Evaluation of new blood collection systems

In order to perform adequate laboratory testing on bloodsamples, the quality of
the blood collection systems (needles and tubes) are essential. Although much
is know from literature, extra independent testing is sometimes necessary
depending on het labtest. Medlon needs to verify the quality of the collection
systems.

The objective of the study is to determine the quality and usability of blood
collection systems.

Healthy volunteers will be asked to take part of the study, which means two
venapunctures. During this procedure a total amount of 43 ml of blood will be
collected. The following tests will be done: HbA1, vitamin B1 and B6, PTH,
ACTH, Methylmalonic Acid, PT, APTT, fibrinogen, PT-INR, Von Willebrand factor,
Protein C, Protein S, Factor VIII, Factor IX, glucose, hs-Trop T, TSH, fT4, T3,
anti-TPO, FSH, LH, hCG, cortisol, PSA, fPSA, CA 19.9, CA 15.3, AFP., CEA,
CA125, S100b, Prolactin, Vitamin D, DHEAS, Tg, anti-Tg, Beta2 microglobulin,
hGH, Testosteron, TSI, C-peptide, insulin, steroidprofiel. Results will be
evaluated according to the CLSI evaluationprotocol number 9.

Also 68 patients attending our outpatient clinic for bloodcollection, will be
asked to participate in this study. During the regular venapuncture
additionally 2 extra tubes will be collected. These tubes without a name, will
be analysed for PT, PT-INR, Von Willebrand factor, Protein C, Protein S, Factor
VIII, Factor IX, drugmetabolites or HIV viralload. Evaluation will take place
according to the abovementioned protocol.

There is no extra burden or risk for participation than the only risk related
to a regular venapuncture. It will take five minutes extra time for patients or
healty volunteers.