Serum Bank Database by gyq10022

VIEWS: 30 PAGES: 7

More Info
									                                                       Scand J Clin Lab Invest 2004; 64: 431 – 438



Nordic Reference Interval Project Bio-bank and
Database (NOBIDA): a source for future
estimation and retrospective evaluation of
reference intervals
P. RUS TAD, * P . S IM ONSSO N, { P. FE LDING { & M. PEDERSE N§
  ¨
*Furst Medical Laboratory, Oslo, Norway; {University Hospital MAS, Malmo, Sweden;
                                                                          ¨
{Copenhagen General Practitioners’ Laboratory, Copenhagen, Denmark; §Danish Institute for
External Quality Assurance for Laboratories in Health Care (DEKS), Herlev University Hospital,
Copenhagen, Denmark


                    Rustad P, Simonsson P, Felding P, Pedersen M. Nordic Reference Interval
                    Project Bio-bank and Database (NOBIDA): a source for future estimation and
                    retrospective evaluation of reference intervals. Scand J Clin Lab Invest 2004; 64:
                    431–438.

                    In the Nordic Reference Interval Project 2000 (NORIP) serum, Li-heparin
                    plasma and EDTA buffy coat were collected at 102 laboratories in 5 Nordic
                    countries from healthy individuals aged 18 years or more and evenly distributed
                    for laboratory, gender and age. Multiple aliquots of these samples from each of
                    about 3000 persons are now stored at the Nordic Reference Interval Project
                    Bio-bank and Database (NOBIDA) at a temperature of below 280‡C. The
                    commutable NFKK Reference Serum X with certified values traceable to
                    reference methods and measured in NORIP in the same series as the samples
                    is also available from NOBIDA. Data describing the person and the sample
                    conditions are stored together with analytical results and data describing
                    the measurement systems. The bio-bank along with material and data is
                    administered by the NOBIDA committee on behalf of the NFKK (Scandinavian
                    Society of Clinical Chemistry) to be used by Nordic laboratories for any purpose
                    beneficial to the development of clinical biochemistry in general and particularly
                    for creating reference intervals for other biochemical properties than those
                    established by NORIP. Furthermore, research on the already stored information
                    alone is encouraged. Thus colleagues are now welcome to use this extensive
                    material for research and development in clinical biochemistry.

                    Key words: Certified; NORIP; reference material; reference samples; reference
                    values

                     ˚           ¨
                    Pal Rustad, Furst Medical Laboratory, Søren Bulls Vei 25, NO-1051 Oslo,
                    Norway. E-mail. prustad@furst.no



IN T R O D U C T I O N                               Interval Project 2000 (NORIP) [1]. Reference
                                                     intervals were established for 25 common
A bio-bank and the attached database were            clinical components in serum or plasma.
established as a part of the Nordic Reference           Reference samples (serum, Li-heparin plasma)
DOI 10.1080/00365510410006694                                                                     431
432    P. Rustad et al.

TABLE I. Summary data from questionnaires                   The samples were treated as follows: serum
completed by 3035 reference individuals (47% M,          from the individuals was separated from the
53% F).
                                                         blood cells within 2 h and frozen within 4 h
                              Yes      No     Not        from sampling. Li-heparin plasma was sepa-
                                            answered     rated from the blood cells within 30 min
                                                         (centrifugation started within 15 min) and
Nordic origin                 96%    4%       0%
Diabetes in family            12%   85%       3%         frozen within 4 h from sampling. The buffy
Chronic disease                5%   95%       0%         coat was frozen within 24 h from sampling. The
Oestrogen use                 17%   82%       0%         frozen material could be kept below 220‡C for
Medication                    17%   79%       4%         up to one month and should thereafter be
Physical activity last week   14%   86%       0%
History of blood donations    16%   76%       8%
                                                         stored below 270‡C until shipment on dry ice
                                                         to the bio-bank [2].
                                                            In relation to the bio-bank, a trueness control
from at least 25 reference individuals evenly            material is available: the NFKK Reference
distributed for gender and age were collected by         serum X — a fresh-frozen pool from blood
each of 102 Nordic laboratories and measured             donors with certified target values [3]. All
on their local measurement system together               NORIP reference intervals are traceable via
with 5 reference materials (controls)—CAL, X             this reference serum.
(later named ‘‘NFKK Reference Serum X’’),
P, HIGH, LOW—so that linearity could be                  The database
verified and a common metrological reference
                                                            As a part of NORIP a database was
point could be obtained.
                                                         established with information on the participat-
   Reference samples, all measured values,
                                                         ing laboratories, information on used measure-
information on each reference individual and
                                                         ment systems, information on each reference
on the measurement system were submitted for
                                                         individual and the measurement results on
central storage. Reference values traceable to
                                                         reference samples and controls.
reference measurement procedures were calcu-
lated centrally.
                                                         Ethical considerations
                                                            The future use of the bio-bank should follow
The reference population and bio-bank                    rules imposed by the ethics committees which
   The reference individuals were subjectively           approved NORIP (see Table III).
healthy, above 17 years of age and without                  In Denmark, Finland and Iceland no new
major chronic disease. From all laboratories,            application to the ethics committees is necessary
individuals were evenly distributed for gender           for use of the material in future studies of
and age. Although 16% of the individuals had a           reference intervals. This is needed for samples
history of blood donation, no subject had given          obtained in Sweden and Norway.
blood in the last 5 months before sample
collection. The samples were collected from
                                                         N O B I DA
sitting individuals from a cubital vein with
minimal stasis. More than half of the samples
                                                         The NOBIDA committee
were collected from fasting individuals in the
morning. The reference individuals were further            Members of the Nordic Reference Interval
characterized as described in Tables I and II            Project Bio-bank and Database (NOBIDA)
and elsewhere [2].                                       committee appointed by the Scandinavian

TABLE II. Summary data from questionnaires concerning tobacco and alcohol consumption.

Tobacco consumption [cigarettes/day]                    0         1–5             w5         Not answered
                                                       83%         6%             10%             2%
                    Ã
Alcohol consumption [units of alcohol/week]             0         1 – 21          w21        Not answered
                                                       45%         53%            0%              1%
TABLE III. Rules for future projects imposed on NORIP by ethics committees, authorities or the consent formula signed by the reference persons.

Problem                      Denmark                  Finland                  Iceland                    Norway                    Sweden

Is permission necessary      Permission is            Permission is            Permission is              Norwegian ethics          Permission from the
   for use of samples          not necessary            not necessary            not necessary             committee should           Swedish ethics committee
   from reference persons                                                                                  be notified when            or a Nordic ethics
   to projects within the                                                                                  samples are used           committee for the new
   scope of the initial                                                                                                               project in question is
   NORIP description, i.e.                                                                                                            necessary
   projects related to
   production of reference
   values?
Permission to use samples    Permission from          Permission from          Permission from the        As above                  Permission from the
   to projects beyond the      the ethics committee     the ethics committee     ethics committee of                                   ethics committee of the
   scope of the NORIP          of the new project       of the new project       the new project                                       new project and the
   description                                                                                                                         reference person
Withdrawal from the bio-     Can be denied            Is the right of the      Is the right of the        Can be denied             Is the right of the person
   bank of samples from                                  person                   person
   a person on request
   from that person
Information to the           NOBIDA cannot            NOBIDA cannot identify The reference individual      NOBIDA cannot identify The reference person can
   person about               identify the person      the person who has        can be traced from the     the person who has      be traced from the sample
   pathological results       who has donated a        donated a given sample.   sample number via the      donated a given sample. number via the local labs
                              given sample. A          A reference individual    local labs in the initial  A reference individual  in the initial project. In a
                              reference individual     identified as such         project. In new projects,  identified as such by    new project, the ethics
                              identified as such by     by name on the consent    the ethics committees of   name on the consent     committees of the new
                              name on the consent      paper at the local lab.   the new projects should    paper at the local lab. projects should make
                              paper at the local lab.  has on request the right  make decision about        has on request the      decision about such
                              has on request the       to the results from local such information           right to the results    information
                              right to the results     analyses in the initial                              from local analyses
                              from local analyses      project but no further                               in the initial project
                              in the initial project   results                                              but no further results




                                                                                                                                                                   NOBIDA
                              but no further results

  NORIP~Nordic Reference Interval Project, NOBIDA~Nordic Reference Interval Project Bio-bank and Database




                                                                                                                                                                   433
434     P. Rustad et al.

Society of Clinical Chemistry (NFKK) (January        . Iceland: 1 laboratory (max. 67 individuals,
2004) are:                                             not buffy coat);
                                            ˚        . Norway: 28 laboratories (max. 783 individuals);
  Ulrik Gerdes, Klinisk Biokemisk Afdeling, Arhus
                          ˚                          . Sweden: 24 laboratories (max. 636 individuals).
Amtssygehus, DK-8000 Arhus C., Denmark. Tel.:
z45 8949 7307. E-mail: gerdes@aas.auh.dk             From each reference individual there are
    ´    ´          ´
  Jon Johannes Jonsson, Landspitallin, IS-101        maximum 761 mL serum, 261 mL heparin
Reykjavik, Iceland. E-mail: jonjj@landspitali.is     plasma, 161 mL buffy coat. If all laboratories
  Veli Kairisto, Clinical Laboratory Dept., Turku    registered in the bio-bank submit all requested
University Central Hospital, Kiiamyllynkatu 4-6,     samples there will be a maximum of approxi-
FIN-20520 Turku, Finland. Tel.: z358 2 261 16        mately 28 000 samples.
11. Fax: z358 2 261 39 20. E-mail: veli.kairisto@
utu.fi
  Arne Martensson, EQUALIS, Box 977, SE-
           ˚                                         Control materials. Reference serum with certi-
751 09 Uppsala, Sweden. Tel.: z46 18 69 31 64.       fied values:
Fax: z46 18 69 31 46. E-mail: arne.martensso-        . NFKK Reference Serum X: 300065 mL
n@equalis.se                                         . Reference sera used as controls in the NORIP
     ˚                             ¨
  Pal Rustad (Chairman), Furst Medical                 project:
Laboratory, Søren Bulls Vei 25, NO-1051
Oslo, Norway. Tel.: z47 22 90 95 54. Fax:              &   NFKK Reference Serum P: ca. 3006
z47 22 90 96 06. E-mail: prustad@furst.no                  2.5 mL, in addition about 1650 mL in
                                                           bulk
                                                       &   NFKK Reference Serum HIGH: 3036
Goals
                                                           2.5 mL, in addition about 1400 mL in bulk
   The goals of the bio-bank are to contribute to      &   NFKK Reference Serum LOW: Ca. 3006
any sensible project for the development of the            2.5 mL LOW, in addition about 1400 mL in
clinical area in general and in particular to:             bulk.
. establish new reference intervals for clinical     Location, storage and quality assurance of the
  biochemical components. This may be done           bio-bank. The Danish Institute for External
  by using the reference samples in the same         Quality Assurance for Laboratories in Health
  way as has been done by NORIP, but by              Care (DEKS) has responsibility for the
  measuring other components;                        bio-bank. It is stored in three – 80‡C freezers.
. establish/verify traceability for measurement      All the freezers are located at Herlev Univer-
  systems to the reference intervals found in        sity Hospital, Herlev, Copenhagen. The free-
  NORIP. This can be done by using the               zers are equipped with acoustic alarms and
  NFKK Reference Serum X;                            are under constant electronic surveillance. A
. relate reference values to phenotype and           warning is activated by a temperature higher
  environmental and other influences;                 than – 60‡C. A warning initiates either imme-
. relate reference values to genotypes (by use of    diate repair of the freezer or removal of the
  the buffy coat).                                   samples to another freezer.
. store new information related to the reference        DEKS employees inspect the freezers at least
  samples, reference intervals and NFKK              three times a week during which the tempera-
  Reference Serum X.                                 tures displayed electronically on the freezers are
                                                     registered in a logbook.
Bio-bank
Reference samples. If all 94 laboratories that are   Database
registered with samples in the bio-bank submit
                                                     Content. The type of information available
all their samples, there will be samples from 2794
                                                     from the database is described in the appli-
individuals in the bio-bank (Jan. 2004):
                                                     cation form in Appendix 1. A summary of
. Denmark: 18 laboratories (max. 554 indivi-         data registered from the questionnaires filled
  duals);                                            out by the reference individuals is presented
. Finland: 23 laboratories (max. 754 individuals);   in Tables I and II. Further information on
                                                                                     NOBIDA       435

reference individuals is given by Felding et al.     How to prepare an application? The applica-
[2] and on reference values and measurement          tion should be short and of no more than 2 –
systems by Rustad et al. [4].                        3 pages (application form: Appendix 1).
                                                        The application should include information
Location, storage and quality assurance of           concerning:
the database. The MS1 Access database is             1. The principle investigator for the project and
                ¨
located at the Furst Medical Laboratory on a            other key participants.
server with access only for the person in            2. The aim of the study.
charge and the local IT administrator. The           3. A brief plan for the project including
content of the server is backed up each day             information about the components to be
to tape and stored in a fire-proof cabinet.              measured, the method to be used as well as
Back-up is available for 3 months by the local          the statistical analyses to be made.
IT administrator. A copy of the database is          4. A description of the samples needed (e.g.
also stored on a compact disc located in                number, age, sex, nationality).
another building and is accessible only to the       5. A description of information requested from
person responsible.                                     the database.
                                                     6. A description of sample and data handling
Request for NFKK Reference Serum X and                  and storage during and after the study.
other control materials                              7. If relevant, a copy of acceptance from the
                                                        local ethics committee.
  Clinical laboratories in the Nordic countries      8. Information about transport, storage during
can request NFKK Reference Serum X, High,               use and the fate of the samples after the
Low and P. The materials should, for the                study has been completed (returned or
specified price, immediately be delivered from           destroyed).
the local EQA-organization. The materials are        9. Information about publications.
sent on dry ice.
                                                     Where and when to submit the application? The
                                                     application should be submitted in electronic
Application for reference samples and data and
                                                     form to the chairman of NOBIDA. Name
response
                                                     and address can be identified at the NFKK
Application for   sets of reference samples. After   homepage: http://nc.ibk.liu.se/nfkk/. An appli-
approval of a     project by the NOBIDA com-         cation can be submitted at any time.
mittee, Nordic    laboratories can request refer-
ence samples       including NFKK Reference          What is to be done once the project is fina-
Serum X from      DEKS for a specified price.         lized? When the project is finalized, a brief
                                                     report should be send to NOBIDA that will
Who is eligible for use of the bio-bank and          forward it to the board of the NFKK. The
data obtained from the database? Laboratories        results should be presented in peer-reviewed
engaged in the measurement of routine clinical       journals if relevant or at least in Klinisk
components can apply.                                Biokemi i Norden or at the NFKK home-
                                                     page: http://nc.ibk.liu.se/nfkk/.
What are the restrictions concerning samples            Results of new measurements performed on
obtained from the bio-bank? A minimum of             the reference samples should be made accessible
130 samples from the bio-bank has to be              via the database. The format of data to be
requested. NFKK Reference Serum X and                submitted to the database will be specified to
where analytically reasonable HIGH and               the applicant when the project is accepted.
LOW must be measured in the same series as
the samples.                                         Handling of application. The application will
  The applicant will be informed about possible      generally be handled within 2 months of
restrictions in the use of the material, number      receipt.
and selection of samples and the data that are         If the committee cannot reach unanimity, the
available from the database.                         board of the NFKK will make the decision.
436   P. Rustad et al.

  The committee handles each application            Information on project
according to the requirements from the local
                                                      Component(s) to be measured:
ethics committees having approved the NORIP
                                                      Purpose of project:
project. This implies that samples from some
countries may not be used in some studies.            Measurement system(s):
  The NOBIDA chairman will give a written             Traceability of method(s):
decision to the applicant with information on         Storage of samples:
possible restrictions in the use of the materials     Time frame:
and information on number and selection of            Publication of results:
samples and what data are attached from the           General usefulness of project data:
database.
  Refusal should be motivated.
                                                    Specification of request
APPENDIX 1: APPLICATION FORM                        Samples

An electronic version is available on the           Reference samples: Number of samples (1 mL in
NORIP home site (www.furst.no/norip)                each vial):
 Application for samples and/or data                   Serum, Li-heparin plasma or buffy coat:
 To:                                                   Specify information on reference persons by
                                                    underscore: Age, gender, height, weight, date of
   ˚
  Pal Rustad                                        1st day of last menstrual period (women), ethnic
   ¨
  Furst Medisinsk Laboratorium                      origin, heredity for diabetes, number of years
  Søren Bulls Vei 25                                residing in a Nordic country, chronic disease(s),
  NO-1051 Oslo                                      medication, strenuous exercise last week, alcohol
  Norway                                            consumption, habitual smoking, number of hours
                                                    since the last meal, date of blood sampling,
By applying for samples and/or data from            number of total blood donations.
NOBIDA, you give consent to the following
conditions:                                         Controls: NFKK Reference Serum X, number
   The samples and/or data must not be used for     of vials (5 mL); HIGH, number of vials; LOW,
purposes other than those explained in this         number of vials.
application.
   The results from the project should be
published in peer-reviewed journals if relevant     Data
and should be made available in the NOBIDA             Specify requested data by underscore:
database.                                              Reference person data: Person ID, age, gender,
   The data produced by using NOBIDA                height, weight, date of 1st day of last menstrual
samples must be kept in their original form         period (women), ethnic origin, heredity for
for a minimum of 5 years.                           diabetes, number of years residing in a Nordic
   The samples and/or data received from            country, chronic disease(s), medication, strenuous
NOBIDA should be destroyed after the project        exercise last week, alcohol consumption, habitual
is finished. If, for any reason, any part of these
                                                    smoking, number of hours since the last meal,
data has to be stored as original data, this
                                                    date of blood sampling, number of total blood
should be specified in the application or
                                                    donations, country of sample collection.
NOBIDA notified at the end of the project at
                                                       Analytical and measurement system data
the latest.
                                                    are available from the NOBIDA database for
                                                    the following components: Alanine transami-
Investigator
                                                    nase, albumin, amylase, amylase pancreatic,
  Principle investigator:                           aspartate transaminase, alkaline phosphatase,
  Institution:                                      bilirubin, calcium, carbamide, cholesterol, HDL-
  Address:                                          cholesterol, glucose, creatininium, creatinine
  Telephone no:                                     kinase, c-glutamyltransferase, iron, lactate dehy-
  E-mail address:                                   drogenase, magnesium, phosphate, potassium,
                                                                                          NOBIDA        437

protein, sodium, TIBC, triglyceride, urate. Analy-   R E F E RE N C E S
tical data are also available for the following
derived components: albumin-corrected calcium,       1 Rustad P, Felding P, Franzson L, Kairisto V,
iron saturation, LDL-cholesterol.                                    ˚
                                                       Lahti A, Martensson A, Hyltoft Petersen P,
                                                       Simonsson P, Steensland H, Uldall A. The
   Analytical method: Instrument manufacturer,         Nordic Reference Interval Project 2000: recom-
instrument name, method group, method name,            mended reference intervals for 25 common
unit, slope and intercept (Vs ~Vi 6slopez              biochemical properties, Scand J Clin Lab Invest
intercept where Vs is submitted value and Vi           2004; 64: 271 – 84.
                                                                                  ˚
                                                     2 Felding P, Rustad P, Martensson A, Kairisto V,
is original measured value). Control analytical
                                                       Franzson L, Hyltoft Petersen P, Uldall A.
data for CAL, X, P, LOW, HIGH: Control ID,             Reference individuals, blood collection, treatment of
measurement date, series no., measurement              samples and descriptive data from the questionnaire in
value.                                                 the Nordic Reference Interval Project 2000. Scand J
   Reference person analytical data: Person ID,        Clin Lab Invest 2004; 64: 327 – 42.
                                                     3 Pedersen MM, Rustad P, Simonsson P. Certificate
measurement date, series no., material (serum          of analysis: NFKK Reference Serum X: a reprint.
or plasma), material handling (fresh or thawed),       Scand J Clin Lab Invest 2004; 64: 321 – 26.
measurement value.                                   4 Rustad P, Felding P, Hyltoft Petersen P, Lahti A.
                                                       Descriptive analytical data and consequences for
                                                       calculation of common reference intervals in the
Additional specification                                Nordic Reference Interval Project 2000 (NORIP).
                                                       Scand J Clin Lab Invest 2004; 64: 343 – 70.
Format of requested data
                                                     Received: 22 January 2004
  Signature and date                                 Accepted: 23 March 2004

								
To top