Determine whether the finger prick blood collection procedure can reliably replace venepuncture blood collection for the following tests: PSA, Covid-19 serology, HbA1c and a series of standard and routine chemistry tests.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
- To determine whether the finger prick blood collection system procedure can
reliably replace venepuncture blood collection for the PSA, Covid-19 serology,
HbA1c and routine clinical chemistry testing.
Validation requirements:
- Correlation coefficient (Spearmans) of finger prick with venipuncture serum
is > 0,90.
- Regression analysis: 95% CI of slope includes 1.00
- Less than 5% outliers (recovery < 70% or > 130%)
Secondary outcome
- Finger prick blood collection procedure performed by patients or healthy
volunteers is feasible: > 80% of finger prick blood collection procedures
performed results in a suitable sample for analysis.
Background summary
At the Netherlands Cancer Institute a home blood collection system was
developed. This follow-up study aims do demonstrat that it can reliable replace
the venipuncture procedure by a health care professional for a selection of
blood tests.
Study objective
Determine whether the finger prick blood collection procedure can reliably
replace venepuncture blood collection for the following tests: PSA, Covid-19
serology, HbA1c and a series of standard and routine chemistry tests.
Study design
The study is designed to allow a pre-analytical method comparison between the
standard venipuncture performed by a health care professional and a capillary
blood sample collection using the developed by system by the patient or person
him or herself for the PSA, Covid-19 serology, HbA1c and routine chemistry
tests.
Study burden and risks
The study takes about 1 hour in which the participants need to perform a finger
prick blood collection themselves using the developed system.
Participating healthy volunteers and health care professionals also undergo a
venipuncture procedure.
Finally a questionaire is filled-in.
The fingerprik blood collection procedure might result in a sensitive finger
and small bleedings afterwards.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Patients:
120x PSA requirest at blood collection facility
120x HbA1c request at blood collection facility
Healthy volunteers:
120X Proven Covid-19 infection health care professional
120X Partner of NKI patient (without Cancer)
Exclusion criteria
N.A.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76225.031.20 |