickly included or excluded. The manufacturers of the point of care testing cartridges, however, state that these can only be used with urine or serum, both of which there is often a delay in obtaining. This study aims to validate the use of whole blood for rapid point of care investigation for pregnancy. The hypothesis is that the whole blood point of care testing will have similar sensitivity and specificity to lab serum testing for detection of pregnancy.
Interventions
The study aims to validate the use of whole blood for point of care testing to quickly determine a patient's pregnancy status. 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 wou
The study aims to validate the use of whole blood for point of care testing to quickly determine a patient's pregnancy status. 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. All samples will be collected and tested as soon as practically able after the patient has been triaged into the Emergency Department, in keeping with routine practice. Urine samples will be collected as soon as the patient is able to provide them, and tested as soon as able following that. Blood samples (which will be used for both point of care B-hCG testing and the lab serum test), will be drawn as soon as the phlebotomists or clinicians are able to draw blood from the patient. 3 drops of the blood obtained will be tested using the bedside point of care B-hCG test immediately, and the rest will be sent to the lab for testing, as per current practice. There will be no predetermined order of obtaining the samples. The point of care test kit that will be used is the Alere TestPack Plus hCG Combo, which has a manufacturer stated sensitivity and specificity of 99%. The serum sample will be sent to pathology for a quantitative B-hCG result, and will be used as the standard for comparison. A result of <1.2 units/L is a negative pregnancy test. A result of >1.2 units/L is a positive 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.
Sponsors
Mater Adult Hospital 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
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Female Childbearing age (16-50 years old) Would have serum B-hCG tested as part of usual care
Exclusion criteria
Younger than 16 years old - not seen at this facility Patients who do not wish to participate in the study
Outcome results
None listed