ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2021 - External quality Control of diagnostic Assays and Tests
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ECAT FOUNDATION
External quality Control of diagnostic Assays and Tests
with a focus on Thrombosis and Haemostasis
PARTICIPANT INFORMATION
Programme and Prices 2021
ECAT FOUNDATION Postal address Visiting address ECAT Foundation ECAT Foundation P.O. BOX 107 Dobbeweg 1 2250 AC Voorschoten 2254 AG Voorschoten The Netherlands The Netherlands Contact details (general) Contact details (financial department) T. +31 71 3030910 T. +31 71 3030911 F. +31 71 3030919 F. +31 71 3030919 E. info@ecat.nl E. finance@ecat.nl W. www.ecat.nl Registration no. at the Chamber of Commerce: 41174102 VAT number: NL802836872B01 IBAN no.: NL38 INGB 0006 9304 71 BIC code: INGBNL2A
INTRODUCTION
Dear Participant,
It is our pleasure to inform you in this brochure about the ECAT’s external quality programme 2021.
The ECAT Foundation is an independent and impartial organisation with the objective to provide an international
External Quality Assessment Programme (EQAP) for laboratories working in the field of haemostasis and
thrombosis.
The ECAT (External quality Control of diagnostic Assays and Tests) provides this international external quality
control programme since 1994. It was started as a small-scale quality control programme only in Western
Europe. Today more than 1775 laboratories from more than 50 different countries are participating in this worldwide
programme.
Our primary aim is to contribute to quality assessment and improvement of clinical laboratories operating within the
field of thrombosis and haemostasis with respect to the diagnosis and treatment of patients.
The ECAT Foundation is based in The Netherlands but provides EQAP for assays and tests in the field of
thrombosis and haemostasis on an international scale. The programme is open for every laboratory providing
services in the mentioned discipline.
In 2021 the ECAT programme includes 35 modules for regular laboratory tests, 1 module for case studies and 1
electronic module for the pre- and post-analytical phase and a quality control programme for the CoaguChek INR
monitors. There is also 1 pilot study scheduled (APTT Mixing Study).
Via ECAT also 2 interpretative electronic modules on platelet testing of the NASCOLA (United States) are provided
as well as 14 modules for molecular biology provided by the DGKL (Germany).
We look forward to work with you also in 2021.
On behalf of the ECAT team,
Dr. Piet Meijer
Director
Since 25 April 2012 the EQA programme of the ECAT is accredited according to the international standard ISO/IEC
17043:2010 by the Dutch Accreditation Council (RvA). For details see page 20.
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CONTENT
INFORMATION 2021 ..................................................................................................................................................... 3
PROGRAMME CHANGES ........................................................................................................................................................... 3
PRICES ....................................................................................................................................................................................... 3
SUBSCRIPTION INSTRUCTIONS ................................................................................................................................ 4
Instructions and deadline.......................................................................................................................................................... 4
Cancellation .............................................................................................................................................................................. 6
SURVEY SCHEDULE .................................................................................................................................................... 7
PROGRAMME AND PRICES ........................................................................................................................................ 9
ANNUAL SUBSCRIPTION ............................................................................................................................................................ 9
MAIN PROGRAMME ................................................................................................................................................................. 9
LUPUS PROGRAMME ................................................................................................................................................................ 9
ANTICOAGULATION PROGRAMME ......................................................................................................................................... 10
D-DIMER PROGRAMME .......................................................................................................................................................... 10
THROMBIN GENERATION PROGRAMME ................................................................................................................................ 10
PFA PROGRAMME................................................................................................................................................................... 10
THROMBOELASTOGRAHY PROGRAMME ................................................................................................................................ 10
HIT PROGRAMME ................................................................................................................................................................... 10
HOMOCYSTEINE PROGRAMME .............................................................................................................................................. 10
SCREEN PROGRAMME ............................................................................................................................................................ 11
POCT INR QC PROGRAMME .................................................................................................................................................... 11
OTHER SURVEYS ...................................................................................................................................................................... 11
MOLECULAR BIOLOGY ............................................................................................................................................................ 12
SHIPMENT COSTS .................................................................................................................................................................... 12
DETAILED SAMPLE INFORMATION (I) ..................................................................................................................... 13
LIST OF PARAMETERS .............................................................................................................................................. 14
DETAILED SAMPLE INFORMATION (II) .................................................................................................................... 15
PILOT STUDY .............................................................................................................................................................. 16
POCT FOR COAGUCHEK MONITORS ...................................................................................................................... 17
POCT INR QC Programme ....................................................................................................................................................... 18
POCT INR QC Single kits .......................................................................................................................................................... 18
How to order POCT Quality Control Single Kits ....................................................................................................................... 18
GENERAL INFORMATION ECAT FOUNDATION ...................................................................................................... 19
Staff......................................................................................................................................................................................... 19
Members of Supervisory Board ............................................................................................................................................... 19
Website ................................................................................................................................................................................... 19
Survey Manual ........................................................................................................................................................................ 19
Accreditation........................................................................................................................................................................... 20
Products and services from third parties ................................................................................................................................ 20
Confidentiality policy .............................................................................................................................................................. 20
Intellectual property rights and copyrights ............................................................................................................................. 21
Provision of global survey reports ........................................................................................................................................... 21
FINANCES ................................................................................................................................................................... 22
Contact details financial department ..................................................................................................................................... 22
Details ECAT bank account ..................................................................................................................................................... 22
Terms of delivery ..................................................................................................................................................................... 22
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INFORMATION 2021
INFORMATION 2021
Below you will find general information about the ECAT EQA Programme 2021.
PROGRAMME CHANGES
1. Thromboelastography Programme:
(previously ROTEM/TEG Programme)
Within the Thromboelastography Programme it will also be possible to participate for the Clot-Pro instrument.
2. Von Willebrand Factor Module:
Starting in 2021 the Von Willebrand Factor Module includes 2 different samples (2 vials each) per survey. For
this reason there is a significant increase in the module price.
See for more details the section “Programme Details 2021”.
3. Emicizumab:
A new module for the quantitative measurement of Emicizumab is added to programme. This module is part of
the Main programme. There will be two surveys per year, including two samples per survey.
See for more details the section “Programme Details 2021”.
4. APTT mixing study
Mixing studies represent a simple but very useful tool for the first investigations when APTT prolongations are
unexpectedly found. By mixing the patient’s sample with normal (pooled) plasma, they can help to distinguish
between factor deficiencies, the presence of specific or unspecific inhibitors or lupus anticoagulant. The
purpose of this pilot study is to investigate different analytical methodologies (e.g. ratio patient plasma –
normal plasma, incubation yes or no) in relation to the interpretation of the test results. The study includes
several samples with different causes for a prolonged APTT.
This pilot study is free-of-charge and will take place in May/June 2021.
PRICES
General price information:
The general increase of the prices is approx. 2.5%. This is mainly caused by inflation, increasing costs for staff and
distribution of samples.
Due to a change in the shipment procedure at DGKL (courier service instead of postal service) an extra annual fee
of € 50,= will be charged per registration for one or more Molecular Biology surveys.
Printed survey report:
Some laboratories still would like to have a printed copy of the report (despite the fact that their report is online
available). Due to a continuous increase in costs for printing and postal service we have to further increase the
extra annual price for printed reports from € 105.= to € 125.= The annual subscription fee + printed report will be
€ 250.00.
Extra samples:
If you would like to receive extra samples of a specific module of the ECAT programme in every survey this needs
to be specifically indicated on the website subscription form. The default setting is your current subscription. You
can change this number to the required number of sets. The cost for a set of extra samples is 70% of the module
price and this will be added to your invoice.
We don’t provide single samples, but always send a complete set.
For a detailed overview of the prices 2021 see page 9 – 12.
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SUBSCRIPTION INSTRUCTIONS 2021
SUBSCRIPTION INSTRUCTIONS
Instructions and deadline
Closing date subscription 2021: Friday 20 November 2020 !!!
For your subscription 2021 you should use the electronic subscription form on our website.
Always complete this subscription form, even when you don’t intend to change your modules!
Your subscription profile of 2020 is used as default setting, but you are able to modify the selection and to adjust
the number of required sets.
The subscription form should be fully completed before it is submitted. After submission no
modifications can be made anymore.
Instructions:
Go to he ECAT website (www.ecat.nl) and select
Participant Area (upper menu).
Select the option Subscription 2021 (left menu)
Select the blue button Subscription 2021.
Login with your Labcode and Password
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SUBSCRIPTION INSTRUCTIONS 2021
Select the button ECAT Subscription
Now the subscription form appears (see example below).
- In the column Select you can select and deselect modules.
- In the column Number of Sets you can indicate the required number
of sample sets (Default is your number of last year. For a new
selected module the default is 1). For details about the pricing of
extra sample sets see page 3.
- In the column Amount the total price, excl. VAT appears. At the
bottom of the form the total price appears. If you are obliged to pay
VAT, this is added to the total amount.
- If you want to indicate an Order Number, please enter this in the
apropriate field at the bottom of the form (see figure below). This
order number will be used on the invoice.
- A confirmation e-mail is sent after submission. For this e-mail you
can select one of the e-mail addresses currently available in our
database.
- Before you are able to submit your subscription you have to accept
the ECAT terms of delivery (at the bottom of the form – see figure
below).
- With the PDF button on the bottom of the page you can create a
PDF of the subscription form and store and/or print this form.
- When the subscription form is completed it should be submitted by
selecting the Submit button at the bottom of the form.
Only submit when the subscription form has been fully completed!
Order number Submit button
Accept terms of delivery Confirmation e-mail address PDF button
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SUBSCRIPTION INSTRUCTIONS 2021
Cancellation
If you would like to cancel in 2021 your participation in the ECAT EQA programme you can also use the ECAT
subscription application. Follow the instructions described on page 4 to get access to the subscription form.
At the bottom of this form you may find a Cancel button (see figure below).
Before you cancel, please select an e-mail address to whom the cancellation confirmation should be sent (see
figure below).
Confirmation e-mail address Cancel button
The deadline for cancellation is November 20th 2020.
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PROGRAMME DETAILS 2021
SURVEY SCHEDULE
Survey Sample dispatch date Survey period start Survey period end Survey report available
MAIN PROGRAMME
2021 - M1 9 March 16 March 13 April 11 May
2021 - M2 25 May 1 June 29 June 27 July
2021 - M3 24 August 31 August 28 September 26 October
2021 - M4 2 November 9 November 7 December 18 January 2022
LUPUS PROGRAMME
2021 - L1 9 March 16 March 13 April 11 May
2021 - L2 25 May 1 June 29 June 27 July
2021 - L3 24 August 31 August 28 September 26 October
2021 - L4 2 November 9 November 7 December 18 January 2022
ANTICOAGULATION PROGRAMME
2021 - A1 9 March 16 March 13 April 11 May
2021 - A2 25 May 1 June 29 June 27 July
2021 - A3 24 August 31 August 28 September 26 October
2021 - A4 2 November 9 November 7 December 18 January 2022
D-DIMER PROGRAMME
2021 - D1 29 March 7 April 19 April
2021 - D2 14 June 22 June 2 July
Beginning of March 2021
2021 - D3 13 September 21 September 1 October
2021 - D4 22 November 30 November 10 December
SCREEN PROGRAMME
2021 - S1 29 March 2 April 12 April
2021 - S2 3 May 7 May 17 May
2021 - S3 21 June 25 June 5 July
2021 - S4 2 August 6 August 16 August
Beginning of March 2021
2021 - S5 13 September 17 September 27 September
2021 - S6 25 October 29 October 8 November
2021 - S7 6 December 10 December 20 December
2021 - S8 17 January 2022 21 January 2022 31January 2022
THROMBIN GENERATION PROGRAMME
2021 - TG2 25 May 1 June 29 June 27 July
2021 - TG4 2 November 9 November 7 December 18 January 2022
THROMBOELASTOGRAPHY PROGRAMME
2021 - T1 9 March 16 March 13 April 11 May
2021 - T2 25 May 1 June 29 June 27 July
2021 - T3 24 August 31 August 28 September 26 October
2021 - T4 2 November 9 November 7 December 18 January 2022
HIT PROGRAMME
2021 - HIT 24 August 31 August 28 September 26 October
HOMOCYSTEINE PROGRAMME
2021 - H1 9 March 16 March 13 April 11 May
2021 - H2 25 May 1 June 29 June 27 July
2021 - H3 24 August 31 August 28 September 26 October
2021 - H4 2 November 9 November 7 December 18 January 2022
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PROGRAMME DETAILS 2021
POCT INR QC PROGRAMME
Quarter Sample dispatch date Survey period start Survey period end Survey report available
2021 - Q1 16 February 16 February 31 March 30 April
2021 - Q2 6 April 6 April 30 June 31 July
2021 - Q3 6 July 6 July 30 September 31 October
2021 - Q4 5 October 5 October 31 December 31 January 2022
OTHER SUREYS
Survey Period
Post Analytical Platelet Function EQA (electronic survey) Spring, Autumn (2 surveys per year)
Platelet Dense Granule exercise (electronic survey) Spring, Autumn (2 surveys per year)
Case studies on bleeding disorders Autumn (1 survey per year)
Pre- and post-analytical electronic surveys in haemostasis Autumn (1 survey per year)
MOLECULAR BIOLOGY (via DGKL, Germany)
Survey Sample dispatch date Survey period start Survey period end
MG1 1/21 10 March 15 March 3 April
MG1 2/21 1 September 6 September 25 September
MG2 1/21 10 March 15 March 3 April
MG2 2/21 1 September 6 September 25 September
SQ 1/21 10 March 15 March 10 April
SQ 2/21 1 September 6 September 2 October
DI 1/21 10 March 15 March 10 April
DI 2/21 1 September 6 September 2 October
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PROGRAMME AND PRICES
# Prices are excluding VAT
Annual Subscription
The annual subscription fee is mandatory for each participant and will be added to the fee for the selected
modules.
The following options are available for the annual subscription fee:
internet result submission, survey report only via internet as PDF
internet result submission, survey report via internet as PDF and a printed copy by postal service
ANNUAL SUBSCRIPTION
The annual subscription fee is mandatory for each participant.
Description Price (Euro) # Product code
Annual Subscription Fee (result submission via internet / survey report via internet) 125.00 101
Annual Subscription Fee (result submission via internet / survey report via internet + by post) 250.00 102
NUMBER
PRICE PRODUCT
DESCRIPTION OF
SURVEYS SURVEY CODES (EURO) # CODE
MAIN PROGRAMME
Thrombophilia - I:
Antithrombin (activity and antigen), Protein C
(activity [chromogenic and clotting] and antigen), 4 2021-M1 2021-M2 2021-M3 2021-M4 365.00 402
Protein S activity, Protein S antigen (total and
free)
Thrombophilia - II
4 2021-M1 2021-M2 2021-M3 2021-M4 147.50 417
APC Resistance
Coagulation Factor - I
Factor VIII (clot and chromogenic activity),
4 2021-M1 2021-M2 2021-M3 2021-M4 180.00 406
IX (clot and chromogenic activity), XI:C and
XII:C
Coagulation Factor - II
4 2021-M1 2021-M2 2021-M3 2021-M4 180.00 407
Factor II:C, V:C, VII:C and X:C
Von Willebrand Factor parameters
(antigen, ristocetin cofactor activity, activity, 4 2021-M1 2021-M2 2021-M3 2021-M4 275.00 408
collagen binding, multimers, Factor VIII)
ADAMTS13 - I (activity and antigen) 4 2021-M1 2021-M2 2021-M3 2021-M4 192.50 409
ADAMTS13 - II (antibodies) 2 2021-M2 2021-M4 125.00 410
Factor XIII (activity and antigen) 4 2021-M1 2021-M2 2021-M3 2021-M4 137.50 411
Fibrinolysis - I
4 2021-M1 2021-M2 2021-M3 2021-M4 133.50 412
Plasminogen, Antiplasmin
Fibrinolysis - II
4 2021-M1 2021-M2 2021-M3 2021-M4 133.50 413
t-PA, PAI-1
Haemophilia
Factor VIII (clot and chromogenic activity) 4 2021-M1 2021-M2 2021-M3 2021-M4 232.50 418
Factor IX (clot and chromogenic activity)
Factor VIII inhibitor 2 2021-M2 2021-M4 180.00 202
Factor IX Inhibitor 2 2021-M1 2021-M3 180.00 201
Emicizumab 2 2021-M2 2021-M4 180.00 223
LUPUS PROGRAMME
Lupus Anticoagulant / Antiphospholipid
4 2021-L1 2021-L2 2021-L3 2021-L4 172.50 404
Antibodies
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NUMBER
PRICE PRODUCT
DESCRIPTION OF
SURVEYS SURVEY CODES (EURO) # CODE
ANTICOAGULATION PROGRAMME
Unfractionated Heparin Monitoring
4 2021-A1 2021-A2 2021-A3 2021-A4 120.50 414
(anti-Xa)
Low-Molecular Weight Heparin Monitoring
4 2021-A1 2021-A2 2021-A3 2021-A4 120.50 415
(anti-Xa)
Orgaran (anti-Xa) 2 2021-A2 2021-A4 61.50 205
Fondaparinux (anti-Xa) 2 2021-A2 2021-A4 61.50 206
Rivaroxaban (anti-Xa) 2 2021-A2 2021-A4 61.50 207
Apixaban (anti-Xa) 2 2021-A2 2021-A4 61.50 208
Edoxaban (anti-Xa) 2 2021-A2 2021-A4 61.50 221
Argatroban (anti-IIa/dTT) 2 2021-A2 2021-A4 61.50 209
Dabigatran (anti-IIa/dTT) 2 2021-A2 2021-A4 61.50 210
D-DIMER PROGRAMME
D-Dimer 4 2021-D1 2021-D2 2021-D3 2021-D4 133.50 405
THROMBIN GENERATION PROGRAMME
Thrombin Generation Test 2 2021-TG2 2021-TG4 143.50 203
PFA PROGRAMME
PFA-100/200 2 2021-P2 2021-P4 435.00 222
THROMBOELASTOGRAHY PROGRAMME
ROTEM delta
□ 1 instrument / 1 set of samples ROTEM 305.00 212
4 2021-T1 2021-T2 2021-T3 2021-T4
□ 2 instruments / 2 sets of samples ROTEM 518.50 213
□ 3 instruments / 3 sets of samples ROTEM 732.00 214
ROTEM sigma
□ 1 instrument / 1 set of samples ROTEM 305.00 215
4 2021-T1 2021-T2 2021-T3 2021-T4
□ 2 instruments / 2 sets of samples ROTEM 518.50 216
□ 3 instruments / 3 sets of samples ROTEM 732.00 217
TEG
□ 1 instrument / 1 set of samples TEG 305.00 218
4 2021-T1 2021-T2 2021-T3 2021-T4
□ 2 instruments / 2 sets of samples TEG 518.50 219
□ 3 instruments / 3 sets of samples TEG 732.00 220
CLOT-PRO
□ 1 instrument / 1 set of samples CLOT-PRO 4 2021-T1 2021-T2 2021-T3 2021-T4 305.00 224
□ 2 instruments / 2 sets of samples CLOT-PRO 518.50 225
□ 3 instruments / 3 sets of samples CLOT-PPRO 732.00 226
HIT PROGRAMME
HIT - I (immunological testing) 1 2021-HIT 105.00 204
HOMOCYSTEINE PROGRAMME
Homocysteine 1 2021-H1 2021-H2 2021-H3 2021-H4 120.50 416
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NUMBER
PRICE PRODUCT
DESCRIPTION OF SURVEY CODES
SURVEYS (EURO) # CODE
SCREEN PROGRAMME
Screen - I: APTT, PT/INR 2021- 2021- 2021- 2021- 2021- 2021- 2021- 2021-
8 235.00 501
and Fibrinogen S1 S2 S3 S4 S5 S6 S7 S8
Screen - II: Thrombin 2021- 2021- 2021- 2021- 2021- 2021- 2021- 2021-
8 235.00 502
Time, Reptilase Time S1 S2 S3 S4 S5 S6 S7 S8
NUMBER PRICE PRODUCT
DESCRIPTION OF (EURO)
SURVEYS SURVEY CODES # CODE
POCT INR QC PROGRAMME
No annual subscription fee applicable if only participating in the POCT INR QC Programme.
POCT INR QC Programme
4 2021-Q1 2021-Q2 2021-Q3 2021-Q4 415.00 301
for CoaguChek INR monitors (any type)
* Annual shipping costs for countries outside Europe: on request.
NUMBER PRICE
ORGANISED SURVEY PRODUCT
DESCRIPTION OF (EURO)
BY PERIOD(S) # CODE
SURVEYS
OTHER SURVEYS
Post Analytical Platelet Function EQA
Nascola, USA 2 Spring, Autumn 195.00 701
(electronic survey)
Platelet Dense Granule exercise
Nascola, USA 2 Spring, Autumn 195.00 704
(electronic survey)
Case studies on bleeding disorders
ECAT/
(distribution separately from the regular 1 Autumn 102.50 703
INSTAND
surveys)
Pre- and post-analytical electronic surveys
ECAT 1 Autumn 75.00 705
in haemostasis
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MOLECULAR BIOLOGY
(In co-operation with the DGKL, Germany)
NUMBER
PRICE PRODUCT
SURVEY DESCRIPTION OF SURVEY CODES
(EURO) # CODE
SURVEY
MOLECULAR GENETICS MG1 S
FV-Leiden, Prothrombin, MTHFR (C677T,
MG1 Set A A1298C), PAI-I 4G5G
2 MG1 1/20 MG1 2/20 ** 601
FXIII V34L, GPIIIa, βFib (g455a), VKORC1
MG1 Set B (G-1639A/C1173T), FXII c46t, FV-H1299R
2 MG1 1/20 MG1 2/20 ** 602
MG1 Set C a1 PI, Apo E, ApoB100, ACE, CETP 2 MG1 1/20 MG1 2/20 ** 603
Aldo B (149,174,334), HFE (H63D, C282Y,
MG1 Set D S65C), LCT c-13910t, 2 MG1 1/20 MG1 2/20 ** 604
NOD2 (R702W, G908R, L1007fins C)
M. Wilson (ATP7B-C3207A), FSAP (Marburg-I),
MG1 Set E ITGA2 Gplalla C807T, Col1A1 SP1, VDR 2 MG1 1/20 MG1 2/20 ** 605
(BsmI/Apal,TaqI)
Faktor VII (R353Q), AT3 Cambridge Typ I/II,
MG1 Set F CYP3A5*3
2 MG1 1/20 MG1 2/20 ** 606
MOLECULAR GENETICS MG2
TPMT, CYP2C8 (K399R), CYP2C9 *2/*3,
UGT1A1 (*28), DPYD *2A (Ex 14 skipping),
MG2 Set A BCHE A/K, DPYD *13, DPYD D949V
2 MG2 1/20 MG2 2/20 ** 801
(rs67376798), DPYD 1129 (rs75018182)
K-Ras: Codon 12/13/61, BRAF V600E, BRAF
MG2 Set B V600K, cKit D816V, NRAS Q61 (rs121913254, 2 MG2 1/20 MG2 2/20 ** 802
rs11554290, rs121913295)
MG2 Set C HLA-B27, TNF alpha (238, 308) 2 MG2 1/20 MG2 2/20 ** 803
MG2 Set D CYP2D6, CYP2C19 (*2/*17), CYP2C19*3 2 MG2 1/20 MG2 2/20 ** 804
HLA B*5701, CYP2B6*6, ABCB1 (MDR1)
MG2 Set E c.3435>T, CCR5-del-32bp
2 MG2 1/20 MG2 2/20 ** 805
IL28B (C/T Polymorphismus), IL6 (G174C),
MG2 Set F CYP3A4*22
2 MG2 1/20 MG2 2/20 ** 806
PRICES MG1 or MG2
** MG1 or MG2: One set : € 116.00 Three sets: € 256.00 Five sets: € 396.00
Two sets: € 186.00 Four sets: € 326.00 Six sets: € 466.00
DNA SEQUENCING SQ
DNA Sequencing (Sequencing and corresponding diagnostic
2 SQ 1/20 SQ 2/20 264.00 901
interpretation)
DNA ISOLATION DI
DNA Isolation (DNA isolation and FV genotyping)
The FV genotyping includes: FV-Leiden (ARG506GLN),
FV-H1299R (HIS1299ARG), FV-Cambridge (ARG306THR), 2 DI 1/20 DI 2/20 124.00 902
FV-Hong-Kong (ARG306GLY), FII g20210a, MTHFR C677T,
HFE (H63D, C282Y, S65C)
Per registration for one or more of the Molecular Biology surveys
Extra costs for shipment of Molecular Biology surveys
an annual fee of € 50,= will be charged.
SHIPMENT COSTS
Prices includes delivery of samples by regular postal service.
When delivery of samples by courier service is required, additional costs have to be paid. These costs depend on
the country of delivery. For questions about delivery by courier service, please contact the ECAT office.
Due to a change in the shipment procedure at DGKL (courier service instead of postal service) an extra annual fee
of € 50,= will be charged per registration for one or more Molecular Biology surveys.
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DETAILED SAMPLE INFORMATION (I)
Number of Number of
Survey different vials per
Description Code samples sample
Component
per survey code
Thrombophilia - I
Antithrombin (activity and antigen), Protein C (activity [chromogenic and M 2 2 Plasma, lyophilised
clotting] and antigen), Protein S activity, Protein S antigen (total and free)
Thrombophilia - II M 2 1 Plasma, lyophilised
APC Resistance
Coagulation Factor - I
Factor VIII (clot and chromogenic activity), IX (clot and chromogenic M 2 2 Plasma, lyophilised
activity), XI:C and XII:C
Coagulation Factor - II M 2 2 Plasma, lyophilised
Factor II:C, V:C, VII:C and X:C
Von Willebrand Factor parameters
(antigen, ristocetin cofactor activity, activity, collagen binding, multimers, M 2 2 Plasma, lyophilised
Factor VIII)
ADAMTS13 - I (activity and antigen) M 2 1 Plasma, lyophilised
ADAMTS13 - II (antibodies) M 2 1 Plasma, lyophilised
Factor XIII (activity and antigen) M 2 1 Plasma, lyophilised
Fibrinolysis - I M 2 1 Plasma, lyophilised
Plasminogen, Antiplasmin
Fibrinolysis - II M 2 1 Plasma, lyophilised
t-PA, PAI-1
Haemophilia M 2 1 Plasma, lyophilised
Factor VIII / Factor IX (clot and chromogenic activity)
Factor VIII inhibitor M 2 1 Plasma, lyophilised
Factor IX Inhibitor M 2 1 Plasma, lyophilised
Emicizumab M 2 1 Plasma, lyophilised
Lupus Anticoagulant / Antiphospholipid Antibodies L 1 2 Plasma, lyophilised
Unfractionated Heparin Monitoring (anti-Xa) A 2 1 Plasma, lyophilised
Low-Molecular Weight Heparin Monitoring (anti-Xa) A 2 1 Plasma, lyophilised
Orgaran (anti-Xa) A 2 1 Plasma, lyophilised
Fondaparinux (anti-Xa) A 2 1 Plasma, lyophilised
Rivaroxaban (anti-Xa) A 2 1 Plasma, lyophilised
Apixaban (anti-Xa) A 2 1 Plasma, lyophilised
Edoxaban (anti-Xa) A 2 1 Plasma, lyophilised
Argatroban (anti-IIa/dTT) A 2 1 Plasma, lyophilised
Dabigatran (anti-IIa/dTT) A 2 1 Plasma, lyophilised
D-Dimer D 2 1 Plasma, lyophilised
Screen - I S 2 1 Plasma, lyophilised
APTT, PT/INR and Fibrinogen
Screen - II S 2 1 Plasma, lyophilised
Thrombin Time, Reptilase Time
Thrombin Generation Test TG 3 1 Plasma, lyophilised
PFA-100/200 PFA 2 2 tubes ± additives
ROTEM delta T 2 1 Plasma, lyophilised
ROTEM sigma T 2 1 Plasma, lyophilised
TEG T 2 1 Plasma, lyophilised
CLOT-PRO T 2 1 Plasma, lyophilised
HIT - I (immunological testing) HIT 2 1 Plasma or serum, lyophilised
Homocysteine H 2 1 Plasma, lyophilised
POCT INR QC Programme Q 4 1 Plasma, lyophilised
Post Analytical Platelet Function EQA (electronic survey) - - -
Platelet Dense Granule exercise (electronic survey) - - -
Case studies on bleeding disorders 1 1 or 2 Plasma, lyophilised
Pre- and post-analytical electronic surveys in haemostasis - - -
Molecular Genetics MG1 2 1 DNA preparation, lyophilised
Molecular Genetics MG2 2 1 DNA preparation, lyophilised
DNA Sequencing 5 1 DNA preparation, lyophilised
DNA Isolation 2 1 Full blood, K-EDTA
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LIST OF PARAMETERS
Parameter Module Survey Code
ADAMTS-13 activity ADAMTS13 - I M
ADAMTS-13 antigen ADAMTS13 - I M
ADMATS-13 antibodies ADAMTS13 - II M
Anticardiolipin antibodies (IgG, IgM) Lupus Anticoagulant / Antiphospholipid Antibodies L
Antithrombin activivty Thrombophilia - I M
Antithrombin antigen Thrombophilia - I M
APC Resistance Thrombophilia - II M
Apixaban (anti-Xa) Apixaban A
APTT (clotting time / ratio) Screen – I S
Argatroban (anti-IIa / dTT) Argatroban A
CLOT-PRO CLOT-PRO T
Dabigatran (anti-IIa / dTT) Dabigatran A
D-Dimer D-Dimer D
Edoxaban (anti-Xa) Edoxaban A
Emicizumab Emicizumab M
Factor II:C Coagulation Factor - II M
Factor V:C Coagulation Factor - II M
Factor VII:C Coagulation Factor - II M
Factor VIII (clot and chromogenic) Coagulation Factor - I / Haemophilia M
Factor VIII Inhibitor Factor VIII Inhibitor M
Factor IX (clot and chromogenic) Coagulation Factor - I / Haemophilia M
Factor IX Inhibitor Factor IX Inhibitor M
Factor X:C Coagulation Factor - II M
Factor XI:C Coagulation Factor - I M
Factor XII:C Coagulation Factor - I M
Factor XIII activity Factor XIII M
Factor XIII antigen Factor XIII M
Fibrinogen (Clauss) Screen – I S
Fibrinogen (Derived) Screen – I S
Fondaparinux (anti-Xa) Fondaparinux A
ß2-Glycoprotein I antibodies (IgG, IgM) Lupus Anticoagulant / Antiphospholipid Antibodies L
HIT (immunological testing) HIT – I HIT
Homocysteine Homocysteine H
INR Screen – I S
INR POCT POCT INR QC Programme Q
Low-Molecular Heparin (anti-Xa) Low-Molecular Heparin Monitoring A
Lupus Anticoagulant Lupus Anticoagulant / Antiphospholipid Antibodies L
Orgaran (anti-Xa) Orgaran A
PAI-1 activity Fibrinolysis - II M
PAI-I antigen Fibrinolysis - II M
PFA-100/200 PFA-100/200 PFA
Plasminogen activity Fibrinolysis - I M
Plasmin Inhibitor (antiplasmin) activity Fibrinolysis - I M
Protein C acivity (chromogenic / clotting) Thrombophilia - I M
Protein C antigen Thrombophilia - I M
Protein S activity Thrombophilia - I M
Protein S antigen (total and free) Thrombophilia - I M
PT (clotting time, percentage) Screen – I S
Reptilase Time (clotting time / ratio) Screen – II S
Rivaroxaban (anti-Xa) Rivaroxaban A
ROTEM delta ROTEM delta T
ROTEM sigma ROTEM sigma T
TEG TEG T
Thrombin Generation Test Thrombin Generation Test TG
Thrombin Time (clotting time / ratio) Screen – II S
t-PA antigen Fibrinolysis - II M
Unfractionated Heparin (anti-Xa) Unfractionated Heparin Monitoring A
Von Willebrand Factor antigen Von Willebrand Factor Parameters M
Von Willebrand Factor ristocetin cofactor activity Von Willebrand Factor Parameters M
Von Willebrand Factor activity Von Willebrand Factor Parameters M
Von Willebrand Factor collagen binding Von Willebrand Factor Parameters M
Von Willebrand Factor multimers Von Willebrand Factor Parameters M
Von Willebrand Factor / Factor VIII Von Willebrand Factor Parameters M
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M015 / Release: 081020PMPROGRAMME DETAILS 2021
DETAILED SAMPLE INFORMATION (II)
Measuring range Number of participants
Description
(approx.) (approx.)
Thrombophilia - I
Antithrombin (activity and antigen), Protein C (activity
20 – 120% 395
[chromogenic and clotting] and antigen), Protein S activity, Protein
S antigen (total and free)
Thrombophilia - II APC Resistance normal / FV Leiden 260
Coagulation Factor - I
0 – 200% 300
Factor VIII (clot and chromogenic activity), IX:C, XI:C and XII:C
Coagulation Factor – II
0 – 200% 250
Factor II:C, V:C, VII:C and X:C
Von Willebrand Factor parameters
0 – 125% 415
(antigen, activity, collagen binding, multimers, Factor VIII)
ADAMTS13 - I (activity and antigen) 0 – 125% 120
ADAMTS13 - II (antibodies) 0 – 10 BU/mL 70
Factor XIII (activity and antigen) 0 – 120% 180
Fibrinolysis - I Plasminogen, Antiplasmin 0 – 120% 155
Fibrinolysis - II t-PA, PAI-1 0 – 50 ng/mL 70
Haemophilia 0 – 100% 110
Factor VIII inhibitor 0 – 15 BU/mL 355
Factor IX Inhibitor 0 – 15 BU/mL 265
Emicizumab therapeutic range New
Lupus Anticoagulant / Antiphospholipid Antibodies negative - positive 620
Unfractionated Heparin Monitoring (anti-Xa) 0 – 1.25 IU/mL 160
Low-Molecular Weight Heparin Monitoring (anti-Xa) 0 – 1.25 IU/mL 280
Orgaran (anti-Xa) therapeutic range 130
Fondaparinux (anti-Xa) therapeutic range 130
Rivaroxaban (anti-Xa) therapeutic range 250
Apixaban (anti-Xa) therapeutic range 225
Edoxaban (anti-Xa) therapeutic range 85
Argatroban (anti-IIa, dTT) therapeutic range 55
Dabigatran (anti-IIa, dTT) therapeutic range 195
D-Dimer normal - elevated 665
Thrombin Generation Test normal / abnormal 55
PFA normal - pathological 105
ROTEM delta normal - pathological 85
ROTEM sigma normal - pathological 35
TEG normal - pathological 15
Clot-Pro normal - pathological New
HIT - I (immunological testing) negative / positive 465
Homocysteine 0 – 100 µmol/L 50
Screen - I
APTT, PT normal – prolonged
290
INR 1.0 – 5.0
Fibrinogen 1.0 – 4.0 g/L
Screen - II Thrombin Time, Reptilase Time normal – prolonged 110
POCT INR QC Programme 2 – 4.5 45
Post Analytical Platelet Function EQA (electronic survey) - 115
Platelet Dense Granule exercise (electronic survey) - 15
Case studies on bleeding disorders - 80
Pre- and post-analytical electronic surveys in haemostasis - 55
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M015 / Release: 081020PMPROGRAMME DETAILS 2021
Part of the samples used in the surveys is from commercial source. For abnormal samples real patient plasma is
used when appropriate. Samples are provided as lyophilized material.
Instructions for use of the samples will be given in the Survey Manual and the Survey Instructions.
Molecular Biology
In co-operation with the DGKL in Germany several EQA programmes related to Molecular Biology are provided.
Molecular Diagnostic Testing
Twice a year an EQA programme for Molecular Diagnostic Testing is provided. There are two modules on molecular
genetic testing (MG1 and MG2), each including 6 sets with different genetic defects to be tested. Within a module
the relevant sets for participation should be selected. For details see page 12. The material provided is purified DNA.
DNA isolation
Twice a year an EQA programme for DNA isolation is provided. Here whole EDTA-blood is provided. These surveys
focus on the determination of concentration of DNA, ratio 260/280, method of identification and defined genotypes.
DNA sequencing
Twice a year an EQA programme for DNA sequencing is provided. Purified DNA is provided. DNA sequencing should
be performed and corresponding diagnostic interpretation should be given.
Special surveys
Electronic post-analytical platelet function survey:
In co-operation with the NASCOLA in the United States twice a year a post-analytical survey for platelet function
testing is provided. These surveys focus on the interpretation of aggregation patterns in combination with a case
description.
Platelet Dense-Granual Survey:
In co-operation with the NASCOLA in the United States twice per year a platelet dense-granule survey is provided.
This is a paper or electronic challenge in which electron microscopy images have to be evaluated.
Case studies on bleeding disorders:
Case studies on bleeding disorders is a combination of analytical aspects as well as case-based interpretation of the
laboratory results. The participant will receive plasma to perform laboratory tests, which can be selected based on a
given case description. Genetic testing will be included as an option. In addition a questionnaire on the interpretation
of test results has to be completed as well. The scope of this case studies is to investigate the ability of proper
interpretation of the clinical case description and the obtained laboratory test results, resulting in the correct diagnosis.
Pre- and post-analytical survey:
This is an electronic survey in which multiple choice questions with respect to aspects of the pre- and post-analytical
phase have to be answered. Comments on the given answers are shown and an overview of the score is given.
Disclaimer:
The ECAT Foundation is not responsible for either the content or the evaluation of the test results of surveys provided
either by the NASCOLA or DGKL.
PILOT STUDY
APTT mixing study
Mixing studies represent a simple but very useful tool for the first investigations when APTT prolongations are
unexpectedly found. By mixing the patient’s sample with normal (pooled) plasma, they can help to distinguish
between factor deficiencies, the presence of specific or unspecific inhibitors or lupus anticoagulant. The purpose of
this pilot study is to investigate different analytical methodologies (e.g. ratio patient plasma – normal plasma,
incubation yes or no) in relation to the interpretation of the test results. The study includes several samples with
different causes for a prolonged APTT.
This pilot study is free-of-charge and will take place in May/June 2021.
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M015 / Release: 081020PMPOINT-OF-CARE TESTING 2021
POCT FOR COAGUCHEK MONITORS
Introduction
The ECAT Foundation provides an external quality control kit for CoaguChek INR monitors. It can be used for
quality control of reference monitors in coagulation clinics, monitors used in hospital settings, medical centres etc.
as well as individual monitors of patients.
It is possible to evaluate more than one monitor (max. approx. 5) at the same time with one quality control kit.
Because of the use of a set of 4 certified plasma samples it is possible to get, within a certain confidence interval,
insight in the correctness of INR measurement within the therapeutic interval. The results can be evaluated using
an online evaluation tool and the evaluation report per monitor is immediately available.
It is advisable to evaluate the performance of each monitor at least twice a year or after the change of a lot number
of test strips.
Examples of QC kit and evaluation tool
Ready-to-use QC kit (excl. test strips):
Clear instructions:
4. The control samples must now be mixed well with the water. This should be
done as follows:
Firmly hold the bottle as shown in the photo opposite.
Turn the bottle upside down and back up again by rotating your lower arm. (The
bottle must not be shaken, as this will cause foam to appear in the bottle of the
control sample. This must be avoided .)
Repeat this action 5 times.
Repeat this procedure for all control sample bottles.
Then leave the bottles to stand for 15 minutes.
During this time prepare the CoaguChek monitor for use.
Online evaluation tool:
(evaluation report immediately available)
Clearly structured and informative evaluation report:
ECAT Foundation Page 17 of 22
M015 / Release: 081020PMPOINT-OF-CARE TESTING 2021
POCT INR QC 2021
For 2021 the ECAT offers the following options:
POCT INR QC Programme
Samples are provided as QC kit 4 times per year. Each quarter you will receive a different lot-number of the
quality control kit. For evaluation the webtool is available and the reports per monitor are generated
immediately. You will receive an overall evaluation report after each quarter.
More information about the dispatch date of the kits and survey period can be found on page 8. Information
about the cost is given on page 11.
Registration POCT INR QC Programme:
Registration for this POCT INR QC Programme is included in the online subscription form 2021.
POCT INR QC Single kits
The single kits can be ordered and evaluated at any time. For evaluation the webtool is available and the
reports per monitor are generated immediately.
Price (Euro) Product
Description
Excl. VAT and shipment cost ** code
ECAT INR Quality Control single kit 75.00 ECAT11001
** Shipping and handling costs per order: - within the Netherlands: € 12,50
- within Europe: € 25,=
- outside Europe: price on request
For orders of more than 25 sets at once a special price can be provided.
Orders for these POCT quality control kits will be separately invoiced from the regular EQA programme.
How to order POCT Quality Control Single Kits
In the POCT section at the ECAT website (POCT →
POCT single kit - order form) a special order form can
be found for ordering POCT QC kits. This online order
form can only be used to order a number of single kits,
Product code ECAT11001.
ECAT Foundation Page 18 of 22
M015 / Release: 081020PMGENERAL INFORMATION ECAT FOUNDATION 2021
GENERAL INFORMATION ECAT FOUNDATION
The ECAT is an independent and impartial organisation. Its legal entity is a foundation directed by the director,
dr. P. Meijer. A Supervisory Board oversees the foundation and also serves as the Scientific Advisory Board.
Members of the Supervisory Board are well experienced in the field of thrombosis and haemostasis.
Staff
Name Position
Dr. P. Meijer Director
Mrs. M. Van der Voorn Quality Programme Coordinator
Dr. M. van Essen Programme Expert
Mrs. J. Begieneman Customer Support
Mr. C. van den Broek Assistant Quality Programme Coordinator
Mrs. A. de Haan Survey Assistant
Mrs. W. Hoogenboom Financial Manager
Mrs. G. Zandbergen Financial co-worker / Survey Assistant
Members of Supervisory Board
Name Specialism Position
Prof. Dr. M.P.M. de Maat Biochemist/epidemiologists/clinical chemist Chair
Drs. F. van den Hurk Financial specialist Member
Dr. W. van Gelder Clinical chemist Member
Dr. F.J.M. van der Meer Internist Member
Dr. J. Ruinemans-Koerts Clinical chemist Member
Prof. Dr. J.C.M. Meijers Biochemist Member
Website
At the ECAT website (www.ecat.nl) there is a
specific participant area which contains the result
submission facility, survey reports, information
and documents. These sections can be accessed
with a Login function.
Each participant has his own unique username
and password. These are provided by the ECAT
office at the start of the participation.
For laboratories using our quality control for the
CoaguChek monitors an evaluation tool is
available at our website. This can be accessed
by a special login (POCT, followed by
Evaluation) from the main menu at our website.
This requires a different username and
password.
Each user has his own unique username and
password. These are provided by the ECAT
office at the start of the participation.
Survey Manual
The Survey Manual 2021, which includes detailed instructions how to perform the surveys, will become online
available before the start of the first survey.
ECAT Foundation Page 19 of 22
M015 / Release: 081020PMGENERAL INFORMATION ECAT FOUNDATION 2021
Accreditation
Since 25 April 2012 the EQA programme of the ECAT is accredited according to the international
standard ISO/IEC 17043:2010 by the Dutch Accreditation Council (RvA).
The following modules of ECATs’ EQAP are part of the accreditation scope:
Screen – I
Screen - II
Thrombophilia - I
Thrombophilia - II
Lupus Anticoagulant / Antiphospholipid Antibodies
D-Dimer
Coagulation Factor - I
Coagulation Factor - II
Von Willebrand Factor module
Factor VIII inhibitor
Thrombin Generation Test
Factor XIII
Fibrinolysis - I
Fibrinolysis - II
Monitoring for Anticoagulation Drugs (UFH, LMWH, Orgaran, Fondaparinux, Rivaroxaban, Apixaban,
Argatroban, Dabigatran)
Homocysteine
It is our intention to add new modules to the scope of the accreditation as soon as possible after the introduction.
The latest version of the scope can always be found at our website.
Products and services from third parties
ICT-related issues Back-up services, web design and Health e.solutions – The
maintenance, web and database hosting, Netherlands
POCT application.
Participant management and survey KPMD – United Kingdom
evaluation software, web-based data
submission.
Sample production Sample production and testing for Affinity Biologicals – Canada
homogeneity and stability. Hyphen Biomed – France
Technoclone – Austria
MCA – The Netherlands
Klinikum Augsburg – Germany
RCPA - Australia
Laboratory testing Reference laboratory for testing of Erasmus Medical Center – The
homogeneity and stability. Netherlands
Confidentiality policy
1. ECAT is obliged to keep confidential any and all information they acquired from participants within the scope of
their registration.
2. Any results from research conducted by ECAT within the scope of the programme offered by ECAT that can be
traced to a certain participant shall be confidential and shall only be notified to the relevant participant.
3. If ECAT should, on the basis of a statutory provision or court decision, be obliged to disclose confidential
information to a third party designated by the law or the competent court, and ECAT cannot in such case invoke
the right of non-disclosure acknowledgement or allowed under the law or by the competent court, ECAT shall
not be obliged to pay compensation or damages, and the participant shall not have the right to dissolve the
agreement on the basis of any resultant damage. ECAT is obliged to notify affected participants of this action in
written.
ECAT Foundation Page 20 of 22
M015 / Release: 081020PMGENERAL INFORMATION ECAT FOUNDATION 2021
(for further details see our general terms delivery which can be found on our website)
Intellectual property rights and copyrights
1. ECAT reserves the rights and powers vested in ECAT pursuant to the intellectual property right.
2. The participant shall not be permitted to modify the items delivered or made available, unless the nature of the
items delivered or made available should require otherwise or unless agreed otherwise.
3. Any designs, presentations, drawings, films, software or other material or files, whether electronic or
otherwise, made by ECAT within the scope of the contract shall remain the property of ECAT, irrespective of
whether they were handed over to the participant or to third parties, unless agreed otherwise.
4. Any and all documents provided by ECAT such as reports, advice, agreements, etc. shall exclusively be
intended for use by the participant and they may not be reproduced, published or disclosed to third parties by
the participant without ECAT’s permission obtained in advance, unless the nature of the documents should
dictate otherwise.
5. ECAT reserves the right to use the know-how acquired due to the carrying out of the work for other purposes,
insofar as no confidential information is disclosed to third parties.
(for further details see our general terms delivery which can be found on our website)
Provision of global survey reports
ECAT may provide to third parties, like distributors of the ECAT programme or diagnostic companies, global
survey reports which only demonstrate the overall statistical analysis without any traceable results to a specific
participant.
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M015 / Release: 081020PMFINANCES 2020
FINANCES
You will receive an invoice for your participation as soon as possible in 2021. When the appropriate information is
available the invoice will be sent directly by e-mail to the financial department of your hospital/institution. Otherwise
the invoice will be sent to the sample or responsible person.
Payment should be done by bank transfer. Cheques are not accepted.
When the invoice is not paid within 6 weeks after receipt of the invoice, no samples and survey reports will be
provided anymore till payment is done.
For participants of one of the EMU countries we ask for a VAT number. If the VAT number of your organisation is
not available at our Financial Department, the ECAT is legally obliged to add 21% VAT to the invoice.
Contact details financial department
T. +31 71 3030911
F. +31 71 3030919
finance@ecat.nl
Details ECAT bank account
Bank office: ING
Address: P.O. Box 94780
1090 GT Amsterdam
The Netherlands
Account no.: 6930471
IBAN no.: NL38 INGB 0006 9304 71
BIC code: INGBNL2A
ECAT VAT number: NL802836872B01
Terms of delivery
The terms of delivery of the ECAT Foundation can be found on our website. If you want a printed copy, please
contact our office
ECAT Foundation Page 22 of 22
M015 / Release: 081020PMYou can also read
