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TEST GUIDE

SPECIALISED MEDICAL

PATHOLOGY

INTERNATIONAL DIVISION

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - The International Division ........................................................................ Useful contacts ........................................................................ Practical information ........................................................................

Regulatory requirements and specificities ................................................................

Histopathology and cytology ........................................................................ Test guide ........................................................................

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - THE INTERNATIONAL DIVISION Biomnis is a european leader in specialised medical pathology

with

Two specialised sites in France:

oParis (Ivry-sur-Seine): treatment of large-volume specialised tests on an autolab platform oLyon (Gerland): treatment of highly specialised requests, requiring specific expertise

International clients in over 40 countries

A specialised, clinical reference laboratory in Dublin, Ireland Numerous partnerships within Eurofins networkOn the strength of the Eurofins net work and its p artnerships with numerus reference international laboratories, of fers i ts c lients ac cess t o an unmatc hed test m enu. serves hospitals, medical centres, public and priv ate laboratories, pharmaceutical companies and clinical trial centres on a global scale and is particularly well established in the

Middle

-East, Europe and Asia. is organised in such a way as to optimise and ensure the best service levels to our International clients. It provides a remote and highly responsive c

ustomer support through a dedicated team and will cater for all of your patient's requirements

including: preanalytical advice, local, tec hnical and logistical support as and when required, test information and pos t -analytical provision of clinical advice, through ' network of 45 expert c linical pathologist s. The principal role of the International Division is to: Provide remote, highly responsive customer support via a dedicated account manager. Facilitate client contact with our network of 45 expert clinical pathologists. Coordinate with representatives within the country of operation where relev ant, t o provide local/technical/logistical support as and when required. Above all, ensure client satisfaction and maintain close working relationships.

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - USEFUL CONTACTS CONTACT INTERNATIONAL

International Division

T. +33 4 72 80 23 85

- F. +33 4 72 80 73 56

Monday

- Friday:

8:30 am

- 6:30 pm (GMT+1)

Saturday: 9:00 am

- 12:00 pm (GMT+1)

CONTACT IRELAND & UK

Sales Department Ireland

T. +353 1 295 85 45 - F. +353 1 295 85 50

sales@biomnis.ie

Sales Department UK

Mob. +44 7801 599 161

adr ian.appleby@biomnis.co.uk

Skype: adrian_appleby

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

PRACTICAL INFORMATION

Medical pathology test guide ........................................................................

Profiles and Panels ........................................................................ Dynamic tests ........................................................................ Supplies ........................................................................

Request forms and other documents .......................................................................

Samples preparation ........................................................................ Test procedure ........................................................................ Result turn-around times ........................................................................ Results ........................................................................

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - MEDICAL PATHOLOGY TEST GUIDE

Updated daily, our test guide provides direct acces s to information on all of the tests offered at , including preanalytical information, methodologies, clinical significance, forms to be included, stability /en/Test guide You may wish to be enrolled in mailing list to receive the monthly l etter, i f s o, p lease provide us y our contact details at international biomnis.com. M edical Pathology Test Guide in digital format also offers a version of the Medical Pathology Test Guide in the form of digital c atalogue: "The Digital T est G uide". This c omplet e version of the Test Guide is updated monthly and is made available onli ne at the e nd of month, r eady t o come int o effect o n t he 1 st day of the following month. D ownloadable in pdf format, the Medical Pathology Test Guide allows you to have a version of the catalogue that is always up-to-date for use off-line.

Access

t he Medical Pathology Test Guide in digital format at www.biomnis.com. /en/Test guide

PROFILES AND PANELS

/en/Services Profiles and panels

Allergy

Autoantibody

Neonatal screeningl

Infectious disease

Hormones

Haematology

Drug of abuse screensDYNAMIC TESTS

Dynamic

t ests m akes a list of d ynamic t ests av ailabl e t o its c lients. It i s possible to print t hem. /en/Services Dynamic tests The procedures for sampling, labelling and storage of the biological samples are described in this

guide. It is important to follow these procedures in order to facilitate the processing of your samples.

Failure to comply with the sampling, labelling and storage conditions constitutes a major non conformity criterion which could lead to the inability to perform the analysis requested.

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - supplies shipping materials and useful documents for your routine practice, free of

charge on request. The material request form must be used to request the supply of test request forms, practical documents, transport bags, sampling kits or specific transport media. This request form is available from your local agent or from the or from your dedicated key account manager.

REQUEST FORMS AND OTHER DOCUMENTS We encourage you to use request forms which contain all the information needed to

process s amples. If using other forms, ensure that they contain all the information requested and please follow the following instructions: no staples, adhesive tape, paper clips or highlighting or double -sided printing. The ISO 15189 norm highlights the importance of clinical details to enable

the most complete results interpretation. You may find on the website (www....) the required information or the

specific /en/Test guide Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

SAMPLES PREPARATION

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - TEST PROCEDURE

All tests are carried out in compliance with written standard operating procedures that are updated in

conjunction with any development in the method used. Any modification to a test method that could affect result expression or reference values is subject to a memo that is addressed to referring laboratories. The preparation, set-up and biological and analytical validation of tests are subject to written

procedures. The internal quality control policy for each test is described in details in terms of control

samples, testing conditions, acceptability guidelines and actions to be taken in cases of anomalies. ' participation in different external quality control programmes enables the methods us ed to be validated and allows an y abnormalities t o be detec ted.

RESULT TURNAROUND TIMES

The turn

-around-times indicated in the test guide correspond to the maximum time needed for the result to be released. It is calculated from the time/date the sample is registered at , providing the file is complete (date of birth, sex of the patient, clinical data essential for the analysis, clinical information sheet, or regulatory documents, if applicable). I t does not take into account Sundays, bank holidays, complementary verifications or the addition of

reflex tests. If clinical details/information are specifically requested but not provided, the turn-around

time cannot be maintained.

RESULTS

Test results are returned in compliance with regulations to ensure confidentiality according to the information provided by the referring la boratory.

By telephone

T: +33 4 72 80 23 85

Monday - Friday: 8:30 am - 6:30 pm (GMT+1) - Saturday: 9:00 am - 12:00 am (GMT+1) @biomnis.com

By FAX

Results can be faxed to the referring laboratory, either systematically following configuration in our

information system, or occasionally on express request.

By HPRIM Connection

The results can be released by HPRIM connection to the laboratory in compliance with the spe cifications provided by HPRIM SANTÉ V2.2 and HPRIM Net V1. These exchanges use secured Internet, S/MIME, through networks based on the SMTP and TCP/IP

protocols. Authentication of the origin of the messages and the confidentiality of the data transferred

are all assured. To gain access to this service, please contact the International Division

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - Via the secure result server

Results are available to the referring laboratory via a secure results server: Round-the-clock access, 7 days a week, to the data related to any file you send us "Real-time" access to your patients' results which are transferred on-line once they have been authorised The possibility to be notified (by fax or email) of an urgent result as soon as it is available The price of each file is indicated on the consultation screen

To be able to

ac cess t his s erver, please contact your International Division team. Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

REGULATORY REQUIREMENTS

- Article R2131-1 and subsequent passages from the French Public Health Code Decree

Post-natal diagnostics

FOETAL TRISOMY 21 RISK EVALUATION - PRENATAL BIOCHEMISTRY

- Decree dated 14 January 2014 stipulating the model of the document mentioned in the second sub paragraph of article R.2131-18 from the French Public Health Code

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

HISTOPATHOLOGY AND C

YTOLOGY

Sheets N20

-INTGB (anatomical pathology) and N21-INTGB (cytopathology) also contain the information from the tables below and are available in the test guide for PATHO and PATHS tests.

ANATOMICAL PATHOLOGY TESTS (BIOMNIS CODE: PATHO)

Type of

Temperature

Sample notes Technique

Maximum

time

Histopathological

Histopathological

examination of a simple

Simple

surgical

Histopathological

examination of a

Complex

If benign

If malignant

Histopathological

examination of a

Resection/cur

Histopathological

examination during an Room

Immunohistochemistry

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

CYTOPATHOLOGY TESTS

(BIOMNIS

CODE: PATHS)

Cytopathological

examination of

Mucous

Cytopathological

examination of

Ascites/pleural

Cytopathological

examination of CSF

Cytopathological

examination of

Synovial fluid

Cytopathological

Cytopathological

Cytopathological

examination of

Bronchial

Cytopathological

examination of

Bronchoalveolar

Cytopathological

examination of

Ganglion

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

CYTOPATHOLOGY TESTS

(CONTINUED) (Biomnis code: PATHS)

Cervical/thyroid/

gland

Cytopathological

Cytopathological

examination of /lung/pancreas

Liver/lung/pancr

multilevel

Breast puncture

Multilevel breast

Unilateral breast

Bilateral breast

Eurofins Biomnis - International Division - Test Guide Specialised medical pathology -

TEST GUIDE

For any test that is not listed in this test guide, please contact the International Division before sending your samples:

Tel. +33 4 72 80 23 85 - Fax +33 4 72 80 73 56

Monday

- Friday:

8:30 am

6:30 pm (GMT+1) and Saturday: 9:00 am

- 12:00 pm (GMT+1)

E-mail: international@biomnis.com

You are now equipped with all the essential information needed to ensure the smooth processing and testing of your samples (pre -analytical information, prices etc.)

Samples

If a particular type of sample is not specified, its use is contraindicated.

Plasma

Unless otherwise specified, the term "Plasma" refers to EDTA or heparin plasma. Citrated, oxalated or

fluorinated plasma is never required unless specifically requested. Serum Serum may be collected either in plain tubes or phase separating tubes. However, phase separating tubes should be avoided for medicinal product assays (absorption).

Non-haemolysed

Indicates that the presence of haemolysis, even minimal, may seriously impair the quality of the result.

Urine Fresh samples must be collected. Unless otherwise specified, no additives or preservatives should be added to the specimen. For 24 -hour specimens, the urine should be stored refrigerated unless

specified otherwise. Pre-analytical recommendations from the Study Group on Haemostasis and Thrombosis

(GEH T): Pleas e sen d us a citrat e sampl e that has be en centrif uged an d frozen. Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - Guidelines

1 Amprenavir AMPRE

3 mL EDTA

Plasma • < 4h

3 weeks • HPLCT0 sample (before taking), T1h30 and T3h

(after taking)

Amylase AMY

1 mL heparinised serum or plasma • Refrigerated

1 day • Chemistry - Spectrophotometry

Aneuploidy of chromosomes 13, 18, 21, X and Y

- Rapid diagnosis - QFPCR -

Amniotic fluid

- Prenatal NCDR 2 mL fresh amniotic fluid (non-haemor rhagic) • Room temperature

1 to 2 days • QF-PCR

In order to ensure the traceability of s

amples, we ask you to contact

International Division

before sending any sample for this test. A ttach the medical prescription, the clinical information sheet, doctor's consultation certificate and patient's consent form in accordance with Article R.2131 -1 of

Decree 2006

1661 of 22 December 2006

2,5 Hexanedione

- Urine HEXA * 10 mL urine sample • Refrigerated

2 weeks • Gas chromatography /

Glass bottle with PTFE stopper

Flame ionisation detector

Sample at end of work shift

T18: Glass bottle, PFTE stopper for solvents

(provided on request) Eurofins Biomnis - International Division - Test Guide Specialised medical pathology - Guidelines

Name of the reference test

Volume and type of sample

Sample storage and transportation:

The indication < 4h indicates that the sample must be frozen within 4 hours is cquotesdbs_dbs26.pdfusesText_32

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