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The Nordic immunohistochemical Quality Control
(NordiQC) quality assessment scheme provides fully
comprehensive service consisting of
► Assessment of antigen stains on NordiQC multitissue block sections
as indicated in
Assessment
method below.
► A general review of each assessment run on the website
www.nordiqc.org including:
-
photos of optimal and insufficient stains with
explanations and hints for improvement
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recommendations for optimizing staining protocols
-
examples of complete protocols for optimal
staining of each epitope (based on different antibodies and systems,
when appropriate)
► Individual e-mail information including
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assessment scores for each stain
-
explanation of probable causes of insufficient
(borderline or poor)
stains
-
recommendations
for improvement
-
e-mail alerts and information about new runs,
website updates etc.
► Participant help line by e-mail (nordiqc@rn.dk)
► Free seminars for participants (intended annually).
► Workshops (intended annually).
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The aim, policy, and
background of NordiQC:
See
Organization
Important dates, epitopes,
enrolment, participant data, and protocol form:
See Participation |
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The General module comprises three annual runs
with IHC tests for about 16 different antigens to be detected in
formalin fixed paraffin embedded tissues.
The antigenic markers
are selected to cover a spectrum of commonly used as well as selected special
or new markers.
The Breast cancer module comprises
two annual runs with IHC tests for HER-2 and Estrogen receptor or Progesterone receptor
(alternating), and CISH/SISH test for HER-2 to be detected in formalin
fixed paraffin embedded tissues. FISH test is not included.
Currently all pathology laboratories performing
immunohistochemistry are invited to participate
in the quality assessment of immunostains. Nordic laboratories
have first claim. In case the number of applicant exceeds 250, new
laboratories will be put on a waiting list. However, we expect that
the capacity can be expanded during 2010.
Participants apply for enrolment in the general module and/or the
breast cancer module as detailed in
Participation
(New participant).
To enrol for the first time, the laboratory must
fill out the electronic form on
www.nordiqc.org -> Participation -> New participant.
Sponsored participation must be indicated in the
Comments field: Module, company, and time range.
Participant data and assessment results are anonymous to all but the NordiQC
staff. However, in case of optimal results, participant data may appear on recommended
protocols, see below. By appointment with the laboratories, individual
assessment results may be passed on to scientific boards.
The laboratories enrolled are given a unique three digit
identification number, which is used for all assessments. All
participating laboratories are registered in a password protected
database. On the website, the laboratories have direct access to their own
data and are solely responsible for keeping names, e-mail addresses etc.
up-to-date.
By submitting protocols electronically for one or more markers
in a run announced, the enrolled laboratory
automatically participates in the scheme for the rest of the year.
By 1 January each year, all participants get an e-mail alert inviting to continue participation in
the year concerned. Laboratories not submitting protocols for the first
run in the annual scheme (deadline 15 January) and not responding to a
reminder, will have their participation closed. It can be reopened by
request. Laboratories not submitting protocols for the second and third
run in the annual scheme (deadlines 15 May and 15 September, resp.) and
not responding to reminders, will have their participation closed. It
can be reopened by request.
● Pathology
laboratories enrolled in the scheme
participate in an assessment run by staining slides circulated
from NordiQC. The laboratories can only obtain unstained slides
from NordiQC after electronic
submission of relevant
protocols before the deadline filling out the form on www.nordiqc.org -> Participation.
Protocols sent via e-mail or letter are NOT accepted. Only one protocol is
accepted for each epitope. If a laboratory submits a second
protocol for a given epitope (e.g., because of corrections), it
automatically
overwrites the first.
● Only the stains listed at a particular run can be submitted
for assessment. If a laboratory does not stock an antibody
needed for the detection of an epitope, it cannot be replaced by
another antibody. This is due to the design of multitissue blocks
and the need for a large number of comparable stains in order
to make a proper assessment.
For the same reason, stains are not assessed if inappropriate
(irrelevant) antibodies have been used.
●
The
sections circulated are serial sections cut from multitissue
blocks containing several anonymized normal and tumour tissues fixed
in 10% neutral buffered formalin and embedded in paraffin.
For each epitope two (and only two) unstained
sections are sent
to laboratories, which have submitted protocols before the announced deadline. Together
with the slides, basic information (tissues included, deadline for submission etc.)
is provided. Unstained slides are sent at the date indicated on the
Participation page.
●
Laboratories are requested to stain the slides using their standard protocol. One (and only one) slide for
each epitope should be submitted to NordiQC for assessment together with the in-house
control slide. The other NordiQC slide should be kept in the
laboratory as a reference (or as a reserve in case of a staining
failure). In case slides are broken at the receipt,
NordiQC should be contacted by e-mail.
● All stained
slides returned to NordiQC are assessed and marked by the assessor group.
Generally, the assessment is based on the
staining intensity and distribution in cells expected to stain,
background staining, signs of cross-reactivity, counter-staining and
tissue preservation during the staining process.
Detailed criteria are indicated on the assessment page for each
marker. The control stains are not assessed. However, they are requested in
order to interpret insufficient stains and - in the future - also to
guide the selection of controls.
● Submitted stains (including
control stains) are stored in the NordiQC file for future
documentation. The laboratories may request the stains for review but
they must be returned to NordiQC.
●
Examples of optimal and
suboptimal staining results are uploaded on the website as of the date
indicated on the Participation page. Among protocols giving an optimal
staining, 2-4 are presented as recommended protocols. These
are selected to reflect a spectrum of antibodies and methods and to
represent different participating laboratories. The names and e-mail
addresses of laboratories providing optimal protocols are given in the
protocols to encourage direct communication between laboratories.
If a participant providing a protocol wish to remain anonymous, this
should be specified in the Comments field. Companies will, however,
always be anonymous. Suboptimal stains are
presented anonymously with indication of possible
problems or errors in the protocols.
● The NordiQC lab
informs all participants about their individual scores via e-mail.
In case of a borderline or poor staining result, suggestions for
protocol optimization are given. In some cases comments are given
also to good stains, e.g., in case of excessive counter-stain.
● The laboratory should compare their
stains and protocols
with
the optimal stains
and recommended protocols published at www.nordiqc.org. A protocol recommended by NordiQC as well as
changes suggested by the assessment have to be tested carefully in
the individual laboratory before implementation into the diagnostic work.
NordiQC cannot take any responsibility for the consequences of changes
in protocols or methods in a laboratory.
●
Provided the use of an appropriate
antibody, each stain is marked as optimal,
good, borderline or poor.
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Optimal staining:
The staining is considered perfect or close to perfect in all of the
included tissues.
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Good staining:
The staining is considered fully acceptable in all of the included
tissues. However, the protocol may be optimized to ensure the best staining intensity and signal-to-noise ratio.
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Borderline staining:
The staining is considered
insufficient, e.g., because of a generally too weak staining or a
false negative staining of one of the included tissues, or a false
positive staining reaction. The protocol should be optimized.
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Poor staining:
The staining is considered very insufficient e.g., because of false
negative staining of several of the included tissues, or a marked
false positive staining reaction. An optimization of the protocol is
urgently needed.
Moderate or strong false positive
staining due to, e.g., endogenous biotin is not
compatible with an optimal staining.
In case of borderline or poor
marks, the laboratory may request an immediate reassessment
of the original stain, or a later reassessment based on a new stain in
the following run.
Reassessment of the
original stain:
If a participant disagrees
with borderline or poor marks given, or wishes a more elaborate
motivation, a request should be e-mailed to NordiQC. The stain will
then be reanalysed within 2-3 weeks to make sure that no error has
happened and supplementary documentation for the marks provided.
Reassessment based on
a new stain: If a participant wishes to document improvement,
e.g., after correcting an error or changing the protocol, two new unstained sections may be obtained from NordiQC for a new staining
in the following run.
To obtain new unstained slides, the participant must fill out a new protocol
form before the deadline for the next run. In the form, select "Other epitope by appointment", specify the epitope,
fill in protocol data, and write "Reassessment' in the Comments
field.
The new slides are sent together with the slides for the next
run and the stains will be included for assessing at the assessor meeting.
If the test is already included in the following run (e.g., HER-2),
reassessment based on a new stain cannot be requested.
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Module |
Runs |
Tests |
Rates
2010 |
| General |
3 |
16 |
DKK 6,900 (€ 927) |
| 2 (new labs after 13th Jan.) |
10 |
DKK 4,900 (€ 658) |
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1 (new labs after 13th
Apr.) |
5 |
DKK 2,900 (€ 390) |
| Breast cancer |
2 |
6 |
DKK 2,900 (€ 390) |
| 1 (new labs after 13th Apr.) |
3 |
DKK 1,900 (€ 255) |
| General and Breast cancer |
5 |
22 |
DKK 9,300 (€ 1,250)* |
*
Reduced fee for labs participating on an annual basis in
both modules, invoiced inclusively in January.
Both modules must be ticked in Participant data. |
NordiQC is a non-profit organization, and the rates
indicated in the table are meeting the expenses only, wherefore discount is
not available. Laboratories with financial difficulties are encouraged
to contact, e.g., a local vendor or distributor of antibodies for
sponsorship (see below). Apart from new participants, laboratories can
only participate on an annual basis (i.e., the fee is not reduced if a
laboratory temporarily omits submitting protocols or slides).
Invoicing
Laboratories are invoiced when unstained slides are circulated by
NordiQC in the first run of the year.
If a
payer e-mail address is indicated in Participant data, an invoice is sent electronically to this address
with an e-mail copy to the 1st contact person. If no payer e-mail
address is indicated, a printed invoice is enclosed with the
slides circulated
to the 1st contact person, who must forward the invoice
to the hospital accounting department.
Deadline for payment is indicated in the invoice. Fee is
non-refundable.
If the amount is not paid before deadline, an electronic reminder will
be sent to all the e-mail addresses indicated.
Laboratories neither paying the fee invoiced nor
responding to a reminder will have their participation closed until the
fee is paid.
Sponsored
participation
If a participant obtain a sponsorship from
a company to be able to participate for free in NordiQC (General module
and/or Breast cancer module), the name of the
sponsor and the sponsored period must be indicated in Participant data
(Comments' field). If a
payer e-mail address is indicated in Participant data, an invoice is sent electronically to this address
with an e-mail copy to the 1st contact person. If no payer e-mail
address is indicated, the invoice is enclosed with the
year's first set of slides circulated
to the 1st contact person, who must forward the invoice
to the sponsor. Reduced fee is not available.
Individual assessment results will not be sent to the sponsor, unless a
specific agreement has been
made.
Individual assessment results may be sent to a scientific board, if the
board has got acceptance from the participants.
Bank address:
Spar Nord Bank
Skelagervej 15
P.O.Box 162
DK-9100 Aalborg
For participants outside
Denmark:
The payment
should
be forwarded to
SWIFT-BIC code: SPNODK22
IBAN number: DK 90 90 35 45 70 14 68 10
Mark the payment
with your three digit participant number (NQC…)
and research account
88.38 NordiQC
4202HK.
For Danish participants:
Reg. no. 9035, account no. 45 70 14 68 10
Mark the payment
with your three digit participant number (NQC…)
and
research account
88.38 NordiQC
4202HK.
Cheques
should be made payable to: NordiQC, Aalborg Hospital quoting the
above invoice number and forward to:
NordiQC
Institute of Pathology
Aalborg Hospital
Ladegaardsgade 3
DK-9000
Aalborg
Denmark
Credit cards can unfortunately not be accepted by
NordiQC.
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Region Nordjylland (Aalborg Hospital) SE number = VAT
number = CVR no.: 29 19 09 41
Aalborg Hospital EAN* number for invoices:
5798003281179
*EAN: European Article
Numbering, the number is an electronic location number
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Contracts with Laboratory for Immunohistochemistry and
Development
Institute of Pathology, Aalborg Hospital
Banking details
Bank address:
Spar Nord Bank
Skelagervej 15
P.O.Box 162
DK-9100 Aalborg
Denmark
For contractors outside
Denmark:
The payment
should
be forwarded to
SWIFT-BIC code: SPNODK22
IBAN number: DK 90 90 35 45 70 14 68 10
Mark the payment: research account
88.39 IHCU 4202HK.
For Danish contractors:
Reg. no. 9035, account no. 45 70 14 68 10
Mark the payment: research account
88.39 IHCU 4202HK.
Almost all participants return the
slides the same way as they are forwarded, i.e., by ordinary mail.
The risk of loss is generally very little. Circulation of slides in worldwide parcels via air waybill with
logistics services companies like FedEx or DHL may be
needed on special occasions. The expenses must be paid by the
participant.
Street
address for air waybill:
NordiQC
Institute of Pathology
Aalborg Hospital
Ladegaardsgade 3
DK-9000
Aalborg
Denmark
Tel.: +45 9932 1620 (waybill only!)
Do not write P.O.Box on
waybills.
Sponsorships for NordiQC scientific projects from organisations, producers, vendors and distributors affiliated
immunohistochemistry are welcome (as for
sponsored participation for individual laboratories, see
above).
Sponsorships support the scientific work but have no influence on the
NordiQC methods, results or conclusions.
The annual
NordiQC sponsorship fee is DKK 12,000 (€ 1610). Sponsors may have their logo
or advertisement placed on the frontpage (max 120 x max 32 pixels) with link to their own website.
Sponsorship including annual participation for one
laboratory (general module and breast cancer module) is DKK 18,000
(€2415) annually.
Payment for sponsorships should be forwarded to
account in Spar Nord Bank (see address
above):
For sponsors outside
Denmark:
SWIFT-BIC code: SPNODK22
IBAN number: DK 90 90 35 45 70 14 68 10
Mark the payment: research account
59.05 NordiQC 4202HK.
For Danish sponsors:
Reg. no. 9035, account no. 45 70 14 68 10
Mark the payment: research account
59.05 NordiQC 4202HK.
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