Number: S Effective date: July, 2011 Revision Date: N/A

Transcription

1 Number: S Page 1 of 6 TITLE: TOTAL TESTOSTERONE TESTING 10 PURPOSE To establish a for processing Total Testosterone specimens on the Vitros ECiQ at South Shore Regional Hospital 20 SCOPE AND RELATED POLICIES This procedure provides instructions for Total Testosterone testing performed on the ECiQ analyzer in association with South Shore Health 30 SPECIMENS Specimens recommended- serum or heparinized plasma Testosterone is affected by lipemia and hemolysis Centrifuge specimens and remove the serum or plasma from the cellular material within 4hrs of collection Specimens are processed daily from Monday to Fridays excluding holidays on the ECiQ Specimens must be at room temperature before analysis Specimen stability: Refrigerated- 7 days Frozen- 4 weeks 40 MATERIALS Testosterone Reagent Testosterone Calibrator Testosterone Controls Immunoassay Plus Controls Sample trays Sample adapters Sample cups 50 QUALITY CONTROLS / MANAGEMENT Testosterone reagent is stable on board the ECiQ for 8 weeks and until the expiration date on the carton when unopened Testosterone calibrators are stable for 13 weeks at 2-8 C or frozen at -20 C once reconstituted and until the expiration date on the carton when unopened Testosterone controls are stable for 5 days at 2-8 C or 4 weeks frozen once reconstituted and until the expiration date on the carton when unopened in, Quality Management System It is prohibited to photocopy or write on SOPs

2 Number: S Page 2 of 6 Quality Controls: Immunoassay Plus Controls are used as our daily Quality Control for Testosterone testing Vitros Testosterone controls and the Immunoassay Plus QC are both processed after a calibration is performed Please reconstitute Vitros Testosterone controls according to the Instruction for Use for Testosterone controls (Version 21) or Form# F259006Reconstitute the Immunoassay Plus Controls as per the package insert or Form# F Testosterone specimens are processed on Monday to Fridays excluding holidays QC is to be performed when specimens are processed, after analyzer calibration or certain maintenance procedures indicated by the analyzer Process QC as per SOP S ECiQ Processing Quality Controls QC must be within acceptable range before patient results may be reported All Daily QC processed on the ECiQ is located on top of the Maintenance manual for the analyzer Follow SOP D QC Troubleshooting when QC limits exceed 2 or 3SD Testosterone reagent is calibrated with Testosterone Calibrator with each new lot, every 28 days, and when maintenance or troubleshooting warrants See SOP S ECiQ Calibrating 60 PROCEDURE Summary and Explanation of the Test: Testosterone is produced by the adrenals, the theca cells in the ovary and the leydig cells in the testes As much as 97% of circulating testosterone is bound to serum proteins such as sex hormone binding globulin (SHBG) In the male, testosterone stimulates the maturation of genitalia and secondary sexual characteristics and its measurement is used to investigate sexual dysfunction in juveniles and adults In females testosterone concentrations are much lower and an elevated concentration may indicate polycystic ovarian syndrome among other conditions Clinical symptoms of testosterone excess in females include infertility, amenorrhea, obesity and hirsutism Processing a Testosterone Specimen: Note: Samples are to be loaded in trays so that the barcode is facing out Ensure that Testosterone QC has been performed for that day and is within acceptable limits Examine samples for fibrin, clots and bubbles and remove before analysis Note any Hemolysis, Lipemia or Icterus as a specimen comment Remove the cap on the sample and load into a sample tray: 7 ml and 10 ml vaccutainer tubes can be loaded in the ECiQ sample trays with no adapter required in, Quality Management System It is prohibited to photocopy or write on SOPs

3 Number: S Page 3 of 6 45 ml vaccutainer tubes and plastic pour off tubes must be loaded on the ECiQ sample trays with the tab moved to the left so the sample sits on the tab Short sample specimens and micro samples must be placed in a sample cup on top of a sample adapter with the appropriate barcode label on the specimen and then loaded on the sample tray Place the tray on the ECiQ sample supply Select the Start button 70 REPORTING Assay range: nmol/l Reference range: Normal males (aged 20-49) nmol/l Normal males (aged >50) nmol/l Females with normal menstrual cycles nmol/l Look for specimen codes and review the results in Meditech when you get the printout from the ECiQ(Laboratory Analyzer Process SSECiQ Today s Date Number 1 T Hotkey Result Transmission) Do not dilute testosterone results >75 nmol/l Report as >75 nmol/l Compare the results to previous history by selecting Previous Results and if no repeat testing is required press F12 to file the results If repeat testing is required, place a \Z behind the assay to be repeated then press F12 and place the specimen back on the ECiQ Place the original printout on top of the ECiQ with a note as to what is being repeated When the recheck is done both results are entered in Meditech using the \R feature, a repeat claimed and the sheet can be removed from on top of the ECiQ 80 PROCEDURAL NOTES Testosterone is affected by lipemia and hemolysis 90 REFERENCES Ortho-Clinical Diagnostics Johnson & Johnson (2008) Testosterone Reagent Pack and Calibrator Instructions for Use Document Version 30 Retrieved Feb 10, 2011 from wwworthoclinicalcom in, Quality Management System It is prohibited to photocopy or write on SOPs

4 Number: S Page 4 of 6 Ortho-Clinical Diagnostics Johnson & Johnson (2008) Testosterone (TESTO) Controls Instructions for Use Document Version 21 Retrieved Feb 10, 2011 from wwworthoclinicalcom 100 IZATION SOUTH SHORE HEALTH LABORATORY SERVICES STANDARD OPERATING PROCEDURE SOP No : S Title: Testosterone Testing Effective Date: 01/07/2011 Revision Date: Version: DESIGNATION NAME DATE () SIGNATURE Author Senior Technologist Lab Supervisor Acting Lab Manager Claire Wentzell Richard Crouse Medical Director Dr Brigit Albiston in, Quality Management System It is prohibited to photocopy or write on SOPs

5 Number: S Page 5 of 6 REVIEW / REVISION LOG SOP Title: Testosterone Testing ORIGINAL DOCUMENT EFFECTIVE DATE () # S /07/2011 Review / Revision Description Effective Date Signature in, Quality Management System It is prohibited to photocopy or write on SOPs

6 Number: S Page 6 of 6 SOP Title: Testosterone Testing SOP REVIEW FORM FOR STAFF I, the undersigned, acknowledge that I have read, understand and will comply with the said Name Job Title Signature Date Reviewed Tammy Chen Lab Tech Jacqueline Swim Lab Tech Bonnie Misner Lab Tech Bonnie Kerwin Lab Tech Tai Wu Lab Tech Jennifer Gow Lab Tech Cindy Greenwell Lab Tech Leanne Nowe Lab Tech Susan Tanner Lab Tech Terry Nanowski Lab Tech Alisha Rykenhuizen Lab Tech Joanne D Entremont Lab Tech Wendy Crawford Lab Tech Eve Brown Lab Tech in, Quality Management System It is prohibited to photocopy or write on SOPs