Hemoglobin Assessment: Precision and Practicability Evaluated in the Netherlands

The blood bank uses finger prick (capillary) Haemoglobin (Hb) measurement to
evaluate whether a donor is eligible to donate given his or her venous Hb. The
measurement used should be as precise and valid as possible in this context.
The blood bank is always looking for a better way to measure venous Hb. In the
past year, Hemocue has introduced a new measurement device for finger prick
measurement, and three other manufacturers have marketed new devices that
measure Hb non-invasively. The non-invasive measurements are thought of as an
improvement because there is no need to prick the donor. The prick is
considered painful by many donors. However, we do not know whether non-invasive
measurements have a validity similar to the Hemocue device. Nor is it certain
that the measurement can be done in all donors.

With this study, we aim to evaluate precision and practicability of three new
measurements for (venous) Hb, as compared with the present standard.
* Precision will be studied as sensitivity and specificity of the measurements
for a venous Hb under the cutoff for women (7.8 mmol/l) and men (8.4 mmol/l).
We will also evaluate the standard deviation of the measurements in donors with
a venous Hb around the cutoff value.
* Practicability will be studied based on the proportion of donors in whom a
measurement is not possible, or needs to be restarted. We will also evaluate
the duration of the measurement, and how the measurements are associated with
characteristics of the donors. Finally, we will evaluate the satisfaction of
donors with the measurement devices.

The study is designed as a two by three factorial in which randomisation occurs
to either one of the invasive measurements and (independently) to one of the
non-invasive methods. Each donor will thus have both a non-invasive and an
invasive peripheral Hb measurement. These will be related to the venous Hb,
measured with the Sysmex 1800i.

Donor willingness to participate will be assessed at entry. Participants will
be randomised before the examination, and a case record form with devices to
which the donor was randomised will be attached to the KAF. The donors will be
examined as usual. Finger prick measurement will be done with either Hemocue
201 (standard) or Hemocue 301 (new). The non-invasive measurement device, to
which the donor was randomised, will be used to measure Hb after the
examination, while participants wait before donation or before they leave (if
deferred). A venous sample will be taken from the monster pouch at donation. A
venous sample will be taken from deferred donors before they leave and they
will be asked to fill out a questionnaire on satisfaction with the
measurements.

The burden associated with participation is mainly time. A finger prick is
already part of usual practice and the venous sample is always available from
the sampling pouch for non-deferred donors. For deferred donors, additional
venous sampling is required. Risks associated with this are minimal and range
from a hematoma in the fossa to a bleeding. There are no risks associated with
the use of the non-invasive devices.