This is an observational prospective study. The main purpose is to evaluate the stability of the Bilistick system in a humid and hot climate compared to the quantitative test for serum bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a controlled environment. The secondary aim is to assess the operational feasibility of the Bilistick system in a tropical limited-resource setting, when used by locally trained nurses.
Study procedure: 1. SBR will be measured in parallel with two tests during three distinct seasons. (Cold, hot, rainy). The Blood is from an extra capillary sample taken from a single heel prick done for routine SBR) BR-501 total bilirubin meter, the quantitative test for SBR currently used, will be kept in a controlled environment while the new bilirubin test (Bilistick system) will be exposed to tropical conditions. 2. Trained nurses will use the Bilistick system observed by a qualified laboratory technician; Usability of the Bilistick system by the trained nurses will be evaluated via a 5-point Likert scale questionnaire and focus groups discussions.
Study Type
OBSERVATIONAL
Enrollment
180
* One full capillary tube (50µl blood) will be used to measure the Hct level and the routine SBR using the BR-501 bilirubin meter machine (non-study procedure). * An additional half- filled capillary tube (25µl blood) will be used for the SBR measurement with the Bilistick system
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, Thailand
Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons
The main outcome of interest is the potential effect of environmental conditions on the quantitative outcome of the Bilistick System, using BR-501 bilirubin meter machine as a reference. The Bland-Altman analysis will be used to compare the two tests.
Time frame: 18 months
Within each season, evaluation of the impact of temporal variation on the agreement of serum bilirubin measurement between the two tests.
A linear regression analysis will be done to look for statistically significant effect of exposure time on the difference between the average total bilirubin serum levels of the two tests.
Time frame: 18 months
Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions
5-point likert scale questionnaire will be filled individually by the trained nurses at the end of each defined season. Quantitative variables related to the secondary outcomes will be measured with the mean, median and ratio according to the distribution of the variable and compared with appropriated statistical test.
Time frame: 18 months
Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD).
The FGD will be centered around the answers obtained from the questionnaires and the concerns raised by the trained nurses and laboratory technicians during each recruitment period. Qualitative variable from the focus group will be analysed with Nvivo.
Time frame: 18 months
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