Beruflich Dokumente
Kultur Dokumente
EQAS
External Quality Assurance
Services
Immunoassay
(Monthly) Program
BC7L/70/75
8th Edition
Contact Information
email: eqas@bio-rad.com
Subgroup Information
Participants in subgroups should authorize Bio-Rad to disclose their results to a nominated Subgroup
organizer. It is assumed that such authorization is valid until specifically cancelled.
Accreditation
In countries where participation and performance in this scheme can be used for laboratory
accreditation purposes, Bio-Rad will provide all relevant information to participating laboratories and
obtain individual permissions to divulge laboratory results to the accrediting body.
Staff of participating laboratories agree to maintain in strict confidence and not to publish or otherwise
disclose to any third party, any information supplied to them by Bio-Rad without first obtaining the
consent in writing of the organizers. Please note that this restriction applies to all publications,
including commercial and promotional literature.
It is understood that:
(a) Such consent is not required for disclosure in confidence to colleagues with whom they are
working for their personal scientific interest.
(b) Bio-Rad will not use information gained by the operation of the Program for any purposes other
than the compilation of confidential reports for participants, the provision of assay values for
batches of material from the Program or the publication of pooled data of general scientific
interest, except for subgroup and/or accreditation reports (see above).
Abbreviations Used
CISBIO Cisbio Bioassays
DIASource DIASource Immunoassays S.A.
DSL Diagnostic Systems Laboratories, Inc
Siemens Siemens Healthcare Diagnostics
The Method Questionnaire
New participants to the Program should complete a Method Questionnaire and an Enrollment Document.
Current participants should use a Change Notification Form to notify us of any change in method. Please supply
details of your methodology, units, reagent/instrument used and mode of operation, as appropriate. Please use
the Method Classification Guide valid for the program and cycle in which you are participating. Correct
classification ensures that your results are appropriately compared. If no method codes are on your file, no
analysis of your result can be given.
1. Methodology Code
Enter the relevant 3-digit numerical code for your methodology (assay technology). The methodology code is
printed to the left of each methodology description. For example:
Thyroid Stimulating Hormone
Methodology code
The most common methodologies are included in the Method Classification Guide for each analyte. If your
methodology is not listed please use the most appropriate "Other Methods" category, and give full details in the
space provided on the last page of the Questionnaire.
2. Reagent/Instrument Code
A list of reagents/instruments and the corresponding codes are given for each analyte. The reagent/instrument
code is printed to the right of the reagent/instrument description. For example:
Thyroid Stimulating Hormone
Reagent/Instrument code
For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
3. Mode of Operation
Where appropriate, indicate if your assay is automated or manual.
4. Units
Results for certain analytes may be submitted in either SI or Mass units. Results must be reported in the units
listed on the Method Questionnaire/Results forms. Please indicate your units in the boxes on the Method
Questionnaire. If your reporting unit is not listed, please convert your result to either Unit 1 or Unit 2 before
submitting data. Alternatively, if you provide details of the conversion factor, we can automatically apply this
conversion factor on receipt of your results. Please notify us if you wish to subsequently remove a conversion
factor.
Examples of Method Questionnaire completion:
Free Thyroxine (FT4): Roche Elecsys
Auto nmol/L
23 Testosterone
212 327
Manual μg/L
Notes
i) For codes marked * or 999 please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
ii) The relevant codes must be registered for all analytes for which you intend to submit results. Without
such codes, results cannot be processed and no histogram will be produced. If you wish to receive a
results summary and histogram for an analyte for which you do not intend to submit values, please use the
methodology code '888'.
List of Analytes
Analyte
Analyte
Number
Thyroid Function
1 Thyroid Stimulating Hormone (TSH)
2 Thyroxine (T4), Total
3 Free Thyroxine (FT4)
4 Triiodothyronine (T3), Total
5 Free Triiodothyronine (FT3)
Pregnancy
6 Alphafetoprotein (AFP)
7 Chorionic Gonadotropin (hCG)
Iron Metabolism
8 Ferritin
9 Folate
10 Vitamin B12
Specific Proteins
11 Immunoglobulin E (IgE)
12 -2 Microglobulin
Reproductive Endocrinology
13 Follicle Stimulating Hormone (FSH)
14 Luteinizing Hormone (LH)
15 Prolactin
16 Estradiol
17 Progesterone
18 Testosterone
19 DHEA-Sulfate
General Endocrinology
20 Growth Hormone (hGH)
21 17--OH-Progesterone
22 Cortisol
23 Parathyroid Hormone (PTH), Intact
Oncology
24 Carcinoembryonic Antigen (CEA)
25 CA 125
26 CA 19-9
27 CA 15-3
28 Prostate Specific Antigen (PSA), Total
29 Prostate Specific Antigen (PSA), Free
List of Analytes (cont.)
Analyte
Analyte
Number
Therapeutic Drugs
30 Carbamazepine
31 Digoxin
32 Phenobarbital
33 Phenytoin
34 Theophylline
35 Valproic Acid
1
Thyroid Stimulating Hormone
(TSH)
151 Any Other Radioactive Tracer Method Siemens ACS 180/Centaur/XP 298
ACS 180/Centaur TSH III 307
*Any instrument 999 ADVIA Centaur CP 280
Centaur TSH3-Ultra 313
Dimension 343
Non-Isotopic Methods Dimension Vista 353
Immulite 328
301 Spectrophotometric Immunoassay Methods Immulite 2000/2500 340
Reportable Units:
Unit 1 - mU/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
2
Thyroxine (T4), Total
Syva 696
Reportable Units:
Unit 1 - nmol/L
Unit 2 - g/dL
Please see section 4, Units of the instructions
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
3
Free Thyroxine (FT4)
151 Any Other Radioactive Tracer Method *Any other instrument 999
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
4
Triiodothyronine (T3), Total
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
5
Free Triiodothyronine (FT3)
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
6
Alphafetoprotein (AFP)
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
7
Chorionic Gonadotropin (hCG)
Beckman Coulter Access 673 *Any other method for measurement 990
Unicel DxI 180 of intact hCG only.
Ortho Vitros ECi 469 *Any other method for measurement 991
Vitros ECi hCG II 468 of total hCG.
Reportable Units:
Unit 1 - U/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
** Please verify the instrument and kit reporting mode for HCG.
8
Ferritin
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
9
Folate
Reportable Units:
Unit 1 - nmol/L
Unit 2 - ng/mL
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
10
Vitamin B12
Reportable Units:
Unit 1 - pmol/L
Unit 2 - pg/mL
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
11
Immunoglobulin E (IgE)
RADIM 631
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
12
-2 Microglobulin
351 Immunoturbidimetry
Abbott Architect 106
Reportable Units:
Unit 1 - mg/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
13
Follicle Stimulating Hormone
(FSH)
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
14
Luteinizing Hormone (LH)
151 Any Other Radioactive Tracer Method 311 Luminescence Immunoassay Methods
*Any instrument 999 Abbott Architect 106
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
15
Prolactin
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
16
Estradiol
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
17
Progesterone
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
18
Testosterone
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
19
DHEA-Sulfate
Reportable Units:
Unit 1 - mol/L
Unit 2 - g/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
20
Growth Hormone (hGH)
151 Any Other Radioactive Tracer Method *Any other instrument 999
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
21
17--OH-Progesterone
RADIM 631
Pantex 900
RSL 671
Reportable Units:
Unit 1 - nmol/L
Unit 2 - g/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
22
Cortisol
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
23
Parathyroid Hormone (PTH), Intact
Reportable Units:
Unit 1 - pmol/L
Unit 2 - ng/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
24
Carcinoembryonic Antigen (CEA)
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
25
CA 125
Reportable Units:
Unit 1 - kU/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
26
CA 19–9
151 Any Other Radioactive Tracer Method Beckman Coulter Access 673
Unicel DxI 180
*Any instrument 999
DiaSorin LIA-mat 264
LIAISON 267
Reportable Units:
Unit 1 - kU/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
27
CA 15–3
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
28
Prostate Specific Antigen (PSA), Total
Reportable Units:
Unit 1 - g/L
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
29
Prostate Specific Antigen (PSA), Free
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
30
Carbamazepine
Reportable Units:
Unit 1 - mol/L
Unit 2 - g/mL
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
31
Digoxin
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
32
Phenobarbital
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
33
Phenytoin
Reportable Units:
Unit 1 - mol/L
Unit 2 - g/mL
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
34
Theophylline
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.
35
Valproic Acid
Immunological Methods
122 Enzymeimmunoassay
(Spectrophotometric, Fluorimetric
or Luminescence)
Abbott Aeroset 115
Architect 106
Note: For codes marked * or 999, please supply manufacturers’ reagent insert and instrument model information, as
appropriate.