Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 1 of 98 EUROFINS BIOMNIS Written / Revised By: Date: Barry O’Dea, Medical Scientist Reviewed By: Date: Dr. Mike Louw, Medical Director Authorised By: Date: Jean-Sébastien Charles, QA Manager Effective Date: 15/07/20 Supersedes: 4.04 File Type: Master Assigned to: Quality Department Electronic copies are available to all staff on Q-Pulse and on the Eurofins Biomnis website. Additional copies of this SOP must not be made without prior approval and documentation. Refer to SOP G94. Issue No. Revision Details Effective Date 1.01 Original 18/04/11 1.02 Added: Theophyline, C3, C4, Tacrolimus, Digoxin, Hepatitis C 31/08/12 Ag, Troponine I, IGF-1 1.03 Added consultant reference 25/10/12 1.04 Full review: Removed immunology and infectious serology 06/05/15 tests. Included reference ranges and source for IgE. 1.05 Updated SOP numbers and accreditation status for several 30/09/15 tests. 1.06 Updated phosphate reference range and PLAC-2 TAT. 01/02/16 Updated gentamicin therapeutic range comment to reflect new Abbott IFU 1E11-20 May 2014 306414/R06. 1.07 Added new test: lipase. Corrected ref ranges TSH, Lp(a) 26/05/16 1.08 Add new in-house tests: lipase, A1AT, caeruloplasmin, 04/01/17 fructosamine, urine free cortisol, urine total protein. Corrected reference ranges for TSH and Lp(a). Updated accreditation status of several tests. 1.09 Addition of anti-thyroglobulin and anti-TPO antibodies. 18/01/17 2.01 Updating of sample requirements for glucose. Update of 04/04/17 reference range for urine sodium in spot sample. Update of link to France test guide. Methods updated for Ferritin, Gentamicin, Glucose, Homocysteine, Vancomycin. 3.01 Remove EDTA plasma as suitable sample for SHBG following 24/05/17 Abbott Field Safety notice dated 18/04/2017. Eurofins Biomnis rebranding. 3.02 Addition of plasma as suitable sample type for iron. Addition of 09/03/18 ACE test and accreditation of caeruloplasmin. 3.03 Updated FT3 reference range. Updated Bile acid method and 29/06/18 sample types. PRODUCTION OF UNAUTHORISED COPIES OF THIS SOP IS FORBIDDEN. AUTHORISED COPIES ARE STAMPED IN GREEN – OFFICIAL COPY Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 2 of 98 EUROFINS BIOMNIS Issue No. Revision Details Effective Date 3.04 Updated transferrin and PSA sample stability. Removed 18/04/19 Troponin I. Updated hyperlink. Added LDH and CK. Updated B12 reference ranges. 3.05 Updated ACE to Glenbio assay. New reference ranges 24/05/19 Updated maximum storage time for C3, IGA, IGG, IGM. EDTA not anymore acceptable for those tests. Updated PSA stability. 3.06 Marked CK as unaccredited 29/05/19 3.07 Updated PSA reference ranges 29/05/19 3.08 Updated C3, C4 and caeruloplasmin sample types. Removed 22/07/19 Red Cell Folate. 3.09 Updated accreditation status for A1AT, theophylline, SPE, 27/09/19 immunofixation. Added back TSH. 4.01 Updated urinary calcium details. SPE method updated to 16/03/20 Capillarys 3 Octa. 4.02 Added lithium. 20/04/20 4.03 Updated with urine chemistry reference ranges 06/06/20 Replace BNP with NTproBNP 4.04 Updated FT3 reference range 10/06/20 4.05 Update anti-TPO units from kIU/L to IU/mL as per IFU 15/07/20 PRODUCTION OF UNAUTHORISED COPIES OF THIS SOP IS FORBIDDEN. AUTHORISED COPIES ARE STAMPED IN GREEN – OFFICIAL COPY Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 3 of 98 EUROFINS BIOMNIS INTRODUCTION This is a list of the biochemistry, endocrinology, and therapeutic drug monitoring tests performed at Eurofins Biomnis’ Dublin Laboratory. For a searchable list of tests performed by Eurofins Biomnis in France, in our laboratories in Lyon and Paris, click here. Please note that these lists were complete at the time of publishing. Eurofins Biomnis is continuously updating its menu of tests, and some tests may be available even though they are not listed in this document or at the above link. If you cannot find details of a test you require, please contact our Client Services department on Free Phone 1800-252-966, or e- mail [email protected]. For sample collection, please contact our Logistics department on Free Phone 1800-252-967, or e-mail [email protected]. PRODUCTION OF UNAUTHORISED COPIES OF THIS SOP IS FORBIDDEN. AUTHORISED COPIES ARE STAMPED IN GREEN – OFFICIAL COPY Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 4 of 98 EUROFINS BIOMNIS LAYOUT OF TEST INFORMATION TEST INFORMATION TEMPLATE Brief information on clinical background, indications for test and interpretation of test results. Preparation of Patient: any special preparation required, such as fasting. Precautions: any special circumstances, conditions etc. to be aware of. Accredited Whether or not the test is accredited by INAB to ISO 15189 Method Test method Sample Type of tube required, transport temperature and other information. Requirements Avoid gel separation tubes for therapeutic drug assays. Some gels (depending on manufacturer) cause adsorption of the drug to the gel. Turnaround The maximum turnaround time in working days from receipt of the Time sample in the laboratory’s pre-analytics department to final authorisation of results. Stability Sample stability under various conditions. RT = room temperature i.e.: 16 – 25 °C. Please see SAMPLE STABILITY notes below. Stability data indicated by a superscript numeral 1 are taken from the publication referenced below1. Units - Units and reference range(s) for the test. Reference Source of the reference ranges: Ranges and 1. Test manufacturer’s instructions for use (IFU). Source 2. National and international guidelines. 3. Ranges established in-house. PRODUCTION OF UNAUTHORISED COPIES OF THIS SOP IS FORBIDDEN. AUTHORISED COPIES ARE STAMPED IN GREEN – OFFICIAL COPY Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 5 of 98 EUROFINS BIOMNIS NOTES ON SAMPLE STABILITY The majority of incorrect laboratory test results are due to improper sample collection and transport. For details regarding correct phlebotomy technique and our patient identification requirements, please click here. In order for you to arrange and properly time phlebotomy and sample collection, we have indicated, for each test, its stability after collection. Stability is indicated for whole blood at various temperatures, and for plasma or serum separated from cells, also at various temperatures. Note: RT = room temperature, i.e. 16 – 25 °C. Stability data are taken from the manufacturers’ instructions for use (IFUs), and from the World Health Organisation publication indicated below1. Sample stability data is not available for all tests under all conditions, either in the manufacturers’ IFUs or the published literature. If no information is available, in general, unless otherwise specified (such as when the required sample is whole blood), serum should be centrifuged and separated from cells after completion of clotting (20 – 30 minutes), and transported to the laboratory at 2 – 8 °C. Plasma may be centrifuged and separated from cells immediately after sampling and gently mixing the sample by inverting the tube 10 times. It should then be transported to the laboratory at 2 – 8 °C. Whole blood should be transported at 2 – 8 °C and reach the laboratory as soon as possible. However, please check each test for specific stability information. If in doubt, please contact our Client Services department on Free Phone 1800-252-966, or e- mail [email protected]. Reference: 1. World Health Organisation: Use of anticoagulants in diagnostic laboratory investigations. WHO/DIL/LAB99.1 Rev.2, 2002. 2. Clinical Biochemistry 45 (2012) 464–469. PRODUCTION OF UNAUTHORISED COPIES OF THIS SOP IS FORBIDDEN. AUTHORISED COPIES ARE STAMPED IN GREEN – OFFICIAL COPY Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 6 of 98 EUROFINS BIOMNIS REASONS FOR REJECTION OF SAMPLES/NON-REPORTING OF TESTS 1. Samples received beyond the stability limits and/or not at the correct temperature indicated below for each test. 2. Samples received in the incorrect tube/with the incorrect anticoagulant or lack of the correct anticoagulant. 3. Samples received without the necessary patient identifiers. For more details, see here. 4. Samples which fail specific criteria for certain tests. See individual tests for details. 5. All samples have 3 tests run on them called “serum indices”. These measure the extent of haemolysis, lipaemia and icterus in the sample. Each test has a specific level of each of these indices above which the test result is not valid. If any index is too high for a given test, that test is not reported. A comment such as “result invalid; sample haemolysed” is printed on the report instead. Clinical Chemistry Consultant: Dr. Mike Louw Telephone: 00-353-1-295-8545 PRODUCTION OF UNAUTHORISED COPIES OF THIS SOP IS FORBIDDEN. AUTHORISED COPIES ARE STAMPED IN GREEN – OFFICIAL COPY Primary Sample Manual – Clinical Chemistry Issue No. 4.05 Effective Date: 15/07/20 Page 7 of 98 EUROFINS BIOMNIS CONTENTS TEST INFORMATION TEMPLATE ............................................................................. 4 ALANINE AMINOTRANSFERASE (ALT) ................................................................... 10 ALBUMIN ............................................................................................................. 11 ALKALINE PHOSPHATASE (ALP) ...........................................................................