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 +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
  
 +                      Free T3 Examination Procedure
 +**Purpose of examination:** 
 +Free T3  estimation from serum or plasma by CMIA technology Method.
  
-Purpose of examination:  +**Responsibility and Authority:**  
-● Free T3  estimation from serum or plasma by CMIA technology Method.+  * Calibration: Technician  
 +  * Quality Control: Technician  
 +  * Routine operation: Technician  
 +  * Overall Monitoring: Quality Manager
  
-Responsibility and Authority:  +**Sample Details:**  
-● Calibration: Technician  +  - Type of Sample: Serum,  Plasma 
-● Quality Control: Technician  +  - Type of container and additives: Plain without any additives  
-● Routine operation: Technician  +  - Patient Preparation: As per Primary Sample Collection Manual [[sample_collection_manual|]] 
-● Overall Monitoring: Quality Manager+  - Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours 
 +  - Handling and transport: As per Primary Sample collection manual  
 +  - Storage: 24 hours at 2-8° C
  
- Sample Details:  +**Required Equipment:**  
-● Type of Sample: Serum,  Plasma +Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer
-● Type of container and additives: Plain without any additives  +
-● Patient Preparation: As per Primary Sample Collection Manual {{Sample collection manual}} +
-● Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours +
-● Handling and transport: As per Primary Sample collection manual  +
-● Storage: 24 hours at 2-8° C+
  
-Required Equipment:  +**Required reagents:** 
-●Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer+  * Microparticles anti-T3 (sheep) coated Microparticles in MES buffer with sheep IgG stabilizers. 
 +  * Conjugate T3 acridinium-labeled Conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. 
 +  * Multi Assay manual dilution  
 +  * Pre trigger solution 1.32% (w/v) hydrogen peroxide. 
 +  * Trigger solution 0.35 N sodium hydroxide. 
 +  * Wash-buffer  phosphate buffered saline solution.
  
-Required reagents: +**Reagent Handling** 
-Microparticles anti-T3 (sheep) coated Microparticles in MES buffer with sheep IgG stabilizers. +  - Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to settle at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles 
-Conjugate T3 acridinium-labeled Conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. +  - Reagent Storage and stability 
-Multi Assay manual dilution  +  - Unopened reagent stable at 15-30°C until expiration date. 
-Pre trigger solution 1.32% (w/v) hydrogen peroxide. +  - On board System temperature reagent is stable for 28 days 
-Trigger solution 0.35 N sodium hydroxide. +  - Instability or deterioration should be suspected if there are precipitates, visible signs of leakage or 
-Wash-buffer  phosphate buffered saline solution.+  - contamination, turbidity, or if calibration or controls do not meet the appropriate criteria. 
 +  -  
 +**Calibration Procedure:** 
 +  * ARCHITECT Free T3 Calibrators 
 +  * Frequency: 
 +  - Reagent lot change 
 +  - QC out of range 
 +  - After service or maintenance 
 +  - Replacement in any parts of Instrument
  
-Reagent Handling +**Procedure:** 
- ● Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to settle at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles +  - Start the equipment.WDI abbotte fully.docx 
-Reagent Storage and stability +  - Calibrators are ready to use. 
-Unopened reagent stable at 15-30°C until expiration date. +  - Put calibrator 15-20 minutes at room temperature   
-On board System temperature reagent is stable for 28 days +  - Prior to use, mix the contents by inverting the vial. Do not shake the vial to prevent foam formation.  
-Instability or deterioration should be suspected if there are precipitates, visible signs of leakage or +  - Take a 150 µl calibrator solution in to separate aliquots. 
-contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.+  - Go to the calibration and give the calibration order. 
 +  - Verify calibration with at least two levels of controls 
 +  - If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.
  
-Calibration Procedure: +**Quality control Procedure:** 
-●ARCHITECT Free T3 Calibrators +  * Name: Bio Rad Level 1 ,2 & 3 
-● Frequency: +  * Frequency: As per Quality Control Procedure 
-Reagent lot change +  * Procedure for Reconstitution of IQC  
-QC out of range +  - Reconstitution of QC material with 5 ml Distilled water by using calibrated fixed volume pipette. 
-After service or maintenance +  - Leave to stand for 30 min in the dark place. 
-Replacement in any parts of Instrument +  - Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved. 
-Procedure: +  - Prior to use, mix the contents by inverting the vial. Do not shake the vial as the information of foam should be avoided. Ensure that no lyophilized material remains un-reconstituted. 
-Start the equipment.WDI abbotte fully.docx +  - Prepare aliquots of 150 µl from the reconstituted QC material. 
-Calibrators are ready to use. +  - Store these aliquots at -15° C to -20° C. 
-Put calibrator 15-20 minutes at room temperature   +  - Prior to use, make sure that aliquots should be at room temperature for at least 15 min.
-Prior to use, mix the contents by inverting the vial. Do not shake the vial to prevent foam formation.  +
-Take a 150 µl calibrator solution in to separate aliquots. +
-Go to the calibration and give the calibration order. +
-Verify calibration with at least two levels of controls +
-If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.+
  
-Quality control Procedure: +**Procedure to run IQC** 
-Name: Bio Rad Level 1 ,2 & 3 +  * Press Control order  
-Frequency: As per Quality Control Procedure +  * Select Assay /Panel, to be run. 
-●Procedure for Reconstitution of IQC  +  * Select the control/s and its level/s 
-Reconstitution of QC material with 5 ml Distilled water by using calibrated fixed volume pipette. +  * Give Carrier Number and Position number 
-Leave to stand for 30 min in the dark place. +  * Press F3 / Add order 
-Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved. +  * Put respected carrier in RSH rack 
-Prior to use, mix the contents by inverting the vial. Do not shake the vial as the information of foam should be avoided. Ensure that no lyophilized material remains un-reconstituted. +  * Check IQC results, in case outliers call residents.
-Prepare aliquots of 150 µl from the reconstituted QC material. +
-Store these aliquots at -15° C to -20° C. +
-Prior to use, make sure that aliquots should be at room temperature for at least 15 min. +
-●Procedure to run IQC +
-Press Control order  +
-Select Assay /Panel, to be run. +
-Select the control/s and its level/s +
-Give Carrier Number and Position number +
-Press F3 / Add order +
-Put respected carrier in RSH rack +
-Check IQC results, in case outliers call residents.+
  
-Principle of the procedure used for examinations: +**Principle of the procedure used for examinations:** 
-1. Sample and anti-T3 coated paramagnetic microparticles are combined. Free T3 (unbound) present in the sample binds to the anti-T3 coated microparticles. +  - Sample and anti-T3 coated paramagnetic microparticles are combined. Free T3 (unbound) present in the sample binds to the anti-T3 coated microparticles. 
-2. After washing, T3 acridinium-labeled conjugate is added. +  - After washing, T3 acridinium-labeled conjugate is added. 
-3. Pre-Trigger and Trigger Solutions are then added to the reaction  mixture. +  - Pre-Trigger and Trigger Solutions are then added to the reaction  mixture. 
-4. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is an inverse relationship between the amount of Free T3 in the sample and the RLUs detected by the ARCHITECT iSystem optics.+  - The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is an inverse relationship between the amount of Free T3 in the sample and the RLUs detected by the ARCHITECT iSystem optics.
  
- Sample Preparation: +**Sample Preparation:** 
- ● Required SampleVolume: 150 µl of the sample  +Required SampleVolume: 150 µl of the sample  
- ● Temperature: 37°  +Temperature: 37°  
-     Take 150-200µl of the sample from Primary tube to the secondary aliquot. Write the sample ID on the aliquot.  +Take 150-200µl of the sample from Primary tube to the secondary aliquot. Write the sample ID on the aliquot. 
-●Procedure to run Patient sample +       
-Press Patient order  +**Procedure to run Patient sample** 
-Select Assay /Panel, to be run. +  * Press Patient order  
-Give Carrier Number and Position number +  * Select Assay /Panel, to be run. 
-Press F3 / Add order +  * Give Carrier Number and Position number 
-Put respected carrier in RSH rack+  * Press F3 / Add order 
 +  * Put respected carrier in RSH rack
  
-Performance Characteristics:  +**Performance Characteristics:**  
-● Linearity:   3 to 3300 U/L +  * Linearity:   3 to 3300 U/L 
-● The limit of detection (LOD):1.07 pg/mL +  * The limit of detection (LOD):1.07 pg/mL 
-● The limit of quantification(LOQ): 1.25 pg/mL.* +  * The limit of quantification(LOQ): 1.25 pg/mL.* 
-● Unit: pg/mL.+  * Unit: pg/mL.
  
- Normal and critical ranges:+**Normal and critical ranges**:
  
-Child and adult +^Child and adult^2.10-4.40^pg/mL^
-2.10-4.40 +
-pg/mL+
  
- +**Laboratory Clinical interpretation**:
- +
- +
- Laboratory Clinical interpretation:+
 Free T3 is a secondary indicator of thyroid status. Although the majority of patients with hyperthyroidism will have free T3 values greater than the upper limit of the euthyroid range, some may have free T3 values which fall within the normal range.  Free T3 is a secondary indicator of thyroid status. Although the majority of patients with hyperthyroidism will have free T3 values greater than the upper limit of the euthyroid range, some may have free T3 values which fall within the normal range. 
  
- Interference and cross reaction:+**Interference and cross reaction**:
 Free t3 assay demonstrated <10% interference at the levels indicated below: Free t3 assay demonstrated <10% interference at the levels indicated below:
-Hemoglobin < 500 mg/dl +^Hemoglobin^ < 500 mg/dl^ 
-Bilirubin <  to 20 mg/dl +^Bilirubin^ <to 20 mg/dl^ 
-Triglyceride < 2000 mg/dl +^Triglyceride^ < 2000 mg/dl^ 
-Protein < 12 g/dl +^Protein^ < 12 g/dl^ 
-Potential source of variation: + 
 +**Potential source of variation:** 
 Turn around time (TAT): Turn around time (TAT):
 Routine: 6.0 hours Routine: 6.0 hours
 Urgent: 2.0 hours Urgent: 2.0 hours
  
- Recording of observation: +**Recording of observation:** 
-Software backup  +  * Software backup  
-Machine raw data +  * Machine raw data 
-Storage & Disposal of waste: Follow storage & discard procedure + 
-Environmental & Safety control:+**Storage & Disposal of waste:** Follow storage & discard procedure 
 + 
 +**Environmental & Safety control:**
 Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations. Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations.
  
-References: +**References:** 
-Tietz NW, Huang WY, Rauh DF, et al. Laboratory tests in the differential diagnosis of hyperamylasemia. Clin Chem 1986 32(2):301-307 +  - Tietz NW, Huang WY, Rauh DF, et al. Laboratory tests in the differential diagnosis of hyperamylasemia. Clin Chem 1986 32(2):301-307 
-6 Junge W. Troge B, Klein G, et al. Evaluation of a New Assay for Pancreatic Amylase: Performance Characteristics and Estimation of Reference Intervals Clin Biochem 1989,22 109-114 +  - 6 Junge W. Troge B, Klein G, et al. Evaluation of a New Assay for Pancreatic Amylase: Performance Characteristics and Estimation of Reference Intervals Clin Biochem 1989,22 109-114 
-Stuttgart/New York Georg Thieme Verlag 1991 354-361. 3 Salt WB II, Schenker S. Amylase its clinical significance: a review ofthe literature [Review] Medicine 1976,55 269-281. +  - Stuttgart/New York Georg Thieme Verlag 1991 354-361. 3 Salt WB II, Schenker S. Amylase its clinical significance: a review ofthe literature [Review] Medicine 1976,55 269-281. 
-4 Steinberg WM, Goldstein SS, Davies ND, et al. Diagnostic assays in acute pancreatitis [Review]. Ann Intern Med 1985,102.576-580 +  - 4 Steinberg WM, Goldstein SS, Davies ND, et al. Diagnostic assays in acute pancreatitis [Review]. Ann Intern Med 1985,102.576-580
  
 +^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH),Bhavnagar ^^^^
 +^Document No.1^**Document Name**: Free T3 Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^
 +^Issue No. : 01^Issue Date :30/04/2024^Page No.^^
 +^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^